Carvedilol HEXAL® 25 mg Tablet

Country: Malaysia

Language: English

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

Active ingredient:

CARVEDILOL

Available from:

IMEKS PHARMA SDN. BHD.

INN (International Name):

CARVEDILOL

Units in package:

50Tablet Tablets; 30Tablet Tablets; 100Tablet Tablets

Manufactured by:

Salutas pharma GmbH

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
CARVEDILOL HEXAL
_® _
6.25/ 12.5/25MG TABLET
_ _
_ _
Carvedilol (6.25/12.5/25mg)
Page no.
WHAT IS IN THIS LEAFLET
1. What
CARVEDILOL HEXAL
is used
for
2. How
CARVEDILOL HEXAL
works
3.
Before
you
take
CARVEDILOL
HEXAL
4. How to take
CARVEDILOL HEXAL
5. While you are using
CARVEDILOL
HEXAL
6. Possible side effects
7. After using
CARVEDILOL HEXAL
8. Product description
9. Marketing authorization holder and
manufacturer
WHAT CARVEDILOL HEXAL IS USED
FOR
CARVEDILOL HEXAL
is used to treat

High blood pressure (hypertension)

Chest pain (angina pectoris)

Chronic heart failure
HOW CARVEDILOL HEXAL WORKS
CARVEDILOL
HEXAL
contains
the
active ingredient carvedilol. It belongs
to the group of medicines called ‘beta
blockers’. These medicines works by
relaxing the blood vessels and slowing
down the heart rate. Carvedilol also
possesses antioxidant effect.
BEFORE YOU USE CARVEDILOL HEXAL
_- When you must not use it _
Do not take
CARVEDILOL HEXAL
if
you:

Have ever had allergic reaction to
carvedilol, the active ingredient, or to
any other ingredients in
CARVEDILOL
HEXAL

Have severe heart failure

Have asthma or other conditions that
causes breathing difficulties

Have liver problems, including liver
failure

Have a slow heart beat or serious
problems
with
the
heart
rhythm
(second or third degree heart block)

Suffering
from
cardiogenic
shock
(second or third degree heart block)

Suffering from cardiogenic shock (a
state
where
heart
is
damaged
and
unable to supply sufficient blood to
organs in body)

Have very low blood pressure

Have metabolic acidosis (excessive
acidity in the body fluid)

Have Prinzmetal’s angina, a type of
chest pain

Untreated
phaeochromocytoma
(a
rare tumor in adrenal gland)

Have poor circulation to your fingers
and/or
toes
(peripheral
vascular
disease)

Taking
injectables
medicine
of
verapamil or diltiazem.
_If you are not sure whether you should _
_start taking this medicine, consult your _
_d

Summary of Product characteristics

DIRECTIONS FOR USE PLEASE READ CAREFULLY!
CONTENT
Each
CARVEDILOL
HEXAL
®
6.25MG,
CARVEDILOL
HEXAL
®
12.5MG
and
CARVEDILOL
HEXAL
®
25MG
TABLET
contains
6.25mg,
12.5mg
and
25mg
carvedilol respectively for the purpose of oral administration.
bisected tablet with a pressure-sensitive scoring notch, encoded
C2.
CARVEDILOL HEXAL
®
12.5MG TABLET:
Red/brown, round, convex,
bisected
tablet with a pressure-sensitive scoring notch, encoded
C3.
CARVEDILOL HEXAL
®
25MG TABLET:
White, round, convex, bisected
tablet
with a pressure-sensitive scoring notch, encoded C4.
PHARMACODYNAMICS
Carvedilol
is
a
vasodilative non-selective
beta-blocker
which
reduces
the
peripheral
vascular
resistance
by
selective
alpha
1-
receptor
blockade
and
suppresses
the
renin-angiotensin
system
through
non-
selective
beta-blockade.
Plasma
renin
activity
is
reduced,
and
fluid
retention is rare.
Carvedilol
has
no
intrinsic
sympathomimetic
activity
(ISA).
Like
propranolol, it has membrane-stabilizing properties.
Carvedilol is a racemate of two stereoisomers. Both enantiomers
were
found to have alpha-adrenergic blocking activity. Non-
selective beta
1
-
and
beta
2
-adrenoceptor
blockade
is
attributed
mainly
to
the
S
(-)
enantiomer.
Carvedilol
is
a
potent
antioxidant,
a
scavenger
of
reactive
oxygen
radicals
and
anti-proliferative
agent.
The
antioxidant
properties
of
carvedilol and its metabolites have been demonstrated in _ in vitro _
and
_in vivo _ animal studies and _ in vitro _ in a number of human cell
types.
In
hypertensive
patients,
a
reduction
in
blood
pressure
is
not
associated
with
a
concomitant
increase
in
peripheral
resistance,
as
observed
with
pure
beta-blocking
agents.
Heart
rate
is
slightly
decreased. Stroke volume remains unchanged. Renal blood flow
and
renal function remain normal, as does peripheral blood flow,
therefore,
cold
extremities,
often
observed
with
beta-blockers,
are
only
rarely
seen.
In
hypertensive
patients,
carvedilol
increases
the
plasma
concentration of norepinephrine.
In prolonged treatment of patients with angina pec