Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: Unichem Laboratories Ltd, Studio 8B, Ard Gaoithe Commercial Centre, Ard Gaoithe Business Park, Cashel Road, Clonmel, Co Tipperary, Ireland
Hypertension.
Chronic stable angina pectoris.
The dosage should be individually adjusted. It is recommended to start with the lowest possible dose. In some patients, 5 mg per day may be adequate. The usual dose is 10 mg once daily with a maximum recommended dose of 20 mg per day.
In patients with severe renal impairment, (creatinine clearance <20ml/min) the dose should not exceed 10 mg once daily. This dosage may eventually be divided into halves.
No dosage adjustment is required, however careful monitoring is advised. In patients with severe liver function disorders a daily dose of 10mg bisoprolol should not be exceeded.
No dosage adjustment is normally required. It is recommended to start with the lowest possible dose.
There is no paediatric experience with this medicine, therefore its use cannot be recommended.
Treatment should not be stopped abruptly (see section 4.4). The dosage should be diminished slowly by a weekly halving of the dose.
Bisocor 5 mg Tablets are for oral administration.
The tablet should be taken in the morning and be swallowed with a sufficient amount of fluid (e.g. one glass of water) .The tablet can be taken with food.
The most common signs expected with overdose of a beta-blocker are bradycardia, hypotension, bronchospasm, acute cardiac insufficiency and hypoglycaemia. There is limited experience with overdose of bisoprolol, only a few cases of overdose with bisoprolol have been reported. Bradycardia and/or hypotension were noted. All patients recovered. There is a wide inter-individual variation in sensitivity to one single high dose of bisoprolol and patients with heart failure are probably very sensitive.
In general, if overdose occurs, discontinuation of bisoprolol treatment and supportive and symptomatic treatment is recommended.
Based on the expected pharmacologic actions and recommendations for other beta-blockers, the following general measures may 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 temporary pacing.
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.
Limited data suggest that bisoprolol is hardly dialysable.
3 years.
Store below 30°C.
Bisocor 5 mg tablets are presented in:
Blisters comprising of PVC/PVdC/aluminium foil, contained within a printed carton box. Each carton will contain either; 10, 20, 28, 30, 50, 56, 60, or 100 tablets.
Not all pack sizes may be marketed.
No special requirements.
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