Ramipril-BP

Ramiprilum

Ramipril-BP 5 mg tablets: Each tablet contains ramipril 5 mg. Excipient with known effect: lactose monohydrate.

Ramipril-BP 10 mg tablets: Each tablet contains ramipril 10 mg. Excipient with known effect: lactose monohydrate.

Indication: ▪ Treatment of hypertension. ▪ Cardiovascular prevention: reduction of cardiovascular mortality and morbidity in patients with: − manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or − diabetes mellitus with at least one cardiovascular risk factor (see section 5.1). ▪ Treatment of renal disease: − early-stage diabetic glomerular nephropathy, defined by the presence of microalbuminuria, − manifest diabetic glomerular nephropathy, defined by the presence of macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1), − manifest non-diabetic glomerular nephropathy, defined by the presence of macroproteinuria ≥ 3 g per day (see section 5.1). ▪ Treatment of symptomatic heart failure. ▪ Secondary prevention following acute myocardial infarction: reduction of mortality in the acute phase of myocardial infarction in patients with clinical signs of heart failure beginning more than 48 hours after an acute myocardial infarction.

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or to any other ACE inhibitor (angiotensin-converting-enzyme inhibitor). − Concomitant use with sacubitril/valsartan. Ramipril-BP must not be started earlier than 36 hours after the last dose of sacubitril/valsartan (see also sections 4.4 and 4.5). − History of angioedema (hereditary, idiopathic, or previous angioedema associated with ACE inhibitors or angiotensin II receptor antagonists (ARBs)) − Extracorporeal treatment involving contact of blood with negatively charged surfaces (see section 4.5) − Significant bilateral renal artery stenosis or unilateral renal artery stenosis in a solitary functioning kidney. − Second and third trimesters of pregnancy (see sections 4.4 and 4.6). − Ramipril must not be used in patients with hypotension or those who are haemodynamically unstable − Concomitant use of Ramipril-BP with medicinal products containing aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²) (see sections 4.5 and 5.1).

Special patient groups. Pregnancy. Treatment with ACE inhibitors, such as ramipril, or angiotensin II receptor antagonists (ARBs), must not be started during pregnancy. Unless continued ACE inhibitor/ARB treatment is considered essential, women planning to become pregnant should be switched to alternative antihypertensive treatments with an established safety profile for use in pregnancy. When pregnancy is confirmed, treatment with ACE inhibitors/ARBs must be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6). Patients at particular risk of hypotension. ▪ Patients with an activated renin-angiotensin-aldosterone system. Patients with activation […]