Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Fexofenadine hydrochloride
Sanofi-Aventis Ireland Limited T/A SANOFI
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
Marketed
1997-11-11
16/08/2021 11:39 - VISTAlink folder 4142241 - Page 1/7 _créé le_ _par_ _modifié le_ _par_ 09/12/2020 DERIGNY C 14/06/2021 DERIGNY C SANOFI IRLANDE _Laboratoires_ _Pays_ _Couleur_ _Nbre/Réf._ _Version N°_ _Type Article_ _Nom du produit_ _Référence article_ _Dosage_ _Quantité_ _N° version Logo/Name_ _N° version Country Ex._ _N° plan Dimensionnel_ _N° plan positionnement_ _Dimensions_ _Taille mini caractères_ _Code sécurité_ R790360 N.A. CRIE-V1-10/09/2012 1-606251 606251-1A 150 X 210 MM 9 PTS 2 NOTICE TRIPLE TAVANIC R790360 250 MG & 500 MG CPRS 1 PANTONE REFLEX BLUE U _Numéro de pages_ 1/6 PACKAGE LEAFLET: INFORMATION FOR THE USER IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 403 5600 FOR HELP READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 illness are the same as yours. • 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. WHAT IS IN THIS LEAFLET 1. What Tavanic tablets are and what they are used for 2. What you need to know before you take Tavanic tablets 3. How to take Tavanic tablets 4. Possible side effects 5. How to store Tavanic tablets 6. Contents of the pack and other information 1. WHAT TAVANIC TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Tavanic tablets. Tavanic tablets contain a medicine called levofloxacin. This belongs to a group of medicines called antibiotics. Levofloxacin is a ‘quinolone’ antibiotic. It works by killing the bacteria that cause infections in your body. TAVANIC TABLETS CAN BE USED TO TREAT INFECTIONS OF THE: • Sinuses • Lungs, in people with long-term breathing problems or pneumonia • Urinary tract, including your kidneys or Read the complete document
Health Products Regulatory Authority 09 June 2021 CRN009WL8 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Telfast 120 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 120 mg of fexofenadine hydrochloride, which is equivalent to 112 mg of fexofenadine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablets. Peach, modified capsule-shaped, film-coated tablet of 6.1 x 15.8mm debossed with 012 on one side and a scripted e on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Telfast 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 once 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 hydrochloride should be administered with care in these special groups (see section 4.2). Health Products R Read the complete document