Telfast/Telfast Oral Suspension Adverse Reactions

Film-coated tablet: 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; 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).
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. Healthcare professionals are asked to report any suspected adverse reactions.
Oral suspension: Telfast is generally well-tolerated. In placebo-controlled trials involving seasonal allergic rhinitis and chronic idiopathic urticarial patients, adverse events were comparable in fexofenadine- and placebo-treated patients. The most common adverse events reported in controlled clinical trials were headache, fatigue, dizziness or drowsiness and nausea. The incidence of these effects was similar to that observed with placebo. No apparent dose trends were revealed in adverse events.
Events that have been reported during controlled trials involving seasonal allergic rhinitis and chronic idiopathic urticarial patients with incidences less than 1% and similar to placebo and have been reported rarely during post-marketing surveillance include: nervousness, insomnia, sleep disorders and paranoia. In rare cases, rash, urticaria, pruritus and hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis have been reported.
Adverse events reported in placebo-controlled chronic idiopathic urticarial studies were similar to those reported in placebo-controlled seasonal allergic rhinitis studies. In placebo-controlled trials involving pediatric seasonal allergic rhinitis patients (6-11 years of age), adverse events were similar to those observed in trials involving seasonal allergic rhinitis patients 12 years and older. In controlled clinical trials involving pediatric patients 6 months to 5 years of age, there were no unexpected adverse events in patients treated with fexofenadine hydrochloride.