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Ramipril Abbreviated Prescribing Information


Abbreviated Prescribing Information: Ramipril 2.5mg/5ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: A clear colourless solution, each 5ml of solution contains 2.5mg Ramipril. Therapeutic Indications: Ramipril oral solution is indicated for the treatment of hypertension. Cardiovascular prevention in patients with manifest atherothrombotic cardiovascular disease or diabetes with at least one cardiovascular risk factor. Treatment of renal disease: Incipient glomerular diabetic nephropathy, manifest glomerular diabetic nephropathy, manifest glomerular nondiabetic nephropathy. Treatment of symptomatic heart failure. Secondary prevention after acute myocardial infarction. Posology and Method of Administration: Ramipril should be taken each day at the same time. Depending on the indication and the patient the dosage ranges from 1.25mg (2.5ml) initially up to a maximum daily dosage of 10mg (20ml). Paediatric population: The safety and efficacy of ramipril in children has not yet been established. Oral use. Suitable for administration via nasogastric or percutaneous endoscopic gastrostomy tubes. Contra-indications: Hypersensitivity to ramipril, to any of the excipients or any other ACE inhibitors, history of angioedema, extracorporeal treatments leading to contact of blood with negatively charged surfaces, bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney, 2nd and 3rd trimester of pregnancy, patients with hypotensive or haemodynamically unstable states, concomitant use with sacubitril/valsartan and or aliskiren containing products in patients with diabetes mellitus or renal impairment. Special warnings and Precautions for use: Ramipril should not be initiated during pregnancy and should be stopped immediately when pregnancy is diagnosed. Caution should be exercised with the following: patients at risk of hypotension, strongly activated renin-angiotensin-aldosterone system, severe hypertension, decompensated congestive heart failure, haemodynamically relevant left ventricular inflow or outflow impediment, unilateral renal artery stenosis with a second functional kidney, fluid or salt depletion, liver cirrhosis and/or ascites, surgery or during anaesthesia with agents that produce hypotension, concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren, transient or persistent heart failure post MI, patients at risk of cardiac or cerebral ischemia in case of acute hypotension, and the elderly. Ramipril should be discontinued one day before surgery. Where there is renal impairment, dosage should be adjusted. In case of angioedema, Ramipril must be discontinued. The likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom and other allergens are increased under ACE inhibition. Hyperkalaemia and hyponatraemia have been observed in some patients. Neutropenia/agranulocytosis, thrombocytopenia, and anaemia have been rarely seen and bone marrow depression has also been reported. ACE inhibitors may be less effective and cause higher rate of angioedema in black patients. Cough has been reported with the use of ACE inhibitors. Excipient warnings: contains ethyl and butyl hydroxybenzoate which may cause allergic reactions. Also contains sodium, propylene glycol which may induce adverse effects in children less than 5 years old and potentially pregnant or breast-feeding patients. Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: not applicable. Legal Category: Prescription only medicine. Undesirable Effects. A list of common and serious adverse reactions are presented here and refer the SmPC for details of other adverse reactions. Angioedema, hyperkalaemia, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia/agranulocytosis, blood potassium increased, headache, dizziness, hypotension, orthostatic blood pressure decreased, syncope, non-productive tickling cough, bronchitis, sinusitis, dyspnoea, gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, diarrhoea, nausea, vomiting, rash in particular maculo-papular, muscle spasms, myalgia, chest pain, and fatigue. Pack Size and NHS Price: 150ml – £196.00. Marketing Authorisation Number: PL 00427/0162 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE. Date of Preparation: November 2022.

Adverse Drug Events

Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400