Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
efavirenz
Teva B.V.
J05AG03
efavirenz
Antivirals for systemic use
HIV Infections
Efavirenz is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children 3 years of age and older.Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with protease inhibitors (PIs) has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing efavirenz.
Revision: 12
Authorised
2012-01-09
45 B. PACKAGE LEAFLET 46 PACKAGE LEAFLET: INFORMATION FOR THE USER EFAVIRENZ TEVA 600 MG FILM-COATED TABLETS efavirenz 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Efavirenz Teva is and what it is used for 2. What you need to know before you take Efavirenz Teva 3. How to take Efavirenz Teva 4. Possible side effects 5. How to store Efavirenz Teva 6. Contents of the pack and other information 1. WHAT EFAVIRENZ TEVA IS AND WHAT IT IS USED FOR Efavirenz Teva, which contains the active substance efavirenz, belongs to a class of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It is an ANTIRETROVIRAL MEDICINE THAT FIGHTS HUMAN IMMUNODEFICIENCY VIRUS (HIV-1) infection by reducing the amount of the virus in blood. It is used by adults, adolescents and children 3 years of age and older. Your doctor has prescribed Efavirenz Teva for you because you have HIV infection. Efavirenz Teva taken in combination with other antiretroviral medicines reduces the amount of the virus in the blood. This will strengthen your immune system and reduce the risk of developing illnesses linked to HIV infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EFAVIRENZ TEVA DO NOT TAKE EFAVIRENZ TEVA - IF YOU ARE ALLERGIC to efavirenz or any of the other ingredients of this medicine (listed in section 6). Contact your doctor or pharmacist for advice. - IF YOU HAVE SEVERE LIVER DISEASE . - IF YOU HAVE A HEART CONDITION, SUCH AS CHANGES IN THE RHYTHM OR RATE OF THE HEART BEAT, Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Efavirenz Teva 600 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg efavirenz. Excipients with known effect Each film-coated tablet contains 9.98 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Yellow, capsule-shaped, film-coated tablet debossed with “Teva” on one side and “7541” on the other 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Efavirenz is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older. Efavirenz has not been adequately studied in patients with advanced HIV disease, namely in patients with CD 4 counts < 50 cells/mm 3 , or after failure of protease inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing efavirenz. For a summary of clinical and pharmacodynamic information, see section 5.1. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection. Posology Efavirenz must be given in combination with other antiretroviral medicines (see section 4.5). In order to improve the tolerability of nervous system adverse reactions, bedtime dosing is recommended (see section 4.8). _Adults and adolescents over 40 kg _ The recommended dose of efavirenz in combination with nucleoside analogue reverse transcriptase inhibitors (NRTIs) with or without a PI (see section 4.5) is 600 mg orally, once daily. Efavirenz film-coated tablets are not suitable for children weighing less than 40 kg. Other formulations are available for these patients. 3 _Dose adjustment _ If efavirenz is co-administered with voriconazole, the voriconazole m Aqra d-dokument sħiħ