Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
BISOPROLOL FUMARATE
Rowex Ltd
C07AB; C07AB07
BISOPROLOL FUMARATE
10 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Beta blocking agents, selective; bisoprolol
Marketed
2008-12-08
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BISOP 5 MG FILM-COATED TABLETS BISOP 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 of the 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 Bisop is and what it is used for 2. What you need to know before you take Bisop 3. How to take Bisop 4. Possible side effects 5. How to store Bisop 6. Contents of the pack and other information 1. WHAT BISOP IS AND WHAT IT IS USED FOR Bisop belongs to the group of medicinal products that are indicated as beta blockers. They protect the heart from too much activity. Bisop is used to treat: high blood pressure angina pectoris(heart pain) heart failure causing breathlessness on exertion or fluid retention. In this instance, Bisop may be given as an additional treatment to other medications for heart failure. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOP DO NOT TAKE BISOP_ _ if you are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6) if you have a cardiogenic shock, a serious heart condition causing a rapid, weak pulse; low blood pressure; cold, clammy skin; weakness and fainting if you have ever suffered from severe wheezing or severe asthma, as they can affect your breathing if you have a slow heart rate (less than 60 beats per minute). Ask your doctor if you are not sure. if you have very low blood pressure if you have severe blood circulation problems (which may cause your fingers and toes to tingle or turn pale or blue) i Lugege kogu dokumenti
Health Products Regulatory Authority 31 March 2022 CRN00CHCT Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisop 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of bisoprolol fumarate. Excipient with known effect Each film-coated tablet contains 2.4 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Apricot coloured, round, scored film-coated tablet with a one-sided embossment "BIS 10". The tablet can be divided into four equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypertension Angina pectoris Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides (for additional information see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology HYPERTENSION/ANGINA PECTORIS _Adults_ The dosage should be individually adjusted, in particular according to the pulse rate and therapeutic success. It is recommended to start with 5 mg per day. The usual dose is 10 mg once daily with a maximum recommended dose of 20 mg once daily. _Elderly_ It is recommended to start with the lowest possible dose. _Renal or hepatic impairment_ In patients with liver or kidney function disorders of mild to moderate severity, no dosage adjustment is normally required. 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 is not exceeded. Experience with the use of bisoprolol in renal dialysis patients is limited. However, there is no evidence that the dosage regime needs to be altered. _Discontinuation of treatment_ Health Products Regulatory Authority 31 March 2022 CRN00CHCT Page 2 of 10 Treatment must not be stopped abruptly (see section 4.4). The dosage should be diminished slowly by a weekly halving of the dose. STABLE CHRON Lugege kogu dokumenti