Generic drug of claritin
Therapeutic class: Allergology
Active ingredients: Loratadine

what is HUMEX ALLERGY LORATADINE 10 mg tablet medication used for and indication?

HUMEX ALLERGY LORATADINE 10 mg tablet Dosage

Adults and children over 12 years:

• 10 mg once a day or one tablet once a day.

Children over 30 kg body weight:

• 10 mg once a day or one tablet once a day.
• The 10 mg tablet form is not suitable for children weighing less than 30 kg.
• The efficacy and safety of HUMEX ALLERGY LORATADINE have not been established in children less than 2 years of age.

Severe hepatic impairment

• In patients with severe hepatic impairment, the starting dose should be reduced due to the risk of reduced clearance of loratadine.
• An initial dose of 10 mg every other day is recommended for adults and children over 30 kg.

Elderly subjects or renal failure

• No dosage adjustment is necessary in elderly patients or patients with renal impairment.

Duration of the treatment

• The duration of treatment should not exceed 3 days without medical advice.

HUMEX ALLERGY LORATADINE 10 mg tablet Contraindications

How To Take HUMEX ALLERGY LORATADINE 10 mg tablet ?

• The tablet can be taken regardless of meals.

how does HUMEX ALLERGY LORATADINE 10 mg tablet work?

• After oral administration, loratadine is rapidly and well absorbed, and undergoes a significant hepatic first-pass effect, through essential metabolism by CYP3A4 and CYP2D6. The main metabolite – desloratadine – is pharmacologically active and largely responsible for the clinical effect. Maximum plasma concentrations of loratadine and desloratadine are reached (T _max ) between 1-1.5 hours and 1.5-3.7 hours, respectively, after administration.
• In controlled clinical studies, increased plasma concentrations of loratadine have been reported with concomitant administration of ketoconazole, erythromycin or cimetidine, but without significant clinical consequences (or changes in ECG tracings).
• The binding of loratadine to circulating proteins is intense (97% to 99%), while that of the metabolite is more moderate (73% to 76%).
• In healthy volunteers, the distribution half-lives of loratadine and its active metabolite are approximately 1 and 2 hours, respectively. The main elimination half-life in healthy volunteers was 8.4 hours (range 3 to 20 hours) for loratadine and 28 hours (range 8.8 to 92 hours) for the main active metabolite.
• Approximately 40% of the dose is excreted in the urine and 42% in the faeces over 10 days and mainly as conjugated metabolites. Approximately 27% of the dose is eliminated in the urine during the first 24 hours. Less than 1% of the active substance is excreted in the unchanged active form loratadine or desloratadine.
• The bioavailability of loratadine and its active metabolite is dose dependent.
• The pharmacokinetic profile of loratadine and its metabolites is comparable in healthy adult and elderly volunteers.
• Concomitant ingestion of food may cause a slight delay in the absorption of loratadine without consequence on the clinical effect.
• In patients with chronic renal failure, the AUC and peak plasma concentrations ( _Cmax ) of loratadine and its metabolite were greater than the AUC and peak plasma concentrations ( _Cmax ) observed in patients with normal kidney function. The mean elimination half-lives of loratadine and its metabolite were not significantly different from those observed in normal subjects. Hemodialysis has no effect on the pharmacokinetics of loratadine and its active metabolite in patients with chronic renal failure.
• In patients with chronic hepatic impairment of ethyl origin, the AUC and peak plasma concentrations (C _max ) of loratadine observed were doubled, while the pharmacokinetic profile of the active metabolite was not significantly altered compared to that of patients with normal liver function. The elimination half-lives of loratadine and its metabolite were 24 hours and 37 hours, respectively, and increased with increasing severity of hepatic injury.
• Loratadine and its active metabolite are excreted in human milk in lactating women.

How To Store HUMEX ALLERGY LORATADINE 10 mg tablet ?

Keep out of the reach and sight of children.

Expiration date

• Do not use HUMEX ALLERGY LORATADINE 10 mg, tablet after the expiry date stated on the box, bottle or blister. The expiration date refers to the last day of the month.

Storage conditions

No special storage conditions.

If necessary, warnings against certain visible signs of deterioration

• Do not use HUMEX ALLERGY LORATADINE 10 mg if you notice any change in the appearance of the tablets.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with any unused medicine. These measures will help protect the environment.

HUMEX ALLERGY LORATADINE 10 mg tablet Side Effects

• In clinical studies conducted in the pediatric population, in children aged 2 to 12 years, the common side effects reported with greater frequency than with placebo were: headache (2.7%), nervousness (2.3%) and fatigue (1%).
• In clinical studies conducted in adults and adolescents in the indications allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 10 mg, adverse reactions with loratadine were reported in 2% more patients than those treated with placebo. The most frequently reported adverse reactions with greater frequency than placebo were: somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1 %).

The other undesirable effects very rarely reported in the post-marketing experience are listed in the following table:

HUMEX ALLERGY LORATADINE 10 mg tablet Interactions

Interactions with other drugs

• Taking or using other medicines
• If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
• Laboratory test:
  • Tell your doctor that you are taking this medicine if he or she orders a skin test for the diagnosis of an allergy. In this case, the treatment must be stopped 48 hours before the test because this medicine can falsify the result.

Interactions with food and drink

Food and drinks

• HUMEX ALLERGY LORATADINE 10 mg, tablet can be taken with or without food.

Interactions with phytotherapy products or alternative therapies

• Not applicable.

Drive and use machines

At the therapeutic dose, HUMEX ALLERGY LORATADINE 10 mg, tablet does not generally make drowsy and does not reduce alertness. However, very rarely, drowsiness have been reported which may affect the ability to drive or use machines.

Warnings and Precautions

Take special care with HUMEX ALLERGY LORATADINE 10 mg, tablet:

• Tell your doctor if you have severe liver disease.
• The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
• Tell your doctor that you are taking this medicine if he or she orders a skin test for the diagnosis of an allergy. In this case, the treatment must be stopped 48 hours before the test because this medicine can falsify the result.
• IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

PREGNANCY & BREAST-FEEDING & FERTILITY

Pregnancy

• Animal studies have not revealed a teratogenic effect of loratadine. The safety of loratadine during pregnancy has not been established. Therefore, the use of HUMEX ALLERGY LORATADINE during pregnancy is not recommended.

Feeding with milk

• Loratadine is excreted in human milk. Therefore, administration of loratadine during breast-feeding is not recommended.

What happens if I overdose from HUMEX ALLERGY LORATADINE 10 mg tablet ?

• Loratadine overdose increases the occurrence of anticholinergic symptoms. Somnolence, tachycardia and headache have been reported in overdose.
• In the event of overdose, symptomatic treatment and maintenance of vital functions are recommended. Activated charcoal suspended in water can optionally be administered. Gastric lavage may be considered. Loratadine is not removed by hemodialysis and it is not known whether peritoneal dialysis is able to remove it. The patient should remain under medical supervision after emergency treatment.

What should I do if I miss a dose?

If you forget to take HUMEX ALLERGY LORATADINE 10 mg, tablet:

If you forget to take your dose on time, take it as soon as possible and then continue your treatment as normal. Do not take a double dose to make up for the dose you forgot to take.

What happens if you stop taking this tablet ?

• Not applicable.
• Not applicable.
• Not applicable.
• Not applicable.

What is  Forms and Composition ?

Pharmaceutical form and content

What is HUMEX ALLERGY LORATADINE 10 mg, tablet and contents of the pack?

• This medication is in the form of a tablet, white, round with a score line.
• Box of 5, 6 or 7 tablets in blister packs or bottle of 5 or 7 tablets.
• Not all presentations may be marketed.

Composition

* per unit dose

Active ingredients: Loratadine

The other ingredients are:

• Lactose monohydrate, microcrystalline cellulose, corn starch, magnesium stearate.

Excipients with known effects ? 

Lactose monohydrate

Other excipients: 

Microcrystalline cellulose, Corn starch, Magnesium stearate

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

Generic drug of the Therapeutic class: Allergology
active ingredients: Loratadine

Medicinal product subject to medical prescription

what is claritin used for and indication?

• CLARITIN 10 mg tablet is indicated for the relief of symptoms associated with allergic rhinitis (eg hay fever) such as sneezing, a runny or itchy nose, itchy or watery eyes.
• CLARITIN 10 mg tablets are also used to relieve symptoms associated with chronic idiopathic urticaria (itching, redness, and number and size of hives patches).

PRESENTATION (S) AVAILABLE FOR CLARITIN 10 MG

5 presentations are available for this drug:

• PVC-Aluminum blister pack (s) of 7 tablet (s)
• PVC-Aluminum blister pack (s) of 10 tablet (s)
• PVC-Aluminum blister pack (s) of 14 tablet (s)
• PVC-Aluminum blister pack (s) of 15 tablet (s)
• PVC-Aluminum blister pack (s) of 20 tablet (s)

claritin tablet Dosage

• Adults and adolescents (12 years and over): 1 tablet per day.
• Children from 2 to 12 years old and weighing more than 30 kg: 1 tablet per day.
• Subjects with severe hepatic impairment: the dose should be reduced. Adults and children weighing more than 30 kg: 1 tablet every 2 days.

