Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Sofosbuvir
Gilead Sciences Ireland UC
J05AX15
sofosbuvir
Antivirals for systemic use
Hepatitis C, Chronic
Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1).For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Revision: 28
Authorised
2014-01-16
79 B. PACKAGE LEAFLET 80 PACKAGE LEAFLET: INFORMATION FOR THE USER SOVALDI 400 MG FILM-COATED TABLETS SOVALDI 200 MG FILM-COATED TABLETS sofosbuvir 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 Sovaldi is and what it is used for 2. What you need to know before you take Sovaldi 3. How to take Sovaldi 4. Possible side effects 5. How to store Sovaldi 6. Contents of the pack and other information IF SOVALDI HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL THE INFORMATION IN THIS LEAFLET IS APPLICABLE TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD” INSTEAD OF “YOU”). 1. WHAT SOVALDI IS AND WHAT IT IS USED FOR Sovaldi contains the active substance sofosbuvir which is given to treat hepatitis C virus infection in adults and children 3 years of age and older. Hepatitis C is a virus that infects the liver. This medicine works by lowering the amount of hepatitis C virus in your body and removing the virus from your blood over a period of time. Sovaldi is always taken with other medicines to treat hepatitis C. It will not work on its own. It is commonly taken with either: • Ribavirin (children and adult patients), or • Peginterferon alfa and ribavirin (adult patients) It is very important that you also read the leaflets for the other medicines that you will be taking with Sovaldi. If you have any questions about your medicines, please ask your doctor or pharmacist. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOVALDI DO NOT TAKE SOVALDI • If you are allergic to sofosbuvir or Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Sovaldi 400 mg film-coated tablets Sovaldi 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sovaldi 400 mg film-coated tablets Each film-coated tablet contains 400 mg of sofosbuvir. Sovaldi 200 mg film-coated tablets Each film-coated tablet contains 200 mg of sofosbuvir. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Sovaldi 400 mg film-coated tablets Yellow, capsule-shaped, film-coated tablet of dimensions of approximately 20 mm x 9 mm, debossed on one side with “GSI” and “7977” on the other side. Sovaldi 200 mg film-coated tablets Yellow, oval-shaped, film-coated tablet of dimensions of approximately 15 mm x 8 mm, debossed on one side with “GSI” and “200” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1). For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Sovaldi treatment should be initiated and monitored by a physician experienced in the management of patients with CHC. Posology The recommended dose of Sovaldi in adults is one 400 mg tablet, taken orally, once daily with food (see section 5.2). The recommended dose of Sovaldi in paediatric patients aged 3 years and above is based on weight (as detailed in Table 2). Sovaldi should be taken with food (see section 5.2). 3 Sovaldi oral granules are available for the treatment of chronic HCV-infection in paediatric patients aged 3 years and above having difficulty in swallowing film-coated tablets. Please refer to the Summary of Product Characteristics for Sovaldi 150 mg or 200 mg granules. Sovaldi should be used in combination with other medicinal products. Monotherapy of Sovaldi is not recommended (see section Przeczytaj cały dokument