CONCOR 10 MG

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

BISOPROLOL FUMARATE

Dostopno od:

MERCK SERONO LTD

Koda artikla:

C07AB07

Farmacevtska oblika:

TABLETS

Sestava:

BISOPROLOL FUMARATE 10 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

MERCK HEALTHCARE KGAA, GERMANY

Terapevtska skupina:

BISOPROLOL

Terapevtsko območje:

BISOPROLOL

Terapevtske indikacije:

- 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.- Hypertension- Coronary heart disease (angina pectoris)

Datum dovoljenje:

2015-01-31

Navodilo za uporabo

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is dispensed with a doctor's prescription only
CONCOR 5 MG
CONCOR 10 MG
Film-coated tablets
Film-coated tablets
ACTIVE INGREDIENTS:
Each film-coated tablet of Concor 5 mg contains: bisoprolol fumarate 5
mg
Each film-coated tablet of Concor 10 mg contains: bisoprolol fumarate
10 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.
Additionally, Concor is intended for treatment of hypertension and
coronary heart disease
(angina pectoris).
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

Lastnosti izdelka

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PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Concor 5 mg film-coated tablets
Concor 10 mg film-coated tablets_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CONCOR 5 MG:
Each tablet contains 5 mg bisoprolol fumarate
CONCOR 10 MG:
Each tablet contains 10 mg bisoprolol fumarate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Concor 5 mg
yellowish white, heart-shaped, scored and film-coated tablets
Concor 10 mg
pale orange - light orange, 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
.
-
Hypertension
-
Coronary heart disease (angina pectoris)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
CHRONIC HEART FAILURE
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.
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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 follo