CLARITIN 10 mg tablets are not suitable for the treatment of subjects weighing less than 30 kg.

The use of CLARITIN 10 mg tablets is not recommended in children under 2 years of age.

IN ALL CASES, STRICTLY COMPLY WITH YOUR DOCTOR’S ORDER.

If you have the impression that the effect of CLARITIN 10 mg tablet is too strong or too weak, talk to your doctor or pharmacist.

claritin tablet Contraindications

CLARITIN is contraindicated in cases of hypersensitivity to loratadine or to any of the excipients of the drug.

How To Take claritin tablet ?

Administration mode

• Oral route.
• Swallow the tablet with a glass of water.
• This medication can be taken regardless of meals (during or without meals).

how does claritin tablet work?

Pharmacotherapeutic group: ANTIHISTAMINICS FOR SYSTEMIC USE, ATC code: R06AX13.

• Loratadine, the active substance in CLARITIN, is a tricyclic antihistamine that acts selectively on peripheral H1 receptors.
• Loratadine does not have a significant sedative or anticholinergic effect in most of the population when used at the recommended dose.
• During long-term treatment, no clinically significant changes in vital functions, laboratory parameters, clinical examination or electrocardiographic tracings have been observed.

Loratadine has no significant action at the H2 receptors. It does not inhibit norepinephrine uptake and has virtually no influence on cardiovascular function or intrinsic pacemaker activity

How To Store claritin tablet ?

• Keep this medication out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP. The expiration date refers to the last day of that month.
• No special storage conditions.
• Do not use CLARITIN 10 mg if you notice any change in the appearance of the tablets.
• Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

claritin tablet Side Effects

In clinical studies conducted in the pediatric population, in children aged 2 to 12 years, the common side effects reported with greater frequency than with placebo were: headache (2.7%), nervousness (2.3%) and fatigue (1%).

In clinical studies conducted in adults and adolescents in the indications allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 10 mg, adverse reactions with loratadine were reported in 2% more patients than those treated with placebo. The most frequently reported adverse reactions with greater frequency than placebo were: somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1 %).

The other undesirable effects very rarely reported in the post-marketing experience are listed in the following table:

claritin tablet Interactions

• If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

INTERACTIONS OF CLARITIN 10 MG WITH FOOD AND DRINK

• CLARITIN 10 mg, tablet can be taken with or without food.

Effects on ability to Drive and use machines

At the therapeutic dose, CLARITIN 10 mg, tablet does not generally make drowsy and does not reduce alertness. However, very rarely, drowsiness have been reported which may affect the ability to drive or use machines.

Warnings and Precautions

• Tell your doctor if you have severe liver disease.
• The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).
• Tell your doctor that you are taking this medicine if he or she orders a skin test for the diagnosis of an allergy. In this case, the treatment must be stopped 48 hours before the test because this medicine can falsify the result.
• IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

PREGNANCY & BREAST-FEEDING & FERTILITY

Pregnancy

• Animal studies have not revealed a teratogenic effect of loratadine. The safety of loratadine during pregnancy has not been established. Therefore, the use of CLARITIN during pregnancy is not recommended.

Feeding with milk

• Loratadine is excreted in human milk. Therefore, administration of loratadine during breast-feeding is not recommended.

What happens if I overdose from claritin tablet ?

• Loratadine overdose increases the occurrence of anticholinergic symptoms. Somnolence, tachycardia and headache have been reported in overdose.
• In the event of overdose, symptomatic treatment and maintenance of vital functions are recommended. Activated charcoal suspended in water can optionally be administered. Gastric lavage may be considered. Loratadine is not removed by hemodialysis and it is not known whether peritoneal dialysis is able to remove it. The patient should remain under medical supervision after emergency treatment.

What should I do if I miss a dose?

• Do not take a double dose to make up for the dose you forgot to take.

What happens if you stop taking claritin tablet ?

• Not applicable.

• Not applicable.
• Not applicable.

If you have any further questions on the use of this medicine, ask your pharmacist for more information.

What is  Forms and Composition ?

Forms

Compressed.

• White to off-white, oval tablet with a ‘score line’ on one side and smooth on the other side.
• The score line on the tablet is only there to make it easier to take the tablet in order to facilitate swallowing, it does not divide it into two equal half-doses.

Blister pack consisting:

• of 20 µm aluminum foil covered with heat-fusing vinyl lacquer and 250 µm transparent PVC film or 250 µg transparent PVC film coated with polyvinylidene chloride (PVdC).
• Box of 15 tablets.

Other shapes

• CLARITIN 10 mg, effervescent tablet, box of 15
• CLARITIN 1 mg / ml, syrup, 60 ml vial (+ 5 ml measuring spoon)
• CLARITIN 1 mg / ml, syrup, 120 ml vial (+ 5 ml measuring spoon)

COMPOSITION

Active substance

• Loratadine: 10 mg
• For a tablet.

Other components

• Lactose monohydrate, corn starch, magnesium stearate.

COMPONENTS WITH KNOWN EFFECT OF CLARITIN 10 MG

• CLARITIN 10 mg, tablet contains lactose: if your doctor has informed you that you have an intolerance towards certain sugars, contact him before taking this medicine.

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

MERCALM, scored film-coated tablet >> Generic drug of the Therapeutic class: Allergology
active ingredients: Dimenhydrinate ,caffeine

what is Mercalm ?

This medication contains an antihistamine, dimenhydrinate and caffeine.

what is Mercalm medication used for and indication?

It is indicated for the prevention and treatment of motion sickness in adults and children over 6 years old.

PRESENTATION (S) AVAILABLE FOR MERCALM

2 presentations are available for this medication:

• 2 blister pack (s) PVC aluminum of 10 tablet (s)
• PVC aluminum blister pack (s) of 15 tablet (s)

Mercalm Dosage

RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS OLD.

Swallow the tablets with a little water ½ hour before departure. If the symptoms persist, renew the intake at an interval of more than 6 hours. Do not exceed 3 doses per day.

The usual dosage is:

• Adult and child over 15 years: 1 to 2 tablets per dose, without exceeding 6 tablets per day.
• Child from 6 to 15 years old: 1/2 to 1 tablet per dose, without exceeding 3 tablets per day.

Mercalm Contraindications

Never take MERCALM, scored film-coated tablet in the following cases:

• child under 6 due to the presence of caffeine,
• certain forms of glaucoma (increased pressure in the eye),
• difficulty urinating from prostate or other causes,
• known allergy to antihistamines.

This medication MUST NOT BE USED GENERALLY, unless your doctor advises otherwise, in case of breast-feeding and in case of treatment with enoxacin.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR YOUR PHARMACIST FOR THE ADVICE.

How To Take Mercalm ?

Administration mode

• Oral route.
• The pills must be swallowed with a glass of water.
• In children, in order to facilitate the intake, it is possible to crush the ½ or the tablet in a glass of sugar water.

how does Mercalm work?

ANTINAUPATHIC

(N: Central nervous system)

Dimenhydrinate : H1 antihistamine, with an ethanolamine structure, which is characterized by:

• A significant sedative effect at normal doses of histamine origin and central adrenergic blocking;
• Anticholinergic effect causing peripheral adverse effects, put to use in the prevention and treatment of motion sickness;
• An adrenergic blocking effect device, which can resound in hemodynamically (risk of orthostatic hypotension).

Antihistamines have in common the property of opposing, by more or less reversible competitive antagonism, the effects of histamine in particular on the skin, the bronchi, the intestine and the vessels.

How To Store Mercalm ?

• Keep this medication out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the package. The expiration date refers to the first day of that month.
• Do not use this medicine if you notice any visible signs of deterioration.
• Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

Mercalm Side Effects

Like all medicines, MERCALM, film-coated tablet can cause side effects, although not everybody gets them.

• Some side effects require IMMEDIATELY STOPPING TREATMENT AND TELL A DOCTOR.
  • Allergic reactions:
    • rash type (erythema, eczema, purpura, urticaria);
    • angioedema (hives with sudden swelling of the face and neck which can cause difficulty in breathing);
    • anaphylactic shock.

• Significant drop in white blood cells in the blood, which may be manifested by the onset or resurgence of a fever with or without signs of infection.
• Abnormal decrease in platelets in the blood which may result in bleeding from the nose or gums.
• Other side effects may occur, such as:

• Drowsiness, decreased vigilance.
• Impaired memory or concentration, dizziness (more frequent in the elderly), balance disturbances.
• Motor incoordination, tremors.
• Confusion, hallucinations.
• Dry mouth, visual disturbances, retention of urine, constipation, palpitations, drop in blood pressure.
• Possibility of excitement, insomnia and palpitations.
• Very rare cases of abnormal movements of the head and neck in children.

If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Mercalm Interactions

Not recommended associations

Alcohol

• Alcohol enhancement of the sedative effect of H1 antihistamines. Impaired vigilance can make driving and using machines dangerous.
• Avoid taking alcoholic beverages and drugs containing alcohol.

Enoxacin

• Significant increase in caffeine levels in the body which can lead to excitement and hallucinations (decrease in hepatic caffeine catabolism).

Associations to take into account

• · Related to the presence of dimenhydrinate.

