Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
FAMCICLOVIR
Fannin UK Ltd
500 Milligram
Film Coated Tablet
2011-10-14
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Famciclovir 500 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 mg famciclovir. Each tablet contains 44 mg lactose. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Famciclovir 500 mg tablets are white to off-white coloured, capsule shaped, biconvex film-coated tablets plain on both sides. 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 immunocompromisedadults 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. Treatment should be initiated as soon as possible after a diagnosis of herpes zoster. Genital herpes in immunocompetent adults First episode of genital herpes: 250 mg three times daily for five days. Initiation of treatment is recommended as soon as possible after a diagnosis Lire le document complet