FEXOFENADINE HYDROCHLORIDE

Posology Adults The recommended dose of fexofenadine hydrochloride for adults is 180 mg once daily taken before a meal. Paediatric population Children aged 12 years and over The recommended dose of fexofenadine hydrochloride for children aged 12 years and over is 180 mg once daily taken before a meal.

Children under 12 years of age The efficacy and safety of fexofenadine hydrochloride 180 mg has not been studied in children under 12. Fexofenadine should not be given to this population. Special populations There is no need to adjust the dose in elderly, renally or hepatically impaired patients, however as limited data are available fexofenadine should be administered with care in the special groups.

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) Eye disorders Vision blurred 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 Google Play or Apple App Store.

There is limited data in the elderly and renally or hepatically impaired patients. 2). 8).

Excipients:

Fexofenadine Hydrochloride 180 mg Film-Coated Tablets contains Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose galactose malabsorption should not take this medicine.

Fexofenadine Hydrochloride 180 mg Film-Coated Tablets contains Sodium:

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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