Pajjiż: Malasja
Lingwa: Ingliż
Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BISOPROLOL FUMARATE
MERCK SDN. BHD.
BISOPROLOL FUMARATE
100 Tablet Tablets
Merck Healthcare KGaA
_Consumer Medication Information Leaflet (RiMUP)_ 1 CONCOR ® FILM-COATED TABLETS Bisoprolol fumarate (2.5mg, 5mg, 10mg) WHAT IS IN THIS LEAFLET 1. What Concor is used for 2. How Concor works 3. Before you use Concor 4. How to take Concor 5. While you are using Concor 6. Side effects 7. Storage and Disposaldisposable of Concor 8. Product Ddescription 9. Manufacturer and Product Rregistration hHolder 10. Date of revision 10.11. Serial Number WHAT CONCOR IS USED FOR Concor 2.5 mg is used to treat chronic stable heart failure Concor 5 mg and 10mg is used to treat high blood pressure, angina pectoris and chronic stable heart failure HOW CONCOR WORKS The active substance in Concor 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. Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the body's needs. Heart failure may begin with no symptoms, but as the condition progresses, you may feel shortness of breath. You may experience palpitations (initially during ordinary exercise, but later on also at rest), feel tired, and notice swelling of the feet and ankles due to fluid build up. BEFORE YOU USE CONCOR - _When you must not take it _ Do not take Concor if one of the following conditions applies to you: allergy (hypersensitivity) to bisoprolol or to any of the other ingredients severe asthma or severe chronic obstructive airway disease severe blood circulation problems in your limbs (such as Raynaud’s syndrome), which may cause your fingers and toes to tingle or turn pale or blue untreated phaeochromocytoma, which is a rare tumour of the adrenal gland metabolic acidosis, which is a condition when there is too much acid in the blood. Do not take Concor if you have one of the following heart problems: acute he Aqra d-dokument sħiħ
Concor® 2.5 mg film coated tablet Active ingredient: bisoprolol fumarate Composition Each film-coated tablet contains 2.5 mg bisoprolol fumarate as active ingredient Excipients: Tablet core: Silica, colloidal anhydrous; magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate, anhydrous Film coating: Dimethicone, macrogol 400, titanium dioxide, hypromellose Product Description White, heart-shaped, biconvex film-coated tablet, scored on both sides Properties Pharmacodynamics Bisoprolol, the active ingredient of Concor is a beta1-selective-adrenoceptor blocking agent, lacking intrinsic stimulating and relevant membrane stabilising activity. It only shows very low affinity to the beta2-receptor of the smooth muscles of bronchi and vessels as well as to the beta2-receptors concerned with metabolic regulation. Therefore, bisoprolol is generally not to be expected to influence the airway resistance and beta2-mediated metabolic effects. Its beta1-selectivity extends beyond the therapeutic dose range. Pharmacokinetics Absorption. Bisoprolol is almost completely (>90%) absorbed from the gastrointestinal tract and, because of its small first pass metabolism of approximately 10%, has a bioavailability of approximately 90% after oral administration. The bioavailability is not affected by food intake. Bisoprolol shows linear kinetics and the plasma concentrations are proportional to the administered dose over the dose range 5 to 20 mg. Peak plasma concentrations occur within 2-3 hours. Distribution. Bisoprolol is extensively distributed. The volume of distribution is 3.5 l/kg. Binding to plasma proteins is approximately 30%. Metabolism. Bisoprolol is metabolised via oxidative pathways with no subsequent conjugation. All metabolites, being very polar, are renally eliminated. The major metabolites in human plasma and urine were found to be without pharmacological activity. In vitro data from studies in human liver microsomes show that bisoprolol is primarily metabolised via CYP3A4 Aqra d-dokument sħiħ