TELFAST

Posology Paediatric population • Children 6 to 11 years of age The recommended dose of Fexofenadine hydrochloride in children aged 6 to 11 years is 30 mg twice daily. • Children under 6 years of age The efficacy of Fexofenadine hydrochloride has not been established in children under 6 years of age.

4). Studies conducted in adults in special risk groups (renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of Fexofenadine hydrochloride in adults.

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 controlled clinical trials in children aged 6 to 11 years, the most commonly reported adverse reaction considered at least possibly related to fexofenadine hydrochloride by the investigator was headache.

0% for patients taking fexofenadine hydrochloride 30 mg (673 children) and for patients taking placebo (700 children). There are no clinical safety data in children treated with fexofenadine hydrochloride for periods longer than two weeks In controlled clinical trials in 845 children aged 6 months to 5 years with allergic rhinitis, 415 children were administered 15 mg or 30 mg of fexofenadine hydrochloride (capsule content sprinkled onto dosing vehicle) and 430 children were administered placebo.

2). 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 (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) 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.

2). Fexofenadine hydrochloride should be administered with caution in these patients. 8). Telfast contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1.