Tablets "EdarbiKlor ^® " are applied at treatment of arterial hypertension for the purpose of lowering of blood pressure:

• at patients at whom arterial blood pressure adequately is not controlled by monotherapy;
• as initial therapy for patients who need the combined antihypertensive therapy.

Structure

One tablet contains (active ingredients):

• an azilsartan of a medoksomil of potassium - 42.68 mg (40 mg of an azilsartan of a medoksomil are equivalent);
• Chlortalidonum - 25 mg.

Excipients: a mannitol (E 421), cellulose microcrystalline, fumaric acid, sodium hydroxide, hydroxypropyl cellulose, krospovidon, magnesium stearate, a gipromelloza 2910, talc, the titan dioxide (E 171), ferrous oxide red (E 172), polyethyleneglycol 8000, blackened gray F1.

Contraindication

• hypersensitivity to active agent or other components of drug;
• anury;
• hypopotassemia, resistant to therapy, hypercalcemia, hyponatremia;
• heavy abnormal liver functions and kidneys (clearance of creatinine <30 ml/minute);
• cholestasia, obstruction of biliary tract;
• pregnancy and feeding by a breast;
not to apply
• together with the aliskiren-containing means to patients with diabetes;
• children's age;
to
• it is contraindicated to the women planning pregnancy.

by

for oral administration, a pill can be taken irrespective of meal.

Recommended initial dose for adults makes one tablet (40/12.5 mg) of 1 times a day. The antihypertensive effect is shown mainly within 1-2 weeks of treatment. In 2-4 weeks of treatment the dose if necessary can be increased up to 40/25 mg for the purpose of achievement of target level of arterial blood pressure.

medicament Use "EdarbiKlor ^® " in doses more on 40/25 mg is inexpedient

.

Drug "EdarbiKlor ^® " can be applied to providing an additional lowering of arterial pressure at patients at whom hypertensia is insufficiently controlled against the background of monotherapy by the antagonist of receptors of angiotensin II or diuretic. Patients at whom appropriate control against the background of reception of an azilsartan of a medoksomil in a dose of 80 mg is not provided can reach additional clinical decrease in systolic/diastolic arterial blood pressure by 13/6 mm of a mercury column after prescribing of medicament "EdarbiKlor ^® " in a dose of 40/12.5 mg. Patients at whom appropriate control against the background of intake of Chlortalidonum in a dose of 25 mg is not provided can reach additional clinical a lowering of arterial pressure on 10/7 mm of a mercury column after prescribing of medicament "EdarbiKlor ^® " in a dose of 40/12.5 mg.

Drug "EdarbiKlor ^® " can be applied as therapy of the first line if the patient needs complex therapy for achievement of target level of arterial blood pressure.

Patients for whom it is already chosen doses of separate components of medicament (the azilsartana medoksomit also Chlortalidonum), can receive in exchange the corresponding dose of medicament "EdarbiKlor ^® ".

If necessary "EdarbiKlor ^® " can appoint medicament by

together with other antihypertensive drugs.

Before an initiation of treatment medicament "EdarbiKlor ^® " needs to modify a hypovolemia, in the presence, especially at patients with a renal failure and at the patients receiving high doses of diuretics.

to Patients at whom dozolimitiruyushchy undesirable reactions to Chlortalidonum are observed can appoint by

medicament "EdarbiKlor ^® ", since a low dose of Chlortalidonum.

Feature of use

Pregnant

Use of antagonists of angiotensin II to contraindicated pregnant women or women who plan pregnancy.

whether it is removed azilsartan in breast milk, but azilsartan in small concentration it is removed in breast milk of animals at a lactation, and tiazidopodobny diuretics, such as Chlortalidonum, are excreted in breast milk. Considering potentiality of emergence of side effects at babies on breastfeeding, it is necessary to make the decision concerning the feeding termination by a breast or medicament withdrawals taking into account importance of this medicament for mother.

Children

"EdarbiKlor ^® " do not appoint Drug to children as data on safety and efficiency of use to children (aged up to 18 years) are absent.

Drivers

Data on influence of medicament on the speed of psychomotor reactions at control of motor transport or other mechanisms, but it is necessary to consider a possibility of dizziness or increased fatigue.

Overdose

Is limited data on overdose by medicament of the person.

. The person has limited data on overdose by drug. During controlled clinical trials with participation of healthy volunteers of an azilsartan medoksomit which was applied in doses to 320 mg of 1 times a day within 7 days, was transferred well. In case of overdose it is necessary to carry out maintenance therapy taking into account a clinical condition of the patient. Azilsartan is not brought by means of dialysis.

Chlortalidonum. Treat symptoms of acute overdose: nausea, weakness, dizziness and disturbance of electrolytic balance. Drug LD50 level at oral administration at animals is more than 25000 mg/kg of body weight. The minimum lethal dose for the person is not established. Specific antidote to medicament is absent. Gastric lavage with the subsequent maintenance therapy is recommended. If necessary it is possible to add solution of glucose and sodium of chloride with potassium which should be entered with care to this therapy.

medoksomit

Side reactions which are possibly connected with treatment which were found in controlled clinical trials with a frequency ≥ 0.3% and above, than in placebo group, are given below.

from digestive tract: diarrhea, nausea.

General disorders: asthenia, fatigue.

from the musculoskeletal system and connective tissue: spasm of muscles.

from nervous system: dizziness, postural dizziness.

from a respiratory system: cough.

Metabolic and alimentary disturbances: hyponatremia.

from a cardiovascular system: arterial hypotension.

Chlortalidonum

In clinical trials on studying Chlortalidonum observed such undesirable reactions: rash, headache, dizziness, gastrointestinal disorder and increase in level of uric acid and cholesterol.

Post-marketing period

observed such undesirable reactions: nausea, faint, loss of consciousness, rash, itching, Quincke's disease. As the reactions given about these concern group of patients of uncertain volume, not always perhaps authentically to estimate their frequency or to establish existence of relationship of cause and effect using drug.

to Store

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

Expiration date - 3 years.