Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
FAMCICLOVIR
Arrow Generics Limited
250 Milligram
Film Coated Tablet
2008-10-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Famlov 250mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250mg 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 “250” 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. 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 of first episode of genital herpes. Episodi read_full_document