NEBIWORLD
(Nebivolol)




COMPOSITION

A tablet contains

Active substance: nebivolol (as nebivolol hydrochloride) 2.5 mg or 5 mg.

Excipients: microcrystalline cellulose, lactose monohydrate, maize starch, croscarmellose sodium, hypromellose, silica colloidal anhydrous, magnesium stearate.

THERAPEUTIC INDICATIONS

- arterial hypertension;

- ischemic heart disease: prevention of exercise-induced angina attacks;

- chronic heart insufficiency (as a part of combined therapy).

CONTRAINDICATIONS

- hypersensitivity to nebivolol or any ingredient in the formulation;

- heart failure (decompensated);

- pronounced arterial hypotension (systolic arterial pressure less than 90 mm Hg);

- sick sinus syndrome including sinoauricular block;

- severely impaired liver function;

- bradycardia (heart rate less than 60 beats/min.);

- atrioventricular block II and III degree (without an artificial pacemaker);

- pheochromocytoma;

- metabolic acidosis;

- cardiogenic shock;

- a history of bronchospasm and bronchial asthma;

- severe obliterative peripheral vessel diseases (intermittent lameness, Reynaud’s syndrome);

- myasthenia;

- mental depression.

The medicinal product should be taken with care by patients with renal insufficiency, diabetes mellitus, hyperthyroidism, a history of allergic diseases, psoriasis, chronic obstructive pulmonary disease, first degree atrioventricular block as well by patients above 75 years old.

ADVERSE EFFECTS

Used parameters below adverse effects are defined as follows: common (from ≥ 1/100 to < 1/10), uncommon (from ≥ 1/1000 to < 1/100), very rare (< 1/10000), unknown frequency.

Immune system disorders: unknown frequency – angioneurotic oedema, hypersensitivity.

Psychiatric disorders: uncommon – nightmares, depression.

Nervous system disorders: common – headache, dizziness, paraesthesia; very rare – syncope.

Eye disorders: uncommon – impaired vision.

Cardiac disorders: uncommon – bradycardia, heart failure, slowed AV conduction/AV-block.

Vascular disorders: uncommon – hypotension, (increase of) intermittent claudication.

Respiratory, thoracic and mediastinal disorders: common – dyspnea; uncommon – bronchospasm.

Gastrointestinal disorders: common – constipation, nausea, diarrhoea; uncommon – dyspepsia, flatulence, vomiting.

Skin and subcutaneous tissue disorders: uncommon – pruritus, rash erythematous; very rare – psoriasis aggravated; unknown frequency – urticaria.

Reproductive system and breast disorders: uncommon – impotence.

General disorders and administration site conditions: common – tiredness, oedema.

The following adverse reactions have also been reported with some beta adrenergic antagonists: hallucinations, psychoses, confusion, cold/cyanotic extremities, Raynaud phenomenon, dry eyes, and oculomucocutaneous toxicity of the practolol type.

DOSAGE AND ADMINISTRATION

Nebiworld tablets should be taken once daily, preferably at the same time of the day, with or without food, with a sufficient amount of fluid.

For treatment of arterial hypertension and ischemic heart disease the average daily dose is 2.5-5 mg of nebivolol. The optimal effect is reached only after 1-2 weeks of therapy and in some cases – after 4 weeks. If the arterial pressure control is insufficient 4 weeks after the initiation of therapy with Nebiworld, the medicinal product dose may be increased up to 40 mg daily within 2 weeks. Nebiworld may be used in monotherapy or in combination with other AP-lowering medicinal products.

The treatment of chronic cardiac insufficiency should be initiated by gradually increasing the dose up to the individual optimal maintenance dose. The medicinal product is prescribed in case of no episodes of chronic heart failure decompensation during the last 6 weeks. The doses of other medicinal products (diuretics, digoxin, ACE inhibitors, angiotensin II receptor antagonists), taken by the patient, should be adjusted within 2 weeks prior to the initiation of the therapy with Nebiworld. Adjustment of the drug dose at the therapy initiation should be made at the intervals of 1-2 weeks and basing on the dose tolerability by the patient: the dose, equal to 1.25 mg of nebivolol once a day may be increased at first up to 2.5-5 mg once a day and afterwards up to 10 mg once a day. The maximum daily dose is 10 mg.

In patient with renal insufficiency as well as in patients above 65 years old, the recommended initial dose is equal to 2.5 mg of the medicinal product daily. If necessary, the daily dose may be increased up to 10 mg.

DRUG INTERACTIONS

Concomitant use of nebivolol with non-steroidal anti-inflammatory drugs doesn’t decrease its hypotensive action.

Concomitant use of β-adrenergic blocking agents with the calcium channel-blocking agents (verapamil and diltiazem) results in an increased adverse effect on myocardial contractility and atrioventricular conduction.

Intravenous administration of verapamil against the therapy with nebivolol is contraindicated.

Pronounced arterial hypotension may develop in concomitant use of nebivolol and antihypertensive agents nitroglycerin or calcium channel-blocking agents (special care is required in concomitant use with prazosin).

Increased negative inotropic effect and prolongation of the atrial conduction time may be observed in concomitant use of nebivolol with class I antiarrhythmic drugs and amiodarone.

Concomitant use of nebivolol with cardiac glycosides has shown no increased influence on the delayed atrioventricular conduction.

Concomitant use of nebivolol with agents for general anesthesia may induce suppression of reflex tachycardia and increase a risk of arterial hypotension.

Concomitant use of nebivolol with tricyclic antidepressants, barbiturates and phenothiazine derivatives may increase the hypotensive action of nebivolol.

Concomitant use of nebivolol with serotonin reuptake inhibitors or other agents, biotransformed with the involvement of isoenzyme CYP2D6, contributes to increased plasma nebivolol levels and delayed metabolism that may result in a risk of brachycardia.

When administered concurrently with digoxin, nebivolol doesn’t affect the pharmacokinetic parameters of digoxin.

When nebivolol is administered concurrently with cimetidine, plasma nebivolol levels increase.

Concomitant use of nebivolol with ranitidine doesn’t affect the pharmacokinetic parameters of nebivolol.

When nebivolol is administered concurrently with nicardipine, plasma active substance concentrations increase however such an increase is of no clinical significance.

Concomitant use of nebivolol with ethanol, furosemide or hydrochlorothiazide doesn’t affect the pharmacokinetics of nebivolol.

No clinically significant interaction between nebivolol and warfarin has been established.

Symptoms of hypoglycemia (tachycardia) may be masked in concomitant use of nebivolol with insulin and oral antihyperglycaemic agents.

PREGNANCY AND LACTATION

Nebiworld is prescribed during pregnancy only if the estimated benefit for mother overweighs a potential risk for the fetus or newborn (due to possible development of bradycardia, arterial hypotension, hypoglycemia in the fetus or newborn). If treatment with Nebiworld is considered necessary, the uteroplacental blood flow and the foetal growth should be monitored. The treatment should be discontinued 48-72 hours prior to the delivery. If it’s impossible, the newborn infant must be closely monitored within 48-72 hours after the delivery.

Nebivolol is excreted in breast milk. If Nebiworld is to be used during lactation, breast feeding should be discontinued.

MANUFACTURED FORM AND PACKAGE

Tablets.

14 tablets in a blister.

2 or 6 blisters together with a leaflet in a carton box.

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