Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FEXOFENADINE HCL
MYLAN HEALTHCARE SDN. BHD.
FEXOFENADINE HCL
10tablet Tablets
Medreich Limited (Unit 3)
_Consumer Medication Information Leaflet (RiMUP) _ XAFEN ™ 180 Fexofenadine (180mg) 1 WHAT IS IN THIS LEAFLET 1. What _Xafen _ is used for 2. How _Xafen _ works _3._ _ _ Before you use _Xafen _ _4._ _ _ How to use _Xafen _ 5. While you are using it 6. Side effects _7._ _ _ Storage and Disposal of _Xafen _ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT _XAFEN _IS USED FOR Relief of symptoms associated with seasonal allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation. Relief of symptoms associated with chronic idiopathic urticarial. Relief of symptoms associated with perennial allergic rhinitis. HOW _XAFEN _WORKS Fexofenadine hydrochloride is a non- sedating H1 antihistamine. Fexofenadine is a pharmacologically active metabolite of terfenadine. Human histamine wheal and flare studies following single and twice daily doses of fexofenadine hydrochloride demonstrate that the drug exhibits an antihistaminic effect beginning within one hour, achieving maximum at 6 hours and lasting 24 hours. There was no evidence of tolerance to these effects after 28 days of dosing. A positive dose-response relationship between doses of 10 mg to 130 mg taken orally was found to exist. In this model of antihistaminic activity, it was found that doses of at least 130 mg were required to achieve a consistent effect that was maintained over a 24 hour period. BEFORE YOU USE _XAFEN _ - _When you must not use it _ _Pregnancy and lactation _ There are no adequate data from the use of fexofenadine hydrochloride in pregnant women. Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development. Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary. LACTATION There are no data on the content of human milk after administering fexofenadine hydrochloride. However, when terfenadine was administered to n read_full_document
XAFEN 180 ( Fexofenadine Hydrochloride Tablets 180 mg ) LABEL CLAIM Each film tablet contains Fexofenadine Hydrochloride Ph.Eur 180 mg equivalent 168 mg of Fexofenadine. DESCRIPTION _Fexofenadine Hydrochloride Tablets 180 mg: _ Peach colored, Caplet shape film coated tablet, debossed as ‘180’ on one side and plain on other side. LIST OF EXCIPIENTS: Silicified Microcrystalline Cellulose, Mannitol, Croscarmellose Sodium, Magnesium Stearate, Hypromellose, Titanium Dioxide, Colloidal Anhydrous Silica, Talc, Macrogols, Iron oxide Red, Iron oxide Yellow. THERAPEUTIC INDICATIONS Indicated for the relief of symptoms associated with chronic idiopathic urticaria and allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose / palate / throat itchy / watery red eyes. POSOLOGY AND METHOD OF ADMINISTRATION ALLERGIC RHINITIS 60 mg twice daily OR 120 mg once daily OR 180 mg once daily. CHRONIC IDIOPATHIC URTICARIA 60 mg twice daily OR 180 mg once daily. SPECIAL RISK GROUP It is not necessary to adjust the dose of fexofenadine hydrochloride in special risk groups (elderly, renally or hepatically impaired patients). CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. 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. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Fexofenadine hydrochloride does not undergo hepatic biotransformation and therefore will not interact with other drugs through hepatic mechanisms. Co-administration of fexofenadine hydrochloride with erythromycin or ketoconazole has been found to result in a read_full_document