Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Cipla Europe NV, De Keyserlei 58-60, Box-19, 2018 Antwerp, Belgium
Fexofenadine Hydrohloride is indicated in adults and children 12 years and over 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 120mg has not been studied in children under 12.
In children from 6 to 11 years of age: fexofenadine hydrochloride 30mg tablet is the appropriate formulation for administration and dosing in this population.
Studies in special risk groups (elderly, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients.
Symptoms of dizziness, drowsiness, fatigue and dry mouth have been reported with overdose of fexofenadine hydrochloride. Single doses up to 800mg, and doses up to 690mg twice daily for 1 month, or 240mg 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 fexofenadine. Symptomatic and supportive treatment is recommended. Haemodialysis does not effectively remove fexofenadine hydrochloride from blood.
3 years.
Store the tablets in the original package. This medicinal product does not require any special temperature storage conditions.
PVC/PVDC foil blister packs of 7, 10, 15, 20, 30, 50, 100 or 500 tablets.
Not all pack sizes may be marketed.
No special requirements.
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