Enap of the tab. of 5 mg No. 20

Tablets "Enap ^® " 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 a maleate (one tablet contains 5 mg of enalapril of a maleate).

Excipients: Natrii hydrocarbonas, lactoses monohydrate, starch corn, hydroxypropyl cellulose, talc, magnesium stearate.

Contraindication

• hypersensitivity to enalapril or to any other components of drug, or other inhibitors of angiotensin-converting enzyme (APF);
• existence in the anamnesis of the Quincke's disease connected with the previous treatment by APF inhibitors;
• hereditary or idiopathic Quincke's disease;
• pregnant women or women who are going to become pregnant;
• should not apply medicine "Enap ^® " with medicaments which contain aliskiren, to patients with diabetes or with renal failures (SKF <60 ml/minute / 1.73 m ² ).

Route of administration

Meal does not influence absorption of these tablets. A dosage it is necessary to select individually according to a condition of each patient and reaction of arterial blood pressure in reply.

Arterial hypertension

Dose of medicament makes

from initial - 2.5 mg to maximum - 20 mg of 1 times a day depending on degree of arterial hypertension and a condition of the patient. In arterial hypertension of easy degree the recommended initial dose makes 5-10 mg.

At patients with the system which is very activated renin-angiotensin-aldosteronovoy (for example with renovascular hypertensia, disturbance of salt and/or liquid balance, a decompensation of warm function or heavy arterial hypertension) perhaps excessive lowering of arterial pressure after reception of an initial dose. The initial dose of 5 mg or below is recommended to such patients, and the patient has to be in an initiation of treatment under observation of the doctor.

Previous therapy by high doses of diuretics can result

in deficiency of liquid and risk of developing of arterial hypotension at the beginning of therapy by enalapril. For such patients the initial dose of 5 mg or below is recommended. At an opportunity the therapy by diuretics should be stopped in 2-3 days prior to medicament treatment "Enap ^® ". For patients who cannot stop intake of diuretics before therapy by medicament "Enap ^® " the initial dose makes 2.5 mg in the form of a single dose. It is necessary to control function of kidneys and level of potassium in blood serum.

Usual maintenance dose - 20 mg of 1 times a day. The maximum maintenance dose makes 40 mg a day once or is divided into 2 receptions.

Children with arterial hypertension aged from 6 years

Experience of clinical use of medicine "Enap ^® " to children with arterial hypertension is limited by

.

to Children who can swallow of tablets should appoint a dose by

individually, according to a condition of the patient, reaction of arterial blood pressure in response to treatment and the body weight of the patient. The recommended initial dose makes 2.5 mg of 1 times a day for patients with body weight from 20 to 50 kg and 5 mg of 1 times a day - for patients with body weight ≥ 50 kg. A dosage it is necessary to adjust depending on requirements to the maximum dose 20 mg/days for patients with body weight from 20 to 50 kg and 40 mg/days - for patients with body weight ≥ 50 kg (0.58 mg/kg of body weight).

Drug is not recommended to

for newborns and children with glomerular filtration rate <30 ml/minute / 1.73 m ² due to the lack of data.

Heart failure / asymptomatic dysfunction of a left ventricle

enalapril should be applied To treatment of clinically apparent heart failure with diuretics and, in case of need, with medicaments of a foxglove or beta-blockers. The initial dose of medicament "Enap ^® " for patients with clinically apparent heart failure or asymptomatic dysfunction of a left ventricle makes 2.5 mg, at the same time use of medicament needs to be carried out under observation of the doctor to establish primary influence of medicament on arterial blood pressure. In case of lack of effect or after the corresponding correction of the symptomatic hypotension which arose in an initiation of treatment of heart failure enalapril, the dose should be raised gradually to a usual maintenance dose 20 mg, to accept once or to divide into 2 receptions depending on the fact that the patient transfers better. Selection of a dose is recommended to be carried out within 2-4 weeks. The similar therapeutic mode effectively reduces indicators of lethality of patients with clinically apparent heart failure. The maximum dose makes 40 mg a day in 2 receptions.

Offered titration of a dose of enalapril for patients with heart failure / asymptomatic dysfunction of a left ventricle:

• week 1:
  • from 1st to the 3rd day - 2.5 mg/days for 1 reception;
  • from the 4th to the 7th day - 5 mg/days in 2 receptions;
• week of 2 - 10 mg/days in 1 or 2 receptions;
• week of 3 and 4 - 20 mg/days in 1 or 2 receptions.

