BILOBLOK Film-coated tablet Ref.[115310] Active ingredients: Bisoprolol

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Smart Pharmaceuticals (Pty) Ltd, 247 Voortrekker Road, Kraaifontein, Cape Town, 7570

Therapeutic indications

BILOBLOK is indicated in the management of mild to moderate hypertension and angina pectoris.

Posology and method of administration

Posology

BILOBLOK 5 mg tablet should be taken once a day in the morning, either on an empty stomach or with breakfast. If necessary, the dosage can be increased to 10 mg in the morning. An increase in the dosage to 20 mg daily may sometimes be necessary. The dose should always be selected individually, particularly according to the heart rate and the therapeutic result.

Special populations

Patients with hepatic or renal impairment

It is not necessary to adjust the dose in patients suffering from mild to moderate disturbance of the liver or renal function. In patients with severe renal impairment (creatinine clearance <20 mL/min) and in patients with severe liver function disturbance, the daily dose of 10 mg BILOBLOK must not be exceeded.

In some of these patients, halving the dose may be necessary.

The normal dose of beta-blockers should be reduced in elderly patients.

Paediatric population

Safety and efficacy in children have not been established.

Method of administration

BILOBLOK should be taken orally. The tablets should be swallowed with liquid and should not be chewed.

Overdose

Overdosage may produce bradycardia and severe hypotension. Bronchospasm and heart failure may be produced in certain individuals.

Cases of mild overdose should be observed for at least four hours, as apnoea and cardiovascular collapse may appear suddenly. Repeated activated charcoal is necessary in severe overdose.

Intravenous atropine (1–2 mg) may be used to treat severe bradycardia. If necessary, this should be followed up by a slow intravenous infusion of 25 g isoprenaline. Intravenous cardiac pacing may be required for severe bradycardia.

Bronchospasm should be treated with IV aminophylline and heart failure with digitalis and diuretics.

Shelf life

3 years.

Special precautions for storage

Store at or below 25°C in the original package. Protect from light.

Do not remove the blisters from the carton until required for use.

Nature and contents of container

The film-coated tablets are packed in PVC/Aluminium foil blisters strips. The blister strips are packed in cartons containing 30 tablets.

Special precautions for disposal and other handling

No special requirements.

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