Regulatory Information
MERCK PTE. LTD.
MERCK PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET
**4.2 Posology and method of administration** Concor® AMLO is indicated in patients whose blood pressure is adequately controlled with separately administered monocomponent preparations of the same doses as the recommended fixed dose combination. 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. Exact dosage recommendations concerning amlodipine have not been established, but the drug should therefore be administered with special caution in these patients (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In case of severe hepatic impairment the daily dose of bisoprolol must not exceed 10mg. Patients with renal impairment: No dosage adjustment is required for patients with mild to moderate renal impairment. Amlodipine is not dialyzable. Amlodipine should be administered with particular caution to patients undergoing dialysis (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). In case of severe renal impairment (creatinine clearance < 20ml/min) the daily dose of bisoprolol must not exceed 10mg. Elderly patients: The usual doses can be administered to elderly people; however, caution is advised when the dose is increased (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Paediatric population: The safety and efficacy of Concor® AMLO in children and adolescents below the age of 18 years have not been established. No data are available. Method of administration Concor® AMLO should be taken in the morning with or without food, without chewing it.
ORAL
Medical Information
**4.1 Therapeutic indications** Concor® AMLO is indicated for 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.
**4.3 Contraindications** In connection with amlodipine: - Severe hypotension - Shock (including cardiogenic shock) - Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis) - Haemodynamically unstable heart failure after acute myocardial infarction In connection with bisoprolol: - Acute heart failure or during episodes of heart failure requiring i.v. inotropic therapy - Cardiogenic shock - Second or third degree AV block (without a pacemaker) - Sick sinus syndrome - Sinoatrial block - Bradycardia (heart rate less than 60 beats/min) prior to start of therapy - Hypotension (systolic blood pressure < 100mmHg) - Severe bronchial asthma - Severe forms of peripheral arterial occlusive disease and severe forms of Raynaud’s syndrome - Untreated phaeochromocytoma (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - Metabolic acidosis In connection with Concor® AMLO: - Hypersensitivity to amlodipine, dihydropyridine derivates, bisoprolol and/or any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
C07 FB 07
bisoprolol and amlodipine
Manufacturer Information
MERCK PTE. LTD.
EGIS Pharmaceuticals PLC (Bökényföldi)
Active Ingredients
Documents
Package Inserts
Concor Amlo Tablet PI.pdf
Approved: January 9, 2023