Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sofosbuvir; Velpatasvir
Gilead Sciences International Ltd
J05AP55
Sofosbuvir; Velpatasvir
400mg ; 100mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05030302
1 PACKAGE LEAFLET: INFORMATION FOR THE USER EPCLUSA 400 MG/100 MG FILM-COATED TABLETS sofosbuvir/velpatasvir 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 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 1. WHAT EPCLUSA IS AND WHAT IT IS USED FOR Epclusa is a medicine that contains the active substances sofosbuvir and velpatasvir in a single tablet. It is given to treat a chronic (long-term) viral infection of the liver called hepatitis C in adults of 18 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. Epclusa is sometimes taken with another medicine, ribavirin. 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 t Læs hele dokumentet
OBJECT 1 EPCLUSA 400 MG/100 MG FILM COATED TABLETS. Summary of Product Characteristics Updated 11-Jun-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 Epclusa 400 mg/100 mg film-coated tablets. 2. Qualitative and quantitative composition Each film-coated tablet contains 400 mg sofosbuvir and 100 mg velpatasvir. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. 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. 4. Clinical particulars 4.1 Therapeutic indications Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults (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 is one tablet, taken orally, once daily with or without food (see section 5.2). TABLE 1: RECOMMENDED TREATMENT AND DURATION FOR ALL HCV GENOTYPES PATIENT POPULATION A TREATMENT AND DURATION Patients without cirrhosis and patients with compensated cirrhosis Epclusa for 12 weeks Addition of ribavirin may be considered for genotype 3 infected patients with compensated cirrhosis (see section 5.1.) Patients with decompensated cirrhosis Epclusa + ribavirin for 12 weeks a. Includes patients co-infected with human immunodeficiency virus (HIV) and patients with recurrent HCV post-liver transplant (see section 4.4.)_._ When used in combination with ribavirin, refer also to the Summary of Product Characteristics of the medicinal product containing ribavirin. The following dosing is recommended where ribavirin is divided in two daily doses and g Læs hele dokumentet