Aspegic painkiller Uses, Dosage, Side Effects, Precautions &Warnings
Aspegic painkiller,Generic drug of the therapeutic class: Analgesics
active ingredients: Acetylsalicylic acid
Table of Contents
What is Aspegic used for and indication ?
Powder for oral solution 500 mg:
- Symptomatic treatment of mild to moderate pain and / or febrile conditions.
- Chronic inflammatory rheumatism, rheumatic fever in children.
- Symptomatic treatment of inflammatory rheumatism in adults.
Powder for adult oral solution at 1000 mg:
- Symptomatic treatment of mild to moderate pain and / or febrile conditions.
- Symptomatic treatment of inflammatory rheumatism.
aspegic dosage 100/500/1000
Administration mode
Oral way.
- Pour the contents of the sachet into a glass and add a small amount of drink (eg water, milk, fruit juice).
Dosage
Pains of mild to moderate intensity and / or febrile states:
- Reserved for adults and children from 30 kg (about 9 to 15 years).
- In children, it is imperative to respect the dosages defined according to the weight of the child and to choose a suitable presentation. Approximate ages by weight are given for information.
- The recommended daily dose of acetylsalicylic acid is approximately 60 mg / kg / day, divided into 4 or 6 doses, approximately 15 mg / kg every 6 hours or 10 mg / kg every 4 hours.
- · For children weighing 30 to 40 kg (approximately 9 to 13 years), the dosage is 1 sachet per dose, to be renewed if necessary after 6 hours, without exceeding 4 sachets per day.
- · For children weighing 41 to 50 kg (approximately 12 to 15 years), the dosage is 1 sachet per dose, to be renewed if necessary after 4 hours, without exceeding 6 sachets per day.
- · For adults and children weighing more than 50 kg (from about 15 years of age):
The recommended maximum daily dosage is 3 g of acetylsalicylic acid, which is 6 sachets per day.
The usual dosage is 1 sachet 500 mg, to renew if necessary after 4 hours minimum. In case of pain or fever more intense, 2 sachets to 500 mg, to renew when necessary after 4 hours minimum, without exceeding 6 sachets per day. - · For elderly subjects:The recommended maximum daily dosage is 2 g of acetylsalicylic acid, 4 sachets per day.The usual dosage is 1 sachet 500 mg, to renew if necessary after 4 hours minimum. In case of pain or fever more intense, 2 sachets to 500 mg, to renew in case of need after 4 hours minimum, without exceeding 4 sachets per day.
Frequency of administration:
Systematic catches prevent pain or fever oscillations:
- · In adults : catches should be spaced at least 4 hours apart .
- · In children : the intakes should be regularly spaced, including at night , preferably 6 hours and at least 4 hours: comply with the dosage specified above.
Duration of treatment :
- the patient must be informed not to use acetylsalicylic acid more than 3 days in case of fever and 5 days in case of pain without the opinion of a doctor or a dentist.
Rheumatic conditions:
Reserved for adults and children from 20 kg.
- · In adults : 3 to 6 g maximum per day to be divided into 3 or 4 taken at least 4 hours apart. In the elderly, the dosage will be reduced.
- · In children : this presentation is reserved for children from 20 kg: 50 mg / kg to 100 mg / kg maximum per day to be divided into 4 to 6 taken at least 4 hours apart.
Contraindications
This drug is CONTRAINDICATED in the following situations:
Hypersensitivity to acetylsalicylic acid or to any of the excipients, or to other nonsteroidal anti-inflammatory drugs (cross reaction),
History of asthma caused by the administration of salicylates or substances of similar activity, in particular non-steroidal anti-inflammatory drugs,
Third trimester of pregnancy (beyond 24 weeks of amenorrhea) for doses greater than 100 mg per day (see section Pregnancy and breast-feeding ),
– evolving peptic ulcer,
Any constitutional or acquired hemorrhagic disease,
Risk of bleeding,
Severe hepatic impairment
Severe renal failure
Severe uncontrolled heart failure
In combination with methotrexate used at doses greater than 20 mg / week (see section Interactions with other medicinal products and other forms of interactions ) and for anti-inflammatory doses (≥ 1 g per dose and / or ≥ 3 g per day) or for analgesic or antipyretic doses (≥ 500 mg per dose and / or <3 g per day) of acetylsalicylic acid,
In combination with oral anticoagulants for anti-inflammatory doses of acetylsalicylic acid (≥ 1 g per dose and / or ≥ 3 g per day), or for analgesic or antipyretic doses (≥ 500 mg per dose and / or < 3 g per day) in a patient with a history of peptic ulcer disease (see section Interactions with other medicinal products and other forms of interactions ).
