Composition
Active ingredient: 500 mg paracetamol.
Other ingredients: povidone, sodium croscarmellose, corn starch, talc, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate.
Scope
Mexalen 500 mg tablets are used for: mild to moderate pain (e.g. headache, toothache, menstrual pain).
Fever and pain associated with colds and flu-like infections.
Dosage
In principle, painkillers should be used in doses as low as necessary to achieve sufficient effect in order to minimize the risk of side effects.
The interval between two doses should be at least 6 hours.
Unless otherwise prescribed by a doctor, the recommended dose is:
Adults and adolescents aged 12 years and over (and weighing at least 43 kg):
1 tablet up to 4 times a day.
The maximum daily dose is 4 tablets (equivalent to 2000 mg paracetamol).
Children aged 6 to 12 years:
½ tablet up to 3 times a day.
Children under 6 years
Mexalen 500 mg tablets are not suitable for children under 6 years of age. Suitable alternative dosage forms with a lower active substance content are available for them. For this, consult a doctor or pharmacist.
Elderly patients (aged 65 years and over)
No special dosage adjustment is required depending on age. In case of underweight and organ dysfunction, follow the relevant instructions.
Patients with impaired liver function
In patients with impaired liver function and Gilbert’s syndrome (congenital disease), the dose must be reduced or the interval between doses (= time interval between two doses) must be increased.
Patients with renal insufficiency
In cases of severe renal insufficiency, the interval between doses (= time interval between two doses) must be at least 8 hours.
Method and duration of administration.
The tablets should be taken with a sufficient amount of liquid (preferably a glass of drinking water).
The duration of administration should be limited to the duration of the disease.
Contraindications
Mexalen 500 mg tablets should not be taken: if you are allergic to paracetamol or any of the other ingredients of this medicine, if you suffer from severe liver dysfunction, if you suffer from a certain hereditary metabolic disorder (glucose-6-phosphate dehydrogenase deficiency), if you are a chronic alcoholic.
Children under 6 years of age (see section 3 “How to take Mexalen 500 mg tablets?”).
Side effects
Rare side effects (may affect up to 1 in 1,000 people)
Increase in some liver parameters
Very rare side effects (may affect up to 1 in 10,000 people).
Changes in blood parameters (decrease in all blood cells, decrease in platelet count or sharp decrease in some white blood cells); certain disorder of red blood pigment (methemoglobinemia).
In sensitive people – asthma-like narrowing of the airways, hypersensitivity reactions from simple reddening of the skin or urticaria to shock reactions with circulatory disorders.
Severe inflammatory skin reactions with blistering, such as acute generalized exanthematous pustulosis (AGEP), erythema multiforme exudative (Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell’s syndrome).
Adverse events of unknown frequency (frequency cannot be estimated from the available data)
Liver damage, rash.
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