Telfast

/ Sanofi

Adults
Telfast 120 mg film-coated tablets: The recommended dose of fexofenadine hydrochloride for adults is 120 mg once daily taken before a meal.
Telfast 180 mg film-coated tablets: The recommended dose of fexofenadine hydrochloride for adults is 180 mg once daily taken before a meal. Fexofenadine is a pharmacologically active metabolite of terfenadine.
Fexofenadine is a pharmacologically active metabolite of terfenadine.
Pediatric population
Children aged 12 years and over
Telfast 120 mg film-coated tablets: The recommended dose of fexofenadine hydrochloride for children aged 12 years and over is 120 mg once daily taken before a meal.
Telfast 180 mg film-coated tablets: The recommended dose of fexofenadine hydrochloride for children aged 12 years and over is 180 mg once daily taken before a meal.
Children under 12 years of age: The efficacy and safety of fexofenadine hydrochloride has not been studied in children under 12.
Special populations: 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.

Telfast 120 mg film-coated tablets:  Relief of symptoms associated with seasonal allergic rhinitis.
Telfast 180 mg film-coated tablets: Relief of symptoms associated with chronic idiopathic urticaria.

Hypersensitivity to the active substance or to any of the excipients. 

As with most new medicinal products there is only limited data in the elderly and renally or hepatically impaired patients. Fexofenadine hydrochloride should be administered with care in these special groups. Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a medicine class, have been associated with the adverse reactions, tachycardia and palpitations.

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 (≥1/100 to <1/10): headache, drowsiness, dizziness.
Gastrointestinal disorders: Common (≥1/100 to <1/10): nausea.
General disorders and administration site conditions: Uncommon (≥1/1,000 to <1/100): fatigue
In adults, the following undesirable effects have been reported in post-marketing surveillance. The frequency with which they occur is not known (can not 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.

Fexofenadine does not undergo hepatic biotransformation and therefore will not interact with other drugs through hepatic mechanisms. Coadministration of fexofenadine hydrochloride with erythromycin or ketoconazole has been found to result in a 2-3 times increase in the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse reactions compared to the medicinal products given singly.
Animal studies have shown that the increase in plasma levels of fexofenadine observed after coadministration of erythromycin or ketoconazole, appears to be due to an increase in gastrointestinal absorption and either a decrease in biliary excretion or gastrointestinal secretion, respectively. No interaction between fexofenadine and omeprazole was observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of fexofenadine hydrochloride and aluminium and magnesium hydroxide containing antacids.

Pregnancy: There are no adequate data from the use of fexofenadine hydrochloride in pregnant women. Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development. Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary.
Lactation: There are no data on the content of human milk after administering fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers fexofenadine was found to cross into human breast milk. Therefore fexofenadine hydrochloride is not recommended for mothers breast feeding their babies.

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 events 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.