Congescor 1.25mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Bisoprolol fumarate

Tilgjengelig fra:

Tillomed Laboratories 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: 5024655002788

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CONGESCOR 1.25 MG FILM-COATED TABLETS
CONGESCOR 2.5 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 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 section4.
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:
•
allergy (hypersensitivity) to bisoprolol or to any of the other
ingredients (see section 6 ‘What
Congescor contains’)
•
severe asthma
•
severe blood circulation problems in your limbs (such as Raynaud’s
syndrome), which may
cause your fingers and toes to tingle or turn pale

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