Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
Sofosbuvir, velpatasvir
Gilead Sciences Ireland UC
J05A
sofosbuvir, velpatasvir
Antivirals for systemic use
Hepatitis C, Chronic
Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1).
Revision: 22
Authorised
2016-07-06
78 B. PACKAGE LEAFLET 79 PACKAGE LEAFLET: INFORMATION FOR THE USER EPCLUSA 400 MG/100 MG FILM-COATED TABLETS EPCLUSA 200 MG/50 MG FILM-COATED TABLETS sofosbuvir/velpatasvir 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 Epclusa is and what it is used for 2. What you need to know before you take Epclusa 3. How to take Epclusa 4. Possible side effects 5. How to store Epclusa 6. Contents of the pack and other information IF EPCLUSA HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL THE INFORMATION IN THIS LEAFLET IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD” INSTEAD OF “YOU”). 1. WHAT EPCLUSA IS AND WHAT IT IS USED FOR Epclusa is a medicine that contains the active substances sofosbuvir and velpatasvir. Epclusa is given to treat chronic (long-term) hepatitis C virus infection in adults and children aged 3 years and older. The active substances in this medicine work together by blocking two different proteins that the virus needs to grow and reproduce itself, allowing the infection to be permanently eliminated from the body. It is very important that you also read the leaflets for the other medicines that you will be taking with Epclusa. If you have any questions about your medicines, please ask your doctor or pharmacist. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPCLUSA DO NOT TAKE EPCLUSA • IF YOU ARE ALLERGIC to sofosbuvir, velpatasvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet). If this applies to you, DO NOT TAKE Přečtěte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Epclusa 400 mg/100 mg film-coated tablets Epclusa 200 mg/50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Epclusa 400 mg/100 mg film-coated tablets Each film-coated tablet contains 400 mg sofosbuvir and 100 mg velpatasvir. Epclusa 200 mg/50 mg film-coated tablets Each film-coated tablet contains 200 mg sofosbuvir and 50 mg velpatasvir. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Epclusa 400 mg/100 mg film-coated tablets Pink, diamond-shaped, film-coated tablet of dimensions 20 mm x 10 mm, debossed on one side with “GSI” and “7916” on the other side. Epclusa 200 mg/50 mg film-coated tablets Pink, oval-shaped, film-coated tablets of dimensions 14 mm x 7 mm, debossed on one side with “GSI” and “S/V” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Epclusa treatment should be initiated and monitored by a physician experienced in the management of patients with HCV infection. Posology The recommended dose of Epclusa in adults is one 400 mg/100 mg tablet, taken orally, once daily with or without food (see section 5.2). The recommended dose of Epclusa in paediatric patients aged 3 years and above is based on weight as detailed in Table 3. A granule formulation of Epclusa is available for the treatment of chronic HCV infection in paediatric patients aged 3 years and above having difficulty swallowing film-coated tablets. For patients 3 weighing < 17 kg, please refer to the Summary of Product Characteristics for Epclusa 200 mg/50 mg or 150 mg/37.5 mg granules. TABLE 1: RECOMMENDED TREATMENT AND DURATION FOR ADULTS REGARDLESS OF HCV GENOTYPES ADULT PATIENT POPULATION A TREATMENT AND DURATION Patients without cirrhosis and patients with compensate Přečtěte si celý dokument