Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
VALACICLOVIR HYDROCHLORIDE MONOHYDRATE
Clonmel Healthcare Ltd
500 Milligram
Film Coated Tablet
2011-04-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Valaciclovir Clonmel 500mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 556.240 mg Valaciclovir hydrochloride monohydrate, equivalent to 500 mg of Valaciclovir. Excipient(s): Each film-coated tablet contains 55.82 mg lactose (as 58.76mg of lactose monohydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Cream-coloured, oblong film-coated tablets with a breaking notch. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Varicella zoster virus (VZV) infections – herpes zoster_ Valaciclovir PharOS is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults (see section 4.4). Valaciclovir PharOS is indicated for the treatment of herpes zoster in adult patients with mild or moderate immunosuppression (see section 4.4) _Herpes simplex virus (HSV) infections_ Valaciclovir PharOS is indicated • for the treatment and suppression of HSV infections of the skin and mucous membranes including - treatment of first-episode of genital herpes in immunocompetent adults and adolescents and in immunocompromised adults - treatment of recurrences of genital herpes in immunocompetent adults and adolescents, and in immunocompromised adults - suppression of recurrent genital herpes in immunocompetent adults and adolescents, and in immunocompromised adults • Treatment and suppression of recurrent ocular HSV-infections (see section 4.4) Clinical studies have not been conducted in HSV-infected patients immuncompromised for other causes than HIV- infection (see 5.1) _Cytomegalovirus (CMV) infections:_ Valaciclovir PharOS is indicated for the prophylaxis of CMV infection and Read the complete document