Cardicor 7.5mg tablets

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Bisoprolol fumarate

Dostupné z:

Sigma Pharmaceuticals Plc

ATC kód:

C07AB07

INN (Medzinárodný Name):

Bisoprolol fumarate

Dávkovanie:

7.5mg

Forma lieku:

Oral tablet

Spôsob podávania:

Oral

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 02040000

Príbalový leták

PAGE 1
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PACKAGE LEAFLET: INFORMATION FOR THE USER
CARDICOR
® 1.25 MG FILM-COATED TABLETS
CARDICOR
® 2.5 MG FILM-COATED TABLETS
CARDICOR
® 3.75 MG FILM-COATED TABLETS
CARDICOR
® 5 MG FILM-COATED TABLETS
CARDICOR
® 7.5 MG FILM-COATED TABLETS
CARDICOR
® 10 MG FILM-COATED TABLETS
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 Cardicor is and what it is used for
2.
What you need to know before you take Cardicor
3.
How to take Cardicor
4.
Possible side effects
5.
How to store Cardicor
6.
Contents of the pack and other information
1. WHAT CARDICOR IS AND WHAT IT IS USED FOR
The active substance in Cardicor 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. Cardicor 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
CARDICOR
DO NOT TAKE CARDICOR
Do not take Cardicor if one of the following
conditions applies to you:
• allergy (hypersensitivity) to

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cardicor 7.5 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 7.5 mg bisoprolol fumarate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Pale yellow, heart-shaped, scored and 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 (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 pressure) and
symptoms of worsening heart
failure is recommended during t