ENAP Tablet Ref.[49833] Active ingredients: Enalapril

Route of Administration

Oral.

Posology

The absorption of ‘Enap’ is not affected by food.

The dose should be individualized according to patients profile (see section 4.4) and blood pressure response.

Hypertension

The initial dose is 5 to maximally 20mg, depending on the degree of hypertension and the condition of the patient (see below). Enap is given once daily. In mild hypertension, the recommended initial dose is 5 to 10mg. Patients with a strongly activated renin-angiotensin-aldosterone system (e.g. 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 5mg 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 5mg or lower is recommended in such patients. If possible, diuretic therapy should be discontinued for 2-3 days prior to initiation of therapy with Enap. Renal function and serum potassium should be monitored.

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

Heart Failure/Asymptomatic Left Ventricular Dysfunction

In the management of symptomatic heart failure ‘Enap’ is used in addition to diuretics and, where appropriate, digitalis or beta-blockers. The initial dose of ‘Enap’ in patients with symptomatic heart failure or asymptomatic left ventricular dysfunction is 2.5mg, 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 ‘Enap’ in heart failure, the dose should be increased gradually to the usual maintenance dose of 20mg, 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 40mg daily given in two divided doses.

Suggested Dosage titration of Enap in Patients with Heart Failure/ Asymptomatic Left Ventricular Dysfunction.

^* Special precautions should be followed in patients with impaired renal function or taking diuretics. (See Section 4.4).

Blood pressure and renal function should be monitored closely both before and after starting treatment with ‘Enap’ (See Section 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 ‘Enap’. The appearance of hypotension after the initial dose of ‘Enap’ does not imply that hypotension will recur during chronic therapy with ‘Enap’ and does not preclude continued use of the drug. Serum potassium and renal function also should be monitored.

Dosage in Renal Insufficiency

Generally, the intervals between the administration of enalapril should be prolonged and/or the dosage reduced.

Haemodialysis patients

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

Use in Elderly

The dose should be in line with the renal function of the elderly patient (see section 4.4-Renal function impairment)

Paediatric population

There is limited clinical trial experience of the use of Enap in hypertensive paediatric patients (see section 4.4; 5.1 and 5.2).

For patients who can swallow tablets, the dose should be individualised according to patient profile and blood pressure response. The recommended initial dose is 2.5mg in patients 20 to <50kg and 5mg in patients ≥50kg. Enap is given once daily. The dosage should be adjusted according to the needs of the patient to a maximum of 20mg daily in patients 20 to <50kg and 40mg in patients ≥50kg (see section 4.4).

Enap is not recommended in neonates and in paediatric patients with glomerular filtration rate <30ml/min/1.73 m², as no data are available.

Limited data are available for over dosage in humans. The most prominent features of over dosage reported to date are marked hypotension, beginning some six hours after ingestion of tablets, concomitant with blockade of the renin angiotensin system and stupor. Symptoms associated with over dosage of ACE inhibitors may include circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough. Serum enalaprilat levels 100- and 200-fold higher than usually seen after therapeutic doses have been reported after ingestion of 300mg and 440mg of enalapril, respectively

The recommended treatment of over dosage is intravenous infusion of normal saline solution. If hypotension occurs, the patient should be placed in the shock position.

If available, treatment with angiotensin II infusion and/or intravenous catecholamines may also be considered.

If ingestion is recent, take measures aimed at eliminating enalapril maleate (e.g. emesis, gastric lavage, administration of absorbents, and sodium sulfate). Enalaprilat may be removed from the general circulation by haemodialysis.(see section 4.4- haemodialysis patients). Pacemaker therapy is indicated for therapy-resistant bradycardia. Vital signs, serum electrolytes and creatinine concentrations should be monitored continuously.

2 years.

Do not store above 25°C.

Store in the original package in order to protect from light and moisture.

ENAP 5mg Tablets are packed in blisters of aluminium – aluminium welded on an internally varnished aluminium support.

ENAP 5mg Tablets are available in pack sizes of 30 tablets and 50 tablets.

Not all pack sizes may be marketed.

No special requirements.