Tradename

Nivol, Нивол

International non-proprietary name

Nebivolol, Nebivolol

Compound

Each tablet contains

active ingredient: Nebivolol (as Nebivolol Hydrochloride) 5 mg

Color: Red Iron Oxide Excipients: Q . S

Dosage form

Tablets.

Pharmacological properties

Mechanism of action

It works by blocking the effects of certain chemicals on your heart and blood vessels. This slows down the heart rate and helps the heart beat with less force. It lowers blood pressure and helps reduce the risk of stroke, heart attack, other heart or kidney problems in the future.

Indications for application

Nebivolol is indicated for the treatment of hypertension.

Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1.

•          Liver failure or impaired liver function.

•          Acute heart failure, cardiogenic shock or episodes of decompensated heart failure requiring intravenous administration, inotropic therapy. In addition, like other beta-blockers, /.../ is contraindicated in:

•          sick sinus syndrome, including sinoarterial blockade.

•          second and third degree heart block (without a pacemaker).

•          history of bronchospasm and bronchial asthma.

•          untreated pheochromocytoma.

Special instructions and precautions

Special instructions:

Anesthesia Continued beta blockade reduces the risk of arrhythmias during induction and intubation. If beta-blockers are interrupted in preparation for surgery, beta-blockers should be discontinued at least 24 hours in advance. Caution should be observed with some anesthetics that cause myocardial depression. The patient can be protected from vagal reactions by intravenous atropine.

Precautionary measures:

Patients with a history of psoriasis should only take beta-blockers after careful consideration. Beta-adrenergic antagonists may increase sensitivity to allergens and the severity of anaphylactic reactions. Beta-blockers may cause a decrease in lacrimation. Initiation of treatment for chronic heart failure with nebivolol requires regular follow-up. See Section 4.2 for dosage and administration information. Stopping treatment should not be done abruptly unless clearly indicated. See section 4.2 for more information.

Applies to all indications:

In patients with peripheral circulatory disorders (Raynaud's disease or syndrome, intermittent claudication), as these disorders worsen; • in patients with first-degree heart block due to the negative effect of beta-blockers on conduction time; • in patients with Prinz's angina due to unmediated alpha receptor-mediated coronary artery vasoconstriction: beta-blockers may increase the number and duration of angina attacks.

Side effect

•          Bloating or swelling of the face, arms, hands, legs, or feet.

•          pain or discomfort in chest.

•          labored or labored breathing.

•          lightheadedness, dizziness or fainting.

•          rapid increase weight.

•          inconsistent breath.

•          slow or irregular heartbeat.

•          hand tingling or legs.

Influence on the ability to drive vehicles and mechanisms Studies of the effect on the ability to drive vehicles and mechanisms have not been conducted. Pharmacodynamic studies have shown that nebivolol does not affect psychomotor function . When driving vehicles or working with mechanisms, it should be borne in mind that dizziness and fatigue may sometimes occur. These effects are more likely after the start of treatment or after increasing the dose.

Interaction with other drugs

Class I antiarrhythmics (quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone): the effect on atrioventricular conduction time and the negative inotropic effect may increase (see section "Special Instructions"). Calcium channel antagonists such as verapamil / diltiazem: a negative effect on contractility and atrioventricular conduction. Intravenous administration of verapamil in patients receiving treatment with blockers can lead to severe hypotension and trioventricular blockade (see section "Side effect"). Centrally acting antihypertensives (clonidine, guanfacine, moxonidine, methyldopa, thiamidine): Concomitant use of centrally acting antihypertensives may exacerbate heart failure by reducing the tone of the central sympathetic nervous system (decrease in heart rate and cardiac output, vasodilation) (see. section "Special Instructions"). ). Abrupt withdrawal, especially if prior to withdrawal of the beta-blocker, may increase   risk

"rebound hypertension".

Dosage and administration

The usual dose is one tablet (5 mg) per day, preferably at the same time of day. Tablets can be taken with meals. The effect of lowering blood pressure may appear after 1-2 weeks of treatment. Sometimes the optimal effect is achieved only after 4 weeks.

Overdose

In case of overdose or hypersensitivity, the patient should be closely monitored and treated in an intensive care unit. You should check your blood glucose levels. Absorption of any drug residue still present in the gastrointestinal tract can be prevented by gastric lavage and administration of activated charcoal and laxatives. Artificial respiration may be required. Bradycardia or extensive vagal reactions should be treated with atropine or methylatropine. Hypotension and shock should be treated with plasma/plasma substitutes and, if necessary, catecholamines.

Storage conditions

Store below 30° C , protect from light and moisture.

Keep out of the reach of children!

Best before date

3 years. Do not use after the expiry date stated on the packaging.

Holiday conditions

Released by prescription.

Release form

3 Alu - Alu Blister of 10 tablets in a carton with insert. those. 3 x 10 tablets.