Other central nervous system depressants: morphine derivatives (analgesics, cough suppressants and substitution treatments); benzodiazepines; barbiturates; anxiolytics other than benzodiazepines; hypnotics; neuroleptics; sedative antidepressants; central antihypertensive drugs; baclofen; thalidomide.

• Increase in central depression. Impaired vigilance can make driving and using machines dangerous.

Atropine and other atropine substances (imipramine antidepressants, antiparkinsonian anticholinergics, atropine antispasmodics, disopyramide, phenothiazine neuroleptics)

• Addition of atropine side effects such as urinary retention, constipation, dry mouth.
• · Linked to the presence of caffeine.

Ciprofloxacin, norfloxacin

• Significant increase in caffeine levels in the body (decrease in hepatic caffeine catabolism).
• Not applicable.

Effects on ability to Drive and use machines

• The drowsiness and decreased alertness associated with the use of this medication can be severe and make driving and using machines dangerous .
• This phenomenon is accentuated by the intake of alcoholic drinks or drugs containing alcohol, which should therefore be avoided .

Warnings and Precautions

Special warnings

This medicine contains caffeine (10 mg per tablet) which may cause excitement, insomnia and palpitations, especially in children ( ). Avoid association with certain foods also containing it (cola-based drink, coffee, tea, chocolate).

This medicine contains lactose. Its use is not recommended in patients with lactose intolerance (a rare hereditary disease).

Precautions for use

As a precaution, do not use this medication in cases of bronchial asthma.

In case of long-term disease of the liver or kidneys, CONSULT YOUR DOCTOR so that he can adjust the dosage.

The intake of this medication requires MEDICAL ADVICE in the elderly:

• predisposed to constipation, dizziness or drowsiness;
• with prostate problems.

TELL YOUR DOCTOR before taking this antihistamine.

Due to the possibility of caffeine-related insomnia, it is best to avoid taking this medication after 4 p.m.

IN CASE OF DOUBT, DO NOT HESITATE TO ASK FOR THE ADVICE OF YOUR DOCTOR OR YOUR PHARMACIST.

PREGNANCY & BREAST-FEEDING & FERTILITY

The action to be taken during pregnancy and lactation is due to the presence of dimenhydrinate.

Pregnancy

• Malformation aspect (Q1)
  •  In animals, experimental studies have not demonstrated a teratogenic effect of dimenhydrinate.
  • In humans, the risk of malformation from H1 antihistamines is unevenly assessed.
• Foetotoxic Aspect (2nd and 3rd quarters):
  • In newborns of mothers treated long-term with high doses of an anticholinergic antihistamine, digestive signs linked to atropine properties have rarely been described (abdominal distension, meconium ileus, delay in the release of meconium, difficulty in food route, tachycardias, neurological disorders …).
  • Consequently , the teratogenic risk, if any, appears to be low. It is necessary to carefully reassess the indication during pregnancy, and, if possible, to try to limit the duration of the prescription.
  • If the administration of this drug took place at the end of pregnancy, it seems justified to observe a period of monitoring of the neurological and digestive functions of the newborn.

Feeding with milk

• The use of this medicine is not recommended during lactation (dimenhydrinate passes into breast milk).

What happens if I overdose from Mercalm ?

Symptoms of Dimenhydrinate Overdose:

• Convulsions (especially in infants and children);
• Impaired consciousness, coma.

Symptomatic treatment in a specialized environment.

What should I do if I miss a dose?

If you forget to take MERCALM, scored film-coated tablet

• Not applicable
• Not applicable
• Not applicable
• Not applicable
• Not applicable

What happens if you stop taking Mercalm ?

If you stop taking MERCALM, scored film-coated tablet

• Not applicable
• Not applicable
• Not applicable
• Not applicable
• Not applicable

If you have any further questions about the use of this medicine, ask your doctor, pharmacist or nurse for more information.

What is  Forms and Composition ?

Appearance and shape

• Lack of information in the MA.
• Blister pack (PVC / Aluminum) of 15 tablets.

WHAT MERCALM, FILM-COATED TABLETS LOOK LIKE AND CONTENTS OF THE OUTER CARTON

• This medication is in the form of a scored film-coated tablet. Box of 15.

WHAT MERCALM CONTAINS, SCORED FILM-COATED TABLETS  

The active substances are:

• Dimenhydrinate ….. 50 mg
• Caffeine .. …… 10 mg

For a scored film-coated tablet

The other ingredients are:

• Lactose monohydrate, microcrystalline cellulose, modified corn starch, colloidal anhydrous silica, magnesium stearate.
• Coating: hypromellose 15 m Pa.s, lactose monohydrate, macrogol 4000, titanium dioxide (E171), macrogol 6000.

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

Toplexil Syrup Generic drug of the therapeutic class: Allergology
active ingredients: Oxomemazine

Important to know about Toplexil Syrup ?

what is toplexil Syrup used for and indication?

Toplexil Syrup Dosage

RESERVED FOR ADULTS AND CHILDREN OVER 2 YEARS.

toplexil dosage for adults

• 10 ml per dose, 4 times a day.

Pediatric population

toplexil dosage for children

the daily dosage depends on the weight of the child (1 ml of syrup per kg of body weight per day), which is indicative:

• Child from 13 to 20 kg (ie 2 to 6 years): 5 ml per dose, 2 to 3 times a day,
• Child from 20 to 30 kg (6 to 10 years): 10 ml per dose, 2 to 3 times a day,
• Child from 30 to 40 kg (10 to 12 years): 10 ml per dose, 3 to 4 times a day
• Child over 40 kg (12 years old): 10 ml per dose, 4 times a day.

The catches are to be renewed when necessary and spaced at least 4 hours apart.

Administration mode

Oral way.

•  Use the measuring cup.

Evening intake should be favored because of the sedative effect, especially at the beginning of treatment, of oxomemazine.

Contraindications

How it works Toplexil Syrup

Pharmacotherapeutic group: ANTIHISTAMINE FOR SYSTEMIC USE, ATC code: R06AD08 (R: Respiratory system).

Oxomemazine : antihistamine H1, phenothiazine with aliphatic side chain, which is characterized by:

• A marked sedative effect at the usual doses, of histaminergic and central adrenolytic origin,
•  An anticholinergic effect causing peripheral adverse effects,
• A peripheral adrenolytic effect, which may have a hemodynamic effect (risk of orthostatic hypotension).

Antihistamines have in common the property of opposing, by more or less reversible competitive antagonism, the effects of histamine especially on the skin, the bronchi, the intestine, and the vessels.

Toplexil Syrup Side Effects

The pharmacological characteristics of the oxomemazine molecule cause undesirable effects of unequal intensity and linked or not to dose (see section Pharmacodynamic properties ):

· Neurovegetative effects:

•  sedation or drowsiness, more marked at the beginning of treatment;
•  anticholinergic effects such as dryness of the mucous membranes, constipation, accommodation disorders, mydriasis, heart palpitations, risk of urinary retention;
• orthostatic hypotension;
• balance disorders, dizziness, memory loss or concentration (more common in the elderly);
• motor incoordination, tremors;
• mental confusion, hallucinations;
• more rarely, effects like excitation: agitation, nervousness, insomnia.

· Awareness Reactions:

• erythema, eczema, pruritus, purpura, possibly giant urticaria,
• edema, more rarely angioedema,
• anaphylactic shock,
• photosensitization;

· Hematological disorders:

• leukopenia, neutropenia, exceptional agranulocytosis ;
• thrombocytopenia,
• Hemolytic anemia.

Due to the presence of glycerol, risk of digestive disorders and diarrhea.

Toplexil Syrup Interactions

Drugs lowering the epileptogenic threshold :

The joint use of proconvulsant drugs, or lowering the epileptogenic threshold, should be carefully weighed, because of the severity of the risk involved. These drugs are represented by most antidepressants (imipramines, selective serotonin reuptake inhibitors), neuroleptics (phenothiazines and butyrophenones), mefloquine, chloroquine, bupropion, tramadol.

Atropine drugs :

1. It must be taken into account that atropine substances can add their adverse effects and more easily result in urinary retention, acute glaucoma, constipation, dryness of the mouth, etc.
2. The various atropine drugs are represented by imipramine antidepressants, most atropine H1 antihistamines, antiparkinsonian anticholinergics, atropine antispasmodics, disopyramide, phenothiazine neuroleptics and clozapine.

Sedative drugs :

• It must be taken into account that many drugs or substances can add their depressant effects of the central nervous system and help reduce alertness.
• These are morphine derivatives (analgesics, antitussives and substitution treatments), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (eg meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin , mianserine, mirtazapine, trimipramine), sedative H1 antihistamines, central antihypertensives, baclofen and thalidomide.

Associations contraindicated :

• · Dopaminergics, excluding Parkinson’s (cabergoline, quinagolide): Reciprocal antagonism of the dopaminergic agonist and neuroleptics.

Associations advised against :

• ·Other sedative drugs  : Potentiation of the sedative effect of H1 antihistamines.
• ·Alcohol consumption  : Alcohol enhancement of the sedative effect of these substances. Impairment of alertness can make driving and using machines dangerous. Avoid taking alcoholic drinks and drugs containing alcohol.

