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Allergy sufferers – carefully
Diabetics – carefully
For drivers – carefully
Pregnant – prohibited
For children – from 6 years
Pharmacological group: ACE inhibitors, monocomponent. ATX code С09А А02.
Active ingredient: enalapril maleate;
1 tablet contains 10 mg of enalapril maleate; excipients: lactose, corn starch, talc, sodium bicarbonate, magnesium stearate, iron oxide red, iron oxide yellow (for tablets of 20 mg).
Treatment of arterial hypertension. Treatment of clinically significant heart failure. Prevention of clinically significant heart failure in patients with asymptomatic left ventricular dysfunction (ejection fraction <35%).
Hypersensitivity to enalapril, to any excipient of the drug or other ACE inhibitors.
A history of angioedema associated with previous treatment with ACE inhibitors. Pregnancy or planning of pregnancy (see section “Use during pregnancy or lactation”). Hereditary or idiopathic angioedema.
The simultaneous use of enalapril with drugs containing aliskiren in patients with diabetes mellitus or with impaired renal function (glomerular filtration rate <60 ml / min / 1.73 m2).
Method of administration and dosage:
Food intake does not affect the absorption of Enalapril-Teva tablets. The dosage should be selected individually, in accordance with the condition of each patient and the reaction of blood pressure in response to the drug.
Arterial hypertension. The dose of the drug ranges from an initial 5 mg to a maximum of 20 mg, depending on the degree of arterial hypertension and the patient’s condition (see below). Enalapril-Teva is taken once a day. For mild arterial hypertension, the recommended starting dose is 5-10 mg per day. In patients with a very activated renin-angiotensin-aldosterone system (for example, with renovascular hypertension, impaired salt and / or fluid balance, decompensation of cardiac function, or severe arterial hypertension), an excessive decrease in blood pressure may occur after taking the initial dose. For such patients, an initial dose of 2.5 mg to 5 mg is recommended before starting treatment – under medical supervision. Pretreatment with high doses of diuretics can lead to fluid deficiency and the development of arterial hypotension at the beginning of therapy with enalapril. For these patients, an initial dose of 2.5 mg to 5 mg is recommended. If possible, diuretic treatment should be discontinued 2-3 days before starting treatment with Enalapril-Teva. Renal function and serum potassium levels should be monitored. The usual maintenance dose is 20 mg once a day. The maximum maintenance dose is 40 mg once a day.
Heart failure / asymptomatic left ventricular dysfunction. For the treatment of clinically severe heart failure, Enalapril-Teva is used together with diuretics and, if necessary, with digitalis drugs or beta-blockers. The initial dose of the drug Enalapril-Teva for patients with clinically expressed heart failure or asymptomatic left ventricular dysfunction is 2.5 mg, while the use of the drug must be carried out under the supervision of a physician in order to establish the primary effect of the drug on blood pressure. In the absence of effect or after appropriate correction of symptomatic hypotension that occurred at the beginning of treatment with Enalapril-Teva for heart failure, the dose should be gradually increased to the usual maintenance dose of 20 mg, administered once or divided into 2 doses, depending on what is better tolerated by the patient. The selection of the dose is recommended to be carried out within 2-4 weeks. This therapeutic regimen is effective in reducing mortality rates in patients with clinically significant heart failure. The maximum dose is 40 mg per day in 2 divided doses.
The ability to influence the reaction rate when driving or operating machinery: When driving vehicles or working with other mechanisms, the possible development of dizziness or fatigue should be taken into account.
Children: Applied to children aged 6 years and over. Enalapril is not recommended for neonates and children with a glomerular filtration rate <30 ml / min / 1.73 m2 due to lack of data.
Store in its original packaging at a temperature not exceeding 25 °C.
Produced in Poland
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