Concor AM 5 mg5 mg Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

AMLODIPINE BESILATE; BISOPROLOL FUMARATE

Boleh didapati daripada:

MERCK SDN. BHD.

INN (Nama Antarabangsa):

AMLODIPINE BESILATE; BISOPROLOL FUMARATE

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

Egis Pharmaceuticals PLC

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
1
CONCOR AM TABLET
bisoprolol fumarate, amlodipine besilate (5mg/5mg, 5mg/10mg)
WHAT IS IN THIS LEAFLET
1.
What Concor AM is used for
2.
How Concor AM works
3.
Before you use Concor AM
4.
How to take Concor AM
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Concor
AM
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT CONCOR AM IS USED FOR
Concor AM is used to treat high blood
pressure.
HOW CONCOR AM WORKS
The active substances in Concor AM
are
bisoprolol
and
amlodipine.
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.
Amlodipine
prevents
an
inflow
of
calcium ions into heart. It also widens
and reduces blockage of blood vessels
around
the
heart.
Thus,
it
does
not
cause
abnormal
rapid
heart
rate,
myocardial
energy
consumption
and
oxygen requirement will be reduced.
Concor
AM
increases
the
antihypertensive
and
anti-anginal
efficacy
by
decreasing
peripheral
blockage and cardiac output.
BEFORE YOU USE CONCOR AM
-
_When you must not take it _
Do not take Concor AM if one of the
following conditions applies to you:
•
allergy (hypersensitivity) to
bisoprolol, amlodipine or to any of
the other ingredients
Severe hypotension which systolic
blood pressure < 100mmHg
•
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 AM if you have
one of the following heart problems:
•
acute heart failure, that is not
controlled medically
•
wor

Ciri produk

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COMPOSITION
Bisoprolol/Amlodipine 5/5 mg,
5 mg/5 mg tablets: 5 mg bisoprolol fumarate, 5 mg amlodipine (as
besilate)
per tablet.
Bisoprolol/Amlodipine 5/10 mg,
5 mg/10 mg tablets: 5 mg bisoprolol fumarate, 10 mg amlodipine (as
besilate) per tablet.
For the full list of excipients, see section list of excipients
PHARMACEUTICAL FORM
Bisoprolol/Amlodipine 5/5 mg,
White or almost white, odourless, oblong, slightly convex tablets with
a
length of 9.5 mm and a width of 4.5 mm with score line on one side and
with embossed MS on the other side. The score line is only to
facilitate
breaking for ease of swallowing and not to divide into equal doses.
Bisoprolol/Amlodipine 5/10 mg,
White or almost white, odourless, round, flat, bevel edged tablets of
10 mm
with score line on one side and embossed MS on the other side. The
score
line is only to facilitate breaking for ease of swallowing and not to
divide
into equal doses.
ROUTE OF ADMINISTRATION
Oral
INDICATION
Concor AM is indicated for the treatment of hypertension as
substitution
therapy in patients adequately controlled with the individual products
given concurrently at the same doses level as in the combination, but
as
separate tablets.
POSOLOGY AND METHOD OF ADMINISTRATION
Concor AM is indicated in patients whose blood pressure is adequately
controlled with separately administered mono-component preparations of
the same doses as the recommended fixed dose combination.
_Posology_
Recommended daily dose is one tablet of the given strength.
Treatment must not be abruptly discontinued, as it may lead to
temporary
deterioration
of
clinical
condition.
Treatment
must
not
be
abruptly
discontinued especially in case of patients suffering from ischaemic
heart
disease. Gradual decrease of the dose is recommended.
_Patients with hepatic impairment_
In case of hepatic impairment elimination of amlodipine may be
elongated.
Dosage
recommendations concerning amlodipine have not been established in
patients with mild to moderate hepatic impairment. The
pharmacokinetics
o