Both to, and after an initiation of treatment enalapril it is necessary to exercise careful control of arterial blood pressure and function of kidneys as it was reported about arterial hypotension (less often) of a further renal failure. The patients accepting diuretics whenever possible should reduce a dose prior to medicament treatment "Enap ^® ". Development of arterial hypotension after an initial dose of enalapril does not mean that arterial hypotension will remain at long-term treatment and does not speak about need of the termination of administration of drug. It is also necessary to control potassium content in blood serum and function of kidneys.

Pregnant

APF Inhibitors it is contraindicated to the pregnant women and women planning pregnancy to apply

Feature of use

. Limited pharmacokinetic data confirm very low concentration of medicament in breast milk. Though such concentration are also considered as clinically significant, use of this medicament is not recommended during feeding by a breast premature and newborn in the first several weeks after the birth as there is a hypothetical risk of effects from a cardiovascular system and kidneys and also because of insufficient experience in this question. In case of the senior babies of use of medicament during feeding can be considered by a breast if treatment is necessary for mother, and will watch the child concerning emergence of any side effects.

Drivers

At control of motor transport or work with other mechanisms should consider possible development of dizziness or increased fatigue.

Overdose

limited data on overdose at the person Exist. The main signs of overdose, according to the available data, is the profound arterial hypotension which begins approximately in 6 hours after administration 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. Enalaprilat levels in blood plasma which exceed the maximum levels which are reached at reception of therapeutic doses in 100 and 200 times according to messages, were registered after reception according to 300 mg and 440 mg of enalapril.

to

For treatment of overdose recommend intravenous infusions of isotonic solution. At appearance of arterial hypotension of the patient it is necessary to put 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, actions for maleate enalapril elimination (such as artificial vomiting, gastric lavage, intake of absorbents and sodium of sulfate) are recommended. Enalaprilat can be removed from system blood circulation by a hemodialysis. In bradycardia which the rezistentna to therapeutic means, is shown therapy by means of a pacemaker. It is necessary to control constantly important vital signs, concentration of electrolytes and level of creatinine in blood serum.

Side effects

from the system of blood and lymphatic system: anemia, neutropenia, decrease in hemoglobin, decrease in a hematocrit, thrombocytopenia, agranulocytosis, oppression of function of marrow, pancytopenia, lymphadenopathy, autoimmune diseases.

from an endocrine system: syndrome of disturbance of secretion of antidiuretic hormone.

from metabolism and digestion: a hypoglycemia at the patients sick with diabetes accepting oral antihyperglycemic means or insulin.

from nervous system and mentality: headache, depression, confusion of consciousness, drowsiness, insomnia, nervousness, paresthesias, vertigo, abnormal dreams, sleep disorder.

from organs of sight: misting of sight.

from a cardiovascular system: dizziness, arterial hypotension, a syncope, pain behind a breast, disturbance of a warm rhythm, stenocardia, tachycardia, orthostatic hypotension, heartbeat, a myocardial infarction or a cerebral and vascular stroke, perhaps, secondary in excessive arterial hypotension at patients with high risk, Reynaud's phenomenon.

from respiratory organs, a thorax and mediastinum: cough, short wind, rhinorrhea, sore throat and hoarseness, pharyngitis, bronchospasm/asthma, infiltrate of lungs, rhinitis, allergic alveolitis / eosinophilic pneumonia.

from digestive tract: nausea, diarrhea, an abdominal pain, change of taste, impassability of intestines, pancreatitis, vomiting, dyspepsia, a constipation, anorexia, irritation of a stomach, dryness in a mouth, round ulcers, stomatitis / aphthous ulcers, a glossitis, a Quincke's disease of digestive tract at simultaneous use of APF inhibitors, including enalapril.

from a liver and biliary tract: a liver failure, hepatitis - hepatocellular or cholestatic, gepatonekroz, a cholestasia, including jaundice.

from skin and hypodermic fabrics: rashes, hypersensitivity / Quincke's disease; Quincke's disease of the face, extremities, lips, language, glottis and/or throat, sweating, itching, urticaria, alopecia, erubescence of the person, polymorphic erythema, Stephens-Johnson's syndrome, exfoliative dermatitis, toksikodermalny necrolysis, pempigus, erythrosis.

from kidneys and urinary tract: renal failure, renal failure, proteinuria, oliguria.

from a reproductive system and mammary glands: impotence, gynecomastia.

Storage conditions

to Store

in original packing (for protection against moisture influence) at a temperature not above 25 °C, out of children's reach.

Expiration date - 3 years.