Bisoprolol 5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BISOPROLOL FUMARATE

Available from:

Accord Healthcare Limited

ATC code:

C07AB; C07AB07

INN (International Name):

BISOPROLOL FUMARATE

Dosage:

5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Administration route:

oral use

Units in package:

Pack sizes of 20, 28, 30, 50, 56, 60, 90 and 100 tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

Accord Healthcare Limited

Therapeutic group:

Beta blocking agents, selective

Therapeutic area:

Beta blocking agents, selective; bisoprolol

Therapeutic indications:

Treatment of Hypertension Treatment of stable chronic angina Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides

Authorization status:

Authorised

Authorization date:

2015-10-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER BISOPROLOL 2.5 MG FILM-COATED TABLETS BISOPROLOL 5 MG FILM-COATED TABLETS
BISOPROLOL 10 MG FILM-COATED TABLETS
BISOPROLOL FUMARATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bisoprolol fumarate tablet is and what it is used for
2.
What you need to know before you take Bisoprolol fumarate tablet
3.
How to take Bisoprolol fumarate tablet
4.
Possible side effects
5.
How to store Bisoprolol fumarate tablet
6.
Contents of the pack and other information
1.
WHAT BISOPROLOL FUMARATE TABLET IS AND WHAT IT IS USED FOR
The active substance in this medicine is Bisoprolol fumarate.
Bisoprolol fumarate belongs to group of
medicines called beta-blockers. Beta-blocker protects heart from too
much activity. This medicine
works by affecting the body’s response to some nerve impulses,
especially in the heart. As a result,
Bisoprolol fumarate slows down the heart rate and makes the heart more
efficient at pumping blood
around the body. Heart failure occurs when the heart muscle is weak
and unable to pump enough
blood to supply the body’s need.
Bisoprolol 2.5 mg, 5 mg and 10 mg tablet are used in combination with
other medicines to treat stable
heart failure.
Bisoprolol 5 mg and 10 mg tablet are also used to treat high blood
pressure (Hypertension) and angina
pectoris (Chest pain caused by blockages in the arteries that supply
the heart muscle)
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BISOPROLOL FUMARATE TABLET
DO NOT TAKE BISOPROLOL FUMARATE TABLET IF:
-
You are al

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bisoprolol 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg Bisoprolol fumarate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off white, round, biconvex, film coated tablets, debossed
‘b2’ on one side and break line on other side
Tablet diameter is approximately 7.2 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of Hypertension
Treatment of stable chronic angina
Treatment of stable chronic heart failure with reduced systolic left
ventricular function in addition to ACE inhibitors,
and diuretics, and optionally cardiac glycosides (for additional
information see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Bisoprolol
fumarate tablet
should be taken in morning and can be taken with food in morning.
They should be
swallowed in liquid and should not be chewed.
POSOLOGY
_Treatment of hypertension and chronic stable angina pectoris_
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.
DISCONTINUATION OF TREATMENT
Treatment
should not
be stopped abruptly (see section 4.4).
The dosage should be diminished slowly by a weekly
halving of the dose.
_Treatment of stable chronic heart failure_
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