Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
emtricitabine, tenofovir disoproxil phosphate
Zentiva k.s.
J05AR03
emtricitabine, tenofovir disoproxil
Antivirals for systemic use
HIV Infections
Treatment of HIV-1 infectionEmtricitabine/Tenofovir disoproxil Zentiva is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.Emtricitabine/Tenofovir disoproxil Zentiva is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents.Pre-exposure prophylaxis (PrEP)Emtricitabine/Tenofovir disoproxil Zentiva is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk.
Revision: 8
Authorised
2016-11-09
48 B. PACKAGE LEAFLET 49 PACKAGE LEAFLET: INFORMATION FOR THE USER EMTRICITABINE/TENOFOVIR DISOPROXIL ZENTIVA 200 MG/245 MG FILM-COATED TABLETS emtricitabine/tenofovir disoproxil 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 Emtricitabine/Tenofovir disoproxil Zentiva is and what it is used for 2. What you need to know before you take Emtricitabine/Tenofovir disoproxil Zentiva 3. How to take Emtricitabine/Tenofovir disoproxil Zentiva 4. Possible side effects 5. How to store Emtricitabine/Tenofovir disoproxil Zentiva 6. Contents of the pack and other information 1. WHAT EMTRICITABINE/TENOFOVIR DISOPROXIL ZENTIVA IS AND WHAT IT IS USED FOR EMTRICITABINE/TENOFOVIR DISOPROXIL ZENTIVA CONTAINS TWO ACTIVE SUBSTANCES, emtricitabine and tenofovir disoproxil. Both of these active substances are antiretroviral medicines which are used to treat HIV infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir is a nucleotide reverse transcriptase inhibitor. However, both are generally known as NRTIs and they work by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce itself. • EMTRICITABINE/TENOFOVIR DISOPROXIL ZENTIVA IS USED TO TREAT HUMAN IMMUNODEFICIENCY VIRUS 1(HIV-1) INFECTION, IN ADULTS. • IT IS ALSO USED TO TREAT HIV IN ADOLESCENTS AGED 12 TO LESS THAN 18 YEARS WHO WEIGH AT LEAST 35 KG, and who have already been treated with other HIV medicines that are no longer effective or have caused side eff Lue koko asiakirja
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Emtricitabine/Tenofovir disoproxil Zentiva 200 mg / 245 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 291.5 mg of tenofovir disoproxil phosphate or 136 mg of tenofovir). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Blue, oval biconvex film-coated tablet without half-score with dimensions approx. 19.35 x 9.75 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Treatment of HIV-1 infection Emtricitabine/Tenofovir disoproxil Zentiva is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1). Emtricitabine/Tenofovir disoproxil Zentiva is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents (see sections 4.2, 4.4 and 5.1). Pre-exposure prophylaxis (PrEP) Emtricitabine/Tenofovir disoproxil Zentiva is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Emtricitabine/Tenofovir disoproxil Zentiva should be initiated by a physician experienced in the management of HIV infection. Posology _ _ _Treatment of HIV in adults_ _and adolescents aged 12 years and older, weighing at least 35 kg_ One tablet, once daily. _Prevention of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg_ One tablet, once daily. Separate preparations of emtricitabine and tenofovir disoproxil are available for treatment of HIV-1 infection if it becomes necessary to discontinue or modify the dose of one of the components of Emtricitabine/Tenofovir disoproxil Zentiva. Please refer to the Summary of Product Characteristics for these medicina Lue koko asiakirja