Concor 10mg Film coated Tablet

Land: Maleisië

Taal: Engels

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

Werkstoffen:

BISOPROLOL FUMARATE

Beschikbaar vanaf:

MERCK SDN. BHD.

INN (Algemene Internationale Benaming):

BISOPROLOL FUMARATE

Eenheden in pakket:

100Tablet Tablets

Geproduceerd door:

Merck Healthcare KGaA

Bijsluiter

_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

Productkenmerken

Concor® 10 mg film coated tablet
Active ingredient: bisoprolol fumarate
Composition
Each film-coated tablet contains 10 mg bisoprolol fumarate as
ingredient.
Excipients: Tablet core: Silica, colloidal anhydrous; magnesium
stearate, crospovidone,
microcrystalline cellulose, maize starch, calcium hydrogen phosphate,
anhydrous.
Film coating: Iron oxide red, Iron oxide yellow, dimethicone, macrogol
400, titanium dioxide,
hypromellose.
Product Description
Pale orange-light orange, heart shaped, biconvex film-coated tablet,
scored on both sides.
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 data
from studies in human liver microsomes show t