Abbreviated prescribing information for all products mentioned above are available on this page, please scroll to view each one.
Enalapril Maleate 5mg/5ml Oral Solution
Abbreviated Prescribing Information: Enalapril Maleate 5mg/5ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: A clear colourless oral solution, each 5 ml contains 5 mg enalapril maleate. Therapeutic Indications: Enalapril Maleate Oral Solution is used for treatment of hypertension, symptomatic heart failure and prevention of symptomatic heart failure in patients with asymptomatic left ventricular dysfunction. Posology and Method of Administration: For the treatment of hypertension the initial dose ranges from 5 mg to 20 mg (5 ml to 20 ml) taken once a day, some patients may require a lower starting dose. The usual maintenance dose is 20 mg (20 ml) daily and maximum is 40 mg (40 ml). For the treatment of heart failure/asymptomatic left ventricular dysfunction, the initial dose of enalapril is 2.5 mg (2.5 ml) taken once a day, and the dose should be increased gradually to the usual maintenance dose of 20 mg (20 ml), given in a single dose or two divided doses, as tolerated by the patient. This dose titration is recommended to be performed over a 2 to 4 week period. The maximum dose is 40 mg (40 ml) daily given in two divided doses. In the elderly and patients with renal insufficiency, the intervals between the administration of enalapril should be prolonged or the dosage reduced depending on the patient’s renal function. Enalapril should be administered orally. Paediatric population: The recommended initial dose is 2.5mg (2.5ml) in patients 20 to < 50kg and 5mg (5ml) in patients ≥50kg. Enalapril is given once daily. The dosage should be adjusted according to the needs of the patient to a maximum of 20mg (20ml) daily in patients 20 to <50kg and 40mg (40ml) in patients ≥50kg. Contra- indications: Hypersensitivity to the active substance or to any of the excipients listed; History of angioedema associated with previous ACE inhibitor therapy; Hereditary or idiopathic angioedema; The concomitant use of enalapril with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment, Second and third trimesters of pregnancy, and concomitant use with sacubitril/valsartan therapy. Enalapril must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan. Special Warnings and Precautions for use: Care should be exercised in hypertensive patients as symptomatic hypotension is rarely reported. Similar considerations may apply to patients with ischaemic heart or cerebrovascular disease in whom an excessive fall in blood pressure could result in a myocardial infarction or cerebrovascular accident. ACE inhibitors should be given with caution in patients with left ventricular valvular and outflow tract obstruction and avoided in cases of cardiogenic shock and haemodynamically significant obstruction. Renal failure has been reported in association with enalapril and has been mainly in patients with severe heart failure or underlying renal disease, including renal artery stenosis. There is an increased risk of hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with ACE inhibitors, in these patients, therapy should be initiated under close medical supervision with low doses, careful titration, and monitoring of renal function. Treatment with enalapril is therefore not recommended for patients with recent kidney transplantation. Rarely hepatic failure has been reported with ACE inhibitors. Neutropenia, agranulocytosis, thrombocytopenia and anaemia have been reported in patients receiving ACE inhibitors. Patients receiving ACE inhibitor therapy should be cautious due to hypersensitivity and angioneurotic oedema. Concomitant use of ACE inhibitors with racecadotril, mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) and vildagliptin may lead to an increased risk of angioedema (e.g. swelling of the airways or tongue, with or without respiratory impairment). Rarely, anaphylactoid reactions have been reported in patients receiving ACE inhibitors during hymenoptera venom desensitisation and low density lipoprotein apheresis with dextran sulfate. Anaphylactoid reactions have been reported in patients dialysed with high-flux membranes (e.g., AN 69) and treated concomitantly with an ACE inhibitor. Diabetic patients treated with oral antidiabetic agents or insulin starting an ACE inhibitor should be told to closely monitor for hypoglycaemia, especially