How it works Aspegic?
OTHER Analgesics AND Antipyretics , ATC Code: N02BA01 .
- Acetylsalicylic acid belongs to the group of nonsteroidal anti-inflammatory drugs with antalgic, antipyretic and anti-inflammatory properties.
- Its mechanism of action is based on the irreversible inhibition of cyclooxygenase enzymes involved in prostaglandin synthesis.
- Acetylsalicylic acid also inhibits platelet aggregation by blocking platelet synthesis of thromboxane A 2 .
Aspegic 500 mg Side Effects
Like all medicines, ASPEGIC 500 mg powder for oral solution in sachet-dose is likely to have side effects, although not everyone is concerned.
You should immediately stop your treatment and tell your doctor if:
- gastric and intestinal bleeding (see section “Special warnings”). These are all the more frequent as the dosage used is high,
- cerebral hemorrhages,
- allergic reactions such as rash, asthma attack, Quincke’s edema (urticaria of the face with respiratory disorder),
- tinnitus, feeling of lowered hearing, headache, dizziness: these signs usually reflect an overdose of aspirin,
- Reye’s syndrome (appearance of a disturbance of consciousness or behavior and vomiting) in a child with a viral illness receiving aspirin (“Take special care with ASPEGIC 500 mg powder for oral solution in a sachet”), paragraph “Special warnings”)
- Increased liver enzymes, liver damage (mainly liver cells).
Tell your doctor if you have abdominal pain, nosebleeds or gums.
Cases of stomach ulcer have been reported.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist
Keep out of the reach and sight of children.
Aspegic Interactions
Risk associated with antiplatelet effect
- Several substances are involved in interactions due to their antiplatelet properties: abciximab, acetylsalicylic acid, cilostazol, clopidogrel, epoprostenol, eptifibatide, iloprost and iloprost trometamol, tirofiban, ticlopidine, prasugrel and ticagrelor.
- The use of several antiplatelet agents increases the risk of bleeding, as well as their association with heparin and related molecules, oral anticoagulants and other thrombolytics, and should be considered by maintaining regular clinical monitoring.
Associations contraindicated
(See section Contraindications )
Oral anticoagulants
- For anti-inflammatory doses (≥ 1 g per dose and / or ≥ 3 g per day), or for analgesic or antipyretic doses (≥ 500 mg per dose and / or <3 g per day) of acetylsalicylic acid and case of a history of peptic ulcer.
- Increased risk of bleeding, especially in case of a history of peptic ulcer.
+ Methotrexate used at doses greater than 20 mg / week
For anti-inflammatory doses (≥ 1 g per dose and / or ≥ 3 g per day), or for analgesic or antipyretic doses (≥ 500 mg per dose and / or <3 g per day) of acetylsalicylic acid.
Increased toxicity, especially haematological toxicity, of methotrexate (decreased renal clearance by anti-inflammatory drugs).
Associations advised against
(See section Warnings and precautions for use )
Oral anticoagulants
- For analgesic or antipyretic doses (≥ 500 mg per dose and / or <3 g per day) in the absence of a history of peptic ulcer: increased risk of haemorrhage.
- For anti-aggregating doses of acetylsalicylic acid (from 50 mg to 375 mg per day) and in case of a history of peptic ulcer: increased risk of haemorrhage, especially in case of a history of peptic ulcer. Need for control if necessary, especially bleeding time.
Nonsteroidal anti-inflammatory drugs
- For anti-inflammatory doses (≥ 1 g per dose and / or ≥ 3 g per day), or for analgesic or antipyretic doses (≥ 500 mg per dose and / or <3 g per day) of acetylsalicylic acid.
- Increased risk ulcerogenic and haemorrhagic digestive.
Clopidogrel (except validated indications for this association in acute coronary syndrome)
- Increased hemorrhagic risk by adding antiplatelet activities.
Glucocorticosteroids (except hydrocortisone as replacement therapy)
- For anti-inflammatory doses of acetylsalicylic acid (≥ 1 g per dose and / or ≥ 3 g daily).
- Increased hemorrhagic risk.
Low molecular weight (and related) heparins and unfractionated heparins (curative and / or elderly doses)
- For anti-inflammatory doses (≥ 1 g per dose and / or ≥ 3 g per day) or for analgesic or antipyretic doses (≥ 500 mg per dose and / or <3 g per day) of acetylsalicylic acid.
- Increased haemorrhagic risk (inhibition of platelet function and aggression of the gastroduodenal mucosa by acetylsalicylic acid).
- Use another anti-inflammatory or other analgesic or antipyretic.
