EMCORETIC Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
BISOPROLOL FUMARATE HYDROCHLOROTHIAZIDE
Available from:
Merck Serono Limited
Pharmaceutical form:
Tablets
Authorization date:
1997-11-27
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Emcoretic Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg Bisoprolol fumarate and 12.5 mg
Hydrochlorothiazide.
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
Circular, biconvex, pink, film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Management of hypertension.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
METHOD OF ADMINISTRATION: Oral.
ADULTS: One tablet daily.
In patients with moderate to
severe impairment of renal (creatinine clearance < 20ml/min) or liver function
the dose
should be reduced.
ELDERLY: As for adults.
CHILDREN: There is no paediatric experience with bisoprolol and
it is not therefore recommended for children.
4.3 CONTRAINDICATIONS
It should not be used in cases of untreated or decompensated
cardiac failure, cardiogenic shock, sinoatrial block,
second or third degree AV block, marked
bradycardia (heart rate less than 50 beats/min),
acute myocardial infarction,
severe asthma, patients with a known hypersensitivity to
hydrochlorothiazide, severe renal or hepatic failure,
hypokalaemia or hyponatraemia.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Emcoretic can be administered with caution to patients with
obstructive respiratory disorders provided that adequate
supervision is maintained. If increased
airways resistance develops consideration must be given to
discontinuation of
the -blocker, depending on
the degree of airways resistance and the benefit derived
from -blockade.
Use with care in patients with a prolonged PR conduction
interval, poor cardiac reserve and peripheral circulatory
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 01/12/2005_
_CRN 2017412_
_page number: 1_
disturbances, suc
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