ENALAPRIL MALEATE

4) and blood pressure response. Hypertension The initial dose is 5 to maximally 20 mg, depending on the degree of hypertension and the condition of the patient (see below). Enalapril maleate is given once daily. In mild hypertension, the recommended initial dose is 5 to 10 mg.

, renovascular hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension) may experience an excessive blood pressure fall following the initial dose. A starting dose of 5 mg or lower is recommended in such patients and the initiation of treatment should take place under medical supervision.

Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with enalapril. A starting dose of 5 mg or lower is recommended in such patients. If possible, diuretic therapy should be discontinued for 2-3 days prior to initiation of therapy with Enalapril maleate.

Renal function and serum potassium should be monitored. The usual maintenance dose is 20 mg daily. The maximum maintenance dose is 40 mg daily. Heart Failure/Asymptomatic Left Ventricular Dysfunction In the management of symptomatic heart failure, Enalapril maleate is used in addition to diuretics and, where appropriate, digitalis or beta-blockers.

5 mg, and it should be administered under close medical supervision to determine the initial effect on the blood pressure. In the absence of, or after effective management of, symptomatic hypotension following initiation of therapy with Enalapril maleate in heart failure, the dose should be increased gradually to the usual maintenance dose of 20 mg, 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 daily given in two divided doses. 4). 4) because hypotension and (more rarely) consequent renal failure have been reported. In patients treated with diuretics, the dose should be reduced if possible before beginning treatment with Enalapril maleate.

The appearance of hypotension after the initial dose of Enalapril maleate does not imply that hypotension will recur during chronic therapy with Enalapril maleate and does not preclude continued use of the drug. Serum potassium and renal function also should be monitored.

4) Diaphoresis, pruritus, urticaria, alopecia Erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma 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.

Rash, photosensiti vity or other dermatologi c manifestatio ns may occur. Musculosk eletal, connective tissue, and bone disorders Muscle cramps Renal and urinary disorders Renal dysfunction, renal failure, proteinuria Oliguria Reproducti ve system and breast disorders Impotence Gynaecomastia General disorders and administrat ion site conditions Asthenia Fatigue Malaise, fever Investigatio ns Hyperkalae mia, increases in serum creatinine Increases in blood urea, hyponatraemia Elevations of liver enzymes, elevations of serum bilirubin * Incidence rates were comparable to those in the placebo and active control groups in the clinical trials.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4. Enalaprilat is dialysable. Dosage on nondialysis days should be adjusted depending on the blood pressure response. 4). 2). Use in Paediatrics For patients who can swallow tablets, the dose should be individualized according to patient profile and blood pressure response.

5 mg in patients 20 to <50 kg and 5 mg in patients ≥50 kg. Enalapril maleate is given once daily. ). 73 m2, as no data are available. Method of administration. Oral use. Creatinine Clearance (CrCL) mL/min Initial Dose mg/day 30< CrCL <80 ml/min.

5 - 10 mg 10< CrCL ≤30 ml/min. 5 mg CrCL ≤ 10 ml/min. 1 or any other ACE inhibitor. 6). 1). • Concomitant use with sacubitril/valsartan therapy. ). 4 Special warnings and precautions for use Symptomatic Hypotension Symptomatic hypotension is rarely seen in uncomplicated hypertensive patients.

8). In patients with heart failure, with or without associated renal insufficiency, symptomatic hypotension has been observed. This is most likely to occur in those patients with more severe degrees of heart failure, as reflected by the use of high doses of loop diuretics, hyponatraemia or functional renal impairment.

In these patients, therapy should be started under medical supervision and the patients should be followed closely whenever the dose of Enalapril maleate and/or diuretic is adjusted. 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.

If hypotension occurs, the patient should be placed in the supine position and, if necessary, should receive an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further doses, which can be given usually without difficulty once the blood pressure has increased after volume expansion.

In some patients with heart failure who have normal or low blood pressure, additional lowering of systemic blood pressure may occur with Enalapril maleate. This effect is anticipated, and usually is not a reason to discontinue treatment.

1 or any other ACE inhibitor. 6). 1). • Concomitant use with sacubitril/valsartan therapy. ).