Pemetrexed
- In patients with low to moderate renal function (creatinine clearance between 45 ml / min and 80 ml / min), risk of increased toxicity of pemetrexed (decreased renal clearance with acetylsalicylic acid -Inflammatory drugs ≥ 1 g per dose and / or ≥ 3 g per day).
Ticlopidine
- Increased hemorrhagic risk by adding antiplatelet activities.
- If the association can not be avoided, close clinical supervision.
Uricosuric (benzbromarone, probenecid)
- Decrease of the uricosuric effect by competition of the elimination of the uric acid at the level of the renal tubules.
Associations subject to precautions for use
ACE inhibitors, angiotensin II receptor antagonists, diuretics
- For anti-inflammatory doses (≥ 1 g per dose and / or ≥ 3 g per day) or for analgesic or antipyretic doses (≥ 500 mg per dose and / or <3 g per day) of acetylsalicylic acid: Renal insufficiency acute in the dehydrated patient, by decrease in glomerular filtration secondary to a decrease in the synthesis of renal prostaglandins. Moreover, reduction of the antihypertensive effect.
- Hydrate the patient and monitor kidney function at the beginning of treatment.
Methotrexate used at doses less than or equal to 20 mg / week
- With acetylsalicylic acid used at analgesic or antipyretic doses (≥ 500 mg per dose and / or <3 g daily) or anti-inflammatory drugs (≥ 1 g taken and / or ≥ 3 g daily). Increased toxicity, especially hematological toxicity, of methotrexate (decreased renal clearance by anti-inflammatory drugs).
- Weekly control of the blood count during the first weeks of the association. Increased monitoring for impaired (even mild) renal function, as well as in the elderly.
Methotrexate used at doses greater than 20 mg / week
- For antiplatelet platelet doses of acetylsalicylic acid (50 to 375 mg daily). Increased toxicity, especially haematological toxicity, of methotrexate (decreased renal clearance by anti-inflammatory drugs).
- Weekly control of the blood count during the first weeks of the association. Increased monitoring for impaired (even mild) renal function, as well as in the elderly.
Pemetrexed
- In patients with normal renal function, there is a risk of increased toxicity of pemetrexed (reduction of renal clearance by acetylsalicylic acid at anti-inflammatory doses of ≥ 1 g per dose and / or ≥ 3 g per day).
- Biological monitoring of the renal function.
Gastrointestinal topicals, antacids and adsorbents
- Decreased digestive absorption of acetylsalicylic acid.
- Take gastrointestinal topicals or antacids remotely (more than 2 hours if possible) from acetylsalicylic acid.
Clopidogrel (in validated indications for this association in acute coronary syndrome)
- Increased hemorrhagic risk by adding antiplatelet activities.
- Clinical surveillance.
Associations to consider
+ Oral anticoagulants
- For anti-aggregating doses of acetylsalicylic acid (50 mg to 375 mg / day).
- Increased risk of haemorrhage, especially in cases of peptic ulcer.
+ Nonsteroidal anti-inflammatory drugs
- For antiaggregant doses of acetylsalicylic acid (50 mg to 375 mg / day) in one or more doses.
- Increased risk ulcerogenic and haemorrhagic digestive.
Deferasirox
- With acetylsalicylic acid used at analgesic or antipyretic doses (≥ 500 mg per dose and / or <3 g daily) or anti-inflammatory drugs (≥ 1 g taken and / or ≥ 3 g daily).
- Increased risk ulcerogenic and haemorrhagic digestive.
Glucocorticosteroids (except hydrocortisone as replacement therapy)
- For analgesic or antipyretic doses (≥ 500 mg per dose and / or <3 g per day) of acetylsalicylic acid.
- Increased hemorrhagic risk.
Low molecular weight (and related) heparins and unfractionated heparins: curative and / or elderly doses
- For anti-aggregating doses of acetylsalicylic acid (50 mg to 375 mg / day).
- Increased haemorrhagic risk (inhibition of platelet function) and aggression of the gastroduodenal mucosa by acetylsalicylic acid.
Low molecular weight (and related) heparins and unfractionated heparins: preventative doses
- Joint use of drugs acting at various levels of hemostasis increases the risk of bleeding. Thus, in subjects less than 65 years of age, the combination of heparin at preventive doses (low molecular weight and related doses or unfractionated heparins) with acetylsalicylic acid, irrespective of the dose, should be taken into account. now clinical and possibly biological monitoring.
Selective serotonin reuptake inhibitors
- Increased hemorrhagic risk.
Thrombolytics
- Increased haemorrhagic risk
Warnings and Precautions
- This medicine contains acetylsalicylic acid. Other medicines contain it. Do not combine them, so as not to exceed the recommended daily dose.
