Enalapril Maleate 5mg/5ml Oral Suspension Abbreviated Prescribing Information

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 2.5 mg (2.5 ml) in patients 20 to < 50 kg and 5 mg (5 ml) in patients ≥ 50 kg.  Enalapril is given once daily. The dosage should be adjusted according to the needs of the patient to a maximum of 20 mg (20 ml) daily in patients 20 to < 50 kg and 40 mg (40 ml) in patients ≥ 50 kg. 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. The very common and common reported adverse events are 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, angioneurotic oedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported, Asthenia, Fatigue, Hyperkalaemia, and increases in serum creatinine (refer SmPC for other reported events). Pack Size and NHS Price: 150ml- £238.00. Marketing Authorisation Number: PL 00427/0269 Marketing Authorisation Holder: Rosemont Pharmaceuticls Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [May-2024]