Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Fexofenadine hydrochloride
Chanelle Medical Unlimited Company
R06AX; R06AX26
Fexofenadine hydrochloride
120 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Other antihistamines for systemic use; fexofenadine
Not marketed
2007-09-14
ID1088 MRP _ IE VERSION: 08 EFFECTIVE DATE: 21/02/2023 PAGE 1 OF 4 PACKAGE LEAFLET: INFORMATION FOR THE USER FEXOFENADINE HYDROCHLORIDE 120 MG FILM-COATED TABLETS FEXOFENADINE HYDROCHLORIDE 180 MG FILM-COATED TABLETS FEXOFENADINE HYDROCHLORIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of symptoms are the same as yours. - If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet, .(see section 4). IN THIS LEAFLET: 1. What Fexofenadine hydrochloride is and what it is used for 2. What you need to know before you take Fexofenadine hydrochloride 3. How to take Fexofenadine hydrochloride 4. Possible side effects of Fexofenadine hydrochloride 5. How to store Fexofenadine hydrochloride 6. Contents of the pack and other information 1. WHAT FEXOFENADINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR FEXOFENADINE HYDROCHLORIDE contains fexofenadine hydrochloride which is an antihistamines. Fexofenadine hydrochloride 120 mg tablets is used in adults and adolescents of 12 years and older to relieve the symptoms that occur with hay fever (seasonal allerigic rhinitis) such as sneezing, itchy, running or blocked nose and itchy, red an watery eye ). Fexofenadine hydrochloride 180 mg tablets is used in adults and adolescents of 12 years and older to relieve the symptoms that occur with long term allergic skin reactions ( chronic idiopathic urticaria) such as itching, swelling and rashes. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEXOFENADINE HYDROCHLORIDE DO NOT TAKE FEXOFENADINE HYDROCHLORIDE: - 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 read_full_document
Health Products Regulatory Authority 17 October 2023 CRN00DFWL 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 For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Peach coloured oblong, bi-convex film-coated tablet with dimensions of 14.9-15.3 mm x 6.4-6.8 mm; plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fexofenadine hydrochloride 120 mgis indicated in adults and chlidren 12 years and older for the relief of symptoms associated with seasonal allergic rhinitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posolgy _ _ _Adults_ The recommended dose of fexofenadine hydrochloride in 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 once daily taken before a meal. _Children under 12 years:_ 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 (older people renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients. 4.3 CONTRAINDICATIONS Health Products Regulatory Authority 17 October 2023 CRN00DFWL Page 2 of 6 Hypersensitivity to the active substance or to any of the excipients (listed in section 6.1). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with most new medicinal products there is only limited data in the elderly and renally or hepatically impaired pati read_full_document