Berlipril of the tab. of 10 mg No. 30

Tablets "Berlipril ^® 10" are applied at the following indications:

• treatment of arterial hypertension;
• treatment of heart failure with the available symptoms;
• prevention of symptomatic heart failure at patients with asymptomatic dysfunction of a left ventricle (fraction of emission ≤ 35%).

Structure

Active ingredient - enalapril (one tablet contains enalapril of a maleate 10 mg).

Excipients: lactoses monohydrate, magnesium a carbonate easy, sodium krakhmalglikolit (type A), gelatin, silicon dioxide colloidal anhydrous, magnesium stearate, ferrous oxide (E172): brown.

Contraindication

• hypersensitivity to maleate enalapril, to any of excipients or other APF (IAPF) inhibitors;
• existence in the anamnesis of a Quincke's disease which developed owing to purpose of therapy by APF inhibitors;
• hereditary or idiopathic angiootek;
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• it is contraindicated to the pregnant women and women planning pregnancy; it is contraindicated to li to appoint
• "Berlipril ^® 10" along with medicaments which contain aliskiren, to patients with diabetes and a renal failure (SKF <60 ml/minute / 1.73 m ² ).

Route of administration

Dose of medicament should be selected individually depending on a condition of the patient and from effect of medicament on arterial blood pressure.

Meal does not influence medicament absorption process.

Initial medicament dose "Berlipril ^® 10" makes

from 5 mg to 20 mg depending on severity of hypertensia and a condition of the patient. To take the medicament 1 time a day.

In arterial hypertension of easy degree the recommended initial dose makes 5-10 mg.

At patients with the significant activation system renin-angiotensin-aldosteronovoy (for example in renovascular hypertensia, disturbance of salt and/or liquid balance, a decompensation of warm activity or heavy arterial hypertension) after reception of an initial dose the considerable lowering of arterial pressure can take place. At such patients treatment it is necessary to begin with a dose 5 mg or with a smaller dose and under observation of the doctor.

At preliminary therapy by diuretics in high doses the deficiency of liquid can develop and arise risk of developing arterial hypotension in an initiation of treatment enalapril. For such patients the initial dose of 5 mg or less is recommended. Whenever possible, treatment by diuretics should be stopped in 2-3 days prior to medicament treatment "Berlipril ^® 10". Renal function and serum of potassium have to be checked.

Usual maintenance dose makes 20 mg once a day. The maximum maintenance dose makes 40 mg a day.

Heart failure / asymptomatic dysfunction of a left ventricle

At treatment of the symptomatic heart failure (HF) in addition to diuretics and, if necessary, to a foxglove or beta blockers. The initial dose of medicament "Berlipril ^® 10" for patients with symptomatic heart failure or asymptomatic dysfunction of a left ventricle (VLDD) makes 2.5 mg, and therapy should be begun under fixed medical observation to establish primary influence of medicament on arterial blood pressure. If after medicament treatment "Berlipril ^® 10" in heart failure the symptomatic hypotension does not arise or does not pass, it should be increased gradually to the usual maintenance dose 20 mg accepted in the form of a single dose or, depending on shipping of the patient divided into 2 receptions. Such titration of a dose is recommended to be carried out within 2-4 weeks of therapy. The maximum dose of enalapril makes 40 mg a day which should be divided into two doses.

Recommended titration of a dose of medicament "Berlipril ^® 10" at patients with heart failure / asymptomatic dysfunction of a left ventricle:

• week 1:
  • days 1-3 - 2.5 mg/days at one time;
  • days 4-7 - 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.

careful control of arterial blood pressure and renal function as were registered the message about hypotension (less often) as a result a renal failure. Before an initiation of treatment medicament "Berlipril ^® 10", whenever possible, to reduce a dose of diuretics which is applied by patients. Manifestation of hypotension in an initiation of treatment medicament "Berlipril ^® 10" is not sign of its development at long-term treatment and does not exclude further use of medicine. Also it is necessary to control potassium level in blood serum and function of kidneys.

Children

Drug is contraindicated to children is younger than 6 years. Data on efficiency and safety of use of enalapril of a maleate for children are more senior than 6 years having arterial hypertension are limited, and experience of use at other indications is absent. Pharmacokinetic data on use of medicament for children are aged more senior than 2 months are limited. Drug is intended only to children with arterial hypertension, but it is not recommended for use at other indications.

due to the lack of the relevant information is not recommended to use this medicament to children with an indicator of glomerular filtration <30 ml/minute / 1.73 m ² .

Feature of use

Pregnant

it is contraindicated to p to use medicament to the pregnant women or women planning pregnancy.

content of APF inhibitors in mother's milk in insignificant concentration. Though such concentration are also considered clinically not as 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. If the newborn child is more senior, then in such cases treatment by this medicament of women who nurse, it is possible to consider only if treatment is necessary for mother, and will watch the child concerning emergence of any side effects.

Drivers

At control of motor transport and work with mechanisms should consider possibility of dizziness or weakness.

Data on overdose at the person are limited to

. As the most probable signs of overdose still are considered 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 of APF inhibitors can include circulator shock, electrolytic disturbances, a renal failure, a hyperventilation, tachycardia, the strengthened heartbeat, bradycardia, dizziness, alarm and cough. After use of 300 mg and 440 mg of enalapril of a maleate in blood serum concentration of enalaprilat in 100 and 200 times respectively, above indicators which were observed at use of medicament in therapeutic doses were defined.

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For treatment of overdose recommends chloride sodium solution infusion. At appearance of arterial hypotension of the patient it is necessary to put in horizontal position. Also perhaps infusional administration of angiotensin II and/or intravenous administration of catecholamines. If the medicament was taken recently, it is necessary to take measures for a maleate enalapril conclusion (for example calling of vomiting, gastric lavage, prescribing of adsorbents and sodium of sulfate). Enalaprilat is removed from general circulation by a hemodialysis. In resistant bradycardia the electrocardiostimulator is shown. It is necessary to control constantly the vital indicators, level of electrolytes and creatinine in blood serum.

Side effects

from nervous system and mentality: often (≥ 1/100 - <1/10) - a headache, a depression.

from organs of sight: very often (≥ 1/10) - illegibility of sight.

from a cardiovascular system: very often (≥ 1/10) - dizziness; often (≥ 1/100 - <1/10) - arterial hypotension (including orthostatic hypotension), a syncope, pain behind a breast, disturbances of a rhythm, stenocardia, tachycardia.

from a respiratory system, a thorax and mediastinum: very often (≥ 1/10) - cough; often (≥ 1/100 - <1/10) - dispnoe.

from a digestive tract: very often (≥ 1/10) - nausea; often (≥ 1/100 - <1/10) - diarrhea, abdominal pain, change of flavoring perception.

from skin and hypodermic fabrics: often (≥ 1/100 - <1/10) - rashes, hypersensitivity / angiootek persons, extremities, lips, language, phonatory bands and/or a throat.

to Store

at a temperature not above 25 °C, out of children's reach.

Expiration date - 3 years.