CONCOR Film-coated tablet Ref.[50524] Active ingredients: Bisoprolol

Adults

For both indications the normal dosage is 1 tablet (5-10 mg) once daily as a single dose. If 5 mg is not given necessary effect, the dose may be increased to 10 mg once daily or very rarely to 20 mg once daily.

The maximum recommended dose is 20 mg once daily.

In all cases the dosage is adjusted individually, in order to avoid bradycardia.

In hypertension, Concor could be combined with diuretics if necessary effect is not achieved.

Treatment with bisoprolol is generally a long-term therapy.

Especially in patients with ischaemic heart disease, treatment must not be discontinued suddenly since this might lead to a transitory worsening of angina pectoris with risk of heart attack. Gradual reduction of the dosage for 1-2 weeks is recommended.

If it is thought necessary to withdraw Concor before surgery, this should be done gradually and completed about 48 hours before operation except in certain cases, for example thyrotoxicosis and phaeochromocytoma.

Administration

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

Special populations

Renal or liver impairment

In patients with liver or kidney function disorders of mild to moderate severity, no dosage adjustment is normally required. In patients with severe renal impairment (creatinine clearance <20 ml/min) and in patients with severe liver function disorders it is recommended that a daily dose of 10 mg bisoprolol fumarate 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.

Elderly

No dosage adjustment is required.

Children

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

In general the most common signs expected with overdosage of a beta-blocker are bradycardia, hypotension, bronchospasm, acute cardiac insufficiency and hypoglycaemia. There is a wide interindividual variation in sensitivity to one single high dose of bisoprolol.

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 pharmacologic actions and recommendations for other beta-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, beta₂-sympathomimetic drugs and/or aminophylline.

Hypoglycaemia: Administer i.v. glucose.

5 years.

Do not store above 30°C.

Blister pack of PVC film and cover by aluminium blister.

5 mg: 30 tablets.

10 mg: 30 tablets.

No special requirements.