Humex Allergy Loratadine 10mg tablet Uses, Dosage, Side Effects& Precautions

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:

Immune system disorders	Anaphylaxis
Nervous system disorders	Dizziness
Cardiac disorders	Tachycardia, palpitations
Gastrointestinal disorders	Nausea, dry mouth, gastritis
Hepatobiliary disorders	Liver function disorders
Skin and subcutaneous tissue disorders	Rash, alopecia
General disorders and administration site conditions	Tired

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

Active ingredient	Compressed
Loratadine	10 mg *

* 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

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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.