Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
lamivudine
ViiV Healthcare BV
J05AF05
lamivudine
Antivirals for systemic use
HIV Infections
Epivir is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.,
Revision: 50
Authorised
1996-08-08
53 B. PACKAGE LEAFLET 54 PACKAGE LEAFLET: INFORMATION FOR THE USER EPIVIR 150 MG FILM-COATED TABLETS _lamivudine _ 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 of the 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 Epivir is and what it is used for 2. What you need to know before you take Epivir 3. How to take Epivir 4. Possible side effects 5. How to store Epivir 6. Contents of the pack and other information 1. WHAT EPIVIR IS AND WHAT IT IS USED FOR EPIVIR IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION IN ADULTS AND CHILDREN. The active ingredient in Epivir is lamivudine. Epivir is a type of medicine known as an anti-retroviral. It belongs to a group of medicines called _nucleoside analogue reverse transcriptase inhibitors _ ( _NRTIs_ ). Epivir does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection. Not everyone responds to treatment with Epivir in the same way. Your doctor will monitor the effectiveness of your treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPIVIR DO NOT TAKE EPIVIR: • if you are ALLERGIC to lamivudine or any of the other ingredients of this medicine ( _listed in Section _ _6_ ) _._ CHECK WITH YOUR DOCTOR if you think this applies to you. TAKE SPECIAL CARE WITH EPIVIR Some people taking Epivir or other combination treatments for HIV are more at risk of serious side effects. You need Lue koko asiakirja
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Epivir 150 mg film-coated tablets Epivir 300 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Epivir 150 mg film-coated tablets Each film-coated tablet contains 150 mg lamivudine. Epivir 300 mg film-coated tablets Each film-coated tablet contains 300 mg lamivudine Excipient(s) with known effect: Each 150 mg tablet contains 0.378 mg sodium. Each 300 mg tablet contains 0.756 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Epivir 150 mg film-coated tablets Film-coated tablet White, diamond shaped scored tablets engraved with “GX CJ7” on both faces. Epivir 300 mg film-coated tablets Film-coated tablet Grey, diamond shaped and engraved with “GX EJ7” on one face 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epivir is indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The therapy should be initiated by a physician experienced in the management of HIV infection. Epivir may be administered with or without food. To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing. _ _ Epivir is also available as an oral solution for children over three months of age and who weigh less than 14 kg or for patients who are unable to swallow tablets (see section 4.4). Patients changing between lamivudine oral solution and lamivudine tablets should follow the dosing recommendations that are specific for the formulation (see section 5.2) 3 Alternatively, for patients who are unable to swallow tablets, the tablet(s) may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2). _Adults, adolescents and children (weighing at least 25 kg): _ _ _ The recommended dose of Epivir is 300 mg daily. This may be administered as either 150 mg twice daily or 30 Lue koko asiakirja