Associations subject to precautions for use :

• ·Gastrointestinal topicals, antacids and anthrax  : Decreased digestive absorption of phenothiazine neuroleptics. Take gastrointestinal topicals and antacids away from phenothiazinic neuroleptics (more than 2 hours, if possible).

Associations to consider :

• ·Antihypertensive drugs  : Increase the risk of hypotension, including orthostatic.
• ·Beta-blockers (except esmolol and sotalol)  : Vasodilator effect and risk of hypotension, especially orthostatic (additive effect).
• ·Beta-blockers in heart failure (bisoprolol, carved idol, metoprolol, nebivolol ): Vasodilator effect and risk of hypotension, particularly orthostatic (additive effect).
• ·Nitrate and related derivatives  : Increased risk of hypotension, especially orthostatic.

Toplexil Syrup Warnings and Precautions

Special warnings :

• The productive coughs, which are a fundamental element of bronchopulmonary defense, must be respected.
• It is illogical to associate an expectorant or mucolytic with this antitussive drug.
• Before prescribing antitussive therapy, cough causes that require specific treatment should be investigated.
• If the cough is resistant to an antitussive given at a usual dosage, the doses should not be increased, but the clinical situation should be reconsidered.

Precautions for use:

RELATED TO THE PRESENCE DOXOMEMAZINE:

• Since phenothiazines have been considered as hypothetical risk factors in the occurrence of sudden infant death, loxomemazine should not be used in children under 2 years of age.
• Surveillance (clinical and possibly electrical) should be reinforced in epileptics because of the possibility of lowering the epileptogenic threshold.

Loxomemazine should be used with caution:

· In the elderly subject with:

• greater sensitivity to orthostatic hypotension, vertigo and sedation,
• chronic constipation (paralytic diluted risk),
• a possible prostatic hypertrophy.

· In subjects with certain cardiovascular diseases, because of the tachycardic and hypertensive effects of phenothiazines.

· In case of severe hepatic and / or renal insufficiency (due to the risk of accumulation).

If used in children, bronchial asthma or gastroesophageal reflux should be eliminated before using loxomemazine as a cough suppressant.

Taking alcoholic beverages or alcohol-containing medicines (see section 4.5) is strongly discouraged during the course of treatment.

Given the photosensitizing effect of phenothiazines, it is best not to expose to the sun during treatment.

H1 antihistamines should be used with caution because of the risk of sedation. Association with other sedating medicinal products should be discouraged (see section 4.5).

This medicine contains sucrose. It is not recommended for use in patients with fructose intolerance, glucose-galactose malabsorption or sucrase / isomaltase deficiency.

This medicine contains 3.7 g of sucrose per 5 ml dose and 7.3 g per 10 ml dose, which should be taken into account in the daily ration in case of low sugar diet or diabetes.

This medicine contains sodium. This medicine contains 8.25 mg of sodium per 5 ml of syrup and 16.50 mg of sodium per 10 ml of syrup: to be taken into account in people on a strict sodium diet.

Drive and use machines

1. Attention is drawn to the risks of drowsiness associated with the use of this drug, especially in the case of vehicle drivers and machine users , especially at the beginning of treatment.
2. This phenomenon is accentuated by the intake of alcoholic beverages or drugs containing alcohol.

Toplexil Syrup and Pregnancy / Breastfeeding

The presence of oxomemazine determines the course of action during pregnancy and lactation.

toplexil for pregnant

Malformative aspect

• There is no reliable data on teratogenesis in animals.
• There are currently no data of sufficient relevance to evaluate the possible malformative or foetotoxic effect of oxomemazine when administered during pregnancy.

Fetotoxic appearance

• In neonates of long-term mothers treated with high doses of anticholinergic drugs have been rarely described digestive signs related to atropine properties (abdominal distention, meconium ileus, delay in emission of meconium, difficulty of getting started). of food, tachycardias, neurological disorders …).
• Given these data, the use of this drug is not recommended during the first trimester of pregnancy. It should only be prescribed if necessary thereafter, limiting the 3 ^rd quarter, a one-time use.
• If the administration of this drug took place at the end of pregnancy, it seems justified to observe a period of surveillance of the neurological and digestive functions of the newborn.

Breastfeeding

The passage of oxomemazine in breast milk is not known. Given the possibilities of sedation or paradoxical excitement of the newborn, and even more risks of sleep apnea evoked with phenothiazines, this drug is not recommended when breastfeeding.

What should I do if I miss a dose?

What happens if I overdose from Toplexil Syrup ?

What is  Forms and Composition ?

1. 0.33 mg / ml syrup:   150 ml bottle, with measuring cup graduated to 5 ml and 10 ml. 0.33 mg / ml sugar-free
2. oral solution, sweetened with acesulfame potassium:   150 ml vial, with measuring cup graduated to 5 ml and 10 ml.

• Excipients: sodium benzoate, glycerol, citric acid monohydrate, sodium citrate, caramel compound flavor (caramel, fenugreek resin, methylcyclopentenolone hydrate, maltol, butyric acid, piperonal, diacetyl, ethyl vanillin, vanillin, propylene glycol, distilled water), caramel ( E150), sucrose solution, purified water.
• Excipients with known effect: sucrose (3.7 g / 5 ml, 7.3 g / 10 ml), sodium (8.25 mg / 5 ml, 16.5 mg / 10 ml), glycerol.

• Excipients: sodium benzoate, glycerol, citric acid monohydrate, sodium citrate, caramel compound flavor (mainly heliotropine [piperonal], vanilla, propylene glycol, alcohol, maltol, water), liquid maltitol, acesulfame potassium, purified water.
• Excipients with known effect: maltitol, sodium (8.26 mg / 5 ml, 16.53 mg / 10 ml), glycerol.

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

aerius Generic drug of the therapeutic class: Allergology
active ingredients: Desloratadine

what is aerius used for and indication?

Aerius is indicated in adults and adolescents 12 years of age and older for the symptomatic treatment of:

1. allergic rhinitis (see section on Pharmacodynamic properties )
2. urticaria (see section on Pharmacodynamic properties )

aerius 5mg dosage

aerius 5mg dosage for adults

• Adults and adolescents (12 years and older): one tablet once daily, at or outside of meals for the relief of symptoms associated with allergic rhinitis (including intermittent and persistent allergic rhinitis) and urticaria ( see section on pharmacodynamic properties).
  • In adolescents aged 12 to 17, the experience of using desloratadine in clinical efficacy studies is limited (see sections on adverse effects and pharmacodynamic properties).
  • Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or less than 4 weeks) should be managed based on the patient’s history of to be interrupted after the disappearance of symptoms, and restored to their reappearance.
• In persistent allergic rhinitis (presence of symptoms over a period of 4 days or more per week and for more than 4 weeks), continuous treatment may be offered to patients during periods of allergen exposure.

Contraindications

CONTRA-INDICATED:

• Hypersensitivity to the active substance, to any of the excipients, or to loratadine.
• The efficacy and safety of Aerius orodispersible tablets have not been established in children under 12 years of age.
• This product contains 2.9 mg of phenylalanine per 5 mg orodispersible tablet of Aerius. Phenylalanine can have harmful consequences in people with phenylketonuria.

ADVISED AGAINST:

• Pregnancy: desloratadine has not shown a teratogenic effect in studies carried out in animals. The safety of the product during pregnancy has not been established. Therefore, the use of Aerius during pregnancy is not recommended.
• Breast-feeding: Desloratadine is excreted in breast milk, therefore the use of Aerius is not recommended in women who are breast-feeding.

how does aerius work

Pharmacotherapeutic group: antihistamines anti-H ₁ , ATC code: R06A X27

Action mechanism

1. Desloratadine is a non-sedating, long-acting antihistamine that exerts a selective antagonist effect on peripheral Hi receptors. After oral administration, desloratadine selectively blocks peripheral histamine H ₁receptors as it does not diffuse into the central nervous system.
2. The antiallergic properties of desloratadine have been demonstrated from in vitro studies . Inhibition of the release of pro-inflammatory cytokines such as: IL-4, IL-6, IL-8, and IL-13 by human mast cells / basophils has been demonstrated, as well as inhibition of expression of the P-selectin adhesion molecule on endothelial cells. The clinical relevance of these observations remains to be confirmed.

Clinical efficacy and safety data

1. In a repeat dose clinical trial in which up to 20 mg daily of desloratadine was administered for 14 days, no statistically or clinically significant cardiovascular effects were observed. In a clinical pharmacology trial, in which desloratadine was administered at a dose of 45 mg daily (nine times the therapeutic dose) for ten days, no QT prolongation was observed.
2. Repeated dose interaction studies with ketoconazole and erythromycin did not show clinically significant changes in desloratadine plasma concentrations.
3. Desloratadine does not diffuse easily in the central nervous system. In controlled clinical studies, at the recommended dose of 5 mg daily, there was no increase in the incidence of drowsiness compared with placebo. Aerius administered once a day at a single dose of 7.5 mg did not impair psychomotor performance in clinical trials. In a single dose study in adults, desloratadine 5 mg did not change the standard measurement parameters of flight performance, including subjective sleep exacerbation or piloting activities. a plane.
4. In clinical pharmacology trials concomitant administration with alcohol did not increase drowsiness or impaired alcohol-induced performance. No significant difference was found between desloratadine and placebo groups in psychomotility tests, whether administered alone or in combination with alcohol.
5. In patients with allergic rhinitis, Aerius relieved symptoms such as sneezing, runny nose, and pruritus, but also eye pruritus, tearing and redness, and pruritus of the palate. Aerius correctly controlled the symptoms throughout the nycthemeron.

