Indications:
Treatment of Hypertension;Treatment of Symptomatic Heart Failure;Prevention of Symptomatic Heart Failure in patients with Asymptomatic Left Ventricular Dysfunction (ejection fraction ≤35%)

Dosage and Administration:

Usage: Oral use.

Dosage:

1.Hypertension:The initial dose is 5 to maximally 20 mg, depending on the degree of hypertension and the condition of the patient (see below). The usual maintenance dose is 20 mg daily. The maximum maintenance dose is 40 mg daily.

2.Heart Failure/Asymptomatic Left Ventricular Dysfunction: The initial dose is 2.5 mg,The maximum dose is 40 mg daily given in two divided doses.

3.Dosage in Renal Insufficiency:the intervals between the administration of enalapril should be prolonged and/or the dosage reduced.

4.Enalaprilat is dialysable. Dosage on nondialysis days should be adjusted depending on the blood pressure response.

5.Use in Elderly:The dose should be in line with the renal function of the elderly patient

6.Use in Paediatric:For patients who can swallow tablets, the dose should be individualised according to patient profile and blood pressure response. The recommended initial dose is 2.5 mg in patients 20 to <50 kg and 5 mg in patients 50 kg. Enalapril is given once daily. Enalapril is not recommended in neonates and in paediatric patients with glomerular filtration rate <30 ml/min/1.73 m².

Precautions & Warning:

Symptomatic Hypotension;Aortic or Mitral Valve Stenosis/Hypertrophic;Cardiomyopathy: should be given with caution in patients;Renal Function Impairment;Renovascular hypertension;Kidney Transplantation;Hepatic failure;Neutropenia/Agranulocytosis;Hypersensitivity/ Angioneurotic Oedema;Anaphylactoid Reactions during Hymenoptera Desensitisation;Anaphylactoid Reactions during LDL Apheresis;Haemodialysis Patients;Hypoglycaemia;Cough;Surgery/Anaesthesia;Hyperkalaemia;Lithium;Dual blockade of the rennin-angiotensin-aldosterone system (RASS);Paediatric Population;Pregnancy;Ethnic differences;Lactose

Contraindications:

1.Hypersensitivity to enalapril, to the excipients or any other ACE inhibitor

2. History of angioedema associated with previous ACE inhibitor therapy

3.Hereditary or idiopathic angioedema

4.Second and third trimesters of pregnancy .

5.The concomitant use of enalapril 2.5mg tablets with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²)

6.Concomitant use with sacubitril/valsartan therapy. Enalapril must not be initiated earlier than 36 hours after the last dose of sacubitril/ valsartan

Adverse Reactions

Blood and the lymphatic system disorders;Endocrine disorders;Nervous system disorders: dizziness;headache, syncope, taste alteration;somnolence, paraesthesia, vertigo;Psychiatric disorders: depression;confusion, nervousness, insomnia;dream abnormality, sleep disorders;Ear and labyrinth disorders: tinnitus;Eye disorders: blurred vision;Cardiac disorders:chest pain, rhythm disturbances, angina pectoris, tachycardia;palpitations, myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high risk patients;Vascular disorders:hypotension (including orthostatic hypotension);Respiratory, thoracic and mediastinal disorders:cough;dyspnoea;Gastrointestinal disorders: nausea,diarrhoea, abdominal pain;Hepatobiliary disorders;Skin and subcutaneous tissue disorders: rash, hypersensitivity/angioneurotic oedema: angioneurotic oedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported ;Musculoskeletal, connective tissue, and bone disorders;Renal and urinary disorders;Reproductive system and breast disorders;General disorders and administration site conditions: asthenia;fatigue

Investigations:

common: hyperkalaemia, increases in serum creatinine

uncommon: increases in blood urea, hyponatremia

rare: elevations of liver enzymes, elevations of serum bilirubin

Storage instructions:

Do not store above 25°C and store in the original container.