during the first month of combined use. Cough has been reported with the use of ACE inhibitors. Caution should be exercised in patients undergoing major surgery or during anaesthesia with agents that produce hypotension, enalapril blocks angiotensin II formation secondary to compensatory renin release. ACE inhibitors can cause hyperkalaemia. The combination of lithium and enalapril is generally not recommended. The concurrent use of ACE inhibitors, angiotensin II receptor blockers, or aliskiren should be done with caution because there is a risk of hypotension, hyperkalaemia, and decreased renal function. Enalapril is not recommended in children with other indications than hypertension, in neonates, or in paediatric patients with a glomerular filtration rate < 30 mL/min/1.73 m2. ACE inhibitors should not be initiated during pregnancy unless the therapy is considered essential. Given that enalapril is reportedly less effective in lowering blood pressure in Black individuals than in Non-Black individuals, consideration should be given to ethnic differences. Any warning from the MC, CHM CSM or MHRA: N/A. Black Triangle notice (if relevant) N/A. Legal Category: POM. Very common and common reported adverse events: depression, dizziness, headache, syncope, taste alteration, blurred vision, chest pain, rhythm disturbances, angina pectoris, tachycardia, hypotension (including orthostatic hypotension), cough, dyspnoea, nausea, diarrhoea, abdominal pain, rash, hypersensitivity / angioneurotic oedema, asthenia, fatigue, hyperkalaemia and increases in serum creatinine. Angioneurotic oedema of the face, extremities, lips, tongue, glottis and/or larynx has also been reported); Serious reported adverse events: {anaemia (including aplastic and haemolytic), thrombocytopenia, agranulocytosis, bone marrow depression, pancytopenia, autoimmune diseases, hypotension in high risk patients, myocardial infarction, cerebrovascular accident (possibly secondary to excessive hypotension), allergic alveolitis, bronchospasm/asthma, pulmonary infiltrates, eosinophilia pneumonia, intestinal angioedema, ileus, pancreatitis, peptic ulcer, hepatic failure, hepatitis – either hepatocellular or cholestatic, hepatitis including necrosis, cholestasis (including jaundice), Stevens- Johnson syndrome, toxic epidderma necrolysis. renal dysfunction, renal failure and proteinuria, A symptom complex has been reported which may include some or all of the following: fever, serositis, vasculitis, myalgia/myositis, arthralgia/arthritis, a positive ANA, elevated ESR, eosinophilia, and leucocytosis.Refer to the SmPC for other reported events). Pack Size and NHS Price: 150ml- £245.14. Marketing Authorisation Number: PL 00427/0269 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [June-2025]
Ramipril Dose Range Abbreviated Prescribing Information
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, significant 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 (very rarely airway obstruction resulting from angioedema may have a fatal outcome), hyperkalaemia, blood sodium decreased, 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: July 2025.
Abbreviated Prescribing Information: Urospir™ 25 mg/5 ml and 50mg/5ml Oral Solution Consult Summary of Product Characteristics before prescribing. Presentation: A clear colourless to pale yellow non aqueous liquid. Each 5 ml contains 25 mg of spironolactone for Urospir™ 25 mg/5 ml oral solution and 50 mg of spironolactone for Urospir™ 50 mg/5 ml oral solution. Therapeutic Indications: Urospir is indicated for Congestive cardiac failure, Hepatic cirrhosis with ascites and oedema, Malignant ascites, Nephrotic syndrome and Diagnosis and treatment of primary aldosteronism. Posology and Method of Administration: Note – Urospir Oral Solution is only suitable for administration of single doses up to 100 mg and up to 200 mg/day in two equally divided doses. Urospir is not bioequivalent to the innovator tablet. Switching between spironolactone tablets or other spironolactone products and this formulation should be avoided if possible. If a switch is necessary, caution and increased clinical supervision are required. For management of oedema an initial daily dose of 100 mg of spironolactone administered in either single or divided doses is recommended but may range from 25 mg to 200 mg daily. For management of severe heart failure standard therapy should be initiated at a dose of 25 mg once daily if