Enalapril-Tev's tablets are applied at the following indications:

• Treatment of arterial hypertension.
• Treatment of clinically apparent heart failure.
• Prevention of clinically apparent heart failure at patients with asymptomatic dysfunction of a left ventricle (fraction of emission ≤ 35%).

Structure

Active ingredient: enalapril maleate;

1 tablet contains 2.5 mg or 5 mg or 10 mg or 20 mg of enalapril of a maleate;

Excipients:

Tablet on 2.5 mg and 5 mg: lactose, starch corn, talc, Natrii hydrocarbonas, hydroxypropyl cellulose, magnesium stearate;

Tablet on 10 mg and 20 mg: lactose, starch corn, talc, Natrii hydrocarbonas, magnesium stearate, ferrous oxide red, ferrous oxide yellow (for tablets on 20 mg).

Contraindication

• Hypersensitivity to enalapril, to any excipient or to the APF any other inhibitor.
• Existence in the anamnesis of the Quincke's disease connected with use of APF inhibitors.
• Hereditary or idiopathic Quincke's disease.
• Pregnant women or women who are going to become pregnant.
• should not apply enalapril with the medicaments containing aliskiren, to patients with diabetes or with a renal failure (SKF <60 ml/min. / 1.73 m ² ).

Route of administration

Meal does not influence absorption of tablets of Enalapril-Tev.

Dosage needs to be selected individually according to a condition of each patient and reaction of arterial blood pressure in reply.

Feature of use

Pregnant

It is contraindicated.

to Apply

to children from 6 years.

Enalapril is not recommended to be accepted to newborns and children who have a speed of glomerular filtration <30 ml/min. / 1.73 m ² , due to the lack of data.

Drivers

At control of motor transport or other mechanisms should take possible development of dizziness or increased fatigue into account.

Overdose

limited data on medicament overdose Exist. The main signs of overdose, according to the available data, is the profound arterial hypotension which begins approximately in 6 hours after use of medicament and matches blockade of a system renin-angiotensin, and a stupor. The symptoms connected with overdose by APF inhibitors can include circulator shock, an electrolytic imbalance, a renal failure, a hyperventilation of lungs, tachycardia, a cardiopalmus, bradycardia, dizziness, uneasiness and cough. The enalaprilat levels in blood plasma exceeding in 100 and 200 times the maximum levels reached at use of therapeutic doses according to messages were registered after use according to 300 mg and 440 mg of enalapril.

For treatment of overdose recommend intravenous infusions of isotonic solution. At appearance of arterial hypotension of the patient it is necessary to lay in horizontal position. It is possible to consider need of infusions of angiotensin II and/or intravenous administration of catecholamines. If the medicament was taken recently, measures for maleate enalapril elimination (such as artificial vomiting, gastric lavage, use of absorbents and sodium of sulfate) are recommended. Enalaprilat can be removed from system blood circulation by a hemodialysis (see the section "Features of Use": patients who are on a hemodialysis). In the bradycardia resistant to therapeutic means, therapy by means of a pacemaker is shown. It is necessary to control constantly important vital signs, concentration of electrolytes and level of creatinine in blood serum.

Side effects

At enalapril use in most cases side effects were insignificant, had temporality and did not demand therapy cancellation.

• from the system of blood: anemia (including aplastic and hemolytic); neutropenia, decrease in hemoglobin, decrease in a hematocrit, thrombocytopenia, agranulocytosis, oppression of marrow, pancytopenia, lymphadenopathy, autoimmune diseases.
• from an endocrine system: syndrome of disturbance of secretion of antidiuretic hormone.
• Metabolic disturbances: a hypoglycemia (see the section "Features of Use").
• from nervous system and mentality: depression, headache; confusion of consciousness, drowsiness, insomnia, nervousness, paresthesias, vertigo; sleep disorders, abnormal dreams.
• from organs of sight: illegibility of sight.
• from a cardiovascular system: dizziness; hypotension (including orthostatic hypotension), a syncope, pain behind a breast, disturbance of a rhythm, stenocardia, tachycardia; orthostatic hypotension, the accelerated heartbeat, a myocardial infarction or a stroke, perhaps, owing to excessive pressure decline at patients with high risk (see the section "Features of Use"), Reynaud's phenomenon.
• from a respiratory system: cough; asthma; rhinorrhea, sore throat and hoarseness, bronchospasm/asthma; pulmonary infiltrates, rhinitis, allergic alveolitis / eosinophilic pneumonia.
• from digestive system: nausea; diarrhea, abdominal pain, change of taste; intestinal impassability, pancreatitis, vomiting, dyspepsia, a constipation, anorexia, irritation of a stomach, dryness in a mouth, round ulcers; stomatitis / aphthous ulcers, glossitis; Quincke's disease of intestines.
• from a gepatobiliarny system: a liver failure, hepatitis hepatocellular or cholestatic, hepatitis, including necrosis, a cholestasia (including jaundice).
• from skin and hypodermic fabrics: rash, hypersensitivity / a Quincke's disease of the face, extremities, lips, language, a glottis and/or throat (see the section "Features of Use"); the increased sweating, an itching, urticaria, an alopecia; multiple erythema, Stephens-Johnson's syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pempigus, erythrosis.
to
• It was reported about development of difficult symptom complex which included some or all from such manifestations: fever, serositis, vasculitis, myalgia/miositis, arthralgia/arthritis, positive test for antinuclear antibodies, increase in the blood sedimentation rate (BSR), eosinophilia and leukocytosis. As side effects can also arise rash, a photosensitization and other reactions from skin.
• from an urinary system: renal failure, renal failure, proteinuria; oliguria.
• from a reproductive system: impotence; gynecomastia.
• General disturbances and disturbances of conditions of introduction: asthenia; fatigue; muscular spasms, inflows, a ring in ears, sensation of discomfort, a fever.

Interaction

Alcohol enhances hypotensive effect of APF inhibitors.

Sympathomimetics can reduce antihypertensive effects of APF inhibitors.

to Store

out of children's reach in original packing at a temperature not above 25 °C.

Expiration date - 3 years.