Pediatric population

1. The effectiveness of Aerius tablets has not been clearly demonstrated in studies in adolescent patients aged 12 to 17 years.
2. In addition to the established classifications of seasonal and perennial allergic rhinitis, allergic rhinitis may also be classified as intermittent allergic rhinitis and persistent allergic rhinitis depending on the duration of the symptoms. Intermittent allergic rhinitis is defined as the presence of symptoms over a period of less than 4 days per week or over a period of less than 4 weeks. Persistent allergic rhinitis is defined as the presence of symptoms over a period of 4 days or more per week and for more than 4 weeks. 
3. Aerius decreased the disabling character of seasonal allergic rhinitis, as shown by the total score of the rhino-conjunctivitis quality of life questionnaire. The most significant improvement was observed in the area of ​​practical problems and daily activities limited by symptoms. 
4. Chronic idiopathic urticaria has been studied as a clinical model of urticarial manifestations, since the underlying pathophysiology is similar, regardless of etiology, and because chronic patients can be more easily recruited prospectively. As histamine release is a factor responsible for all urticarial pathologies, desloratadine is expected to be effective in relieving the symptoms of other urticarial manifestations, in addition to chronic idiopathic urticaria, as recommended in the literature. clinical guidelines.
5. In two placebo-controlled six-week trials in patients with chronic idiopathic urticaria, Aerius was effective in relieving pruritus and decreasing the number and size of urticaria by the end of the first dose. In each trial, the effects were maintained throughout the nycthemeron. As in other trials of antihistamines in chronic idiopathic urticaria, the few patients identified as non-responders to antihistamines have been excluded. A decrease in pruritus of more than 50% was observed in 55% of patients treated with desloratadine compared to 19% of patients treated with placebo. Aerius treatment also significantly reduced sleep interference and daily activity,

What are the side effects of Aerius?

In clinical trials conducted in allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, adverse events were reported in 3% more patients than those treated with placebo.

The most commonly reported adverse events with an incidence greater than placebo were: asthenia (1.2%), dry mouth (0.8%) and headache (0.6%). In a clinical study in 578 adolescent patients aged 12 to 17, the most common adverse event was headache; it occurred in 5.9% of patients treated with desloratadine and in 6.9% of patients receiving placebo.

Other adverse effects that have been very rarely reported since marketing are listed in the following table:

1. -Psychiatric disorders : Hallucinations.
2. – Nervous system disorders : Dizziness, drowsiness, insomnia, psychomotor hyperactivity, convulsions.
3. – Cardiac disorders : Tachycardia, palpitations.
4. – Gastrointestinal disorders : Abdominal pain, nausea, vomiting, dyspepsia, diarrhea.
5. – Hepatobiliary disorders : Elevations of liver enzymes, increased bilirubin, hepatitis.
6. – Musculoskeletal and systemic disorders : Myalgia.
7. – General disorders : Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnea, pruritus, rash, and urticaria).

AERIUS Interactions

In clinical trials with desloratadine tablets in which patients received erythromycin or ketoconazole in combination, no clinically significant interactions were observed.

Pediatric population

• Interaction studies have only been performed in adults.
• In a clinical pharmacology trial, there was no evidence of potentiation of the deleterious effects of alcohol on performance tests when used with Aerius tablets (see section 5.1 ). However, cases of intolerance and alcohol intoxication have been reported since marketing. Therefore, caution is advised in case of concomitant intake of alcohol.

AERIUS Warnings and Precautions

Aerius should be used with caution in patients with severe renal impairment (see section 5.2 Pharmacokinetic properties ).

Patients with rare hereditary conditions such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Drive and use machines

In view of the available clinical studies, Aerius has only a negligible or no effect on the ability to drive and use machines. Patients should be informed that, although most people do not feel drowsy, there is interindividual variability.

As a result, patients should be informed of the need to test their response to this medication before any activity requiring vigilance, such as driving vehicles or operating machinery.

AERIUS and PREGNANCY / BREAST FEEDING / FERTILITY

aerius during pregnancy

1. On a large number of pregnancies (more than 1000 pregnancies), no malformative or toxic effects of desloratadine have been demonstrated for the fetus or the newborn.
2. Studies in animals have not shown any direct or indirect harmful effects on reproduction ( see Preclinical safety ). As a precaution, it is best to avoid using Aerius during pregnancy.

aerius during Breastfeeding

1. Desloratadine has been identified in neonates / infants breastfed by a treated woman.
2. The effect of desloratadine on newborns / infants is unknown.
3.  A decision must be made either to discontinue breastfeeding or to discontinue / abstain from treatment with Aerius taking into account the benefit of breastfeeding for the child with regard to the benefit of treatment for the woman.

aerius during Fertility

• No data are available to document effects on human fertility.

aerius tablets overdose

The post-marketing adverse event profile of an overdose is similar to that observed at therapeutic doses, however, these effects may be greater.

Treatment

1. In case of overdose, elimination by usual methods of the unabsorbed active substance should be considered. Symptomatic treatment and appropriate therapeutic measures are recommended.
2. Desloratadine is not removed by hemodialysis; it is not known if it is eliminated by peritoneal dialysis. 

sYMPTOMS

1. In a repeat dose clinical trial, no clinically significant effect was observed when desloratadine was administered at a dose of up to 45 mg (nine times the therapeutic dose).

Pediatric population

1. The post-marketing adverse event profile of an overdose is similar to that observed at therapeutic doses, however, these effects may be greater.

What is  Forms and Composition?

• 5 mg film-coated tablet (light blue):   Boxes of 15 and 30, in blister packs.
• Oral solution 0.5 mg / ml:  150 ml bottle (with child safety cap) + graduated syringe (2.5 ml and 5 ml).

• Excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, corn starch, talc.
• Film coating : coating film (containing lactose monohydrate, hypromellose, titanium dioxide, macrogol 400, indigotin E 132), clear coating (containing hypromellose, macrogol 400), wax carnauba, white wax.
• Excipient with known effect: lactose.

• Excipients: sorbitol, propylene glycol, sucralose E 955, hypromellose 2910, sodium citrate dihydrate, natural and artificial flavor (bubble gum), citric acid anhydrous, edetate disodium, purified water.
• Excipient with known effect: sorbitol (150 mg / ml).

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

Xyzal 5 mg drug reviews Generic drug of the therapeutic class: Allergology
active ingredients: Levocetirizine

what is xyzal ?

• XYZAL 5 mg film-coated tablets are indicated for the treatment of the symptoms of allergic rhinitis (including persistent allergic rhinitis).
• XYZAL  film-coated tablets are also indicated for the treatment of urticaria symptoms such as itching and redness.

what is xyzal used for & indication ?

Xyzal, 5 mg film-coated tablets is indicated for the symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and urticaria in adults and children 6 years of age and older.

Xyzal Dosage

Oral way.

The tablets will be swallowed with a drink and can be taken during or after meals. It is advisable to take the daily dose in one take.

Adults and children over 12 years old:

• 5 mg per day, ie 1 film-coated tablet.

Elderly:

• A dose adjustment is recommended in elderly patients with moderate to severe renal impairment (see “renal impairment” below).

Children from 6 to 12 years old:

• xyzal 5 mg per day, ie 1 film-coated tablet.
• The film-coated form does not allow dosage adjustment for children aged 2 to 6 years. It is recommended to use a pediatric form of levocetirizine.

Renal insufficiency:

• The interval between doses should be adjusted according to renal function as shown in the table below.

To use this table, it is necessary to calculate the creatinine clearance (CL _cr ) of the patient in ml / min. The LC _cr (ml / min) can be estimated from the value of serum creatinine (in mg / dl) according to the following formula:

[140 – age (years)] x weight (kg)

CL _cr = ———————————————– x ( 0.85 for women )

72 x serum creatinine (mg / dl)

Dosage adjustment in patients with renal impairment:

In children with renal impairment, the dose will be adjusted individually based on the patient’s renal clearance and weight. There are no specific data in children with kidney failure.

Hepatic insufficiency

• No dose adjustment is necessary in patients with isolated hepatic impairment.

Duration of the treatment

• Intermittent allergic rhinitis, defined by the presence of symptoms less than 4 days per week or over a period of less than 4 weeks, will be treated according to the pathology and its history. The treatment can be stopped once the symptoms have disappeared and resumed at the reappearance of symptoms. In case of persistent allergic rhinitis (defined by the occurrence of symptoms more than 4 times per week and over a period of more than 4 weeks), continuous treatment may be offered to the patient during the period of allergen exposure.
• Clinical experience is 6 months of treatment with 1 tablet 5 mg levocetirizine daily.
• With cetirizine (a racemic form), there is clinical experience of up to one year of treatment for chronic urticaria and chronic allergic rhinitis.

Contraindications

how xyzal works ?

