Bisoprolol fumarate Pinewood 5 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Pinewood Laboratories Ltd BALLYMACARBRY, CLONMEL, CO. TIPPERARY, Ireland

ATC code:

C07AB07

INN (International Name):

BISOPROLOL FUMARATE 5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

BISOPROLOL FUMARATE 5 mg

Prescription type:

POM

Therapeutic area:

BETA BLOCKING AGENTS

Authorization status:

Authorised

Authorization date:

2024-01-05

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
BISOPROLOL FUMARATE PINEWOOD 1.25 MG FILM-COATED TABLETS BISOPROLOL FUMARATE PINEWOOD 2.5 MG FILM-COATED TABLETS BISOPROLOL FUMARATE PINEWOOD 3.75 MG FILM-COATED TABLETS BISOPROLOL FUMARATE PINEWOOD 5 MG FILM-COATED TABLETS BISOPROLOL FUMARATE PINEWOOD 7.5 MG FILM-COATED TABLETS BISOPROLOL FUMARATE PINEWOOD 10 MG FILM-COATED TABLETS
bisoprolol fumarate
The name of this medicine is Bisoprolol fumarate Pinewood 1.25 mg
film-coated tablets, Bisoprolol
fumarate Pinewood 2.5 mg film-coated tablets, Bisoprolol fumarate
Pinewood 3.75 mg film-coated
tablets, Bisoprolol fumarate Pinewood 5 mg film-coated tablets,
Bisoprolol fumarate Pinewood 7.5
mg film-coated tablets, Bisoprolol fumarate Pinewood 10 mg film-coated
tablets which will be called
Bisoprolol fumarate Pinewood throughout this leaflet.
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 your 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 Pinewood is and what it is used for
2.
What you need to know before you take Bisoprolol fumarate Pinewood
3.
How to take Bisoprolol fumarate Pinewood
4.
Possible side effects
5.
How to store Bisoprolol fumarate Pinewood
6.
Contents of the pack and other information
1.
WHAT BISOPROLOL FUMARATE PINEWOOD IS AND WHAT IT IS USED FOR
The active substance in Bisoprolol fumarate Pinewood is bisoprolol
fumarate. Bisoprolol fumarate
belongs to a group of medicines called beta-blockers. These medicines
work by affecting the body`s
response to some nerve impulses, especially in the hear

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Bisoprolol fumarate Pinewood 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 5 mg of bisoprolol fumarate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Yellowish-white, round shaped with diameter of approx. 8.00 mm,
biconvex film coated
tablets debossed with 'C' and score line on one side and '39' on other
side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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
_ _
_Adults:_
_ _
Standard treatment of CHF consists of an ACE inhibitor (or an
angiotensin receptor blocker in
case of intolerance to ACE inhibitors), a beta-blocker, diuretics, and
when appropriate cardiac
glycosides. Patients should be stable (without acute failure) when
bisoprolol treatment is
initiated.
It is recommended that the treating physician should be experienced in
the management of
chronic heart failure.
Transient worsening of heart failure, hypotension, or bradycardia may
occur during the
titration period and thereafter.
_Titration phase _
_ _
The treatment of stable chronic heart failure with bisoprolol requires
a titration phase
The treatment with bisoprolol is to be started with a gradual
uptitration according to the
following steps:
•
1.25 mg once daily for 1 week, if well tolerated increase to
•
2.5 mg once daily for a further week, if well tolerated increase to
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3.75 mg once daily for a further week, if well tolerated increase to
•
5 mg once daily for the 4 following weeks, if well tolerated increase
to
•
7.5 mg once daily for the 4 following weeks, if well tolerated
increase to
•
10 mg once daily for the maintenance ther