Land: Malta
Sprache: Englisch
Quelle: Medicines Authority
FAMCICLOVIR
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
J05AB09
FAMCICLOVIR 500 mg
FILM-COATED TABLET
FAMCICLOVIR 500 mg
POM
ANTIVIRALS FOR SYSTEMIC USE
Withdrawn
2009-03-09
PACKAGE LEAFLET: INFORMATION FOR THE USER FAMCICLOVIR 125MG, 250MG OR 500MG FILM-COATED TABLETS (Famciclovir) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - 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. Do NOT pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Famciclovir Tablets are and what they are used for 2. Before you take Famciclovir Tablets 3. How to take Famciclovir Tablets 4. Possible side effects 5. How to store Famciclovir Tablets 6. Further information 1. WHAT FAMCICLOVIR TABLETS ARE AND WHAT THEY ARE USED FOR Famciclovir is an antiviral medicine. It stops the infecting virus from reproducing. Since the virus reproduces very early in the infection, you will benefit most from treatment if you take Famciclovir Tablets as soon as the first symptoms appear. Famciclovir Tablets are used to treat two types of viral infections in adults: - Shingles (herpes zoster), which is a viral infection caused by a virus called varicella zoster (the same virus that causes chickenpox). Famciclovir stops the virus from spreading in the body so that healing can occur faster. - Famciclovir is also used for the treatment of shingles in the area around the eye or of the eye itself (ophthalmic zoster). - Genital herpes. Genital herpes is a viral infection caused by herpes simplex virus type 1 or 2. It is normally spread by sexual contact. It causes blisters and burning or itching around the genitals, which may be painful. Famciclovir is used to treat genital herpes infections in adults. People who have Lesen Sie das vollständige Dokument
1. NAME OF THE MEDICINAL PRODUCT Famciclovir 125mg Film-coated Tablets FAMCICLOVIR 250MG FILM-COATED TABLETS FAMCICLOVIR 500MG FILM-COATED TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 125mg of famciclovir. EACH FILM-COATED TABLET CONTAINS 250MG OF FAMCICLOVIR. EACH FILM-COATED TABLET CONTAINS 500MG OF FAMCICLOVIR. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated Tablet. White, round, coated tablet with ‘FC’ over “125” on one side and ‘>’ on the other side. WHITE, ROUND, COATED TABLET WITH ‘FC’ OVER “250” ON ONE SIDE AND ‘>’ ON THE OTHER SIDE. WHITE, CAPSULE-SHAPED, COATED TABLET WITH ‘FC 500” ON ONE SIDE AND ‘>’ ON THE OTHER SIDE. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Varicella zoster virus (VZV) infections – herpes zoster Famciclovir is indicated for - the treatment of herpes zoster and ophthalmic zoster in immunocompetent adults (see section 4.4) - the treatment of herpes zoster in immunocompromised adults (see section 4.4) Herpes simplex virus (HSV) infections – genital herpes Famciclovir is indicated for - the treatment of first and recurrent episodes of genital herpes in immunocompetent adults - the treatment of recurrent episodes of genital herpes in immunocompromised adults - the suppression of recurrent genital herpes in immunocompetent and immunocompromised adults Clinical studies have not been conducted in HSV-infected patients immunocompromised for other causes than HIV-infection (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Herpes zoster in immunocompetent adults 500 mg three times daily for seven days. Treatment should be initiated as soon as possible after a diagnosis of herpes zoster. Herpes zoster in immunocompromised adults 500 mg three times daily for ten days. Lesen Sie das vollständige Dokument