Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Bisoprolol hemifumarate
Genthon B.V.
C07AB; C07AB07
Bisoprolol hemifumarate
10 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Beta blocking agents, selective; bisoprolol
Not marketed
2002-11-22
Common Technical Document Bisoprolol hemifumarate 10 mg tablets SynthonBV Module 1 - Section 3.1 SPC, Labelling and Package Leaflet page 1/9 issue date: 22-08-2016 version:M131_03.BSL.hfu.tab10.025.01.IE.296.02 approved: MJo 1.31 Package Leaflet PACKAGE LEAFLET: INFORMATION FOR THE USER BISOPROLOL HEMIFUMARATE GENTHON 10 MG, FILM-COATED TABLETS bisoprolol fumarate 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. WHAT IS IN THIS LEAFLET: 1. What Bisoprolol hemifumarate Genthon 10 mg is and what it is used for 2. What you need to know before you take Bisoprolol hemifumarate Genthon 10 mg 3. How to take Bisoprolol hemifumarate Genthon 10 mg 4. Possible side effects 5. How to store Bisoprolol hemifumarate Genthon 10 mg 6. Contents of the pack and other information 1. WHAT BISOPROLOL HEMIFUMARATE GENTHON 10 MG IS AND WHAT IT IS USED FOR Bisoprolol hemifumarate Genthon 5 mg contains the active substance bisoprolol fumarate. Bisoprolol fumarate belongs to the group of blood pressure lowering medicines. Bisoprolol fumarate is used for: the treatment of high blood pressure a certain form of chest pain (chronic stable angina pectoris) caused by the heart muscle receiving less oxygen than required. This usually occurs under stress. You must talk to your doctor if you do not feel better or if you feel worse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL HEMIFUMARATE GENTHON 10 MG Common Technical Document Bisoprolol hemifumarate 10 mg tablets SynthonBV Module 1 - Section 3.1 SPC, Labelling and Package Leaflet page 2/9 issue date: 22-08-2 Les hele dokumentet
Health Products Regulatory Authority 11 November 2019 CRN009G1H Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisoprololhemifumaraat Genthon 10 mg, film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg bisoprolol hemifumarate, equivalent to 8.49mg of bisoprolol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. The tablet is yellow to orange, round, biconvex, scored on both sides and embossed with BSL10 on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Hypertension. - Chronic stable angina pectoris. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Renal or hepatic impairment In patients with severe renal impairment (creatinine clearance < 20 ml/min) and in patients with severe liver function disorders it is recommended that a daily dose of 10 mg bisoprolol hemifumarate is not exceeded. Elderly: No dosage adjustment is normally required. It is recommended to start with the lowest possible dose. Paediatric population: There is no experience with bisoprolol in children, therefore its use cannot be recommended in children. Method of administration Bisoprolol 10 mg tablets are for oral administration. The dosage should be individually adjusted. It is recommended to start with the lowest possible dose. In some patients, 5 mg per day may be adequate. The usual dose is 10 mg once daily with a maximum recommended dose of 20 mg per day. The tablets should be taken in the morning. They should be swallowed with liquid and should not be chewed. Discontinuation of treatment Treatment should not be stopped abruptly (see section 4.4 Special warnings and precautions for use). The dosage should be diminished slowly by a weekly halving of the dose. 4.3 CONTRAINDICATIONS · hypersensitivity to the active substance or to any of the excipients listed in section 6.1 · acute heart failure or during episode Les hele dokumentet