Concor 5mg Film coated Tablet

País: Malàisia

Idioma: anglès

Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

ingredients actius:

BISOPROLOL FUMARATE

Disponible des:

MERCK SDN. BHD.

Designació comuna internacional (DCI):

BISOPROLOL FUMARATE

Unidades en paquete:

100Tablet Tablets

Fabricat per:

Merck Healthcare KGaA

Informació per a l'usuari

_Consumer Medication Information Leaflet (RiMUP)_
1
CONCOR
® FILM-COATED TABLETS
Bisoprolol fumarate (2.5mg, 5mg, 10mg)
WHAT IS IN THIS LEAFLET
1.
What Concor is used for
2.
How Concor works
3.
Before you use Concor
4.
How to take Concor
5.
While you are using Concor
6.
Side effects
7.
Storage and Disposaldisposable
of Concor
8.
Product Ddescription
9.
Manufacturer and Product
Rregistration hHolder
10.
Date of revision
10.11.
Serial Number
WHAT CONCOR IS USED FOR
Concor 2.5 mg is used to treat chronic
stable heart failure
Concor 5 mg and 10mg is used to
treat high blood pressure, angina
pectoris and chronic stable heart
failure
HOW CONCOR WORKS
The active substance in Concor 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. Heart failure may begin with no
symptoms, but as the condition
progresses, you may feel shortness of
breath. You may experience
palpitations (initially during ordinary
exercise, but later on also at rest), feel
tired, and notice swelling of the feet
and ankles due to fluid build up.
BEFORE YOU USE CONCOR
-
_When you must not take it _
Do not take Concor if one of the
following conditions applies to you:

allergy (hypersensitivity) to
bisoprolol or to any of the other
ingredients

severe asthma or severe chronic
obstructive airway disease

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

untreated phaeochromocytoma,
which is a rare tumour of the
adrenal gland

metabolic acidosis, which is a
condition when there is too much
acid in the blood.
Do not take Concor if you have one of
the following heart problems:

acute he

Fitxa tècnica

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PAGE 1
7878030545
CONCOR
® 5 MG FILM COATED TABLET
Active ingredient: bisoprolol fumarate
COMPOSITION
Each film-coated tablet contains 5 mg bisoprolol
fumarate as active ingredient
_Excipients:_
Tablet
core:
Silica,
colloidal
anhydrous;
magnesium stearate, crospovidone, microcrystalline
cellulose, maize starch, calcium hydrogen phosphate,
anhydrous
_Film coating: _
Iron oxide yellow, dimethicone, macrogol
400, titanium dioxide, hypromellose
PRODUCT DESCRIPTION
Yellowish white,
heart shaped, biconvex film-coated
tablet, scored on both sides.
ROUTE OF ADMINISTRATION
Oral
PROPERTIES
Pharmacodynamics
Bisoprolol, the active ingredient of Concor, is a beta1-
selective-adrenoceptor blocking agent, lacking intrinsic
stimulating and relevant membrane stabilising activity. It
only shows very low affinity to the beta2-receptor of the
smooth muscles of bronchi and vessels as well as to the
beta2-receptors concerned with metabolic regulation.
Therefore, bisoprolol is generally not to be expected
to influence the airway resistance and beta2-mediated
metabolic effects. Its beta1-selectivity extends beyond
the therapeutic dose range.
Pharmacokinetics
_Absorption._
Bisoprolol is almost completely (>90%)
absorbed from the gastrointestinal tract and, because
of its small first pass metabolism of approximately 10%,
has a bioavailability of approximately 90% after oral
administration. The bioavailability is not affected by food
intake. Bisoprolol shows linear kinetics and the plasma
concentrations are proportional to the administered
dose over the dose range 5 to 20 mg. Peak plasma
concentrations occur within 2-3 hours.
_Distribution._
Bisoprolol is extensively distributed. The
volume of distribution is 3.5 l/kg. Binding to plasma
proteins is approximately 30%.
_Metabolism._
Bisoprolol is metabolised via oxidative
pathways
with
no
subsequent
conjugation.
All
metabolites, being very polar, are renally eliminated.
The major metabolites in human plasma and urine were
found to be without pharmacological activity.
_In vitro_
da