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
2022-12-02
PACKAGE LEAFLET: INFORMATION FOR THE USER ZOVIRAX 200 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 200 mg Dispersible Tablets (called ‘Zovirax’ in this leaflet) contains a medicine called aciclovir. This belongs to a group of medicines called antivirals. It works by stopping the growth of viruses. Zovirax 200 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 treat cold sores, genital herpes and other herpes simplex infections (but not to be used to treat herpes simplex infections in newborn infants or severe herpes simplex infections in children whose immune systems work less well, which means their bodies are less able to fight infections) stop cold sores and genital herpes returning after you have had them prevent cold sores and genital herpes in people whose immune systems work less well. 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 take Zovirax if the above applies to you. If you are not Baca dokumen lengkap
Health Products Regulatory Authority 02 December 2022 CRN00D701 Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zovirax 200 mg Dispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg aciclovir Excipient(s) with known effect: This product contains sodium as Sodium starch glycollate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Dispersible Film-coated tablet. _Product imported from Spain_ Zovirax 200 mg tablets are white, round film-coated tablets branded with 'GXCF3' on one side and plain on the other. 4 CLINICAL PARTICULARS As per PA1077/084/007 5 PHARMACOLOGICAL PROPERTIES As per PA1077/084/007 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS CORE: Microcrystalline cellulose (E460) Aluminium magnesium silicate Sodium starch glycollate (type A) Povidone K30 Magnesium stearate (E572) FILM COAT: Hypromellose Titanium dioxide (E171) Macrogol 400 Macrogol 8000 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Health Products Regulatory Authority 02 December 2022 CRN00D701 Page 2 of 2 Do not store above 30°C. Store in the original package. 6.5 NATURE AND CONTENTS OF CONTAINER PVC/PVDC/Aluminium/Paper child resistant foil blister packs. Pack size: 25 dispersible tablets. 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 PPA1463/199/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 2 nd December 2022 10 DATE OF REVISION OF THE TEXT Baca dokumen lengkap