Land: Malta
Tungumál: enska
Heimild: Medicines Authority
LAMIVUDINE, ZIDOVUDINE
Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland
J05AR01
LAMIVUDINE 150 mg ZIDOVUDINE 300 mg
FILM-COATED TABLET
LAMIVUDINE 150 mg ZIDOVUDINE 300 mg
POM
ANTIVIRALS FOR SYSTEMIC USE
Withdrawn
2018-02-09
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LAMIVUDINE/ZIDOVUDINE 150 MG/300 MG FILM-COATED TABLETS lamivudine/zidovudine 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/Zidovudine is and what it is used for 2. What you need to know before you take Lamivudine/Zidovudine 3. How to take Lamivudine/Zidovudine 4. Possible side effects 5. How to store Lamivudine/Zidovudine 6. Contents of the pack and other information 1. WHAT LAMIVUDINE/ZIDOVUDINE IS AND WHAT IT IS USED FOR LAMIVUDINE/ZIDOVUDINE IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION IN ADULTS AND CHILDREN. Lamivudine/Zidovudine contains two active ingredients that are used to treat HIV infection: lamivudine and zidovudine. Both of these belong to a group of anti-retroviral medicines called _nucleoside analogue reverse _ _transcriptase inhibitors _ ( _NRTIs_ ) _._ Lamivudine/Zidovudine 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 Lamivudine/Zidovudine in the same way. Your doctor will monitor the effectiveness of your treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMIVUDINE/ZIDOVUDINE DO NOT TAKE LAMIVUDINE/ZIDOVUDINE: - if you are ALLERGIC to lamivudine or zidovudine or any of the other ingredients of this medicine (listed in section 6). - if y Lestu allt skjalið
Page 1 of 18 1. NAME OF THE MEDICINAL PRODUCT Lamivudine/Zidovudine 150 mg/300 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg lamivudine and 300 mg zidovudine. 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 tablets, debossed with ‘H’ on one side and ‘L and 9’separated by a score line on other side. Tablet length is approximately 17.5 mm and width is approximately 8.0 mm. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lamivudine/Zidovudine is indicated in antiretroviral combination therapy for the treatment of adults, adolescents and children with Human Immunodeficiency Virus (HIV) infection (see section 4.2). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Therapy should be initiated by a physician experienced in the management of HIV infection. _Adults and adolescents weighing at least 30 kg: _ the recommended dose of Lamivudine/Zidovudine is one tablet twice daily. _Children weighing between 21 kg and 30 kg: _ the recommended oral dose of Lamivudine/Zidovudine is one-half tablet taken in the morning and one whole tablet taken in the evening. _Children weighing from 14 kg to 21 kg: _ the recommended oral dose of Lamivudine/Zidovudine is one-half tablet taken twice daily. The dosing regimen for paediatric patients weighing 14-30 kg is based primarily on pharmacokinetic modelling and supported by data from clinical studies using the individual components lamivudine and zidovudine. A pharmacokinetic overexposure of zidovudine can occur; therefore close safety monitoring is warranted in these patients. If gastrointestinal intolerance occurs in patients weighing 21-30 kg, an alternative dosing schedule with one-half tablet taken thrice daily can be applied in attempt to improve tolerability. Page 2 of 18 Lamivudine/Zidovudine tablets should not be used for children weighing less than 14 kg, since d Lestu allt skjalið