Pharmacotherapeutic group: Antihistamines for systemic use, piperazine derivatives, ATC code: R06AE09 .

Action mechanism

• Levocetirizine, the R-enantiomer of cetirizine, is a potent and selective antagonist of peripheral H ₁ receptors .
• Receptor binding studies revealed that levocetirizine has a high affinity for human H ₁ receptors (Ki = 3.2 nmol / l). Levocetirizine has a 2-fold higher affinity than cetirizine (Ki = 6.3 nmol / l). The dissociation half-life of levocetirizine from H ₁ receptors is 115 ± 38 min.
• The receptor occupancy after single administration of levocetirizine has been shown to be 90% after 4 hours and 57% after 24 hours.
• Pharmacodynamic studies in healthy volunteers showed comparable activity between cetirizine and levocetirizine at half-dose, both in the skin and nose.

Pharmacodynamic effects

• The pharmacodynamic properties of levocetirizine have been studied in randomized controlled trials.
• A study compared the effects of levocetirizine 5 mg, 5 mg of desloratadine and a placebo on the reaction erythematous papular induced histamine. Treatment with levocetirizine significantly reduced the formation of papules and erythema with maximum intensity in the first 12 hours and maintained for 24 h ( p  <0.001) compared to placebo and desloratadine.
• In a controlled study against placebo in pollen exposure room, the onset time of symptoms was 1 hour after administration of 5 mg of levocetirizine.
• In vitro studies (Boyden’s chamber and cell culture technique) show that levocetirizine inhibits eotaxin-induced transendothelial migration of eosinophils through dermal and bronchial cells. In an in vivo experimental placebo- controlled pharmacodynamic study in 14 adult patients (dermal chamber technique), three main inhibitory effects of levocetirizine 5 mg were detected in the first 6 hours of the exposure-induced reaction. pollen: inhibition of VCAM-1 release, modulation of vascular permeability and decrease in recruitment to eosinophils.

Efficacy and clinical safety

• The efficacy and safety of levocetirizine has been demonstrated in several clinical studies double-blind, controlled versus placebo in adult patients with seasonal allergic rhinitis, perennial or persistent. Levocetirizine significantly improved the symptoms of allergic rhinitis, including nasal obstruction in some studies.
• A 6-month clinical study in 551 adult patients (276 patients treated with levocetirizine) with persistent allergic rhinitis (symptoms present 4 days a week for at least 4 consecutive weeks) and sensitized to dust mites and grass pollen showed that Levocetirizine 5 mg was significantly more clinically and statistically effective than placebo in improving the overall symptom score for allergic rhinitis throughout the study, without tachyphylaxis. Throughout the study, levocetirizine significantly improved the quality of life of patients.
• In a placebo-controlled clinical study in 166 patients with chronic idiopathic urticaria, 85 patients were treated with placebo and 81 patients received levocetirizine 5 mg once daily for 6 weeks. Levocetirizine treatment significantly reduced the severity of pruritus during the first week and throughout the course of treatment compared with placebo. Levocetirizine also improved the quality of life related health outcomes assessed using the Dermatology Life Quality Index compared to placebo.
• Chronic idiopathic urticaria has been studied as a model for urticarial manifestations. Since histamine release is the factor responsible for urticarial manifestations, the efficacy of levocetirizine in the symptomatic treatment of chronic idiopathic urticaria can be extrapolated to other forms of urticaria.
• ECGs did not show any relevant effects of levocetirizine on the QT interval.

Pediatric population

• The efficacy and safety of pediatric levocetirizine tablets in pediatric patients was studied in two placebo-controlled clinical studies in children aged 6 to 12 years with seasonal or perennial allergic rhinitis. In both studies, levocetirizine treatment significantly improved symptoms and quality of life related to health status.
• In children under 6, clinical safety has been established on the basis of several short or long-term therapeutic studies:
  • A clinical trial in which 29 children aged 2-6 years with allergic rhinitis were treated with levocetirizine 1.25 mg twice daily for 4 weeks;
  • A clinical trial in which 114 children aged 1-5 years with allergic rhinitis or chronic idiopathic urticaria were treated with levocetirizine 1.25 mg twice daily for 2 weeks;
  • A clinical trial in which 45 children aged 6 to 11 months with allergic rhinitis or chronic idiopathic urticaria were treated with levocetirizine 1.25 mg once daily for 2 weeks;
  • A long-term (18-month) clinical trial of 255 atopic patients treated with levocetirizine, 12-24 months of age at baseline.
• The safety profile was similar to that observed in short-term studies in children aged 1 to 5 years.

What are the side effects of Xyzal?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Frequent (may affect up to 1 in 10 people)

• Dry mouth, headache, tiredness and drowsiness / falling asleep

Uncommon (may affect up to 1 in 100 people)

• Exhaustion and stomachaches

Not known (frequency of occurrence can not be estimated from the available data)

• Palpitations, increased heart rate, convulsions, tingling and tingling, dizziness, syncope, tremors, dysgeusia (taste alteration), vertigo (feeling of rotation or movement), visual disturbances, blurred vision, pain or difficulty in passing urine, inability to completely empty the bladder, swelling, pruritus (itching), redness, hives (swelling, redness and itching of the skin), rash, shortness of breath, weight gain, muscle pain, joint pain, aggressive or restless behavior , hallucinations, depression, insomnia, recurrent ideas or suicidal concerns, hepatitis, abnormal liver function, vomiting, increased appetite, nausea and diarrhea. Pruritus (intense itching) after stopping treatment.

At the first sign of an allergic reaction, stop taking XYZAL and contact your doctor. Allergic symptoms may include swelling of the mouth, tongue, face and / or throat, difficulty breathing or swallowing (chest tightness or wheezing), hives, sudden drop in blood pressure which may lead to collapse or a potentially fatal shock.

Xyzal medication interactions

• No interaction studies were performed with levocetirizine (in particular, no study with CYP3A4 inducers); studies with cetirizine (racemic form) revealed no clinically relevant interactions (with antipyrine, azithromycin, cimetidine, diazepam, erythromycin, glipizide, ketoconazole and pseudoephedrine). A slight decrease in the clearance of cetirizine (16%) was observed with theophylline taken repeatedly (400 mg once daily), whereas the bioavailability of theophylline was not affected by concomitant administration of theophylline. cetirizine.
• In a multiple-dose study of ritonavir (600 mg twice daily) and cetirizine (10 mg daily), the extent of cetirizine exposure increased by approximately 40%, while the bioavailability of cetirizine increased by approximately 40%. ritonavir was slightly impaired (-11%) following concomitant administration of cetirizine.
• The absorption rate of levocetirizine is not decreased by diet, although its rate of absorption is reduced.
• Concomitant use of alcohol or other central nervous system (CNS) depressants with cetirizine or levocetirizine may result in increased impairment of alertness or performance in sensitive patients.

Warnings and Precautions

Special warnings

• XYZAL 5 mg , film-coated tablet is not suitable for children under 6 years of age, the tablet form does not allow the adaptation of the dose.

Drive and use machines

• Comparative clinical studies with levocetirizine at the recommended dosage have not revealed any impairment of alertness, reaction time or ability to drive.
• However, some patients may experience somnolence, fatigue, and asthenia during levocetirizine therapy. Therefore, patients who intend to drive a vehicle, engage in potentially hazardous activities, or use machines should consider their response to the medication.

Xyzal and PREGNANCY / BREAST FEEDING / FERTILITY:

xyzal tablet during pregnancy

• No or very little data is available on the use of levocetirizine during pregnancy (less than 300 cases of pregnancy). However, for cetirizine (racemic form of levocetirizine), the available data are numerous (more than 1000 cases of pregnancy) and have not shown evidence of malformative effect or fœto-neonatal toxicity.
• Animal studies have not revealed direct or indirect harmful effects on pregnancy, embryonic and fetal development, parturition and postnatal development ( see Preclinical Safety ).
• The use of levocetirizine may be considered during pregnancy, if necessary.

xyzal tablet during Breastfeeding

• Cetirizine (the racemic form of levocetirizine) has been shown to be excreted in breast milk. Therefore, it is likely that levocetirizine is also. Adverse effects associated with levocetirizine are likely to occur in breastfed infants. Therefore, caution is advised when prescribing levocetirizine in breastfeeding women.

xyzal tablet during Fertility

• No clinical data is available for levocetirizine.

What should I do if I miss a dose?

Do not take a double dose to make up for the dose you forgot to take.

xyzal overdose side effects ?

Overdosage can lead to drowsiness and drowsiness in the adult and to drowsiness and drowsiness.

Contact your doctor if you have taken more tablets than needed.

What is  Forms and Composition ?

• xyzal 5 mg film-coated tablet (white to off-white, oval, engraved “Y” on one side):  Boxes of 14 and 28, in blister packs.

• Excipients: Core: microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica, magnesium stearate. Film coating : Opadry ^® Y-1-7000 (hypromellose compound (E464), titanium dioxide (E171), macrogol 400).
• Excipient with known effect: lactose monohydrate (63.50 mg / cp).

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

atarax medication >> Generic drug of the Therapeutic class: Allergology
active ingredients:Hydroxyzine

what is atarax medicine?

