Lisinopril Oral Solution Abbreviated Prescribing Information:

Abbreviated Prescribing Information Lisinopril 1mg/ml Oral Solution 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. 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). 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, mitral valve stenosis and obstruction in the outflow of the left ventricle, renal function impairment, hypersensitivity/angioedema, anaphylactoid reactions in haemodialysis patients, 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, patients undergoing major surgery or during anaesthesia with agents that produce hypotension, 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 than in non-black patients. The combination of lithium and lisinopril is not recommended. In pregnancy, ACE inhibitors should not be initiated 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. Legal Category: POM. A list of common and serious adverse reactions are: dizziness, headache, orthostatic effects (including hypotension), cough, diarrhoea, vomiting, bone marrow depression, thrombocytopenia, leukopenia, neutropenia, agranulocytosis, haemolytic anaemia, anaphylactic/anaphylactoid reaction, myocardial infarction or cerebrovascular accident, allergic alveolitis/eosinophilic pneumonia, pancreatitis, hepatocellular or cholestatic, jaundice, hepatic failure, pseudolymphoma, angioneurotic oedema, toxic epidermal necrolysis, Stevens-Johnson Syndrome, syndrome of inappropriate antidiuretic hormone secretion (SIADH), acute renal failure and renal dysfunction. Pack Size and NHS Price: 150ml – £228.90. Marketing Authorisation Number: PL00427/0284. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [ 02 December 2024]