Ramipril Dose Range Abbreviated Prescribing Information

Abbreviated Prescribing Information: Ramipril 2.5mg/5ml, 5mg/5ml, and 10mg/5ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: A clear colourless solution, each 5ml of solution contains 2.5 mg, 5 mg, and 10 mg of Ramipril, respectively. 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 1.25 mg initially up to a maximum daily dosage of 10 mg. For elderly patients, initial doses should be lower, and subsequent dose titration should be more gradual. Ramipril is suitable for oral use and administration via nasogastric or percutaneous endoscopic gastrostomy tubes. Paediatric population: The safety and efficacy of ramipril in children has not yet been established. Contraindications: 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. Particularly careful monitoring is required in patients with renal impairment. The risk of angioedema may be increased in patients taking concomitant medications such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin or neprilysin (NEP) inhibitors (such as racecadotril). Intestinal angioedema has been reported in patients treated with ACE inhibitors. 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. Any warning from the MC, CHM CSM or MHRA: N/A. Black Triangle notice (if relevant): N/A. Legal Category: Prescription only medicine. A list of common and serious adverse reactions are Blood potassium Increased, headache, dizziness, hypotension, orthostatic blood pressure decreased, syncope, angioedema, hyperkalaemia, renal or hepatic impairment, pancreatitis, blood potassium increased, eosinophilia, white blood cell count decreased (including neutropenia or agranulocytosis), platelet count decreased, haemolytic anaemia, bone marrow failure, pancytopenia, anaphylactic or anaphylactoid reactions, syndrome of inappropriate antidiuretic hormone secretion (SIADH), cerebral ischaemia including ischaemic stroke and transient ischaemic attack, myocardial ischaemia including angina pectoris or myocardial infarction, bronchospasm including asthma aggravated, jaundice cholestatic, acute hepatic failure, cholestatic or cytolytic hepatitis, hepatocellular damage, photosensitivity reaction, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute renal failure, vasculitis, bilirubin conjugated increased, 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. Refer to the SmPC for details of other adverse reactions. Pack Size and NHS Price: 150ml – 2.5mg/5ml – £205.80, 5mg/5ml – £411.60, 10mg/5ml – £823.20. Marketing Authorisation Number: PL 00427/0299 (2.5mg/5ml Oral Solution), PL 00427/0300 (5mg/5ml Oral Solution), and PL 00427/0301 (10mg/5ml Oral Solution). Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: November 2024.