Source: Health Products Regulatory Authority (IE) Revision Year: 2023 Publisher: Opella Healthcare France SAS T/A Sanofi, 82 Avenue Raspail, 94250 Gentilly, France
Telfast 120 mg is indicated in adults and children 12 years and older for the relief of symptoms associated with seasonal allergic rhinitis.
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.
The recommended dose of fexofenadine hydrochloride for children aged 12 years and over is 120 mg once daily taken before a meal.
The efficacy and safety of fexofenadine hydrochloride 120 mg has not been studied in children under 12.
In children from 6 to 11 years of age: fexofenadine hydrochloride 30 mg tablet is the appropriate formulation for administration and dosing in this population.
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.
Dizziness, drowsiness, fatigue and dry mouth have been reported with overdose of fexofenadine hydrochloride. Single doses up to 800 mg and doses up to 690 mg twice daily for 1 month or 240 mg once daily for 1 year have been administered to healthy subjects without the development of clinically significant adverse reactions as compared with placebo. The maximum tolerated dose of fexofenadine hydrochloride has not been established.
Standard measures should be considered to remove any unabsorbed medicinal product. Symptomatic and supportive treatment is recommended. Haemodialysis does not effectively remove fexofenadine hydrochloride from blood.
3 years.
This medicinal product does not require any special storage conditions.
PVC/PE/PVDC/Al or PVC/PVDC/Al blisters, packaged into cardboard boxes. 2(sample only), 7, 10, 15, 20, 30, 50, 100 and 200 (as 10x20) tablets per package.
Not all pack sizes may be marketed.
No special requirements.
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