Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
ENTECAVIR MONOHYDRATE
Actavis UK Limited
J05AF10
ENTECAVIR MONOHYDRATE
1 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Nucleoside and nucleotide reverse transcriptase inhibitors
Authorised
2017-10-20
ENTECAVIR 0.5MG AND 1MG FILM-COATED TABLETS entecavir PACKAGE LEAFLET: INFORMATION FOR THE USER 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. • The full name of this medicine is Entecavir 0.5mg and 1mg Film-coated Tablets but within the leaflet it will be referred to as Entecavir Tablets. WHAT IS IN THIS LEAFLET 1 WHAT ENTECAVIR TABLETS ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENTECAVIR TABLETS 3 HOW TO TAKE ENTECAVIR TABLETS 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE ENTECAVIR TABLETS 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT ENTECAVIR TABLETS ARE AND WHAT THEY ARE USED FOR ENTECAVIR TABLETS ARE ANTI-VIRAL MEDICINES, USED TO TREAT CHRONIC (LONG TERM) HEPATITIS B VIRUS (HBV) INFECTION IN ADULTS. Entecavir Tablets can be used in people whose liver is damaged but still functions properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease). ENTECAVIR TABLETS ARE ALSO USED TO TREAT CHRONIC (LONG TERM) HBV INFECTION IN CHILDREN AND ADOLESCENTS AGED 2 YEARS TO LESS THAN 18 YEARS. Entecavir Tablets can be used in children whose liver is damaged but still functions properly (compensated liver disease). Infection by the hepatitis B virus can lead to damage to the liver. Entecavir Tablets reduces the amount of virus in your body, and improves the condition of the liver. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENTECAVIR TABLETS DO NOT TAKE ENTECAVIR TABLETS • IF YOU ARE ALLERGIC (HYPERSENSITIVE) to entecavir or any Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Entecavir 1 mg Film-coated Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg entecavir (as monohydrate). Excipients with known effect: Each 1 mg film-coated tablet contains 184 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pink, triangular-shaped, film-coated tablet debossed with “ENT” on one side and “1” on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Entecavir is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with: - compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. - decompensated liver disease (see section 4.4) For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection. With respect to patients with lamivudine- refractory hepatitis B, see sections 4.2, 4.4 and 5.1. Entecavir is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to 18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis. With respect to the decision to initiate treatment in paediatric patients, 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 chronic hepatitis B infection. Posology _Compensated liver disease_ _Nucleoside naïve patients:_ the recommended dose in adults is 0.5 mg once daily, with or without food. _Lamivudine-refractory patients _(i.e. with evidence of viraemia while on lamivudine or the presence of lamivudine resistance [LVDr] mutatio Διαβάστε το πλήρες έγγραφο