BISOPROLOL 10 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
BISOPROLOL FUMARATE
Available from:
Pfizer Healthcare Ireland
INN (International Name):
BISOPROLOL FUMARATE
Dosage:
10 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2012-04-26
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisoprolol Pfizer 10mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of bisoprolol fumarate equivalent to 8.48 mg bisoprolol.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow coloured, circular, biconvex, film-coated tablets debossed with ‘I and score line’ on one side and ‘13’ on the
other side. The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Management of hypertension
Management of chronic stable angina pectoris
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults
The dosage should be individually adjusted. It is recommended to start with 5 mg per day. The usual dose is 10 mg
once daily with a maximum recommended dose of 20 mg per day.
Patients with renal impairment
In patients with severe renal impairment (creatinine clearance < 20 ml/min) the dose should not exceed 10 mg once
daily. This dosage may eventually be divided into halves.
Patients with severe liver impairment
No dosage adjustment is required, however careful monitoring is advised.
Elderly
No dosage adjustment is normally required. It is recommended to start with the lowest possible dose.
Children under 12 years and adolescents
Bisoprolol is not recommended for use in children below age 12 and adolescents owing to a lack of data on safety and
efficacy.
Duration of therapy for all indications
Treatment with bisoprolol is generally a long-term therapy.
The treatment with bisoprolol must not be stopped abruptly since this might lead to a transitory worsening of condition.
Especially in patients with ischaemic heart disease, treatment must not be discontinued suddenly. Gradual reduction of
the da
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