EMCOR Film-coated tablet Ref.[2568] Active ingredients: Bisoprolol

Route of administration

Oral.

Posology

Adults

The usual dose is 10mg once daily, with a maximum recommended dose of 20mg per day. In some patients 5mg per day may be adequate.

Patients with renal or hepatic impairment

In patients with final stage impairment of renal function (creatinine clearance <20ml/minute) or liver function, the dose should not exceed 10mg bisoprolol once daily. 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.

Older people

No dosage adjustment is normally required, but 5mg per day may be adequate. In some patients, as for other adults, dosage may have to be reduced in cases of severe renal or hepatic dysfunction.

Paediatric population

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

In patients with ischaemic heart disease, treatment should not be withdrawn abruptly; gradual dosage reduction over 1-2 weeks is recommended.

Symptoms

The most common signs expected with overdosage of a ß-blocker are bradycardia, hypotension, bronchospasm, acute cardiac insufficiency and hypoglycaemia. To date few cases of overdose (maximum: 2000 mg) with bisoprolol have been reported. Bradycardia and/or hypotension were noted. All patients recovered. There is a wide interindividual variation in sensitivity to one single high dose of bisoprolol; patients with heart failure are probably particularly sensitive.

Management

In general, if overdose occurs, bisoprolol treatment should be stopped and supportive and symptomatic treatment should be provided. Limited data suggest that bisoprolol is hardly dialysable. Based on the expected pharmacological actions and recommendations for other β-blockers, the following general measures should be considered when clinically warranted:

Bradycardia: Administer intravenous atropine. If the response is inadequate, isoprenaline or another agent with positive chronotropic properties may be given cautiously. Under some circumstances, transvenous pacemaker insertion may be necessary.

Hypotension: Intravenous fluids and vasopressors should be administered. Intravenous glucagon may be useful.

AV block (second or third degree): Patients should be carefully monitored and treated with isoprenaline infusion or transvenous cardiac pacemaker insertion.

Acute worsening of heart failure: Administer i.v. diuretics, inotropic agents, vasodilating agents.

Bronchospasm: Administer bronchodilator therapy such as isoprenaline, ß2- sympathomimetic drugs and/or aminophylline.

Hypoglycaemia: Administer i.v. glucose.

5 years.

Do not store above 30°C.

Cartons containing aluminium/PVC blister packs of 4, 14 or 28 tablets. Not all pack sizes may be marketed.

No special requirements.