NEBILET TABLET 5 MG [SIN11728P]

Product Info

NEBILET TABLET 5 MG

[SIN11728P]

Indication

THERAPEUTIC INDICATIONS
Hypertension
Treatment of essential hypertension.

Chronic heart failure (CHF)
Treatment of stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients > 70 years.

Dosing

POSOLOGY AND METHOD OF ADMINISTRATION

Posology

Hypertension
Adults
The dose is one tablet (5 mg) daily, preferably at the same time of the day.
The blood pressure lowering effect becomes evident after 1–2 weeks of treatment. Occasionally, the optimal effect is reached only after 4 weeks.

Combination with other antihypertensive agents
Beta-blockers can be used alone or concomitantly with other antihypertensive agents. Till date, an additional antihypertensive effect has been observed only when Nebilet 5 mg is combined with hydrochlorothiazide 12.5–25 mg.

Patients with renal insufficiency
In patients with renal insufficiency, the recommended starting dose is 2.5 mg daily. If needed, the daily dose may be increased to 5 mg.

Patients with hepatic insufficiency
Data in patients with hepatic insufficiency or impaired liver function are limited. Therefore the use of Nebilet in these patients is contra-indicated.

Older people
In patients over 65 years, the recommended starting dose is 2.5 mg daily. If needed, the daily dose may be increased to 5 mg. However, in view of the limited experience in patients above 75 years, caution must be exercised and these patients monitored closely.

Paediatric population
The efficacy and safety of Nebilet in children and adolescents aged below 18 years has not been established. No data are available. Therefore, use in children and adolescents is not recommended.

Chronic heart failure (CHF)
The treatment of stable chronic heart failure has to be initiated with a gradual uptitration of dosage until the optimal individual maintenance dose is reached.

Patients should have stable chronic heart failure without acute failure during the past six weeks. It is recommended that the treating physician should be experienced in the management of chronic heart failure.

For those patients receiving cardiovascular drug therapy including diuretics and/or digoxin and/or ACE inhibitors and/or angiotensin II antagonists, dosing of these drugs should be stabilised during the past two weeks prior to initiation of Nebilet treatment.

The initial uptitration should be done according to the following steps at 1–2 weekly intervals based on the patient tolerability:

1.25 mg nebivolol, to be increased to 2.5 mg nebivolol once daily, then to 5 mg once daily and then to 10 mg once daily. The maximum recommended dose is 10 mg nebivolol once daily.

For a correct breaking of the tablet the below instructions have to be followed; the tablet can be broken both by a manual method or by the help of a tablet cutter (available on request in pharmacy).

Manual Method

• Tablet has to be placed onto a flat, hard surface (e.g. a table or worktop), with the cross score facing up.

• Break the tablet by pushing it with the index fingers of both hands placed along one breakmark.

(Diagrams 1 and 2).
Tablet quarters are obtained by breaking the halves in the same way

(Diagrams 3 and 4).

Diagrams 1 and 2: Easy breaking of the Nebivolol 5 mg cross-scored tablet in half.
Diagrams 3 and 4: Easy breaking of half of the Nebivolol 5 mg cross-scored tablet into quarters.

Use of tablet cutter

Figure 1: Open the door pressing the button on the front of the tablet cutter.

Figure 2: Place the tablet (with the embossed cross on the tablet facing upwards) into the cutting compartment.

Figure 3: Press the door closed until to hear a click indicating the breaking of the tablet. The pressure applied by closing the door causes the tablet to split into 4 equal parts.

Figure 4: Open the door again and remove 4 equal parts of the Nebilet 5 mg tablet.

Figure 5: WARNING: remaining quarters of the tablet should be stored in the lower storage compartment. The lower storage compartment must not to be used to store intact tablets. All intact tablets should be kept in the original blister packaging.

Initiation of therapy and every dose increase should be done under the supervision of an experienced physician over a period of at least 2 hours to ensure that the clinical status (especially as regards blood pressure, heart rate, conduction disturbances, signs of worsening of heart failure) remains stable.

Occurrence of adverse events may prevent all patients being treated with the maximum recommended dose. If necessary, the dose reached can also be decreased step by step and reintroduced as appropriate.

During the titration phase, in case of worsening of the heart failure or intolerance, it is recommended first to reduce the dose of nebivolol, or to stop it immediately if necessary (in case of severe hypotension, worsening of heart failure with acute pulmonary oedema, cardiogenic shock, symptomatic bradycardia or AV block).

Treatment of stable chronic heart failure with nebivolol is generally a long-term treatment. The treatment with nebivolol is not recommended to be stopped abruptly since this might lead to a transitory worsening of heart failure. If discontinuation is necessary, the dose should be gradually decreased divided into halves weekly.

Patients with renal insufficiency
No dose adjustment is required in mild to moderate renal insufficiency since uptitration to the maximum tolerated dose is individually adjusted. There is no experience in patients with severe renal insufficiency (serum creatinine ≥ 250micromole/L). Therefore, the use of nebivolol in these patients is not recommended.

Patients with hepatic insufficiency
Data in patients with hepatic insufficiency are limited. Therefore the use of Nebilet in these patients is contra-indicated.

Older people
No dose adjustment is required since uptitration to the maximum tolerated dose is individually adjusted.

Paediatric population
The efficacy and safety of Nebilet in children and adolescents aged below 18 years has not been established. Therefore, use in children and adolescents is not recommended. No data are available.

Method of administration
Oral use.
Tablets may be taken with meals.

Contraindications

Contraindications

• Hypersensitivity to the active substance or to any of the excipients.

• Liver insufficiency or liver function impairment.

• Pregnancy and lactation.

• Acute heart failure, cardiogenic shock or episodes of heart failure decompensation requiring i.v. inotropic therapy.

In addition, as with other beta-blocking agents, Nebilet is contra-indicated in:

• sick sinus syndrome, including sino-atrial block.

• second and third degree heart block (without a pacemaker).

• history of bronchospasm and bronchial asthma.

• untreated phaeochromocytoma.

• metabolic acidosis.

• bradycardia (heart rate < 60 bpm prior to start therapy).

• hypotension (systolic blood pressure < 90 mmHg).

• severe peripheral circulatory disturbances.