البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMLODIPINE BESILATE; BISOPROLOL FUMARATE
MERCK SDN. BHD.
AMLODIPINE BESILATE; BISOPROLOL FUMARATE
30tablet Tablets
Egis Pharmaceuticals PLC
_Consumer Medication Information Leaflet (RiMUP)_ 1 CONCOR AM TABLET bisoprolol fumarate, amlodipine besilate (5mg/5mg, 5mg/10mg) WHAT IS IN THIS LEAFLET 1. What Concor AM is used for 2. How Concor AM works 3. Before you use Concor AM 4. How to take Concor AM 5. While you are using it 6. Side effects 7. Storage and Disposal of Concor AM 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT CONCOR AM IS USED FOR Concor AM is used to treat high blood pressure. HOW CONCOR AM WORKS The active substances in Concor AM are bisoprolol and amlodipine. 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. Amlodipine prevents an inflow of calcium ions into heart. It also widens and reduces blockage of blood vessels around the heart. Thus, it does not cause abnormal rapid heart rate, myocardial energy consumption and oxygen requirement will be reduced. Concor AM increases the antihypertensive and anti-anginal efficacy by decreasing peripheral blockage and cardiac output. BEFORE YOU USE CONCOR AM - _When you must not take it _ Do not take Concor AM if one of the following conditions applies to you: • allergy (hypersensitivity) to bisoprolol, amlodipine or to any of the other ingredients Severe hypotension which systolic blood pressure < 100mmHg • 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 AM if you have one of the following heart problems: • acute heart failure, that is not controlled medically • wor اقرأ الوثيقة كاملة
PAGE 1 6395492D COMPOSITION Bisoprolol/Amlodipine 5/5 mg, 5 mg/5 mg tablets: 5 mg bisoprolol fumarate, 5 mg amlodipine (as besilate) per tablet. Bisoprolol/Amlodipine 5/10 mg, 5 mg/10 mg tablets: 5 mg bisoprolol fumarate, 10 mg amlodipine (as besilate) per tablet. For the full list of excipients, see section list of excipients PHARMACEUTICAL FORM Bisoprolol/Amlodipine 5/5 mg, White or almost white, odourless, oblong, slightly convex tablets with a length of 9.5 mm and a width of 4.5 mm with score line on one side and with embossed MS on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Bisoprolol/Amlodipine 5/10 mg, White or almost white, odourless, round, flat, bevel edged tablets of 10 mm with score line on one side and embossed MS on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. ROUTE OF ADMINISTRATION Oral INDICATION Concor AM is indicated for the treatment of hypertension as substitution therapy in patients adequately controlled with the individual products given concurrently at the same doses level as in the combination, but as separate tablets. POSOLOGY AND METHOD OF ADMINISTRATION Concor AM is indicated in patients whose blood pressure is adequately controlled with separately administered mono-component preparations of the same doses as the recommended fixed dose combination. _Posology_ Recommended daily dose is one tablet of the given strength. Treatment must not be abruptly discontinued, as it may lead to temporary deterioration of clinical condition. Treatment must not be abruptly discontinued especially in case of patients suffering from ischaemic heart disease. Gradual decrease of the dose is recommended. _Patients with hepatic impairment_ In case of hepatic impairment elimination of amlodipine may be elongated. Dosage recommendations concerning amlodipine have not been established in patients with mild to moderate hepatic impairment. The pharmacokinetics o اقرأ الوثيقة كاملة