Nebilet, tablets 5 mg 28 pcs

Special Instructions

Beta-adrenoblockers should be withdrawn gradually over 10 days (up to 2 weeks in patients with CHD).

Control of BP and HR at the beginning of the drug administration should be daily.

In elderly patients it is necessary to monitor renal function (once every 4-5 months).

In case of angina pectoris the drug dose should provide resting heart rate within 55-60 beats/min, on load – not more than 110 beats/min.

Beta-adrenoblockers may cause bradycardia: The dose should be reduced if HR is less than 50-55 bpm.

When deciding whether to use Nebilet® in patients with psoriasis the supposed benefit of the drug and the possible risk of exacerbation of psoriasis should be carefully balanced.

Patients who wear contact lenses should be aware that the use of beta-adrenoblockers may reduce tear fluid production.

During surgical interventions, the anesthesiologist should be warned that the patient is taking beta-adrenoblockers.

Nebivolol does not affect the plasma glucose concentration in patients with diabetes. Nevertheless, caution should be exercised when treating these patients since Nebilet® may mask certain symptoms of hypoglycemia (e.g., tachycardia) caused by the use of hypoglycemic agents for oral administration and insulin.

Monitoring of plasma glucose concentration should be carried out once every 4-5 months (in patients with diabetes).

In hyperfunctioning thyroid gland beta-adrenoblockers may mask tachycardia.

Beta-adrenoblockers should be used with caution in patients with chronic obstructive pulmonary disease because bronchospasm may increase.

Beta-adrenoblockers may increase sensitivity to allergens and the severity of anaphylactic reactions.

Influence on the ability to drive vehicles and other mechanisms requiring increased concentration

The effect of Nebilet® on the ability to drive vehicles and operate mechanisms has not been specifically studied. Studies of pharmacodynamics of Nebivolol showed that Nebilet® has no effect on psychomotor function.

During treatment with Nebilet® (in case of side effects) caution should be exercised while driving vehicles and during potentially dangerous activities that require high concentration and quick psychomotor reactions.

Contraindications

– Hypersensitivity to nebivololol or one of the drug components;

– Chronic heart failure in decompensation (requiring intravenous administration of drugs with inotropic action);

p> – acute heart failure;

– CAD, including sinoatrial block;

– AV blockade of II and III degree (without pacemaker);

– significant arterial hypotension (systolic BP less than 90 mm Hg).Hg).);

– cardiogenic shock;

– pheochromocytoma (without concomitant use of alpha-adrenoblockers);

– metabolic acidosis;

– myasthenia gravis;

– significant liver dysfunction;

– bradycardia (HR less than 60 beats/min.

– severe peripheral vascular occlusive disease (intermittent claudication, Raynaud’s syndrome);

– history of bronchospasm and bronchial asthma;

– depression;

– lactose intolerance, lactase deficiency, and glucose/galactose malabsorption syndrome;

– childhood and adolescence under 18 years (effectiveness and safety not studied).

Cautious use of the drug:

– in renal insufficiency,

– diabetes mellitus,

– Thyroid hyperfunction,

– A history of allergic conditions,

p> – psoriasis,

– chronic obstructive pulmonary disease, A

– Grade I V-blockade,

– Prinzmetal angina,

– patients over 75 years of age.

Side effects

Frequency of side effects: infrequent ( > 0.1% and < 1%); very common ( > 10%); common ( > 1% and < 10%); very rare ( < 0.01%, including separate reports); rare ( > 0.01% and < 0.1%).

Cardiovascular system: infrequent – bradycardia, acute heart failure, AV-blockade, orthostatic hypotension, Raynaud’s syndrome.

CNS and peripheral nervous system: frequently – headache, dizziness, fatigue, weakness, paresthesia, rarely – depression, nightmares, confusion, very rarely – fainting, hallucinations.

Skin and subcutaneous tissue: infrequent – erythematous skin rash, itching, very rare – aggravation of psoriasis, in some cases – angioedema.

The digestive system: frequently – nausea, constipation, diarrhea, rarely – dyspepsia, flatulence, vomiting.

Other: infrequent – bronchospasm; rarely – dry eyes.

Overdose

Symptoms:pronounced BP decrease, nausea, vomiting, cyanosis, sinus bradycardia, AV blockade, bronchospasm, loss of consciousness, cardiogenic shock, coma, cardiac arrest.

Treatment: Gastric lavage, administration of activated charcoal. In case of pronounced BP decrease, the patient should be placed in a horizontal position with elevated legs, if necessary, IV fluids and vasopressors should be administered.

In case of bradycardia, 0.5-2 mg of atropine should be administered by IV, if there is no positive effect, transvenous or intracardiac pacemaker can be placed.

In AV-blockade (stage II-III) it is recommended to administer beta-adrenostimulants by IV, and if they are ineffective, an artificial pacemaker should be considered.

In case of heart failure, treatment begins with administration of cardiac glycosides and diuretics; if there is no effect, dopamine, dobutamine or vasodilators are appropriate.

In case of bronchospasm, intravenous β2-adrenoreceptor stimulants are used.

In case of ventricular estrasystole, lidocaine (Class IA antiarrhythmic agents should not be administered).

Pregnancy use

Nebivolol is excreted with the breast milk. If Nebilet® must be taken during lactation, breastfeeding must be stopped.

In pregnancy Nebilet® is administered only with vital indications when the benefit for the mother exceeds the possible risk for the fetus or newborn (due to possible development of bradycardia, arterial hypotension and hypoglycemia in fetus and newborn). If Nebilet® treatment is necessary the uteroplacental blood flow and fetal growth should be monitored.

The treatment should be discontinued 48-72 h before delivery. In cases where this is not possible, strict neonatal monitoring should be established for 48-72 h after delivery.

Similarities

Nebilet, Binelol, Nebilong, Nebivolol, Nebivolol-Teva, Nebivator, Nebivololol-SZ