ALLEVIA

Posology Adults The recommended dose of fexofenadine hydrochloride for adults is 120 mg once daily taken before a meal. Fexofenadine is a pharmacologically active metabolite of terfenadine. Paediatric population Children aged 12 years and over The recommended dose of fexofenadine hydrochloride for children aged 12 years and over is 120 mg once daily taken before a meal.

Children under 12 years of age The efficacy and safety of fexofenadine hydrochloride 120 mg has not been studied in children under 12. Special populations Studies in special risk groups (elderly, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients.

The following frequency rating has been used, when applicable: very common ≥1/10; common ≥1/100 and <1/10; uncommon ≥1/1,000 and <1/100; rare ≥1/10,000 and <1/1,000; very rare <1/10,000 and not known (frequency cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. In adults, the following undesirable effects have been reported in clinical trials, with an incidence similar to that observed with placebo: Nervous system disorders Common: headache, drowsiness, dizziness.

Gastrointestinal disorders Common: nausea. General disorders and administration site conditions Uncommon: fatigue. In adults, the following undesirable effects have been reported in post-marketing surveillance. The frequency with which they occur is not known (cannot be estimated from available data): Immune system disorders Hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis.

Psychiatric disorders Insomnia, nervousness, sleep disorders or nightmares/excessive dreaming (paroniria). Heart pathologies Tachycardia, palpitations. Gastrointestinal disorders Diarrhoea. Skin and subcutaneous tissue disorders Rash, urticaria, pruritus.

Eye disorders Not known:

Vision blurred Reporting of suspected adverse reactions It is important to report suspected adverse reactions that occur after the medicinal product has been authorised as it enables the product’s risk/benefit ratio to be continuously monitored.

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As with most new medicinal products there is only limited data in the elderly and renally or hepatically impaired patients. Allevia 120 mg should only be administered in these special groups on the advice of a doctor. 8) and should use Allevia 120 mg only on the advice of their doctor.

Allevia 120 mg should not be used in children under 12 years of age. In children from 6 to 11 years of age: fexofenadine hydrochloride 30 mg tablet (prescription only medicine) is the appropriate formulation for administration and dosing in this population.

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