Not ticket

Not ticket – generation beta1-adrenoblocker III with vazodilatiruyushchy properties.

Form of release and structure

Dosage form – tablets: a round biconvex form, white color, with crosswise dividing risky (on 7 or 14 pieces in blisters, in a cardboard pack 1, 2 or 4 blisters).

Active ingredient of Nebilet: a nebivolola the hydrochloride micronized in 1 tablet – 5,45 mg that is equivalent to the content of 5 mg of nebivolol.

Auxiliary components: magnesium stearate, starch corn, lactoses monohydrate, sodium of a kroskarmelloz, polysorbate 80, cellulose microcrystallic, silicon dioxide colloid, gipromelloza 15 мПа*с.

Indications to use

• Chronic heart failure, as a part of a combination therapy;
• Arterial hypertension;
• Prevention of attacks of an angina of exertion at coronary heart disease.

Contraindications

• Cardiogenic shock;
• Chronic heart failure in a stage of a decompensation which demands introduction (in/in) medicines with inotropic action;
• Heart failure in an aggravation stage;
• The expressed arterial hypotension (arterial systolic pressure (ABP) is less than 90 mm of a mercury column);
• Atrioventricular (AV) blockade of II and III degrees (in the absence of an artificial pacemaker);
• The Sick Sinus Syndrome (SSS), including sinuatrial blockade;
• Bradycardia, at the heart rate (HR) less than 60 beats per minute;
• Pheochromocytoma (without simultaneous therapy by alpha adrenoblockers);
• Heavy abnormal liver function;
• Metabolic acidosis;
• Bronchial asthma and bronchospasm in the anamnesis;
• Syndrome of glyukozo-galaktozny malabsorption, deficit of lactase, lactose intolerance;
• Myasthenia;
• Severe forms of obliterating diseases of peripheral vessels (Reynaud's syndrome, the alternating lameness);
• Depression;
• Age up to 18 years;
• Breastfeeding period;
• Hypersensitivity to drug components.

Patients should appoint Not ticket with care with a renal failure, Printsmetal's stenocardia, AV blockade of the I degree, a diabetes mellitus, with the instruction in the anamnesis to allergic pathologies, the increased function of a thyroid gland, a chronic obstructive pulmonary disease, psoriasis, 75 years are aged more senior.

Use during pregnancy is shown only according to vital indications if the clinical effect for mother exceeds risk for a fruit or the newborn. Treatment should be carried out under careful control over growth of a fruit and an uteroplacental blood-groove (therapy needs to be interrupted in 48-72 hours prior to childbirth).

Route of administration and dosage

Tablets apply orally, washing down with necessary amount of liquid, irrespective of meal.

Not ticket should be accepted always in at one time 1 once a day.

At coronary heart disease and arterial hypertension the average dose makes ^1/2-1 tablet a day. Use in combination with other reducing ABP means or as monotherapy is shown.

The recommended initial daily dose for patients with a renal failure is also aged more senior than 65 years – ^1/2 tablets, gradual increase in a dose to 2 tablets is allowed.

At chronic heart failure treatment is begun with gradual selection of an optimum maintenance dose. Selection should be carried out, considering portability the patient of the previous dose within 1-2 weeks. An initial dose – ^1/4, then appoint ^1/2 or 1 tablet, if necessary, in 1-2 weeks it can be lifted to maximum – 2 tablets a day.

Careful observation of the doctor within 2 hours after reception of the first dose of drug is necessary and at each its following increase. The clinical condition of the patient is estimated on the basis of indicators of ChSS, the ABP, taking into account disturbance of conductivity and symptoms of aggravation of a course of chronic heart failure.

