Amlodipin-BP

Amlodipinum

Amlodipin-BP 5 mg tablets: each tablet contains amlodipine besilate 6.944 mg, equivalent to amlodipine 5 mg. Amlodipin-BP 10 mg tablets: each tablet contains amlodipine besilate 13.889 mg, equivalent to amlodipine 10 mg.

Indication: Hypertension; chronic stable angina pectoris; vasospastic (Prinzmetal's) angina.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications Amlodipine-BP is contraindicated in patients with: - hypersensitivity to dihydropyridine derivatives, amlodipine or to any of the excipients listed in section 6.1 - severe hypotension - shock (including cardiogenic shock) - obstruction of the left ventricular outflow tract (e.g. severe aortic stenosis) - haemodynamically unstable heart failure after an acute myocardial infarction.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use The safety and efficacy of amlodipine in hypertensive crisis have not been established. Patients with heart failure Patients with heart failure should be treated with caution. In a long-term, placebo-controlled study in patients with severe heart failure (NYHA class III and IV), the reported incidence of pulmonary oedema was higher in the amlodipine group than in the placebo group (see section 5.1). Calcium channel blockers, including amlodipine, should be used with caution in patients with severe heart failure, as they may increase the risk of further cardiovascular events and mortality. Patients with hepatic impairment The plasma elimination half-life of amlodipine is prolonged, and […]