Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
rilpivirine hydrochloride
Janssen-Cilag International N.V.
J05AG05
rilpivirine
Antivirals for systemic use
HIV Infections
Edurant, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in antiretroviral treatment‑naïve patients 12 years of age and older with a viral load ≤ 100,000 HIV‑1 RNA copies/ml. As with other antiretroviral medicinal products, genotypic resistance testing should guide the use of Edurant.,
Revision: 20
Authorised
2011-11-28
31 B. PACKAGE LEAFLET 32 PACKAGE LEAFLET: INFORMATION FOR THE USER EDURANT 25 MG FILM-COATED TABLETS rilpivirine 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 EDURANT is and what it is used for 2. What you need to know before you take EDURANT 3. How to take EDURANT 4. Possible side effects 5. How to store EDURANT 6. Contents of the pack and other information 1. WHAT EDURANT IS AND WHAT IT IS USED FOR EDURANT contains rilpivirine that is used for the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). EDURANT works by reducing the amount of HIV in your body. EDURANT IS USED IN COMBINATION WITH OTHER HIV MEDICINES to treat adolescents and adults 12 years of age and older who are infected with HIV and who have never been treated before with HIV medicines. Your doctor will discuss with you which combination of medicines is best for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EDURANT DO NOT TAKE EDURANT if you are allergic to rilpivirine or any of the other ingredients of this medicine (listed in section 6). DO NOT TAKE EDURANT IN COMBINATION WITH ANY OF THE FOLLOWING MEDICINES as they may affect the way EDURANT or the other medicine works: - carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat epilepsy and prevent seizures) - rifampicin, rifapentine (medicines to treat some bacterial infections such as tuberculosis) - omeprazole, esomeprazole, lansoprazole, pantopr Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT EDURANT 25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine. Excipient with known effect Each film-coated tablet contains 56 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet White to off-white, round, biconvex, film-coated tablet with a diameter of 6.4 mm, debossed with “TMC” on one side and “25” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older with a viral load ≤ 100,000 HIV-1 RNA copies/ml. Genotypic resistance testing should guide the use of EDURANT (see sections 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 The recommended dose of EDURANT is one 25 mg tablet taken once daily. EDURANT MUST BE TAKEN WITH A MEAL (see section 5.2). _Dose adjustment_ For patients concomitantly receiving rifabutin, the EDURANT dose should be increased to 50 mg (two tablets of 25 mg each) taken once daily. When rifabutin co-administration is stopped, the EDURANT dose should be decreased to 25 mg once daily (see section 4.5). _Missed dose_ If the patient misses a dose of EDURANT within 12 hours of the time it is usually taken, the patient must take the medicine with a meal as soon as possible and resume the normal dosing schedule. If a patient misses a dose of EDURANT by more than 12 hours, the patient should not take the missed dose, but resume the usual dosing schedule. If a patient vomits within 4 hours of taking the medicine, another EDURANT tablet should be taken with a meal. If a patient vomits more than 4 hours a Aqra d-dokument sħiħ