CONCOR 1.25 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BISOPROLOL FUMARATE

Available from:

MERCK SERONO LTD

ATC code:

C07AB07

Pharmaceutical form:

FILM COATED TABLETS

Composition:

BISOPROLOL FUMARATE 1.25 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

MERCK HEALTHCARE KGAA, GERMANY

Therapeutic area:

BISOPROLOL

Therapeutic indications:

Treatment of stable chronic, moderate to severe heart failure with impaired systolic ventricular function (ejection fraction < 35 %, determined by echocardiography) in addition to ACE inhibitors and diuretics, and optionally cardiac glycosides.

Authorization date:

2021-04-28

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is dispensed with a doctor's prescription only
CONCOR 1.25 MG
CONCOR 2.5 MG
Film-coated tablets
Film-coated tablets
ACTIVE INGREDIENTS:
Each film-coated tablet of Concor 1.25 mg contains: bisoprolol
fumarate 1.25 mg
Each film-coated tablet of Concor 2.5 mg contains: bisoprolol fumarate
2.5 mg
INACTIVE INGREDIENTS AND ALLERGENS: See section 6 ‘Additional
information’.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains
concise information about this medicine.
If you have any further questions, consult your doctor or pharmacist.
Keep this leaflet handy. You may need to read it again.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
If you get any side effects, contact your doctor or pharmacist. This
includes any possible
side effect not listed in this leaflet. See section 4 ‘Side
effects’.
1.
WHAT IS THIS MEDICINE INTENDED FOR
Concor is intended for treatment of stable chronic, moderate to severe
heart failure with
impaired systolic function (ejection fraction <35%, determined by
echocardiography) in
addition to ACE inhibitors and diuretics, and optionally cardiac
glycosides.
THERAPEUTIC GROUP:
Beta blocking agents, selective
2.
BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to bisoprolol or to any of the other
ingredients in this
medicine (see section 6 ‘Additional information’)
•
You suffer from severe asthma
•
You suffer from severe blood circulation problems in your limbs (such
as Raynaud’s
syndrome), which may cause your fingers and toes to tingle or turn
pale or blue
•
You suffer from untreated phaeochromocytoma, which is a rare tumour of
the adrenal
gland
•
You suffer from metabolic acidosis, which is a condition when there is
too much acid in
the blood
•
You suffer from acute heart failure
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Summary of Product characteristics

1
PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Concor 1.25 mg film-coated tablets
Concor 2.5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Concor 1.25 mg:
Each tablet contains 1.25 mg bisoprolol fumarate
Concor 2.5 mg:
Each tablet contains 2.5 mg bisoprolol fumarate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Concor 1.25 mg
white, round film-coated tablets
Concor 2.5 mg
white, heart-shaped, scored and film-coated tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of stable chronic, moderate to severe heart failure with
impaired systolic ventricular
function (ejection fraction <35%, determined by echocardiography) 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
•
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 t