Zokardis of the tab. of p/o of 7.5 mg No. 28

Tablets "Zokardis ^® 7.5 mg" are applied at the following indications:

• arterial hypertension (treatment of essential hypertensia easy and moderate severity);
• an acute myocardial infarction (treatment of patients with an acute myocardial infarction in the first 24 hours with signs or symptoms (or without them) heart failure with a stable hemodynamics provided that did not carry out by him thrombolytic therapy).

Structure

One tablet, coated, contains (active ingredient) of a zofenopril of calcium of 7.5 mg that is equivalent to 7.2 mg of a zofenopril).

Excipients: kernel: microcrystalline cellulose, lactoses monohydrate, sodium of a kroskarmelloz, magnesium stearate, silicon dioxide colloidal anhydrous; film cover: gipromelloza, titan dioxide (E 171), polyethyleneglycol 400, polyethyleneglycol 6000.

Contraindication

• hypersensitivity to a zofenopril of calcium either to other APF inhibitor or to an odno from excipients which are a part of drug;
• Quincke's disease in the anamnesis connected with the previous treatment by APF inhibitor;
• hereditary or idiopathic Quincke's disease;
• abnormal liver function of heavy degree;
• pregnant women or women who are going to become pregnant;
• woman of reproductive age which do not apply effective contraception;
• a bilateral renal arterial stenosis or unilateral in the presence of one kidney;
to
• simultaneous use of a zofenopril with the aliskiren-containing medicaments is contraindicated to patients with diabetes or a renal failure (SKF <60 ml/minute / 1.73 m ² ).

Route of administration

to use Drug irrespective of meal. The dosage should be selected according to therapeutic response of the patient.

Arterial hypertension

Dose is selected individually, depending on the level of arterial blood pressure, before reception of the following dose. Increase in a dose is carried out with an interval of 4 weeks.

Acute myocardial infarction

within 24 hours after emergence of the first symptoms of a myocardial infarction and to continue within 6 weeks. It is necessary to apply such ​​ the scheme of dosing:

• 1 and 2 day - to 7.5 mg is each 12 hours;
• 3 and 4 day - to 15 mg is each 12 hours;
• from the 5th day and further - to 30 mg.

in case of low systolic pressure (≤ 120 mm of a mercury column) in an initiation of treatment and within the next three days after development of a myocardial infarction a daily dose should not be raised. In case of arterial hypotension (≤ 100 mm of a mercury column) to continue treatment, applying a dose which was appointed earlier. In case of heavy hypotension (≤ 90 mm of a mercury column at two consecutive measurements of pressure with an interval not less than one hour) administration of medicament should be stopped. In 6 weeks of treatment, after the analysis of a condition of the patient to stop treatment for patients without symptoms of left ventricular dysfunction or heart failure. If these signs remained, treatment can be continued for a long time. It is necessary to perform also the corresponding standard treatment, such as treatment by nitrates, acetylsalicylic acid or b-adrenoblockers.

Feature of use

Pregnant

APF Inhibitors are contraindicated to the pregnant women and women planning pregnancy.

As information on use of a zofenopril during feeding by a breast is absent, its use is not recommended. During feeding by a breast, especially newborn or premature children, it is better to apply alternative, safer medicines.

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therefore children should not appoint it.

Drivers

Researches concerning influence of a zofenopril on ability to run motor transport or other mechanisms. At use of medicament there can be a drowsiness, dizziness or fatigue therefore patients have to consider it and with care to estimate the ability to run motor transport or other mechanisms.

Overdose

Symptoms of overdose are heavy arterial hypotension, shock, a stupor, bradycardia, electrolytic disturbances and a renal failure. After overdose the patient has to be under observation of the doctor, it is desirable in intensive care unit. It is necessary to control often the level of electrolytes and creatinine of blood serum. Therapeutic actions depend by nature and weights of symptoms. If the overdose arose recently, then it is necessary to wash out a stomach, to appoint activated carbon and sodium sulfate. At emergence of symptoms of arterial hypotension of the patient it is necessary to put in horizontal position with raised upside down. It is reasonable to consider a question of purpose of the means increasing the volume of blood plasma and/or prescribing of angiotensin II. In the presence of bradycardia and considerable vagal reactions to appoint atropine, and in case of need to use an electrocardiostimulator. APF inhibitors can be removed from circulation by means of a hemodialysis. Not to use polyacrylonitrile membranes with a high capacity.

Side effects

Below all side reactions about which reported in clinical practice of patients who received drug. They are stated on the systems of bodies and orders of frequency, using the following classification: very often (≥ 1/10), it is frequent (≥ 1/100, <1/10), infrequently (≥ 1/1000, ≤ 1/100), is rare (≥ 1/10000, ≤ 1/1000) and is very rare (≤ 1/10,000).

from nervous system: often - dizziness, a headache.

from airways: often - cough.

from digestive tract: often - nausea/vomiting.

from skin and hypodermic fabrics: infrequently - rash; seldom - a Quincke's disease.

from a musculoskeletal system and connective tissue: infrequently - muscular spasms.

Special storage conditions are not required for

. To store out of children's reach.

Expiration date - 3 years.