ENALAPRIL

Posology The absorption of enalapril is not affected by food intake. 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 is given once daily. In mild hypertension, the recommended 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, the diuretic therapy should be discontinued for 2-3 days prior to initiation of therapy with enalapril. Renal function and serum potassium should be monitored.

The usual maintenance dose is 20 mg daily. The maximum maintenance dose is 40 mg daily. 4).

Heart Failure/Asymptomatic Left Ventricular Dysfunction:

In the management of symptomatic heart failure, enalapril 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 in heart failure, the dose should be increased gradually to the usual maintenance dose of 20 mg, given as 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.

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

Undesirable effects reported for enalapril include:

Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). 4) Uncommon: diaphoresis, pruritus, urticaria, alopecia Rare: erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, 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, photosensitivity or other dermatological manifestations may occur.

Musculoskeletal, connective tissue, and bone disorders:

Uncommon: muscle cramps Renal and Urinary Disorders: Uncommon: renal dysfunction, renal failure, proteinuria Rare: oliguria Reproductive System and Breast Disorders: Uncommon: impotence Rare: gynecomastia General Disorders and Administration Site Conditions: Very common: asthenia Common: fatigue Uncommon: malaise, fever Investigations: Common: hyperkalemia, increases in serum creatinine Uncommon: increases in blood urea, hyponatraemia Rare: elevation 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.

4. Enalaprilat is dialysable. Dosage on non-dialysis days should be adjusted depending on the blood pressure response. 2). For patients who can swallow tablets, the dose should be individualised according to patient profile and blood pressure response.

5 mg in patients 20 to <50 kg and 5 mg 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 daily in patients 20 to <50 kg and 40 mg in patients ≥ 50 kg.

73 m2, as no data are available. 73 m2) • Concomitant use with sacubitril/valsartan therapy. 5). 4 Special warnings and precautions for use Symptomatic Hypotension: Symptomatic hypotension is seen rarely in uncomplicated hypertensive patients.

g. 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 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 develops, the patient should be placed in a supine position and, if necessary, should receive an intravenous infusion of normal saline. A transient hypotensive response is not a contra-indication to further doses, which can usually be given 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. This effect is anticipated, and usually is not a reason to discontinue treatment. If such hypotension becomes symptomatic, a reduction of dose and/or discontinuation of the diuretic and/or enalapril may become necessary.

73 m2) • Concomitant use with sacubitril/valsartan therapy. 5).