- In case of combination with other drugs, to avoid a risk of overdose, check the absence of acetylsalicylic acid in the composition of other drugs.
- In patients receiving concomitant treatment with nicorandil and NSAIDs including acetylsalicylic acid, there is an increased risk of serious complications such as gastrointestinal ulceration, perforation and bleeding (see section 4.5).
- In the long-term administration of high-dose analgesic drugs, the occurrence of headache should not be treated with higher doses.
- Regular use of analgesics, especially the combination of analgesics, can lead to persistent kidney damage with a risk of renal failure.
- Reye syndromes, very rare but life-threatening diseases, have been observed in children and adolescents with signs of viral infections (especially chickenpox and influenza-like episodes) and receiving acetylsalicylic acid. As a result, acetylsalicylic acid should only be given in these children and adolescents on medical advice when the other measures have failed. If persistent vomiting, disturbances of consciousness or abnormal behavior occur, treatment with acetylsalicylic acid should be discontinued.
- In some severe cases of G6PD deficiency, high doses of acetylsalicylic acid may have caused haemolysis. The administration of acetylsalicylic acid in case of G6PD deficiency must be under strict medical supervision.
- In children less than 1 month old, the administration of acetylsalicylic acid is justified only in certain situations under medical prescription.
Monitoring of treatment should be strengthened in the following cases:
- · History of peptic ulcer, gastrointestinal bleeding or gastritis,
- · Renal or hepatic insufficiency,
- · Asthma: the onset of asthma attacks in some individuals may be related to an allergy to nonsteroidal anti-inflammatory drugs or acetylsalicylic acid. In this case, this medicine is contraindicated,
- · Metrorrhagia or menorrhagia (risk of increased importance and duration of menstruation).
Gastrointestinal haemorrhage or ulcers / perforations may occur at any time during treatment without necessarily having any prior symptoms or antecedents. The relative risk increases in the elderly, the subject of low body weight, the patient undergoing anticoagulant or antiplatelet therapy (see section 4.5). In case of gastrointestinal bleeding, discontinue treatment immediately.
Given the platelet anti-aggregating effect of acetylsalicylic acid, appearing at very low doses and persisting for several days, the patient should be warned of the risk of bleeding that may occur in the event of even minor surgery (eg extraction dental).
Acetylsalicylic acid modifies serum uric acid (in analgesic dose acetylsalicylic acid increases uricemia by inhibiting the excretion of uric acid, at doses used in rheumatology, acetylsalicylic acid has an uricosuric effect).
At high doses used in rheumatology (anti-inflammatory doses), it is recommended to monitor the appearance of signs of overdose. In the event of tinnitus, hearing loss and vertigo, the treatment modalities should be re-evaluated.
In children, it is recommended to monitor salicylemia especially during the start of treatment.
Use of this medication is not recommended if breast-feeding .
- It has been proven that drugs that inhibit the activity of cyclooxygenase involved in prostaglandin synthesis can alter female fertility by acting on ovulation. This is reversible at the end of the treatment.
- Concomitant use of acetylsalicylic acid is not recommended with:
- Oral anticoagulants, for analgesic or antipyretic doses (≥ 500mg per dose and / or <3 g per day) of acetylsalicylic acid and in a patient with no history of peptic ulcer (see section 4.5),
- Oral anticoagulants, for antiaggregant doses of acetylsalicylic acid (50 mg to 375 mg daily) and in a patient with a history of peptic ulcer (see section 4.5),
- Nonsteroidal anti-inflammatory drugs for anti-inflammatory doses (≥ 1 g per dose and / or ≥ 3 g per day), analgesics or antipyretic (≥ 500 mg per dose and / or <3 g per day) of acetylsalicylic acid,
- Clopidogrel (apart from validated indications for this combination in acute coronary syndrome),
- Glucocorticoids (except hydrocortisone as replacement therapy) for anti-inflammatory doses (≥ 1 g per dose and / or ≥ 3 g daily) of acetylsalicylic acid ),
- Heparins of low molecular weight (and related) and unfractionated heparin in curative and / or elderly doses and for anti-inflammatory doses (≥ 1g per dose and / or ≥3 g per day) or analgesic or antipyretic (≥ 500mg by intake and / or <3 g per day) of acetylsalicylic acid,
- Pemetrexed in patients with low to moderate renal function (creatinine clearance between 45 ml / min and 80 ml / min),
- Ticlopidine,
- Uricosurics.
- Lanagrelide.
- 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).
- 500 mg sachets are not suitable for children under 30 kg for indication of mild to moderate pain and / or febrile conditions and for children under 20 kg for rheumatic diseases indication . There are better dosages for these children.
