Land: Bretland
Tungumál: enska
Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)
Valaciclovir hydrochloride
Aptil Pharma Ltd
J05AB11
Valaciclovir hydrochloride
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05030201
ACCORD LOGO VALACICLOVIR 500MG TABLETS_ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. WHAT VALACICLOVIR TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALACICLOVIR TABLETS 3. HOW TO TAKE VALACICLOVIR TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE VALACICLOVIR TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT VALACICLOVIR TABLETS ARE AND WHAT THEY ARE USED FOR Valaciclovir belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses called herpes simplex (HSV), varicella zoster (VZV) and cytomegalovirus (CMV). Valaciclovir can be used to: • treat shingles (in adults). • treat HSV infections of the skin and genital herpes (in adults and adolescents over 12 years old). It is also used to help prevent these infections from returning. • treat cold sores (in adults and adolescents over 12 years old). • prevent infection with CMV after organ transplants (in adults and adolescents over 12 years old). • treat and prevent HSV infections of the eye that continue to come back (in adults and adolescents over 12 years old). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALACICLOVIR TABLETS DO NOT TAKE VALACICLOVIR TABLETS • if you are ALLERGIC to valaciclovir or aciclovir or any of the other ingredients of -this medicine (listed in Section 6). • Do not take Valaciclovir Tablets if this applies to you. If you are not sure, talk to your doctor or pharmacist before taking Valaciclovir Tablets. WARNINGS AND PRECAUTIO Lestu allt skjalið
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Valaciclovir 500mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500mg, valaciclovir (as valaciclovir hydrochloride monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet 500mg tablets: Oval, white, biconvex, film-coated tablets, 17.6 x 8.8 mm with VC2 on one side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Varicella zoster virus (VZV) infections – herpes zoster _ Valaciclovir tablets are indicated for the treatment of herpes zoster (shingles) and ophthalmic zoster in immunocompetent adults (see sections 4.4). Valaciclovir tablets are 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 tablets are 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 in immunocompetent adults and adolescents and in immunocompromised adults (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 tablets are indicated for the prophylaxis of CMV infection and disease following solid organ transplantation in adults and adolescents (see section 4.4) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Varicella zoster virus (VZV) infections – herpes zoster and ophthalmic zoster _ Patients should be advised to start treatment as soon as possible af Lestu allt skjalið