Side effects

• Nervous system: often – weakness, increased fatigue, dizziness, a headache, paresthesias; infrequently – confusion of consciousness, dreadful dreams, a depression; very seldom – hallucinations, a faint;
• Cardiovascular system: infrequently – an acute heart failure, bradycardia, AV blockade, Reynaud's syndrome, orthostatic hypotension;
• Alimentary system: often – a lock, nausea, diarrhea; infrequently – vomiting, dyspepsia, a meteorism;
• Dermatological reactions: infrequently – a skin itch, rash of erythematic genesis; very seldom – an exacerbation of psoriasis; in some cases – a Quincke's disease;
• Others: infrequently – a bronchospasm; seldom – dryness of a mucous membrane of eyes.

Special instructions

In an initiation of treatment it is necessary to control daily ChSS and the ABP.

In case of drug phase-out Nebilet's dose needs to be reduced gradually, within 10 days, the patient with coronary heart disease – within 14 days.

It is required to control to patients of advanced age of 1 time in 4-5 months function of kidneys.

The maintenance dose at an angina of exertion has to provide ChSS at loading – no more than 110 beats per minute, at rest – 55-60 beats per minute.

At development of bradycardia against the background of use of beta adrenoblockers it is necessary to reduce a dose at ChSS less than 50-55 beats per minute.

With care it is necessary to appoint beta adrenoblockers sick with psoriasis as the risk of an aggravation of disease increases.

Patients with contact lenses should consider decrease in production of the lacrimal liquid against the background of drug use.

It is necessary to inform the anesthesiologist before carrying out surgery on reception by Nebilet's patient.

Drug does not exert impact on the level of concentration of glucose in a blood plasma at patients with a diabetes mellitus, but can mask the tachycardia and other symptoms of a hypoglycemia which resulted from use of insulin and hypoglycemic drugs for intake. Patients with a diabetes mellitus should control 1 time in 4-5 months the content of glucose in a blood plasma.

Against the background of the increased function of a thyroid gland drug can mask tachycardia.

Because of risk of strengthening of a bronchospasm, patients should apply with care beta adrenoblockers with a chronic obstructive pulmonary disease.

Not ticket can increase sensitivity of the patient to allergens and weight of anaphylactic reactions.

As there is a risk of emergence of side effects, patients are recommended to be careful during treatment at control of vehicles and mechanisms.

Medicinal interaction

At simultaneous use to diltiazem, verapamil and other blockers of slow calcium channels there is strengthening of negative effect on AV conductivity and contractility of a myocardium.

The combination of a nebivolol to nitroglycerine, antihypertensives (especially with Prazozinum), blockers of slow calcium channels can cause development of the expressed arterial hypotension.

Against the background of Nebilet's use:

• Intravenous administration of verapamil is contraindicated;
• Antiarrhytmic means of the I class, Amiodaronum can strengthen negative inotropic effect and extend the period of carrying out excitement on auricles;
• Means for the general anesthesia can cause suppression of reflex tachycardia and increase risk of development of arterial hypotension;
• Derivatives of a fenotiazin, barbiturates, tricyclic antidepressants can promote strengthening of hypotensive action of a nebivolol.

At simultaneous use with non-steroidal anti-inflammatory drugs of clinically significant interaction it is not established, increase in influence of cardiac glycosides at AV conductivity delay is also not revealed.

At simultaneous use of Nebilet:

• Cimetidinum, drugs inhibiting the return serotonin reuptake and means which are biotransformed with participation of an isoenzyme of CYP2D6 – slow down metabolism of a nebivolol and increase its concentration in a blood plasma that increases risk of development of bradycardia;
• Furosemide, ethanol, ranitidine, hydrochlorothiazide – do not exert impact on pharmacokinetics of a nebivolol;
• Insulin, hypoglycemic means for intake – can hide hypoglycemia symptoms (tachycardia);
• Nikardipin – increases concentration of active agents in a blood plasma a little, but without clinical effects.

It is not established clinically significant interaction at a combination of a nebivolol to warfarin and digoxin.

Terms and storage conditions

To store at a temperature up to 25 °C. To protect from children.

Period of validity – 3 years.