Instruction for use: Concor

Trade name of the drug – Concor

Dosage Form: tablets

Active substance: Bisoprololum

ATX

C07AB07 bisoprolol

Pharmacotherapeutic group: Beta1-selective blocker [Beta-blockers]

The nosological classification (ICD-10)

I10 Essential (primary) hypertension: hypertension; Arterial hypertension; Arterial hypertension crisis course; Essential Hypertension; Essential hypertension; Essential hypertension; Essential hypertension; Essential hypertension; Primary hypertension; Arterial hypertension, complications of diabetes; The sudden increase in blood pressure; Hypertensive disorders of blood circulation; hypertensive condition; hypertensive crises; arterial Hypertension; malignant Hypertension; Hypertonic disease; hypertensive crises; accelerated hypertension; malignant hypertension; The aggravation of hypertensive disease; Transient hypertension; Isolated systolic hypertension

I15 Secondary hypertension: Arterial hypertension, complications of diabetes; hypertension; The sudden increase in blood pressure; Hypertensive disorders of blood circulation; hypertensive condition; hypertensive crises; hypertension; arterial Hypertension; malignant Hypertension; hypertensive crises; accelerated hypertension; malignant hypertension; The aggravation of hypertensive disease; Transient hypertension; hypertension; Arterial hypertension; Arterial hypertension crisis course; renovascular hypertension; Hypertension symptomatic; Renal hypertension; Renovascular hypertension; renovascular hypertension; Symptomatic hypertension

I20 Angina [angina]: Heberden disease; Angina pectoris; The attack of angina pectoris; recurrent angina; Spontaneous angina; Stable angina pectoris; Angina rest; Angina progressing; Angina mixed; Angina spontaneous; stable angina; Chronic stable angina; Angina Syndrome X

I25.9 Chronic ischemic heart disease, unspecified: CHD; Insufficiency of coronary circulation; Coronary atherosclerosis in patients with coronary artery disease

I50.0 Congestive heart failure: anasarca heart; Decompensated congestive heart failure; Congestive heart failure; Congestive heart failure with high afterload; Congestive chronic heart failure; Cardiomyopathy with severe chronic heart failure; Compensated chronic heart failure; Swelling with circulatory failure; Edema of cardiac origin; Swelling of the heart; Edematous syndrome in diseases of the heart; Edematous syndrome in congestive heart failure; Edematous syndrome in heart failure; Edematous syndrome in heart failure or liver cirrhosis; right ventricular failure; Congestive Heart Failure; Heart failure stagnant; Heart failure with low cardiac output; Heart failure is a chronic; Cardiac edema; Chronic decompensated heart failure; Chronic Congestive Heart Failure; Chronic heart failure; Change of liver function in heart failure

Composition (per tablet):

active substance: bisoprolol fumarate 5 mg

Excipients: anhydrous calcium hydrogen phosphate - 132 mg; corn starch fine powder - 14.5 mg; Anhydrous colloidal silica - 1.5 mg; MCC - 10 mg; crospovidone - 5.5 mg; Magnesium stearate - 1.5 mg

shell film: hypromellose 2910/15 - 2.2 mg; macrogol 400 - 0,53 mg; Dimethicone 100 - 0.11 mg; dye iron oxide yellow (E172) - 0,02 mg; titanium dioxide (E171) - 0.97 mg

active substance: bisoprolol fumarate 10 mg

Excipients: dibasic calcium phosphate anhydrous - 127.5 mg; corn starch fine powder - 14 mg; Anhydrous colloidal silica - 1.5 mg; MCC - 10 mg; crospovidone - 5.5 mg; Magnesium stearate - 1.5 mg

shell film: hypromellose 2910/15 - 2.2 mg; macrogol 400 - 0,53 mg; Dimethicone 100 - 0.22 mg; dye iron oxide yellow (E172) - 0,12 mg; colourant iron oxide red (E172) - 0,002 mg; titanium dioxide (E171) - 0.85 mg

Pharmacological Properties of Concor

Pharmachologic effect - antianginal, hypotensive, anti-arrhythmic.

Dosage and Administration

Inside.

Concor® tablets should be taken one time a day with a small amount of liquid in the morning before breakfast, during or after it. Tablets should not be chewed or triturate.

Arterial hypertension and stable angina

In all cases, the receiving mode and selects the dose the doctor for each patient individually, in particular taking into account the patient's heart rate and condition.