serum potassium is ≤5.0 mEq/L and serum creatinine is ≤2.5 mg/dL. Patients who tolerate 25 mg once daily may have their dose increased to 50 mg once daily as clinically indicated. For management of Hepatic cirrhosis with ascites and oedema If urinary Na+/K+ ratio is greater than 1.0, 100 mg per day. If the ratio is less than 1.0, 200 mg to 400 mg per day. For management of malignant ascites Initial dose usually 100 mg to 200 mg per day. In severe cases the dosage may be gradually increased up to 400 mg per day (note: when doses more than 200 mg/day are required, other suitable spironolactone formulations should be used). For management of Nephrotic syndrome Usual dose 100 mg to 200 mg per day. For management of diagnosis and treatment of primary aldosteronism spironolactone may be administered at doses of 100 mg to 400 mg daily in preparation for surgery. For elderly It is recommended that treatment is started with the lowest dose and titrated upwards as required to achieve maximum benefit. Spironolactone is intended for oral administration. Paediatric population: Initial daily dosage should provide 1-3 mg of spironolactone per kilogram (kg) body weight given in divided doses. Dosage should be adjusted on the basis of response and tolerance.Contra-indications: Spironolactone is contraindicated in acute renal insufficiency, significant renal compromise, anuria, Addison’s disease, hyperkalaemia, hypersensitivity to spironolactone or to any of the excipients listed, and concomitant use of eplerenone or other potassium sparing diuretics. Spironolactone is contraindicated in paediatric patients with moderate to severe renal impairment. Spironolactone should not be administered concurrently with other potassium conserving diuretics and potassium supplements should not be given routinely with spironolactone as hyperkalaemia may be induced. Special Warnings and Precautions for use: Fluid and electrolyte balance to be monitored regularly particularly in the elderly patients with significant renal and hepatic impairment. Hyperkalaemia may occur in patients with impaired renal function or excessive potassium intake and can cause cardiac irregularities which may be fatal. Should hyperkalaemia develop spironolactone should be discontinued and active measures to be taken to reduce the serum potassium to normal. Reversible hyperchloraemic metabolic acidosis, usually in association with hyperkalaemia has been reported to occur in some patients with decompensated hepatic cirrhosis, even in the presence of normal renal function. Concomitant use of spironolactone with other potassium-sparing diuretics, angiotensin converting enzyme (ACE) inhibitors, nonsteroidal anti-inflammatory drugs, angiotensin II antagonists, aldosterone blockers, heparin, low molecular weight heparin or other drugs or conditions known to cause hyperkalaemia. Reversible increases in blood urea have been reported in association with spironolactone therapy, particularly in the presence of impaired renal function. It is crucial to monitor and manage serum potassium in patients with severe heart failure receiving spironolactone. Oral potassium supplements should be avoided. Potassium-sparing diuretics should be used with caution in hypertensive paediatric patients with mild renal insufficiency due to the risk of hyperkalaemia. Any warning from the MC, CHM CSM or MHRA: See below*. Black Triangle notice (if relevant): Not applicable. Legal Category: POM. A list of very common, common, and serious adverse reactions are Hyperkalaemia, Confusional state, Dizziness, Nausea, Pruritus, Rash, Muscle spasms, Acute kidney injury, Gynaecomastia, Breast pain (male), Malaise, Electrolyte imbalance, Hepatic function abnormal, Menstrual disorder, Agranulocytosis, Leukopenia, Thrombocytopenia, Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS), Alopecia, Hypertrichosis, and Pemphigoid. Refer to the SmPC for details of other adverse reactions. Pack Size and NHS Price: 25mg/5ml 150ml – £123.93, 50mg/5ml 150ml – £247.85. Marketing Authorisation Number: 25 mg/5 ml Oral Solution: PL 00427/0250 and 50 mg/5 ml Oral Solution: PL 00427/0251. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [Apr-2025].
*Urospir is not bioequivalent to the innovator tablet. Switching between spironolactone tablets or other spironolactone products and this formulation should be avoided if possible. If a switch is necessary, caution and increased clinical supervision are required.