Binelol, tablets 5 mg 56 pcs.

Antianginal, hypotensive, vasodilator, nitric oxide release modulator, beta₁-adrenoblocker.

Indications

arterial hypertension;

IHD (prevention of angina attacks);

chronic heart failure (as part of combination therapy).

Pharmacological effect

Antianginal, hypotensive, vasodilating, modulating nitric oxide release, beta1-adrenergic blocking.

Special instructions

The withdrawal of beta-blockers should be carried out gradually, over 10 days (up to 2 weeks in patients with coronary artery disease).
Monitoring blood pressure and heart rate at the beginning of taking the drug should be daily.

In elderly patients, monitoring of kidney function is necessary (once every 4-5 months).

For exertional angina, the dose of the drug should ensure that the heart rate at rest is within the range of 55-60 beats/min, and during exercise – no more than 110 beats/min.
Beta blockers can cause bradycardia, so the dose should be reduced if heart rate is less than 50-55 beats/min.

When deciding whether to prescribe Binelol to patients with psoriasis, the expected benefits of the drug should be carefully weighed against the possible risk of exacerbation of psoriasis.

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

When performing surgical interventions, the anesthesiologist should be warned that the patient is taking beta-blockers.
Nebivolol does not affect glucose levels in patients with diabetes. However, caution should be exercised when treating these patients because Binelol may mask certain symptoms of hypoglycemia (eg, tachycardia) caused by the use of hypoglycemic agents.

In patients with diabetes mellitus, blood plasma glucose levels should be monitored once every 4-5 months.
Beta blockers should be used with caution in patients with chronic obstructive pulmonary disease as bronchospasm may be increased.

Beta blockers may increase sensitivity to allergens and the severity of anaphylactic reactions.
The effectiveness of beta-blockers in smoking patients is lower than in non-smoking patients.

Active ingredient

Nebivolol

Composition

1 tablet contains nebivolol (in the form of nebivolol hydrochloride 5.45 mg) 5 mg;

excipients:

Contraindications

hypersensitivity to nebivolol or one of the components of Binelol;
severe liver dysfunction;
acute heart failure;
chronic heart failure in the stage of decompensation (requiring intravenous administration of drugs with an inotropic effect);
cardiogenic shock;
sick sinus syndrome, including sinoauricular block;
AV block II and III degrees (without artificial pacemaker);
bronchospasm and bronchial asthma;
untreated pheochromocytoma;
depression;
metabolic acidosis;
severe bradycardia (heart rate, severe arterial hypotension (sBP), severe obliterating peripheral vascular disease (intermittent claudication, Raynaud’s syndrome);
myasthenia gravis;
age under 18 years;
lactose intolerance, lactase deficiency or glucose-galactose malabsorption.

With caution:

renal failure;
diabetes mellitus;
hyperfunction of the thyroid gland;
history of allergic diseases;
psoriasis;
AV block of the first degree;
Prinzmetal’s angina;
COPD;
in patients over 65 years of age.

Side Effects

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

From the gastrointestinal tract: nausea, constipation, flatulence, diarrhea, dry mouth (more than 1%).

From the cardiovascular system: bradycardia, acute heart failure, AV block, orthostatic hypotension, exacerbation of intermittent claudication, shortness of breath; in very rare cases – cardiac arrhythmias, Raynaud’s syndrome, peripheral edema, cardialgia.
Allergic reactions: skin itching, erythematous rash.

Other: bronchospasm (including in the absence of a history of obstructive pulmonary diseases), photodermatosis, hyperhidrosis, rhinitis, exacerbation of psoriasis, blurred vision, dry eyes.

Interaction

With the simultaneous use of beta-blockers with slow calcium channel blockers (SCBCs) (verapamil and diltiazem), the negative effect on myocardial contractility and AV conductivity increases. IV administration of verapamil is contraindicated while taking nebivolol.

Overdose

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

Treatment: gastric lavage, taking activated carbon. In the case of a pronounced decrease in blood pressure, it is necessary to place the patient in a horizontal position with raised legs, and, if necessary, administer intravenous fluids and vasopressors; 1-10 mg of glucagon may be prescribed as follow-up measures.

Storage conditions

In a place protected from light, at a temperature not exceeding 25°C.

Shelf life

3 years.

Manufacturer

Belupo, medicines and cosmetics d.d., Croatia