This medicine is recommended in minor manifestations of anxiety, in premedication before general anesthesia, in urticaria, as well as in the treatment of certain insomnia in children over 6 years.

what is the drug atarax used for and indication?

• Minor manifestations of anxiety in adults.
• Premedication to general anesthesia.
• Symptomatic treatment of urticaria.
• In children over 3 years (syrup) or 6 years (tablet), second-line treatment of sleep insomnia related to a state of hyper-arousal (increased vigilance related to anxiety at bedtime), after failure of behavioral measures alone.

atarax dosage

The tablet is not a form suitable for children under 6 years (risk of mis-driving).
Oral way.

atarax dose for adults

• Minor manifestations of anxiety : the average dose is 50 to 100 mg per day, up to 300 mg per day.
• Urticaria : the average dose is 50 to 100 mg daily.
• Premedication to general anesthesia : 100 to 200 mg in adults.

atarax dosage for child

• In sleep insomnia in children over 6 years , the suggested dosage is 1 mg / kg / day, and treatment will be short-term (up to 2 weeks).

In other indications in children from 6 years to 15 years :

• The maximum dose is 1 mg per kg and per day.
• These doses can be reduced by half when only a momentary effect is desired.
• Elderly, severe hepatic or renal insufficiency : it is recommended to reduce the dosage by half.
• The treatment will be short-lived.

how atarax works?

Pharmacotherapeutic group: ANXIOLYTICS, ATC code: NO5BB01, (N: Central nervous system).

Hydroxyzine is a piperazine derivative not chemically related to phenothiazines and benzodiazepines.

Action mechanism

• Hydroxyzine is an antihistamine antagonist of central and peripheral H ₁ receptors with anticholinergic properties.

Efficacy and clinical safety

• Hydroxyzine has been shown to be effective in humans in urticaria.
• Hydroxyzine has a sedative effect evidenced by EEG recordings in healthy volunteers.
• Hydroxyzine exhibits activity on minor symptoms of anxiety.

atarax side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

They are related to the action of the drug on the central nervous system, the dose ingested and the individual sensitivity of each.

May occur:

• Drowsiness, headache, fatigue, confusion, excitement, hallucinations, disorientation, insomnia,
• Convulsions, tremors,unconsciousness, abnormal movements, vertigo,
• Rash with or without itching, rash and redness spreading throughout the body with pustules and accompanied by fever (generalized acute exanthematous pustulosis), severe skin manifestations such as blisters or burns on the body (Stevens syndrome) Johnson /Toxic Epidermal Necrolysis or Lyell Syndrome) and Polymorphic Erythema (a severe skin disease),
• Allergic manifestations, sometimes with respiratory embarrassment, even abrupt swelling of the face and neck of allergic origin (Quincke’s edema), or allergic reaction sometimes generalized (anaphylactoid reaction),
• Visual disturbances (accommodation disturbances),
• Pulse acceleration, drop in blood pressure, severe cardiac rhythm disturbance (prolongation of the QT interval at the electrocardiogram and torsade de pointes), with an undetermined frequency of onset,

Stop taking the medicine and see a doctor immediately if heart problems such as palpitations, breathing difficulties, or loss of consciousness occur.

• Nausea, vomiting,constipation, urine retention, hepatitis, increased liver enzymes
• Malaise, fever

atarax drug interactions

Associations contraindicated

Co-administration of hydroxyzine with medicinal products known to prolong the QT interval and / or induce torsades de pointes, eg class IA (eg quinidine disopyramide) and class III (eg amiodarone) anti-arrhythmic drugs sotalol), some antihistamines, some antipsychotics (eg haloperidol), some antidepressants (eg citalopram and escitalopram), some antimalarials (eg mefloquine), some antibiotics (eg, erythromycin, levofloxacin, moxifloxacin), some antifungals (eg pentamidine), some gastrointestinal drugs (eg prucalopride), some anti-cancer drugs (eg, toremifene, vandetanib) and methadone increase the risk of cardiac arrhythmias. Therefore, these combinations are contraindicated (see sectionContraindications ).

Associations advised against

atarax and alcohol

• Alcohol enhancement of the sedative effect of H1 antihistamines. Impairment of alertness can make driving and using machines dangerous.
• Avoid taking alcoholic drinks and drugs containing alcohol.

Associations subject to precautions for use

• Drugs that may induce bradycardia and hypokalemia.
• Hydroxyzine is metabolised by alcohol dehydrogenase and CYP3A4 / 5 and an increase in blood hydroxyzine concentration can be expected when hydroxyzine is co-administered with drugs known to be potent inhibitors of these enzymes.

Associations to consider

Other central nervous system depressants

• Morphine derivatives (analgesics, antitussives and substitution treatments), benzodiazepines; anxiolytics other than benzodiazepines; barbiturates; hypnotics; neuroleptics; sedative antidepressants; central antihypertensives; baclofen; Thalidomide.
• Increase of the central depression. Altered alertness can make driving and using machines more dangerous.

 Atropine and other atropine substances

• Imipraminic antidepressants, antiparkinsonian anticholinergics, atropinic antispasmodics, disopyramide, phenothiazine neuroleptics.
• Addition of atropine adverse effects such as urinary retention, constipation, dry mouth ..

Warnings and Precautions

Special warnings:

Elongation of QT space

• Hydroxyzine is associated with QT prolongation on the electrocardiogram. During post-marketing surveillance, cases of QT interval prolongation and torsade de pointes have been reported in patients taking hydroxyzine. Most of these patients had other risk factors, electrolyte abnormalities and concomitant treatment that may have contributed.
• Hydroxyzine should be used at the lowest effective dose and for the shortest duration of treatment.
• Hydroxyzine treatment should be discontinued if signs or symptoms that may be associated with cardiac arrhythmia occur and patients should seek immediate medical attention.
• Patients should be informed of the need to promptly report any cardiac symptoms.

Elderly

• Hydroxyzine is not recommended in elderly patients because of the decreased elimination of hydroxyzine in this population compared to the adult population and the increased risk of adverse effects (eg, anticholinergic effects)  .
• Patients should be advised against the absorption of alcoholic beverages during treatment.

Pediatric population

In the treatment of sleep insomnia in children:

• Hydroxyzine is not a suitable treatment for insomnia of neurological cause, some insomnia of organic origin (obstructive sleep apnea syndrome – OSA – of the child, gastroesophageal reflux – GERD -, ENT infection, ), and insomnia of psychiatric origin.
• In case of vigilance disorders the morning after taking, treatment with hydroxyzine should be discontinued.
• In the absence of a therapeutic response to well conducted drug treatment, a specialized opinion is recommended.

This medicine contains lactose. Its use is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

Precautions for use:

Hydroxyzine is not a suitable treatment for insomnia of neurological cause, some insomnia of organic origin (see Warnings), and insomnia of psychiatric origin. The following main clinical signs, suggestive of an organic cause, will therefore be sought before any prescription of hydroxyzine in a child with sleep disorders:

• Sound snoring, eating disorders, abnormal regurgitation,
• Prolonged nocturnal awakenings (greater than 15 minutes), or awakenings appearing from the first part of the night, restless sleep between awakenings, inconsolable crying,
• Daytime fatigue, unannounced naps, excessive activity, or behavioral disturbances,
• Failure to thrive or break the weight curve, or abnormal neurological or psychomotor examination.

This medicine should be used with caution:

• In young children, who are particularly sensitive to effects on the central nervous system (including convulsions),
• In cases of severe hepatic and / or renal impairment, due to the risk of accumulation (see section 4.2),

In addition, the administration of Atarax Hydroxyzine is not recommended in patients with cognitive or confounding disorders, because of the risk of aggravation related to the pharmacodynamic properties of the product.

Because of its potential anticholinergic effects, hydroxyzine should be used with caution in patients with glaucoma, urinary retention, decreased gastrointestinal motility, myasthenia gravis, or dementia.

Treatment should be discontinued for at least 5 days (7 days in the elderly) before an allergic test or bronchial provocation test with methacholine is performed to avoid an effect on the test result.

Drive and use machines

Atarax Hydroxyzine may cause drowsiness. This should be taken into account by vehicle drivers and machine users, who are also advised against the use of other sedative drugs. If sleep time is insufficient, the risk of impaired alertness is further increased.

PREGNANCY / BREAST FEEDING / FERTILITY

atarax during pregnancy

Breastfeeding:

• In the absence of data on the passage of hydroxyzine in breast milk, and given the sedative and atropine properties of this substance, breastfeeding is not recommended during treatment with hydroxyzine.

atarax syrup overdose

• Symptoms observed in case of significant overdose include: nausea, vomiting, tachycardia, somnolence, accommodation disturbances, tremors, confusion, hallucinations and sometimes, disturbances of consciousness or even coma, respiratory depression, convulsions, hypotension, disturbances of rhythm cardiac arrest or cardiopulmonary arrest.
• Always think of drug poly-intoxication.
• Monitoring of vital functions, including cardiac function with ECG recording, and, if necessary, symptomatic treatment should be implemented in a specialized environment.
• Vomiting will be caused if it does not occur spontaneously. Immediate gastric lavage is also advised.
• There is no specific antidote.

What is  Forms and Composition?

