Telfast

Telfast Adverse Reactions

fexofenadine

Manufacturer:

Sanofi-Aventis

Distributor:

DKSH
Full Prescribing Info
Adverse Reactions
Tablet: Seasonal Allergic Rhinitis: Adults: In placebo-controlled seasonal allergic rhinitis clinical trials in patients ≥12 years, which included 2461 patients receiving fexofenadine HCl capsules at doses of 20-240 mg twice daily, adverse events were similar in fexofenadine HCl and placebo-treated patients. All adverse events that were reported by >1% of patients who received the recommended daily dose of fexofenadine HCl (60-mg cap twice daily), and that were more common with fexofenadine HCl than placebo, are listed in Table 1.
In a placebo-controlled clinical study in the United States, which included 570 patients ≥12 years receiving fexofenadine HCl tablets at doses of 120 or 180 mg once daily, adverse events were similar in fexofenadine HCl and placebo-treated patients. Table 1 also lists adverse experiences that were reported by >2% of patients treated with fexofenadine HCl tablets at doses of 180 mg once daily and that were more common with fexofenadine HCl than placebo.
The incidence of adverse events, including drowsiness, was not dose-related and was similar across subgroups defined by age, gender and race. (See Table 1.)

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The frequency and magnitude of laboratory abnormalities were similar in fexofenadine HCl and placebo-treated patients.
Pediatric: Table 2 lists adverse experiences in patients (6-11 years) which were reported by >2% of patients treated with fexofenadine HCl tablets at a dose of 30 mg twice daily in placebo-controlled seasonal allergic rhinitis studies in the United States and Canada that were more common with fexofenadine HCl than placebo. (See Table 2.)

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Chronic Idiopathic Urticaria: Adverse events reported by patients ≥12 years in placebo-controlled chronic idiopathic urticaria studies were similar to those reported in placebo-controlled seasonal allergic rhinitis studies. In placebo-controlled chronic idiopathic urticaria clinical trials, which included 726 patients ≥12 years receiving fexofenadine HCl tablets at doses of 20-240 mg twice daily, adverse events were similar in fexofenadine HCl and placebo-treated patients.
Table 3 lists adverse experiences in patients aged ≥12 years which were reported by >2% of patients treated with fexofenadine HCl 60 mg tab twice daily in controlled clinical studies in the United States and Canada and that were more common with fexofenadine HCl than placebo. The safety of fexofenadine HCl in the treatment of chronic idiopathic urticaria in pediatric patients (6-11 years) is based on the safety profile of fexofenadine HCl in adults and adolescent patients at doses equal to or higher than the recommended dose (see Use in children under Precautions). (See Table 3.)

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Events that have been reported during controlled clinical trials involving seasonal allergic rhinitis and chronic idiopathic urticaria patients with incidences <1% and similar to placebo and have been rarely reported during post-marketing surveillance include: Insomnia, nervousness and sleep disorders or paroniria. In rare cases, rash, urticaria, pruritus and hypersensitivity reactions with manifestations eg, angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.
Oral suspension: In placebo-controlled studies involving patients with seasonal allergic rhinitis and chronic idiopathic urticaria, adverse events were similar to those of patients treated with placebo or fexofenadine.
Most frequently reported adverse events by adults include: headache (>3%), drowsiness, dizziness and nausea (1-3%). The adverse events reported during the controlled studies involving patients with seasonal allergic rhinitis and chronic idiopathic urticaria, with an incidence lower than 1% and similar to those of the placebo group and that were rarely reported during post-marketing experience include: fatigue, insomnia, nervousness, sleep disorders or paroniria. Patients also reported rare cases of rash, urticaria, pruritus and hypersensitivity reactions such as: angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis.
The adverse events reported in placebo-controlled studies of chronic idiopathic urticaria were similar to those reported in placebo-controlled studies of allergic rhinitis.
In placebo-controlled studies in children from 6 to 11 years of age with seasonal allergic rhinitis, adverse events were similar to those observed in clinical studies involving adults and children 12 years of age or older with seasonal allergic rhinitis.
In controlled clinical studies involving pediatric patients from 6 months to 5 years of age, no unexpected adverse events were observed in patients treated with fexofenadine hydrochloride.
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