Kraj: Malta
Język: angielski
Źródło: Medicines Authority
LAMIVUDINE
Generics UK Limited
J05AF05
LAMIVUDINE
FILM-COATED TABLET
LAMIVUDINE 150 mg
POM
ANTIVIRALS FOR SYSTEMIC USE
Authorised
2013-04-29
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LAMIVUDINE 150 MG FILM-COATED TABLETS LAMIVUDINE 300 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 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 Lamivudine is and what it is used for 2. What you need to know before you take Lamivudine 3. How to take Lamivudine 4. Possible side effects 5. How to store Lamivudine 6. Contents of the pack and other information 1. WHAT LAMIVUDINE IS AND WHAT IT IS USED FOR Lamivudine is used to treat HIV (human immunodeficiency virus) infection in adults and children. Lamivudine belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside analogue reverse transcriptase inhibitors (NRTIs). Lamivudine 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 CD4 cell count in your blood. CD4 cells are a type of white blood cell that are important in maintaining a healthy immune system to help fight infection. Response to treatment with lamivudine varies between patients. Your doctor will be monitoring the effectiveness of your treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMIVUDINE DO NOT TAKE LAMIVUDINE: 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. Page 2 of 7 WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Lamivudine: if you are currently being treated for HIV wit Przeczytaj cały dokument
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamivudine Mylan 150 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 150 mg film-coated tablet contains 150 mg of lamivudine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off-white capsule shaped, biconvex film-coated tablet, debossed with “M105” on one side and a functional scoreline on the other. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lamivudine Mylan 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. Posology _Adults, adolescents and children (weighing at least 25 kg)_ The recommended dose of Lamivudine Mylan is 300 mg daily. This may be administered as either 150 mg twice daily or 300 mg once daily (see section 4.4). Page 2 of 16 _Children (weighing less than 25 kg) _ Dosing according to weight bands is recommended for lamivudine tablets. _Children weighing ≥20 kg to <25 kg_ The recommended dose is 225 mg daily. This may be administered as either 75 mg (one-half of a 150 mg tablet) taken in the morning and 150 mg (one whole 150 mg tablet) taken in the evening, or 225 mg (one and a half 150 mg tablets) taken once daily. _Children weighing 14 to <20 kg _ The recommended dose is 150 mg daily. This may be administered as 75 mg (one-half of a 150 mg tablet) taken twice daily, or 150 mg (one whole 150 mg tablet) taken once daily. _Children less than three months of age _ The limited data available are insufficient to propose specific dosage recommendations (see section 5.2). Patients changing from the twice daily dosing regimen to the once daily dosing regimen should take the recommended once daily dose (as described above) approximately 12 hours after the last twice dail Przeczytaj cały dokument