Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
BISOPROLOL FUMARATE
KRKA, d.d., Novo mesto
C07AB; C07AB07
BISOPROLOL FUMARATE
5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Beta blocking agents, selective; bisoprolol
Marketed
2013-12-13
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BISOPROLOL KRKA 2.5 MG FILM-COATED TABLETS BISOPROLOL KRKA 5 MG FILM-COATED TABLETS BISOPROLOL KRKA 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. See section 4. WHAT IS IN THIS LEAFLET 1. What Bisoprolol Krka is and what it is used for 2. What you need to know before you take Bisoprolol Krka 3. How to take Bisoprolol Krka 4. Possible side effects 5. How to store Bisoprolol Krka 6. Contents of the pack and other information 1. WHAT BISOPROLOL KRKA IS AND WHAT IT IS USED FOR The active substance in Bisoprolol Krka is bisoprolol. Bisoprolol belongs to a group of medicines called beta-blockers. These medicines work by affecting the body`s response to some nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and makes the heart more efficient at pumping blood around the body. At the same time bisoprolol reduces the oxygen demand and blood supply of the heart. Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the body’s needs. Bisoprolol Krka is used to - treat high blood pressure (hypertension). - treat angina pectoris. - treat stable chronic heart failure. It is used in combination with other medicines suitable for this condition (such as ACE-inhibitors, diuretics, and heart glycosides). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL KRKA DO NOT TAKE BISOPROLOL KRKA Do not take Bisoprolol Krka if you have one of the following conditions: - allergy to the active subst Læs hele dokumentet
Health Products Regulatory Authority 20 December 2021 CRN00CN4P Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Bisoprolol Krka 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg bisoprolol fumarate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet (tablet) Pale brownish yellow, oval, slightly biconvex film-coated tablets, scored on one side (length: 8.3–8.7 mm, width: 5.5 mm, thickness: 2.8–3.6 mm). The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypertension. Treatment of ischemic heart disease (angina pectoris). Treatment of stable chronic heart failure with reduced systolic left ventricular function with ACE inhibitors, diuretics, and optionally cardiac glycosides (for further information see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _HYPERTENSION AND ANGINA PECTORIS_ _Adults_ The dosage should be individually adjusted. The usual dose is 10 mg once daily with a maximum recommended dose of 20 mg per day. In some patients 5 mg per day may be adequate. _Renal or hepatic impairment_ In patients with mild to moderate impairment of renal or hepatic function no dosage adjustment is normally required. In patients with final stage impairment of renal function (creatinine clearance < 20 ml/min) or liver function, the dose should not exceed 10 mg bisoprolol once daily. A lower dose should be used. Experiences with the use of bisoprolol in patients undergoing dialysis are limited; but there is no evidence supporting a change in dosage. _Elderly _ No dosage adjustment is normally required, but 5 mg per day may be adequate in some patients; as for other adults, dosage may have to be reduced in cases of severe renal or hepatic dysfunction. _Paediatric population_ There is no paediatric experience with bisoprolol, therefore its use cannot be recommended in paediatric patients. _STABLE CHRONIC HEART FAILURE_ Healt Læs hele dokumentet