Belanj

Composition

Belanj 2,5 mg: each film coated table contains: bisoprolol fumarate – 2,5 mg.
Belanj 5 mg: each film coated tablet contains: bisoprolol fumarate – 5 mg.
Belanj 10 mg: each film coated tablet contains: bisoprolol fumarate – 10 mg.

Indications for use

• treatment of Hypertension
• treatment of stable chronic angina
• treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides.

Mode of application

For oral use.
Belanj tablet should be taken in morning and can be taken with food in morning. They should be swallowed in liquid and should not be chewed.
Treatment of hypertension and chronic stable angina pectoris:
Adults – the dosage should be individually adjusted. It is recommended to start with 5 mg per day. The usual dose is 10 mg once daily with a maximum recommended dose of 20 mg per day.
Patients with renal impairment:
In patients with severe renal impairment (creatinine clearance < 20 ml/min) the dose should not exceed 10 mg once daily. This dosage may eventually be divided into halves.
Patients with severe liver impairment:
No dosage adjustment is required, however careful monitoring is advised.
Elderly – no dosage adjustment is normally required. It is recommended to start with the lowest possible dose.
Discontinuation of treatment:
Treatment should not be stopped abruptly. The dosage should be diminished slowly by a weekly halving of the dose.
Treatment of stable chronic heart failure:
Adults – standard treatment of CHF consists of an ACE inhibitor (or an angiotensin receptor blocker in case of intolerance to ACE inhibitors), a beta-blocker, diuretics, and when appropriate cardiac glycosides. Patients should be stable (without acute failure) when bisoprolol treatment is initiated.
It is recommended that the treating physician should be experienced in the management of chronic heart failure.
Transient worsening of heart failure, hypotension, or bradycardia may occur during the titration period and thereafter.
Titration phase:
The treatment of stable chronic heart failure with Belanj requires a titration phase.
The treatment with Belanj is to be started with a gradual uptitration according to the following steps:
– 1.25 mg once daily for 1 week, if well tolerated increase to
– 2.5 mg once daily for a further week, if well tolerated increase to
– 3.75 mg once daily for a further week, if well tolerated increase to
– 5 mg once daily for the 4 following weeks, if well tolerated increase to
– 7.5 mg once daily for the 4 following weeks, if well tolerated increase to
– 10 mg once daily for the maintenance therapy.
The maximum recommended dose is 10 mg once daily.
Close monitoring of vital signs (heart rate, blood pressure) and symptoms of worsening heart failure is recommended during the titration phase. Symptoms may already occur within the first day after initiating the therapy.

Treatment modification:
If the maximum recommended dose is not well tolerated, gradual dose reduction may be considered.
In case of transient worsening of heart failure, hypotension, or bradycardia reconsideration of the dosage of the concomitant medication is recommended. It may also be necessary to temporarily lower the dose of Belanj or to consider discontinuation.
The reintroduction and/or uptitration of Belanj should always be considered when the patient becomes stable again.
If discontinuation is considered, gradual dose decrease is recommended, since abrupt withdrawal may lead to acute deterioration of the patient’s condition.

Treatment of stable chronic heart failure with Belanj is generally a long-term treatment.
Renal or hepatic impairment:
There is no information regarding pharmacokinetics of Belanj in patients with chronic heart failure and with impaired hepatic or renal function. Uptitration of the dose in these populations should therefore be made with additional caution.
Elderly – no dosage adjustment is normally required.