Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tenofovir alafenamide fumarate; Rilpivirine hydrochloride; Emtricitabine
Gilead Sciences International Ltd
Tenofovir alafenamide fumarate; Rilpivirine hydrochloride; Emtricitabine
25mg ; 25mg ; 200mg
Tablet
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 05030100
1 B. PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER ODEFSEY 200 MG/25 MG/25 MG FILM-COATED TABLETS emtricitabine/rilpivirine/tenofovir alafenamide This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 Perskaitykite visą dokumentą
OBJECT 1 ODEFSEY 200 MG/25 MG/25 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 30-May-2018 | Gilead Sciences Ltd This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 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 189.8 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. Grey, capsule-shaped, film-coated tablets, 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 _Adults and adolescents aged 12 years and older, weighing at least 35 kg_ 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 Perskaitykite visą dokumentą