Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Bisoprolol fumarate
Sandoz Ltd
C07AB07
Bisoprolol fumarate
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5050650035841
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BISOPROLOL 5 MG AND 10 MG 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. WHAT BISOPROLOL TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL TABLETS 3. HOW TO TAKE BISOPROLOL TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE BISOPROLOL TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT BISOPROLOL TABLETS ARE AND WHAT THEY ARE USED FOR Bisoprolol fumarate belongs to a group of medicines called beta-blockers. It is used to treat: - high blood pressure - angina pectoris (pain in the chest caused by blockages in the arteries leading to the heart). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL TABLETS DO NOT TAKE BISOPROLOL TABLETS - if you are ALLERGIC to Bisoprolol tablets or any of the other ingredients of this medicine (listed in section 6) - if you suffer from SEVERE ASTHMA or from other SEVERE breathing difficulties - if you have acute HEART FAILURE or are in shock caused by heart problems - if you suffer with HEART CONDUCTION or RHYTHM PROBLEMS (2nd or 3rd degree AV-block, sick sinus syndrome or sinoatrial block) - if you have a SLOW HEART RATE of less than 60 beats per minute before starting treatment. - if you have LOW BLOOD PRESSURE - if you suffer from severely BLOCKED BLOOD VESSELS , including BLOOD CIRCULATION PROBLEMS (which may cause your fingers and toes to tingle or turn pale or blue) - if you suffer from INCREASED ACIDITY OF THE BLOOD (metabol Aqra d-dokument sħiħ
OBJECT 1 BISOPROLOL FUMARATE 10 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 01-Nov-2016 | Sandoz Limited 1. Name of the medicinal product Bisoprolol Fumarate 10 mg Film-coated Tablets 2. Qualitative and quantitative composition Each tablet contains 10 mg bisoprolol fumarate Excipients with known effects: Each tablet contains lactose (as lactose monohydrate 2.48 mg) For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet apricot, round tablet with a cross score on one side and encoded "BIS 10" on the other side The tablet can be divided into equal quarters. 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 liver 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: Treatment must not be stopped abruptly (see section 4.4). The dosage should be diminished slowly by a weekly halving of the dose. STABLE CHRONIC HEART FAILURE Standard treatment of CHF consists of an ACE i Aqra d-dokument sħiħ