Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
FEXOFENADINE HYDROCHLORIDE
McDowell Pharmaceuticals
R06AX26
FEXOFENADINE HYDROCHLORIDE
180 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
other antihistamines for systemic use
Authorised
2011-09-23
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Telfast 180mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 180 mg of fexofenadine hydrochloride, which is equivalent to 168 mg of fexofenadine. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM _Product imported from the UK_ Film coated tablets. Peach capsule-shaped, film-coated tablet debossed with "018" on one side and a scripted "e" on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Relief of symptoms associated with chronic idiopathic urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS AND CHILDREN AGED 12 YEARS AND OVER_ The recommended dose of fexofenadine hydrochloride for adults and children aged 12 years and over is 180 mg once daily taken before a meal. Fexofenadine is a pharmacologically active metabolite of terfenadine. _CHILDREN UNDER 12 YEARS OF AGE_ The efficacy and safety of fexofenadine hydrochloride has not been studied in children under 12. _SPECIAL RISK GROUPS_ 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. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with most new drugs 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 drug class, have been associated with the adverse events, tachycardia and palpitations _(see section 4.8)._ IRISH MEDICINES BOARD _____________ Прочитать полный документ