Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Aciclovir
IMED Healthcare Ltd.
J05AB; J05AB01
Aciclovir
Dispersible tablet
Nucleosides and nucleotides excl. reverse transcriptase inhibitors; aciclovir
2023-05-12
PACKAGE LEAFLET: INFORMATION FOR THE USER ZOVIRAX 800 MG DISPERSIBLE 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. Do not pass it on to others. It may harm them, even if their symptoms 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 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 800 mg Dispersible Tablets (called ‘Zovirax’ in this leaflet) contain a medicine called aciclovir. This belongs to a group of medicines called antivirals. It works by stopping the growth of viruses. Zovirax 800 mg Dispersible Tablets can be used to: treat chickenpox treat shingles, and when started right after the rash appears, it can help reduce the nerve pain that can exist after the shingles rash has cleared 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOVIRAX DO NOT USE ZOVIRAX IF: you are allergic (hypersensitive) to aciclovir, valaciclovir or any of the other ingredients (listed in Section 6). Do not have Zovirax if the above applies to you. If you are not sure, check with your doctor or pharmacist before taking Zovirax. WARNINGS AND PRECAUTIONS Check with your doctor or pharmacist before taking Zovirax if: you have kidney problems you are over 65 years of age you are thirsty. You must make sure you drink plenty of liquids such as water whilst taking this medicine your immune system is weak If you are not sure if the above apply to you, check with your doctor or pharmacist before takin Baca dokumen lengkap
Health Products Regulatory Authority 12 May 2023 CRN00DHZ2 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zovirax 800 mg Dispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dispersible tablet contains 800 mg aciclovir. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Dispersible Tablets. _Product imported from Greece:_ White, biconvex, elongated, film-coated tablet, impressed with 'GX CG1' on one face and plain on the other. 4 CLINICAL PARTICULARS As per PA1077/084/009 5 PHARMACOLOGICAL PROPERTIES As per PA1077/084/009 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Microcrystalline cellulose Aluminium magnesium silicate Sodium starch glycollate Povidone K30 Magnesium stearate Hypromellose Titanium Dioxide (E171) Polyethylene glycol 400 Polyethylene glycol 8000 6.2 INCOMPATIBILITIES There are no special requirements for use on handling of this product. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the blister and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30°C. Keep the blisters in the outer carton in order to protect from light and moisture. 6.5 NATURE AND CONTENTS OF CONTAINER Health Products Regulatory Authority 12 May 2023 CRN00DHZ2 Page 2 of 2 Each pack contains 35 dispersible tablets. 7 dispersible tablets per child-resistant foil blister. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER IMED Healthcare Ltd, Unit 625 Kilshane Avenue, Northwest Business Park, Ballycoolin, Dublin 15, Ireland. 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1463/199/002 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 th May 2023 10 DATE OF REVISION OF THE TEXT Baca dokumen lengkap