BISOVELL FILM-COATED TABLET 5MG [SIN16820P]

Product Info

BISOVELL FILM-COATED TABLET 5MG

[SIN16820P]

4.1. Therapeutic Indication
Treatment of hypertension as well as treatment of coronary heart disease (angina pectoris).

Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides (for additional information see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2. Posology and Method of Administration
For all indications
Treatment with bisoprolol is generally a long-term therapy.

Do not stop treatment abruptly or change the recommended dose without talking to your doctor first since this might lead to a transitory worsening of condition. Especially in patients with ischaemic heart disease, treatment must not be discontinued suddenly. If discontinuation is necessary, the daily dose is gradually decreased.

Bisovell tablets are taken in the morning with or without food. They are swallowed with some liquid and not to be chewed.

Treatment of hypertension or angina pectoris
For both indications the dosage is 5 mg bisoprolol once daily. If necessary, the dose may be increased to 10 mg bisoprolol once daily.

In all cases the dosage is adjusted individually, in particular according to the pulse rate and therapeutic success.

Treatment of stable chronic heart failure
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. The initiation of treatment of stable chronic heart failure with Bisovell necessitates a special titration phase.

Precondition for treatment with bisoprolol is stable chronic heart failure without acute failure.

It is recommended that the treating physician be experienced in the management of chronic heart failure.

The treatment of stable chronic heart failure with bisoprolol is initiated according to the following titration scheme, individual adaptation may be necessary depending on how well the patient tolerates each dose, i.e. the dose is to be increased only, if the previous dose is well tolerated.

• 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.

Close monitoring of vital signs (blood pressure, heart rate) and symptoms of worsening heart failure is recommended during the titration phase.

The maximum recommended dose is 10 mg once daily.

Occurrence of adverse events may exclude some patients from being treated with the maximum recommended dose. If necessary, the dose reached can also be decreased step by step and the maintenance treatment will be the maximum dose well tolerated by the patient. The treatment may be interrupted if necessary and reintroduced as appropriate.

Treatment modification
If during the titration phase or thereafter, transient worsening of heart failure, hypotension or bradycardia occurs, reconsideration of the dosage of concomitant medication is recommended. It may also be necessary to temporarily lower the dose of bisoprolol or to consider discontinuation.

The reintroduction and/or uptitration of bisoprolol should always be considered when the patient becomes stable again.

Special populations
Renal or liver insufficiency
Treatment of hypertension or angina pectoris: In patients with liver or kidney function disorders of mild to moderate severity, no dosage adjustment is normally required. In patients with severe renal insufficiency (creatinine clearance < 20 ml/min) and in patients with severe liver function disorders, it is recommended that a daily dose of 10 mg bisoprolol is not exceeded.

Experience with the use of bisoprolol in renal dialysis patients is limited; however, there is no evidence that the dosage regimen needs to be altered.

Treatment of stable chronic heart failure: There is no information regarding pharmacokinetics of bisoprolol in patients with chronic heart failure and with concomitant impaired liver or renal function. Uptitration of the dose in these populations should therefore be made with particular caution.

Elderly
No dosage adjustment is required.

Children
There is no experience with bisoprolol in children, therefore its use cannot be recommended for children.

4.3. Contraindications
Bisoprolol is contraindicated in patients with:

• Acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy

• Cardiogenic shock

• AV block of second or third degree (without a pacemaker)

• Sick sinus syndrome

• Sinoatrial block

• Symptomatic bradycardia

• Symptomatic hypotension

• Severe bronchial asthma

• Late stages of peripheral arterial occlusive disease and Raynaud's syndrome

• Untreated phaeochromocytoma (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Metabolic acidosis

• Hypersensitivity to Bisoprolol or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information