Congescor 1.25mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Bisoprolol fumarate

Tilgjengelig fra:

Teva UK Ltd

ATC-kode:

C07AB07

INN (International Name):

Bisoprolol fumarate

Dosering :

1.25mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 02040000; GTIN: 5017007025887

Informasjon til brukeren

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PACKAGE LEAFLET: INFORMATION FOR THE USER
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
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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 Congescor is and what it is used for
2.
What you need to know before you take Congescor
3.
How to take Congescor
4.
Possible side effects
5.
How to store Congescor
6.
Contents of the pack and other information 1. WHAT CONGESCOR IS AND WHAT IT IS USED FOR
The active substance in Congescor is bisoprolol. Bisoprolol
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 heart. As a result,
bisoprolol 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 needs.
Congescor is used to treat stable chronic heart failure.
It is used in combination with other medicines suitable for
this condition (such as ACE-inhibitors, diuretics, and heart
glycosides).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CONGESCOR
DO NOT TAKE CONGESCOR
Do not take Congescor if one of the following conditions
applies to you:

aller

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Congescor 1.25mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.25 mg bisoprolol fumarate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White, round film-coated tablets
The scored tablets can be divided into two 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 in combination with ACE inhibitors, and when appropriate
with
diuretics, and cardiac glycoside (for additional information see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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.
Posology
_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
•
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 therapy.
The maximum recommended dose is 10 mg once daily.
Close monitoring of vital signs (heart rate, blood p