Typically, the initial dose is 5 mg Concor® 1 time per day. If necessary, the dose may be increased to 10 mg 1 time per day.

In the treatment of hypertension and stable angina maximum recommended dose is 20 mg Concor® 1 per day.

CHF

The standard scheme of CHF treatment involves the use of ACE inhibitors or angiotensin II receptor antagonists (in case of intolerance to ACE inhibitors), β-blockers, diuretics, and optionally cardiac glycosides. Home treatment of CHF requires a mandatory drug Concor® the special titration phase and regular medical supervision.

A prerequisite for treatment with Concor® is stable chronic heart failure without acute symptoms.

CHF Concor® drug treatment is started in accordance with the following titration scheme. This may require individual adaptation depending on how well the patient carries the prescribed dose, ie. E. The dose can be increased only if the previous dose was well tolerated.

To ensure proper titration process in the initial stages of treatment is recommended bisoprolol in a dosage form tablet, 2.5 mg. The recommended initial dose is 1.25 mg 1 time a day. Depending on individual tolerability, the dose should be gradually increased to 2.5 mg, 3.75 mg, 5 mg, 7.5 mg and 10 mg 1 time per day. Each subsequent increase in dose should be administered at least 2 weeks.

If an increase in the dose of the drug is poorly tolerated by the patient, the dose may be reduced.

The maximum recommended dose for the treatment of chronic heart failure is 10 mg Konkor® 1 per day.

During titration we recommend regular monitoring of blood pressure, heart rate and severity of heart failure symptoms. Worsening symptoms of CHF may flow since the 1st day of the drug.

If the patient does not tolerate the maximum recommended dose, you should consider a gradual reduction of the dose.

During the titration phase, or it can occur after a temporary deterioration in the flow of CHF, hypotension or bradycardia. In this case it is recommended first of all carry out the correction of concurrent therapy doses of drugs. It may also require temporary dose reduction or cancellation Concor®.

After stabilization, the patient should undertake a re-titration of the dose or continue the treatment.

The duration of treatment for all indications to the application of the drug Konkor®

Drug treatment is usually long-term therapy.

Special patient groups

Impaired renal or hepatic function:

- In violation of mild or moderate liver or kidney function usually do not need to adjust the dose;

- When expressed violations kidney (Cl creatinine <20 ml / min) and in patients with severe liver disease, the maximum daily dose is 10 mg; increasing the dose in such patients should be administered with extreme caution.

Elderly patients: Dosage adjustment is not required.

Children: Since there is not enough of the drug for use in children Konkor® data, the drug is not recommended for children under 18 years.

There are currently insufficient data on the use of the drug Konkor® in patients with heart failure in combination with diabetes type 1 diabetes, severe impaired renal function and / or liver disease, restrictive cardiomyopathy, congenital heart defects or heart disease valve with severe hemodynamic compromise. Also still not sufficient data has been obtained relative to CHF patients with myocardial infarction within the past 3 months.

Release Form

Tablets, film-coated, 5 mg: in blister packs of PVC and aluminum foil at 10, 25 or 30 pieces .; in a stack of cardboard 3 or 5 blisters of 10 pieces., or 2 blisters of 25 pcs., or 1 or 3 blisters of 30 pieces.

Tablets, film-coated, 10 mg: in blister packs of PVC and aluminum foil at 10, 25 or 30 pieces .; in a stack of cardboard 3 or 5 blisters of 10 pieces., or 2 blisters of 25 pcs., or 1 blister 30 pcs.

Manufacturer

The owner of the registration certificate / manufacturer: Merck KGaA, Germany. Merck KGaA, Germany.

Address registration certificate holder / manufacturer: Frankfurtershtrasse, 250, 64293, Darmstadt, Germany.

Frankfurter Strasse 250, 64293, Darmstadt, Germany.

In the case of secondary packaging / quality control on the issuing of "Nanolek" Russia further point:

secondary packer / producing quality control, "Nanolek" Ltd., Russia. 612079, Kirov region., Orichevsky district, village Levinta, Biomedical complex "NANOLEK".

Claims consumers sent to OOO "Takeda Pharmaceuticals." 119048, Moscow, ul. Usachev, 2, p. 1.

Conditions of supply of pharmacies

On prescription.

Storage conditions of Concor

The temperature is not above 30 ° C.

Keep out of the reach of children.

Shelf life

5 years.

Do not use beyond the expiration date printed on the package.