Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
VALACICLOVIR HYDROCHLORIDE MONOHYDRATE
Pfizer Healthcare Ireland
500 Milligram
Film Coated Tablet
2011-06-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Valaciclovir Pfizer 500 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Valaciclovir 500 mg film-coated tablets Each tablet contains valaciclovir hydrochloride (hydrated) equivalent to 500 mg valaciclovir. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Blue, film-coated, capsule shaped tablets with a partial score bar on both sides containing ‘F’ on one side and ‘9’ and ‘3’ on the other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Varicella zoster virus (VZV) infections – herpes zoster_ Valaciclovir is indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults (see section 4.4). Valaciclovir 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 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 patients - recurrences of genital herpes in immunocompetent and immunocompromised patients - suppression of recurrent genital herpes in immunocompetent and immunocompromised patients • Treatment and suppression of recurrent ocular HSV infections (see section 4.4) Clinical studies have not been conducted in HSV-infected patients immunocompromised for other causes than HIV- infection (see section 5.1). _Cytomegalovirus (CMV) infections_: Valaciclovir is indicated for the prophylaxis of CMV infection and disease following solid organ transplantation in adults and adolescents (see section 4.4) IRISH MEDICINES BOARD ______________ Read the complete document