Country: Malta
Tungumál: enska
Heimild: Medicines Authority
ACICLOVIR
Delorbis Pharmaceuticals Limited 17 Athinon Str, Ergates Industrial Area, 2643 Ergates, PO Box 28629, 2081 Lefkosia, Cyprus
J05AB01
ACICLOVIR 800 mg
TABLET
ACICLOVIR 800 mg
POM
ANTIVIRALS FOR SYSTEMIC USE
Authorised
2006-06-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER VIRUCID 800 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 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 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 800 mg tablets (called “Virucid” in this leaflet) contain a medicine called aciclovir. This belongs to group of medicines called antivirals. It works by killing or stopping the growth of viruses. Virucid can be used to: • treat chickenpox and shingles. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIRUCID DO NOT USE 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. 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 Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. 2 In particular Lestu allt skjalið
1. NAME OF THE MEDICINAL PRODUCT Virucid 800 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 800 mg of aciclovir. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Virucid 800 mg tablets are indicated for the treatment of varicella (chickenpox) and herpes zoster (shingles) infections (excluding neonatal HSV and severe HSV infections in immunocompromised children). Virucid 800 mg is recommended in children over the age of 6. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Dosage in adults: Treatment of varicella and herpes zoster infections: 800 mg Virucid should be taken five times daily at approximately four-hourly intervals, omitting the night time dose. Treatment should continue for seven days. Page 1 of 12 In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing. Dosing should begin as early as possible after the start of an infection: Treatment of herpes zoster yields better results if initiated as soon as possible after the onset of the rash. Treatment of chickenpox in immunocompetent patients should begin within 24 hours after the onset of the rash. Dosage in children: Treatment of varicella infections: 6 years and over: 800 mg Virucid four times daily. Treatment should continue for five days. No specific data are available on the treatment of herpes zoster infections in immunocompetent children. For treatment of neonatal herpes virus infections, intravenous acyclovir is recommended. Dosage in the elderly: The possibility of renal impairment in the elderly must be considered and the dosage should be adjusted accordingly (see Dosage in renal impairment below). Adequate hydration of elderly patients taking high oral doses of aciclovir should be maintained. Dosage in renal impairment: Caution is advised when administering aciclovir to patients with impaired renal function. Adequate hydra Lestu allt skjalið