Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fexofenadine hydrochloride
Sanofi Consumer Healthcare
R06AX26
Fexofenadine hydrochloride
180mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100; GTIN: 5015265300333
04/10/2019 10:04 - VISTAlink folder 103826549 - Page 1/4 PACKAGE LEAFLET: INFORMATION FOR THE USER TELFAST 180 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. • 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 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 fexofenadine is and what it is used for 2. What you need to know before you take fexofenadine 3. How to take fexofenadine 4. Possible side effects 5. How to store fexofenadine 6. Contents of the pack and other information 1. WHAT FEXOFENADINE IS AND WHAT IT IS USED FOR The name of this medicine is Telfast 180 mg film coated tablets, referred to as Fexofenadine throughout this leaflet. Fexofenadine is an antihistamine. Fexofenadine 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 DO NOT TAKE FEXOFENADINE • 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 if: • you have problems with your liver or kidneys. • you have or ever had heart disease, since this kind of medicine may lead to a fast or irregular heartbeat • you are elderly. If any of these apply to you, or you are not sure, tell your doctor before taking fexofenadine. OTHER MEDICINES AND FEXOFENADINE Tell your doctor or pharmacist if you are taking, have recently taken or might t Preberite celoten dokument
OBJECT 1 TELFAST 180MG FILM-COATED TABLETS Summary of Product Characteristics Updated 25-Oct-2019 | SANOFI • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Telfast 180 mg 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 the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet 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 Telfast 180 mg is indicated in adults and children 12 years and older for the relief of symptoms associated with chronic idiopathic urticaria. 4.2 Posology and method of administration Posology _Adults_ 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. _Paed Preberite celoten dokument