Lisinopril Oral Solution Abbreviated Prescribing Information:

Abbreviated Prescribing Information: Lisinopril 1mg/ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: A clear and colourless oral solution with a sweet taste, each 1 ml contains 1 mg lisinopril (as lisinopril dihydrate) Therapeutic Indications: Treatment of hypertension, symptomatic heart failure, acute myocardial infarction, and renal complications of diabetes mellitus. Posology and Method of Administration: Lisinopril 1 mg/ml oral solution should be administered orally in a single daily dose at approximately same time each day. Depending on the indication and the patient’s profile and blood pressure response, the recommended starting dose falls between 2.5 mg and 10 mg once daily and the maximum daily dose can be up to 40 mg. Paediatric population: Lisinopril 1 mg/ml oral solution is not recommended in children aged >6 years in other indications than hypertension and not recommended in children below the age of 6, or in children with severe renal impairment (GFR <30 ml/min/1.73m2). Recommended initial dose is 2.5 mg once daily with the dose adjusted to maximum 20 mg daily in patients 20 to <50 kg, and 5mg once daily with the dose adjusted to maximum 40 mg daily in patients ≥50 kg. Elderly people: the dosage should be adjusted according to the blood pressure response. Use in kidney transplant patients: Lisinopril 1 mg/ml oral solution is not recommended in kidney transplant patients. Contra-indications: Hypersensitivity to Lisinopril or to any of the excipients or to any other angiotensin converting enzyme (ACE) inhibitor; History of angioedema associated with previous ACE inhibitor therapy; Hereditary or idiopathic angioedema; Second and third trimesters of pregnancy; Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2); and concomitant use with sacubitril/valsartan therapy. Lisinopril must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan. Special Warnings and Precautions for use: Caution should be exercised in following conditions: symptomatic hypotension, patients with acute myocardial infarction who are at risk of further serious haemodynamic deterioration after treatment with a vasodilator, aortic and mitral valve stenosis / hypertrophic cardiomyopathy and obstruction in the outflow of the left ventricle, renal function impairment, hypersensitivity/angioedema, anaphylactoid reactions in haemodialysis patients, and during low-density lipoproteins (LDL) apheresis as life-threatening anaphylactoid reactions have been reported, during desensitisation treatment, hepatic failure, neutropenia/agranulocytosis, concomitant use with aliskiren containing medicines increases the risk of hypotension, hyperkalaemia and decreased renal function including acute renal failure, patients undergoing major surgery or during anaesthesia with agents that produce hypotension, may cause hyperkalaemia, ACE inhibitor-induced cough, diabetic patients treated with oral antidiabetic agents or insulin. ACE inhibitors can cause hyperkalaemia in patients with impaired renal function, diabetes mellitus or in patients taking potassium supplements, It was identified that angiotensin-converting enzyme inhibitors cause a higher rate of angioedema in black patients and is less effective than in non-black patients. The combination of lithium and lisinopril is not recommended. ACE inhibitors should not be initiated in pregnant patients and when pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately. Any warning from the MC, CHM CSM or MHRA. No. Black Triangle notice (if relevant): N/A. A list of common and serious adverse reactions: Common: dizziness, headache, orthostatic effects (including hypotension), cough, diarrhoea, vomiting, renal dysfunction. Serious: bone marrow depression, thrombocytopenia, leukopenia, neutropenia, agranulocytosis, haemolytic anaemia, autoimmune disease, anaphylactic/anaphylactoid reaction, myocardial infarction or cerebrovascular accident, Raynaud’s phenomenon, allergic alveolitis/eosinophilic pneumonia, pancreatitis, intestinal angioedema, hepatocellular or cholestatic, jaundice, hepatic failure, cutaneous pseudolymphoma, toxic epidermal necrolysis, Stevens-Johnson Syndrome, syndrome of inappropriate antidiuretic hormone secretion (SIADH), acute renal failure, uraemia, hyperkalaemia, hyponatraemia and renal dysfunction. Consult the SmPC for full details of adverse reactions. Pack Size and NHS Price: 150ml – £228.90. Marketing Authorisation Number: Lisinopril 1mg/ml (PL 00427/0284). Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Legal Category: POM. Date of Preparation: 21 Nov 2025.