DYNAMOL 650 TABLET

Country: Malaysia

Language: English

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

Active ingredient:

Paracetamol

Available from:

DYNAPHARM (M) SDN BHD

INN (International Name):

Paracetamol

Units in package:

1000 Tablets; 100 Tablets

Manufactured by:

DYNAPHARM (M) SDN BHD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DYNAMOL TABLET
Paracetamol (500 mg, 650 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Dynamol Tablet is used for
2.
How Dynamol Tablet works
3.
Before you use Dynamol Tablet
4.
How to use Dynamol Tablet
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Dynamol
Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DYNAMOL TABLET IS USED FOR
It is used for the relief of pain such as
headache, nerve inflammation, muscle
pain, toothache and fever.
HOW DYNAMOL TABLET WORKS
Paracetamol acts by inhibiting the
production of hormone-like substances
that participate in a wide range of body
functions such as the contraction and
relaxation of muscle, the dilation and
constriction of blood vessels, control of
blood pressure and modulation of
inflammation. It is considered to affect
the brain that controls body temperature.
BEFORE YOU USE DYNAMOL TABLET
-
_When you must not use it _
Tell your doctor if you hypersensitive to
Paracetamol or other ingredients in this
product.
This preparation contains
PARACETAMOL. Do not take
Paracetamol containing medicines at the
same time.
-
_Before you start to use it _
_Pregnancy and lactation _
No reports regarding adverse effects.
Lactation: Amount too small to be
harmful.
Ask your doctor or pharmacists for
advice before taking Dynamol Tablet.
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy without a prescription from a
pharmacy, supermarket or health food
shop.
Paracetamol should not be taken
concomitantly with
-
Alcohol
-
Cholestyramine (used to reduce
cholesterol)
-
Warfarin (prevent blood clot)
-
Metoclopramide or Domperidone (treat
nausea and vomitting)
HOW TO USE DYNAMOL TABLET
-
_How much to use _
Dynamol 650 Tablet
Adults: 1 tablet
Children 7 to 12 years: ½ tablet
Dynamol Tablet 500mg
Adults: 2 tablets.
Children 7 to 12 years: ½ - 1 tablet.
The directions given may differ from the
information contained in th

Summary of Product characteristics

DYNAMOL 650 TABLET
MAL19990615XZ
DESCRIPTION:
TABLET
Colour
:
Pink
Shape
:
Round, Flat, Scored
Marking
:
“DYNAMOL”
EACH TABLET CONTAINS:
Paracetamol ..................................................... 650
mg
PHARMACODYNAMICS:
Paracetamol is considered to act mainly by inhibiting the biosynthesis
of prostaglandins. It is often described as peripherally acting
compound.
Antipyretic activity is considered to involve the hypothalamus.
PHARMACOKINETICS:
Paracetamol is readily absorbed from the gastrointestinal tract with
peak plasma concentrations occurring about 30 minutes to 2 hours after
ingestion. It is metabolised in the liver and excreted in the urine
mainly as the glucoronide and sulphate conjugates. Less than 5% is
excreted as
unchanged Paracetamol. The elimination half-life varies from about 1
hour to 4 hours. Plasma protein binding is negligible at usual
therapeutic
concentrations but increases with increasing concentrations. A minor
hydroxylated metabolite which is usually produced in very small
amounts by
mixed-function oxidases in the liver and which is usually detoxified
by conjugation with liver glutathione may accumulate following
Paracetamol
overdosage and cause liver damage.
INDICATIONS:
Paracetamol has both analgesic and antipyretic action. It is used for
the relief of pain such as headache, neuritis, myalgias and toothache,
and fever.
RECOMMENDED DOSE:
Adults
:
1 tablet.
Children 7 to 12 years
:
½ tablet.
To be taken 3 to 4 times daily, as required.
ROUTE OF ADMINISTRATION:
FOR ORAL USE ONLY.
CONTRAINIDCATIONS:
Hypersensitivity.
WARNINGS AND PRECAUTIONS:
This drug should be used with care in hepatic and renal impairment.
Long term usage should be avoided. Do not exceed the recommended dose
or
use for more than 10 days unless prescribed.
Allergy alert: Paracetamol may cause severe skin reactions. Symptoms
may include skin reddening, blisters or rash. These could be signs of
a
serious condition. If these reactions occur, stop use and seek medical
assistance right away.
This preparation contain