Efez (eplerenon) tab. of p/o of 50 mg No. 30

Efez – kaliysberegayushchy diuretics.

Indications

Addition to standard treatment using β-blockers for the purpose of the reduction of risk of incidence and lethality connected with cardiovascular diseases at stable patients with dysfunction of a left ventricle (fraction of emission of a left ventricle ≤ 40%) and clinical signs of heart failure after recently myocardial infarction.

Addition to standard optimum therapy for the purpose of reduction of risk of the incidence and lethality connected with cardiovascular diseases at adult patients with heart failure of class II (chronic) on classification by NYHA and dysfunction of a left ventricle (fraction of emission of a left ventricle) ≤ 3.

Structure

• active ingredient: eplerenon;
• 1 tablet contains 50 mg of an eplerenon;
• other components: lactose monohydrate, cellulose microcrystalline, sodium of a kroskarmeloz, gipromeloz, sodium lauryl sulfate, talc, magnesium stearate, опадрай® II 33G270003 yellowy-brown.

Contraindication

Hypersensitivity to active ingredient or any of excipients.

to Patients with potassium level in blood serum> 5 mmol/l by the time of an initiation of treatment.

to Patients with a renal failure of heavy degree (rated speed of glomerular filtration <30 ml/min. / 1.73 sq.m).

to Patients with a liver failure of heavy degree (class C on classification of Chaylda-Pyyu).

to the Patients applying kaliysberegayushchy diuretics or powerful CYP inhibitors 3A4 (for example, itrakonazol, ketokonazol, ritonavir, nelfinavir, klaritromitsin, telitromitsin and nefazodon).

Simultaneous use of an eplerenon in a triple combination together with APF inhibitor and a blocker of receptors of angiotensin.

Side reactions

Infection and invasion: seldom – pyelonephritis, infections, pharyngitis.

from the respiratory system, bodies of a thorax and mediastinum: often cough.

from digestive tract: often – diarrhea, nausea, a constipation, vomiting; infrequently – an abdominal distension.

from a liver and biliary tract: seldom – cholecystitis.

from kidneys and an urinary system: the renal failure is frequent.

from an endocrine system: seldom – a hypothyroidism.

from a metabolism, metabolism: often – a hyperpotassemia, a hypercholesterolemia; infrequently – a hyponatremia, dehydration, a gipertriglitseridemiya.

from nervous system: often – a syncope, dizziness, a headache; infrequently – a hypesthesia.

from mentality: often – insomnia.

Route of administration

Adult.

For individual selection of a dosage of medicine of a dose of 25 mg and 50 mg. The maximum daily dosage of medicine makes 50 mg.

Eplerenon can be used both with food, and irrespective of meal.

Patients with heart failure after the postponed myocardial infarction. The recommended maintenance dose of an eplerenon makes 50 mg of 1 times a day. Treatment it is necessary to begin with a dose 25 mg of 1 times a day and to gradually increase to a target dose 50 mg of 1 times a day. It is desirable to reach this level of a dose in 4 weeks, considering potassium level in blood serum (see the table given below).

in 3–14 days after an acute myocardial infarction.

Feature of use

Use during pregnancy or feeding by a breast

Pregnancy. Pregnant women do not have adequate data on use of an eplerenon. It is necessary to appoint eplerenon to pregnant women with care.

Feeding by a breast. It is unknown whether gets eplerenon into breast milk of the person after oral administration. At the same time data of preclinical trials confirm existence of an eplerenon and/or its metabolites in milk of rats and normal development of posterity that came under influence of an eplerenon thus. As the potential of emergence of side effects at babies is not investigated, it is necessary to solve, to stop feeding by a breast or to stop medicine use, considering importance of therapy for mother.

Safety and efficiency of use Eplerenona is not established to children by

.

Ability to influence speed of response at control of motor transport or other mechanisms

Research of influence of an eplerenon on ability to run motor transport or to work with other mechanisms were not carried out by

. Eplerenon does not cause drowsiness or disturbance of cognitive functions, but during control of motor transport or other mechanisms it is necessary to consider a possibility of development of dizziness in connection with medicament treatment.

by

Overdose

Messages about side reactions, connected with overdose of an eplerenon at people, it was not received. It is expected that the most probable manifestations of overdose by medicine the person will have an arterial hypotension or a hyperpotassemia. Eplerenon it is impossible to bring out of an organism by means of a hemodialysis. It was shown what eplerenon effectively contacts activated carbon. In case of development of arterial hypotension it is necessary to begin the supporting treatment. At development of a hyperpotassemia it is necessary to begin treatment according to standards.

to Store

in original packing at a temperature not above 25 °C.

to Store

out of children's reach.