Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate
Gilead Sciences International Ltd
J05AR08
emtricitabine, rilpivirine, tenofovir disoproxil
Antivirals for systemic use
HIV Infections
Eviplera is indicated for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load ≤ 100,000 HIV-1 RNA copies/mL. As with other antiretroviral medicinal products, genotypic resistance testing and/or historical resistance data should guide the use of Eviplera.
Revision: 25
Authorised
2011-11-27
45 B. PACKAGE LEAFLET 46 PACKAGE LEAFLET: INFORMATION FOR THE USER EVIPLERA 200 MG/25 MG/245 MG FILM-COATED TABLETS emtricitabine/rilpivirine/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 Eviplera is and what it is used for 2. What you need to know before you take Eviplera 3. How to take Eviplera 4. Possible side effects 5. How to store Eviplera 6. Contents of the pack and other information 1. WHAT EVIPLERA IS AND WHAT IT IS USED FOR EVIPLERA CONTAINS THREE ACTIVE SUBSTANCES that are used to treat Human Immunodeficiency Virus (HIV) infection: • Emtricitabine, a nucleoside reverse transcriptase inhibitor (NRTI). • Rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI). • Tenofovir disoproxil, a nucleotide reverse transcriptase inhibitor (NtRTI). Each of these active substances, also known as antiretroviral medicines, works by interfering with an enzyme (a protein called ‘reverse transcriptase’) that is essential for the virus to multiply. Eviplera reduces the amount of HIV in your body. This, will improve your immune system and reduces the risk of developing illnesses linked to HIV infection. EVIPLERA IS A TREATMENT FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV) infection in adults aged 18 years and over. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EVIPLERA DO NOT TAKE EVIPLERA • IF YOU ARE ALLERGIC to emtricitabine, rilpivirine, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6 of this leaflet). IF THIS APPLIES Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Eviplera 200 mg/25 mg/245 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of emtricitabine, 25 mg of rilpivirine (as hydrochloride) and 245 mg of tenofovir disoproxil (as fumarate). Excipients with known effect Each film-coated tablet contains 277 mg lactose monohydrate and 4 micrograms sunset yellow aluminium lake (E110). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Purplish-pink, capsule-shaped, film-coated tablet of dimensions 19 mm x 8.5 mm, debossed on one side with “GSI” and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Eviplera is indicated for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load ≤ 100,000 HIV-1 RNA copies/mL (see sections 4.2, 4.4 and 5.1). Genotypic resistance testing and/or historical resistance data should guide the use of Eviplera (see sections 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Eviplera should be initiated by a physician experienced in the management of HIV infection. Posology _Adults _ The recommended dose of Eviplera is one tablet, taken orally, once daily. Eviplera MUST BE TAKEN WITH FOOD (see section 5.2). Where discontinuation of therapy with one of the components of Eviplera is indicated or where dose modification is necessary, separate preparations of emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil are available. Please refer to the Summary of Product Characteristics for these medicinal products. If a patient misses a dose of Eviplera within 12 hours of the time it is usually taken, the patient should take Eviplera with food as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Eviplera by Izlasiet visu dokumentu