Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide
Gilead Sciences Ireland UC
J05AR19
emtricitabine, rilpivirine, tenofovir alafenamide
Antivirals for systemic use
HIV Infections
Treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 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.,
Revision: 20
Authorised
2016-06-21
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE USER ODEFSEY 200 MG/25 MG/25 MG FILM-COATED TABLETS emtricitabine/rilpivirine/tenofovir alafenamide 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 Odefsey is and what it is used for 2. What you need to know before you take Odefsey 3. How to take Odefsey 4. Possible side effects 5. How to store Odefsey 6. Contents of the pack and other information 1. WHAT ODEFSEY IS AND WHAT IT IS USED FOR Odefsey is an antiviral medicine used to treat infection by the HUMAN IMMUNODEFICIENCY VIRUS (HIV). It is a single tablet that contains a combination of three active substances: EMTRICITABINE, RILPIVIRINE and TENOFOVIR ALAFENAMIDE. Each of these active substances works by interfering with an enzyme called ‘reverse transcriptase’, which is essential for the HIV-1 virus to multiply. Odefsey reduces the amount of HIV in your body. This will improve your immune system and reduce the risk of developing illnesses linked to HIV infection. Odefsey is used in adults and adolescents aged 12 years and older, who weigh at least 35 kg. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ODEFSEY DO NOT TAKE ODEFSEY • IF YOU ARE ALLERGIC TO EMTRICITABINE, RILPIVIRINE, TENOFOVIR ALAFENAMIDE or any of the other ingredients of this medicine (listed in section 6). • IF YOU ARE CURRENTLY TAKING ANY OF THE FOLLOWING MEDICINES: - CARBAMAZEPINE, OXCARBAZEPINE, PHENOBARBITAL AND PHENYTOIN (used to treat epilepsy and prevent seizures) - RIFABUTIN, RIFAMPICIN AND RIFAPENTINE (u Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Odefsey 200 mg/25 mg/25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of emtricitabine, rilpivirine hydrochloride equivalent to 25 mg of rilpivirine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide. Excipients with known effect Each tablet contains 180.3 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Grey, capsule-shaped, film-coated tablet, of dimensions 15 mm x 7 mm, debossed with “GSI” on one side of the tablet and “255” on the other side of the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Odefsey is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection. Posology _ _ One tablet to be taken once daily with food (see section 5.2). If the patient misses a dose of Odefsey within 12 hours of the time it is usually taken, the patient should take Odefsey with food as soon as possible and resume the normal dosing schedule. If a patient misses a dose of Odefsey by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. If the patient vomits within 4 hours of taking Odefsey another tablet should be taken with food. If a patient vomits more than 4 hours after taking Odefsey they do not need to take another dose of Odefsey until the next regularly scheduled dose. _Elderly_ No dose adjustment of Odefsey is required in elderly patients (se Прочетете целия документ