Nazione: Malta
Lingua: inglese
Fonte: Medicines Authority
ACICLOVIR
Delorbis Pharmaceuticals Limited 17 Athinon Str, Ergates Industrial Area, 2643 Ergates, PO Box 28629, 2081 Lefkosia, Cyprus
J05AB01
ACICLOVIR 400 mg
TABLET
ACICLOVIR 400 mg
POM
ANTIVIRALS FOR SYSTEMIC USE
Authorised
2006-06-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER VIRUCID 200 MG TABLETS VIRUCID 400 MG TABLETS 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 might 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 side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Virucid is and what it is used for 2. What you need to know before you take Virucid 3. How to take Virucid 4. Possible side effects 5. How to store Virucid 6. Contents of the pack and other information 1. WHAT VIRUCID IS AND WHAT IT IS USED FOR Virucid contains a medicine called aciclovir. This belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses. Virucid can be used to: • treat chickenpox and shingles • treat cold sores and genital herpes • 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 VIRUCID DO NOT TAKE VIRUCID: • if you are allergic to aciclovir or valaciclovir or any of the other ingredients of this medicine (listed in Section 6). Do not take Virucid if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Virucid. 2 WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Virucid 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 Virucid. It is important that you drink plenty of water while taking Virucid. OTHER MEDICINES AND VIRUCID Please tel Leggi il documento completo
1. NAME OF THE MEDICAL PRODUCT Virucid 400 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg aciclovir. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Virucid 400 mg tablets are white, flat, round tablets, scored on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Virucid 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). Virucid tablets are indicated for the suppression (prevention of recurrences) of recurrent herpes simplex infections in immunocompetent patients. Virucid tablets are indicated for the prophylaxis of herpes simplex infections in immunocompromised patients. Virucid 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 Ensure that patients on high doses of aciclovir are adequately hydrated. Page 1 of 11 _ _ Dosage in adults _ _ Treatment of herpes simplex infections: 200 mg Virucid 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 severe immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut the dose can be doubled to 400 mg Virucid or alternatively intravenous dosing could be considered. 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 infections in immunocompetent patients: 200 mg Virucid should be taken four times daily at approximately six-hourly intervals. Many patients may be conveniently managed on a regimen of 400 mg Virucid twice daily at approxi Leggi il documento completo