NEBILAN table. 5 mg

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 5.45 mg of nebivolol hydrochloride equivalent to 5 mg of nebivolol.

Excipient: 143.48 mg lactose monohydrate / tablet.

INDICATION:

Treatment of essential hypertension.

Treatment of chronic heart failure in addition to the usual treatment regimens in elderly patients over 70 years of age.

DOSAGE AND ADMINISTRATION

Method of application:

The tablet should be swallowed with some liquid / glass of water as / with or without food.

Hypertension:

Adults:

The dose is one tablet daily, preferably taken at the same time of day. The tablets can be taken with food.

Pronounced effect on lowering blood pressure noted after treatment for 1-2 weeks.

Sometimes the optimal effect is achieved after 4 weeks.

Combination with other antihypertensive MEDICINAL PRODUCT

Beta-blockers can be used alone or concomitantly with other antihypertensive agents. So far, the additional effect is only found when combining Nebilan 5 mg hydrochlorothiazide 12.5 to 25 mg.

Patients with renal insufficiency

In patients with renal insufficiency is recommended that the initial dose of 2.5 mg daily. If necessary, the daily dose may be increased to 5 mg.

Patients with hepatic impairment

Data on drug use in patients with hepatic disease or hepatic impairment are limited. For this reason, the use of Nebilan 5 mg in these patients is contraindicated.

Elderly

Patients over the age of 65 is recommended starting dose of 2.5 mg daily. If necessary, the daily dose may be increased to 5 mg. However, the limited experience of using the drug in patients over 75 years of age, it should be used with caution and such patients should be carefully monitored.

Children and adolescents

not recommended for use Nebilan 5 mg in children and adolescents under 18 years.

Chronic heart failure

Treatment of stable chronic heart failure should start with dose escalation until the optimal individual maintenance dose.

Patients should have stable chronic heart failure without acute episodes of heart failure over the past six weeks. It is recommended that the physician has experience in the treatment of chronic heart failure. Patients taking drugs for the treatment of cardiovascular diseases, including diuretics and / or digoxin and / or ACE inhibitors and / or angiotensin II, recommended dosage of these products to be specified in the last two weeks before treatment with nebivolol.

The initial adaptation gradually increasing dose should be carried out as follows in 1-2 week intervals depending on patient tolerance:

A single daily dose of 1.25 mg nebivolol should be increased to 2.5 mg nebivolol once daily, then to 5 mg once daily, then 10 mg once daily.

Maximum recommended dose is 10 mg once daily nebivolol.

Initiation of therapy and any increase in dose should be done under the supervision of an experienced physician for at least 2 hours to be sure that the clinical condition remains stable.

Usually, treatment of chronic heart failure with nebivolol is long. Not recommended abrupt discontinuation of nebivolol, as this may cause a transient worsening of heart failure. If necessary, discontinuation of therapy, the dose should be gradually reduced by half every week.

The tablets can be taken with food.

Patients with renal insufficiency

In mild or moderate renal impairment is not necessary to change the dose, as the gradual increase in dose until the maximum tolerated dose is individually adjusted.

 Patients with hepatic impairment

Data on drug use in patients with hepatic impairment is limited. For this reason, the use of nebivolol in these patients is contraindicated.

Elderly

No adjustment of the dose as the gradual increase in dose until the maximum tolerated dose is individually adjusted.

CONTRAINDICATIONS:

 Hypersensitivity to the active substance or to any of the excipients

 Liver failure or liver dysfunction

 Acute heart failure, cardiogenic shock or episodes of decompensated heart failure requiring intravenous inotropic therapy.

Syndrome sick sinus

 Heart block, second and third degree

 A history of asthma or bronchospasm

 Untreated phaeochromocytoma

 Metabolic acidosis

 Bradycardia

 Hypotension

 Severe peripheral circulatory disorders

Pregnancy and lactation

Use in pregnancy

Nebivolol has pharmacological effects that may cause harmful effects on pregnancy and / or the fetus / newborn. In general, beta-adrenoceptor blockers reduce placental perfusion, which is associated with delayed fetal growth, intrauterine death, abortion or stillbirth. In the fetus and neonate may be side effects. If necessary, carry out the treatment with beta-adrenoceptor blockers, preferably using selective beta-adrenoceptor blockers.

Nebivolol should not be used during pregnancy unless clearly necessary.

Use during lactation

Most beta-blockers, particularly lipophilic compounds like nebivolol and its active metabolites pass into breast milk, although in varying degrees. Therefore, it is recommended that treatment with nebivolol during lactation.

SIDE EFFECTS

Cardiac disorders:

Very common - bradycardia

Common - worsening heart failure, first degree atrioventricular block

Rare - bradycardia, heart failure, slow AV conduction / AV block

Nervous system disorders:

Common - headache, dizziness, paraesthesia

Eye disorders:

Rare - blurred vision, dry eyes

Respiratory, thoracic and mediastinal disorders:

Common - dyspnea

Rare - bronchospasm

Gastrointestinal:

Common - constipation, nausea, diarrhea

Rare - dyspepsia, flatulence, vomiting

Skin and subcutaneous tissue disorders:

Common - swelling

Rare - itching, rash erythematous

Vascular disorders:

Common - orthostatic hypotension

Rare - hypotension

Psychiatric disorders:

Rare - nightmares, depression