• 25 mg film-coated tablet (white):   Box of 30, in blister packs. Syrup:   200 ml vial, with 0.25 ml 0.25 ml graduated oral syringe.

• Excipients: Core: lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate. Film coating : Opadry Y-1-7000 white (hypromellose 2910, macrogol 400, titanium dioxide E171).
• Excipient with known effect: lactose.

• Excipients: 95 ° ethanol, sucrose, sodium benzoate, levomenthol, purified water. Aroma: nutty.
• Excipients with known effect: ethanol (less than 100 mg for 60 ml [maximum daily dose]), sucrose (700 mg / ml).

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

Generic drug of the Therapeutic class: Ophthalmology – Allergology
active ingredients: Ketotifen

Important to know about Zaditen?

• Ketotifen is an anti-allergy medication.
• In allergy, such as allergic asthma, hay fever, allergy-inflamed eyes and nose, hives and itching.
• Works within a few hours. The operation lasts for about 12 hours.
• Do you constantly have complaints? Use ketotifen every day. Do you occasionally suffer? Then take it if you get complaints.

• Side effects: agitation, anxiety and nervousness. Especially the elderly and young children are sensitive to this.
• Ketotifen can make you drowsy and tired in the first days and reduce your responsiveness. Do you use ketotifen every day? You can drive again after a few days. Do you use it occasionally? Then you can safely drive 24 hours after the last intake.
• Watch out with alcohol. This can still make you suffer.

what is zaditen used for and indication?

Zaditen Dosage

Adult and child over 6 years old :

1 capsule morning and evening.

• The capsule form is not suitable for children under 6 years of age due to the risk of false route.
• In the child of 4 years to 6 years the form oral solution is preferable.
• Because of the risk of drowsiness at the beginning of treatment, a period of adaptation of a few days to 1/2 dose administered only in the evening may be recommended.

Contraindications

CONTRA-INDICATED:

• – Known hypersensitivity to ketotifen or to one of the constituents of the specialty.
• – The compressed form is not suitable for children under 6 years of age due to the risk of aspiration.
• – Due to the presence of lactose , this medication is not recommended in cases of congenital galactosemia, glucose and galactose malabsorption syndrome or lactase deficiency.

ADVISED AGAINST:

• – Breast-feeding: in the absence of data on the passage into breast milk, treatment is not recommended during breast-feeding.
• – Taking this medication is not recommended in combination with alcohol or drugs containing alcohol (see interactions section).

how does zaditen work?

Pharmacotherapeutic group: ANTIHISTAMINE FOR SYSTEMIC USE.
(R: Respiratory System).

• Ketotifen has anti-allergic properties. It is not a bronchodilator.
• Ketotifen has a prolonged inhibitory effect on histamine reactions (H1 receptor blockade).

What are the side effects of zaditen?

In addition to the desired effect, this can cause drug side effects.

The main side effects are the following.

Rarely (from 1 to 10 in 100 people)

• Excitement , restlessness, nervousness, irritation and insomnia. Especially children and the elderly are sensitive to these side effects.
• Drowsiness , fatigue, reduced co-ordination capacity and reduced responsiveness. This is particularly difficult in activities where your attention is required, such as driving a car, climbing a ladder or monitoring a process at work. And children with cycling or playing on the street, climbing and learning at school. Do not engage in risky activities, especially during the first few days of treatment, if you still have to get used to the medicine.

  

Very rare (affects less than 1 in 100 people)

• Dry mouth , nose and throat . If you suffer from a dry mouth at the beginning of the treatment, you can stimulate the production of saliva with (sugar-free) chewing gum or by sucking on ice cubes. This side effect occurs mainly in the beginning of the treatment and will automatically change if you continue to take ketotifen. The dry mouth causes faster holes in your teeth and inflammation of the mucous membrane of the oral cavity. Brush and floss extra well if you notice that you continue to suffer from a dry mouth. If necessary, have the dentist checked more often.
• If you have Sjögren’s syndrome , a condition in which the mucous membranes of, for example, eyes and mouth are drier than normal: you may develop more symptoms. This remedy reduces the production of tears and saliva. Contact your doctor if you have more eye irritation or a dry mouth.
• Dizziness , especially at the beginning of treatment, headaches and ringing in the ears.
• Gastrointestinal complaints such as nausea, abdominal pain, vomiting, constipation or diarrhea. If you suffer from these side effects, take this medicine with some food.
• Double vision , blurred vision and tired, burning eyes . Tired burning eyes are caused by your eyes making less tears. Especially people with contact lenses are more likely to suffer from this. In that case, keep them in for less time or use moisturizing eye drops (artificial tears).
• Weight gain due to increased appetite. Watch your diet if you use this medication.
• Liver disorders . You may notice this by a sensitive swollen belly or a yellow discolouration of the whites or the skin. Warn your doctor with these symptoms.
• Hypersensitivity to this medication. You can notice this by skin rash, hives or because the complaint does not ring or worsens. Consult your doctor.
  In rare cases, there is a serious skin abnormality. Consult a doctor immediately or go to the First Aid Service. You may not use this medicine in the future. Tell the pharmacist that you are hypersensitive to ketotifen. The pharmacy team can then ensure that you do not get the medicine again.
• Cystitis or difficulty urinating . This is especially important if you already have difficulty urinating through an enlarged prostate. Contact your doctor if you notice this. Another medication may be more suitable for you.
• People with epilepsy have a chance of an increase in the number of seizures. Discuss this with your doctor.

Consult your doctor if you suffer too much from one of the above mentioned side effects or if you experience other side effects that you are worried about.

Do you use this medication against allergy and do you have to undergo an allergytest? The result of the test is unreliable if you also use this anti-allergy medication. Therefore, stop taking this medicine for at least three days before you have an allergy test. Discuss this with your doctor.

Zaditen Interactions

ASSOCIATION DECONSEILLEE (voir rubrique mises en garde) :

Alcool : increase by alcohol of the sedative effect..

• Impaired alertness can make driving and using machines dangerous. Avoid taking alcoholic beverages and drugs containing alcohol.

ASSOCIATIONS A PRENDRE EN COMPTE :

– Atropine drugs :

• It should be taken into account that atropine substances can add up their undesirable effects and more easily cause urinary retention, an acute glaucoma attack, constipation, dry mouth, etc.
• The various atropine drugs are represented by imipramine antidepressants, most atropine H1 antihistamines, anticholinergic antiparkinsonians, atropine antispasmodics, disopyramide, phenothiazine neuroleptics as well as clozapine.

– Sedative drugs :

• It must be taken into account that many drugs or substances can add their depressant effects of the central nervous system and help reduce alertness.
• These are morphine derivatives (analgesics, antitussives and substitution treatments), neuroleptics, barbiturates, benzodiazepines, anxiolytics other than benzodiazepines (eg meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin , mianserine, mirtazapine, trimipramine), sedative H1 antihistamines, central antihypertensives, baclofen and thalidomide.

Warnings and Precautions

Zaditen WARNINGS

• The occurrence of bronchial superinfection or ENT requires the additional administration of specific anti-infectious therapies.
• Very rare cases of convulsions have been reported, especially in children, during treatment with ketotifen.
• This medication is not recommended in combination with alcohol or drugs containing alcohol.

PRECAUTIONS FOR USE

• The use of ketotifen is not recommended for children under 4 years of age.
• The absorption of alcoholic beverages during treatment is not recommended.

Drive and use machines

• Attention should be paid to the risk of drowsiness associated with the use of this medication, especially for vehicle drivers and machine users.

PREGNANCY / BREAST FEEDING

Pregnancy 

• Studies in animals have not shown any teratogenic effect. In the absence of teratogenic effect in animals, a malformative effect in the human species is not expected.
•  Indeed, to date, the substances responsible for malformations in the human species have proved teratogenic in animals in well conducted studies on two species.
• In clinical practice, there are currently no data of sufficient relevance to evaluate a potential malformative or foetotoxic effect of ketotifen when administered during pregnancy.
• Therefore, as a precaution, it is best not to use ketotifen during pregnancy.

Breastfeeding

• In the absence of data on passage into breast milk, treatment is not recommended during breastfeeding.

What should I do if I miss a dose?

• If you take this medicine once a day : does it take more than 8 hours before you take the next dose normally? Take the forgotten dose as yet. Does it take less than 8 hours? Skip the dose you missed.
• If you take this medicine twice a day : does it take more than 4 hours before you take the next dose normally? Take the forgotten dose as yet. Does it take less than 4 hours? Skip the dose you missed.

What happens if I overdose from Zaditen?

• The signs of accidental massive overdose poisoning (up to 120 mg) observed are as follows: drowsiness, confusion, slowing or accelerating the heart and / or respiratory rate, excitations and convulsions.
• The treatment is purely symptomatic and requires monitoring of circulatory and respiratory functions.

– Conduct to keep : if the product has been absorbed recently, a gastric lavage may be useful as well as the administration of activated charcoal.

What is  Forms and Composition?

• 2 mg sustained release film-coated tablet (beige):   Box of 30, in blister packs. 1 mg capsule (white):   Box of 60, in blister packs. Oral solution 1 mg / 5 ml:  Bottle of 150 ml, with child safety cap and measuring cup.

NOT’s

Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:

general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.