ANTAROL TABLET 20MG

Country: Malaysia

Language: English

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

Active ingredient:

PROPRANOLOL HYDROCHLORIDE

Available from:

IMEKS PHARMA SDN. BHD.

INN (International Name):

PROPRANOLOL HYDROCHLORIDE

Units in package:

250 Tablet Tablets

Manufactured by:

GoodScience Sdn. Bhd.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
ANTAROL TABLET 20MG
Propranolol Hydrochloride (20mg)
_ _
1
WHAT IS IN THE LEAFLET
1.
What
_Antarol _
is used for
2.
How
_ Antarol_
works
3.
Before you use
_Antarol_
4.
How to use
_Antarol_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_ Antarol_
8.
Product Description
9.
Manufacturer and Product Registra-
tion Holder
10.
Date of Revision
WHAT _ANTAROL _IS USED FOR
_Antarol _
can be used for many conditions
including hypertension (high blood pres-
sure), angina (chest pain), some arrythmias
(disorders of heart rhythm), protection of
the heart after a myocardial infarction
(heart attack), prevention of migraine, es-
sential
tremor,
anxiety,
certain
thyroid
conditions (such as thyrotoxicosis, which
is caused by an overactive thyroid gland),
hypertrophic
cardiomyopathy
(thickened
heart muscle) and phaeochromocytoma
(high blood pressure due to a tumour usu-
ally near the kidney).
HOW _ANTAROL _WORKS
_Antarol _
contains Propranolol hydrochlo-
ride as active ingredient which belongs to
a group of medicines called beta-blockers.
Propranolol hydrochloride works by slow-
ing down and reduces the force of your
heartbeat.
This
reduces
the
pressure
in
your
blood
vessels.
It
also
widens
the
blood vessels in the body and helps the
heart to beat more regularly.
BEFORE YOU USE _ANTAROL _
-
_When you must not use it_
Do not take
_Antarol _
if you:
• Are allergic to active
ingredient, propranolol hydrochloride or
any other ingredients in
_Antarol_
.
• If you have ever had asthma or wheezing.
If any of the above applies to you (or you
are in doubt), please seek your doctor or
pharmacist for advice.
-
_Before you start to use it _
Talk to your doctor or pharmacist before
taking
_ Antarol_
:
• If you have heart failure which is not un-
der control
• If you are fasting or have been fasting re-
cently
• If you have phaeochromocytoma (high
blood pressure due to a tumour near the
kidney) which is not being treated
• If you have metabolic acidosis
• If y

Summary of Product characteristics

DESCRIPTION
Antarol 20 mg & 40 mg Tablet: Dark-purple, film-
coated, round and embossed with “P/20” or “P/40” and
the “a” in italics. Each Antarol 20 mg & 40 mg Tablet
contains propranolol HCl 20 mg and 40 mg respectively.
PHARMACODYNAMICS
Propranolol is a competitive antagonist at both beta-1 and
beta-2 adrenoceptors. It has no agonist activity at the
beta-adrenoceptor, but has membrane stabilising activity
at concentrations exceeding 1 - 3 mg/litre, though such
concentrations are rarely achieved during oral therapy.
Competitive
beta-adrenoceptor
blockade
has
been
demonstrated in man by a parallel shift to the right in the
dose-heart rate response curve to beta agonists such as
isoprenaline.
Propranolol, as with other beta-blockers, has negative
inotropic
effects,
and
is
therefore
contraindicated
in
uncontrolled
heart
failure
(see
WARNINGS
AND
PRECAUTIONS).
Propranolol is a racemic mixture and the active form is the
S(-)
isomer,
of
propranolol.
With
the
exception
of
inhibition of the conversion of thyroxine to triiodothyro-
nine it is unlikely that any additional ancillary properties
possessed by R(+) propranolol, in comparison with the
racemic mixture will give rise to different therapeutic
effects.
Propranolol is effective and well-tolerated in most ethnic
populations, although the response may be less in black
patients.
PHARMACOKINETICS
Propranolol hydrochloride is almost completely absorbed
from the intestine after oral administration, but is subject
to considerable hepatic tissue binding and first pass
metabolism.
Peak plasma concentrations occur about 1 – 2 hours after
a dose, but vary greatly between individuals. The mean
plasma half-life is from 3 – 6 hours.
Propranolol is widely distributed throughout the body
tissues. It is highly protein bound (more than 90 %) and
reported not to be significantly dialyzable. It also has high
lipid
solubility
property.
Propranolol
crosses
the
blood-brain barrier and placenta; traces are found in
breast milk. It is metabolised in the liver; the metabolit