FEXOFENADINE HYDROCHLORIDE

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 (older people, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients.

Method of administration For oral use

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 Eye disorders Not known: Vision blurred 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 (can not 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) Cardiac disorders tachycardia, palpitations Gastrointestinal disorders diarrhoea Skin and subcutaneous tissue disorders rash, urticaria, pruritus Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

As with most new medicinal products there is only limited data in the older people and renally or hepatically impaired patients. 2). 8). Fexofenadine hydrochloride tablets contains sodium This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially sodium free.

1.