国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Fexofenadine hydrochloride
Azure Pharmaceuticals Ltd
R06AX26
Fexofenadine hydrochloride
120 milligram(s)
Film-coated tablet
fexofenadine
Marketed
2020-06-26
Fexofenadine Hydrochloride 120 mg Film-coated Tablets Module 1 Administrative Information and Prescribing Information 1.3 Product Information PACKAGE LEAFLET: INFORMATION FOR THE USER FEXOFENADINE HYDROCHLORIDE 120 MG FILM-COATED TABLETS (fexofenadine hydrochloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What Fexofenadine Hydrochloride Tablets is and what it is used for _2._ _ _ What you need to know before you take Fexofenadine Hydrochloride Tablets _ _ _3._ _ _ How to take Fexofenadine Hydrochloride Tablets _ _ 4. Possible side effects _5._ _ _ How to store Fexofenadine Hydrochloride Tablets _ _ 6. Contents of the pack and other information 1. WHAT FEXOFENADINE HYDROCHLORIDE TABLETS IS AND WHAT IT IS USED FOR Fexofenadine Hydrochloride 120 mg Film-coated Tablets (called Fexofenadine Hydrochloride Tablets throughout this leaflet) contains fexofenadine hydrochloride, which is a non-drowsy antihistamine. Fexofenadine Hydrochloride Tablets is used in adults and adolescents of 12 years and older to relieve the symptoms that occur with hay fever (seasonal allergic rhinitis) such as sneezing, itchy, runny or blocked nose and itchy, red and watery eyes. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEXOFENADINE HYDROCHLORIDE TABLETS DO NOT TAKE FEXOFENADINE HYDROCHLORIDE TABLETS: • if you are allergic to fexofenadine or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Fexofenadine 完全なドキュメントを読む
Health Products Regulatory Authority 16 June 2023 CRN00DKD8 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fexofenadine Hydrochloride 120 mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 120 mg of fexofenadine hydrochloride, which is equivalent to 112 mg of fexofenadine. Excipient(s) with known effect: Each tablet contains 152.42 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Peach-coloured capsule-shaped film-coated tablet of 16.00 mm x 6.20 mm x 4.90 mm, debossed as '120' on one side and 'FX' on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fexofenadine Hydrochloride 120 mg is indicated in adults and children 12 years and older for the relief of symptoms associated with seasonal allergic rhinitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _ADULTS_ 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. _PAEDIATRIC POPULATION_ - Children aged 12 years and over The recommended dose of fexofenadine hydrochloride for children aged 12 years and over is 120 mg one daily taken before a meal. - Children under 12 years of age 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. _ _ _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. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE There is limited data in the elderly and renally or hepatically impaired patients. Fexofenadine hydrochlo 完全なドキュメントを読む