- Taking alcohol can increase the risk of gastrointestinal damage. Caution is therefore recommended in case of concomitant administration .
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PREGNANCY / BREAST FEEDING / FERTILITY
Pregnancy
Low doses, less than or equal to 100 mg per day:
- Clinical studies show that doses up to 100 mg / day seem to be safe for extremely limited obstetric use requiring specialized surveillance.
Doses between 100 and 500 mg per day:
- Clinical experience with doses of 100 mg to 500 mg daily is inadequate. As a result, the following recommendations for doses greater than 500 mg daily apply to these doses.
Doses greater than or equal to 500 mg daily:
- Inhibition of prostaglandin synthesis may affect the course of pregnancy and / or the development of the embryo or fetus.
Malformative aspect: 1st quarter:
- Data from epidemiological studies suggest an increased risk of miscarriage, heart defects and gastroschisis following treatment with an inhibitor of prostaglandin synthesis in early pregnancy. The absolute risk of cardiovascular malformation increased from less than 1% to approximately 1.5%. The risk appears to increase depending on the dose and duration of treatment. In animals, administration of an inhibitor of prostaglandin synthesis has been shown to cause increased pre- and post-implant loss and increased embryo-fetal lethality. In addition, a higher incidence of some malformations, including cardiovascular, has been reported in animals that received a prostaglandin synthesis inhibitor during the
- Fetotoxic and neonatal Appearance: 2 e and 3 e quarters:
- During the 2 e and 3 e trimesters of pregnancy, all inhibitors of prostaglandin synthesis may expose the fetus to:
- cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary arterial hypertension). The constriction of the arterial duct can occur from 5 months and can lead to fetal or neonatal right heart failure or even fetal death in utero . This risk is even more important that the catch is close to the term (less reversibility). This effect exists even for a punctual catch.
- renal functional impairment :
- in utero can be observed as early as 12 weeks of amenorrhea (initiation of fetal diuresis): oligoamnios (most often reversible at the end of treatment), even anamnios especially during prolonged exposure.
- at birth, renal insufficiency (reversible or not) may persist especially in case of late and prolonged exposure (with a risk of delayed severe hyperkalemia).
- At the end of pregnancy, the mother and the newborn can present:
-
- an increase in bleeding time due to antiplatelet action that may occur even after administration of very low doses of drug;
- inhibition of uterine contractions resulting in delayed term or prolonged delivery.
- As a consequence for doses higher than 100 mg / day:
-
- Unless absolutely necessary, acetylsalicylic acid should not be prescribed during the first 24 weeks of amenorrhea (5 months pregnant). If acetylsalicylic acid is administered to a woman who wants to become pregnant or is less than six months pregnant, the dose should be as low as possible and the duration of treatment as short as possible. Prolonged intake is strongly discouraged.
- Beyond 24 weeks of amenorrhea (5 months of pregnancy completed): any intake of acetylsalicylic acid, even punctual, is contraindicated. An inadvertent uptake beyond 24 weeks of amenorrhea justifies cardiac and renal, fetal and / or neonatal monitoring according to the exposure term. The duration of this monitoring will be adapted to the elimination half-life of the molecule.
Breastfeeding
- Since acetylsalicylic acid is passed into breast milk, this medicine is not recommended during breastfeeding.
Do not take a double dose to make up for the single dose you forgot to take.
What happens if I overdose from Aspegic ?
- During treatment, tinnitus, hearing loss, headache and dizziness may occur and usually result in overdose of aspirin.
- YOU MUST INTERRUPT YOUR TREATMENT OR TREATMENT OF YOUR CHILD AND PREVENT A DOCTOR.
- In case of accidental intoxication (especially frequent in young children), CONSULT IMMEDIATELY A DOCTOR.
What is Forms and Composition?
| FORMS and PRESENTATIONS |
- Powder for oral solution 500 mg: Sachets-dose, boxes of 20 and 30. Powder for adult oral solution 1000 mg: Sachets-dose, boxes of 15, 20 and 30.
| COMPOSITION |
| p bag | |
| Acetylsalicylic acid | 500 mg |
| or | 1000 mg |
| (as LD-lysine acetylsalicylate: 900 mg / 500 mg sachet, 1800 mg / 1000 mg sachet) | |
- Excipients (common): glycine, mandarin aroma * , ammonium glycyrrhizate.
- Excipient with known effect: lactose.
* lactose, orange juice, essential oil of mandarin.
NOT’s
Edrug-online contains comprehensive and detailed information about drugs available in the medical field, and is divided into four sections:
general information:
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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.