Land: Indonesien
Sprog: indonesisk
Kilde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
BISOPROLOL FUMARATE, AMLODIPINE BESILATE
MERCK TBK - Indonesia
BISOPROLOL FUMARATE, AMLODIPINE BESILATE
10 MG /6.95 MG
TABLET
DUS, 3 BLISTER @ 10 TABLET
EGIS PHARMACEUTICALS PLC - Hungary
2021-03-28
_Page 1 of 12 _ CONCOR® AM BISOPROLOL FUMARATE/AMLODIPINE BESILATE ANTIHYPERTENSIVE 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Concor AM 5 mg/5 mg tablets: 5 mg Bisoprolol fumarate, 5 mg Amlodipine (as 6.95 mg Amlodipine besilate) per tablet. Concor AM 5 mg/10 mg tablets: 5 mg Bisoprolol fumarate, 10 mg Amlodipine (as 13.9 mg Amlodipine besilate) per tablet. Concor AM 10 mg/5 mg tablet: 10 mg Bisoprolol fumarate and 5 mg Amlodipine (as 6.95 mg Amlodipine besilate) per tablet. 2. PHARMACEUTICAL FORM Tablet. 3. CLINICAL PARTICULARS 3.1 INDICATIONS 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. 3.2 POSOLOGY AND METHOD OF ADMINISTRATION Concor AM is indicated in patients whose blood pressure is adequately controlled with separately administered monocomponent products 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 of Amlodipine have not been studied in severe hepatic impairment. The drug should therefore be administered with special caution in patients with hepatic impairment (_see section _ _Special Warnings and Precautions for Use_). In case of severe hepatic impairment the daily dose of Bisoprolol must not exceed 10 mg. _Patients with renal impairment _ No dosage adjustment is required for patients with mild to moderate renal impai Læs hele dokumentet