Binelol, pills 5mg, 14pcs

Composition

1 tablet contains the Active ingredient:

nebivolol (in the form of nebivolol hydrochloride) – 5.00 mg;

excipients:

lactose monohydrate,

crospovidone (type A),

poloxamer 188,

povidone K-30,

microcrystalline cellulose,

magnesium stearate.

Pharmacological action

Binelol has antihypertensive, antianginal, and antiarrhythmic effects.

Indications

• Arterial hypertension;
• Coronary heart disease (CHD): prevention of tension-type angina attacks.
• Chronic heart failure (as part of combination therapy).

Use during pregnancy and lactation

During pregnancy, Binelol is prescribed only for strict indications, when the benefit to the mother exceeds the risk to the fetus (due to the possible development of bradycardia, hypotension, hypoglycemia and respiratory paralysis in the newborn).

Treatment should be interrupted 48-72 hours before delivery.

In cases where this is not possible, it is necessary to ensure strict monitoring of the newborn within 48-72 hours after delivery.

Contraindications

• hypersensitivity to nebivolol or one of the components of the drug,
• expressed violations of the liver,
• congestive heart failure,
• chronic heart failure decompensation (requiring intravenous drugs with inotropic effect),
• cardiogenic shock,
• sick sinus syndrome node, including sinoauricular blockade,
• atrioventricular (AV) blockade II and III degree (without an artificial pacemaker),
• bronchospasm and bronchial asthma,
• untreated pheochromocytoma,
• depression,
• metabolic acidosis,
• bradycardia (heart rate less than 50 BPM),
• pronounced arterial gaiatsu (systolic BP less than 90 mm Hg. St. ),
• severe occlusive peripheral vascular disease (“intermittent” claudication, Raynaud’s syndrome),
• male,
• age to 18 years of
• lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Side effects

From the central and peripheral nervous system: headache, dizziness, fatigue, weakness, paresthesia (from 1% to 10%); very rarely – depression, decreased ability to concentrate, drowsiness, insomnia, nightmares, hallucinations, psychosis, convulsions.

From the digestive system: nausea, constipation, flatulence, diarrhea, dry mouth (>1%).

From the cardiovascular system: bradycardia, acute heart failure, AV block, orthostatic hypotension, exacerbation of intermittent claudication, shortness of breath; very rarely – cardiac arrhythmias, Raynaud’s syndrome, peripheral edema, cardialgia.

Allergic reactions: pruritus of the skin, erythematous rash.

Others: bronchospasm (including in the absence of obstructive pulmonary diseases in the anamnesis), photodermatosis, hyperhidrosis, rhinitis, exacerbation of psoriasis, visual disturbances, dry eyes.

Interaction

Concomitant use of beta-blockers with BMCC (verapamil and diltiazem) increases the negative effect on myocardial contractility and AV conduction.

Intravenous use of verapamil with nebivolol is contraindicated. When combined with antihypertensive agents, nitroglycerin or BMCC, severe arterial hypotension may develop (special caution is necessary when combined with prazosin). When used concomitantly with Class I antiarrhythmic drugs and amiodarone, it is possible to increase the negative inotropic effect and prolong the time of atrial excitation. When nebivolol was co-administered with cardiac glycosides, there was no increase in the effect on slowing AV conduction.

Concomitant use of nebivolol and general anaesthetic agents may cause suppression of reflex tachycardia and increase the risk of hypotension. There is no clinically significant interaction between nebivolol and NSAIDs. Acetylsalicylic acid as an antiplatelet agent can be used simultaneously with nebivolol. Concomitant use of tricyclic antidepressants, barbiturates and phenothiazine derivatives may increase the hypotensive effect of nebivolol.

How to take, course of use and dosage

Binelol should be taken orally at the same time of day, regardless of food intake, without chewing and with a sufficient amount of liquid.

Overdose

Symptoms:  decreased blood pressure, nausea, vomiting, cyanosis, sinus bradycardia, AV block, bronchospasm, cardiogenic shock, loss of consciousness, coma, cardiac arrest.

Treatment:  gastric lavage, use of activated charcoal. In case of a marked decrease in blood pressure, it is necessary to give the patient a horizontal position with raised legs, if necessary — intravenous use of fluid and vasopressors; as a follow – up,1-10 mg of glucagon may be prescribed. With bradycardia,0.5–2 mg of atropine is administered intravenously; in the absence of a positive effect, a transvenous or intracardiac electrostimulator can be installed. IV use of beta-adrenostimulants is recommended in case of AV block II–III art. If they are ineffective, an artificial pacemaker should be considered. In case of heart failure, treatment begins with the introduction of cardiac glycosides and diuretics, if there is no effect, it is advisable to introduce dopamine, dobutamine or vasodilators. With bronchospasm, intravenous beta-adrenomimetics are prescribed. For ventricular extrasystole — lidocaine (class IA antiarrhythmics should not be administered). For convulsions-IV diazepam.

Special instructions

Beta-blockers should be discontinued gradually over 10 days (up to 2 weeks in patients with CHD). Monitoring of blood pressure and heart rate at the beginning of taking the drug should be daily.

In elderly patients, monitoring of renal function is necessary (1 time in 4-5 months). With angina pectoris, the dose of the drug should provide a resting heart rate in the range of 55-60 beats / min, with a load of no more than 110 beats / min. Beta-blockers can cause bradycardia: the dose should be reduced if the heart rate is less than 50-55 beats / min. When deciding whether to prescribe Binelol to patients with psoriasis, the expected benefit of the drug and the possible risk of exacerbation of psoriasis should be carefully weighed.

Patients who use contact lenses should take into account that the use of beta-blockers may reduce the production of tear fluid.

Form of production

Pills.

Storage conditions

At a temperature not exceeding 30 °C.

Active ingredient

Nebivolol

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For pregnant women as prescribed by a doctor, for Nursing mothers as prescribed by a doctor, For adults as prescribed by a doctor

Indications

Heart Failure, Hypertension, Arrhythmia, Angina