Страна: Мальта
Язык: английский
Источник: Medicines Authority
ACICLOVIR
The Wellcome Foundation 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
J05AB01
ACICLOVIR 200 mg
DISPERSIBLE FILM-COATED TABLET
ACICLOVIR 200 mg
POM
ANTIVIRALS FOR SYSTEMIC USE
Withdrawn
2006-11-20
(GLAXOSMITHKLINE LOGO) PACKAGE LEAFLET: INFORMATION FOR THE USER ZOVIRAX TABLETS 200 MG ACICLOVIR 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. IN THIS LEAFLET: 1 What Zovirax is and what it is used for 2 What you need to know before you take Zovirax 3 How to take Zovirax 4 Possible side effects 5 How to store Zovirax 6 Contents of the pack and other information 1 WHAT ZOVIRAX IS AND WHAT IT IS USED FOR Zovirax Tablets 200 mg (called ‘Zovirax’ in this leaflet) contains a medicine called aciclovir. This belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses. Zovirax can be used to: • treat chickenpox and shingles • treat cold sores, genital herpes and other herpes simplex infections • stop these problems returning after you have had them • stop these problems in people whose immune systems work less well, which means their bodies are less able to fight infections. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOVIRAX DO NOT USE ZOVIRAX: • if you are allergic to aciclovir or valaciclovir or any of the other ingredients of this medicine (listed in Section 6). Do not take Zovirax if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Zovirax. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Zovirax if: • you have kidney problems • you are over 65 years of age. If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking Zovirax. It is important that you drink pl Прочитать полный документ
Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Zovirax Tablets 200 mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Aciclovir BP 200 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dispersible film-coated tablet. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Zovirax Tablets are indicated for the treatment of herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes (excluding neonatal HSV and severe HSV infections in immunocompromised children). Zovirax Tablets are indicated for the suppression (prevention of recurrences) of recurrent herpes simplex infections in immunocompetent patients. Zovirax Tablets are indicated for the prophylaxis of herpes simplex infections in immunocompromised patients. Zovirax Tablets are indicated for the treatment of varicella (chickenpox) and herpes zoster (shingles) infections. Route of administration: Oral. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Zovirax tablets may be dispersed in a minimum of 50 ml of water or swallowed whole with a little water. Ensure that patients on high doses of aciclovir are adequately hydrated. Dosage in adults Treatment of herpes simplex infections: 200 mg Zovirax should be taken five times daily at approximately four hourly intervals omitting the night time dose. Treatment should continue for 5 days, but in severe initial infections this may have to be extended. In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut the dose can be doubled to 400 mg Zovirax or alternatively intravenous dosing could be considered. Page 2 of 10 Dosing should begin as early as possible after the start of an infection; for recurrent episodes this should preferably be during the prodromal period or when lesions first appear. Suppression of herpes simplex infections in immunocompetent patients: 200 mg Zovirax should be taken four times daily at approximately six-hourly intervals. Man Прочитать полный документ