WINSPIRIN Acetylsalicylic Acid Dispersible Tablet 300mg

Land: Malaysia

Språk: engelsk

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

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Preparatomtale Preparatomtale (SPC)
11-08-2022

Aktiv ingrediens:

Aspirin

Tilgjengelig fra:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (International Name):

Aspirin

Enheter i pakken:

30 Tablets; 100 Tablets; 500 Tablets; 1000 Tablets

Produsert av:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Informasjon til brukeren

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
WINSPIRIN
ACETYLSALICYLIC
ACID
DISPERSIBLE
TABLET 300MG
Aspirin (300mg)
1
WHAT IS IN THIS LEAFLET
1.
What WINSPIRIN is used for
2.
How WINSPIRIN works
3.
Before you use WINSPIRIN
4.
How to use WINSPIRIN
5.
While you are using WINSPIRIN
6.
Side effects
7.
Storage and disposal of
WINSPIRIN
8.
Product description
9.
Manufactured by and Product
Registration Holder
10.
Date of revision
WHAT WINSPIRIN IS USED FOR

The
relief
of
headache,
toothache,
migraine, neuralgia (nerve pain), sore
throat, dysmenorrhea (painful period).

The symptomatic relief of influenza,
feverishness, rheumatic pains, sciatica
(pain that starts from the lower back),
lumbago
(low
back
pain),
fibrositis
(musculoskeletal
pain
and
aches),
muscular aches and pains.

It also has an antithrombotic action,
which has been shown to be useful in
secondary
treatment
following
myocardial
infarction
(heart
attack),
and
in
individuals
with
unstable
angina
(chest
pain)
and
cerebral
transient ischaemic attack (stroke).
HOW WINSPIRIN WORKS
WINSPIRIN have analgesic, antipyretic
and anti-inflammatory actions.
BEFORE YOU USE WINSPIRIN
_- When you must not use it _

Not to be given to children under 16
years of age.
Do not use:

if you are allergic to WINSPIRIN or
any of its formulation.

If you are treated with Nonsteroidal
Antiinflammatory Drugs (NSAID).

If you have the syndrome of asthma,
rhinitis (irritation and inflammation of
the
mucous
membrane
inside
the
nose), and nasal polyps.

If you ever had the problem of your
blood not clotting properly.

If
you
ever
had
an
ulcer
in
your
stomach or small intestine.
_ _
_ _
_ _
_-Before you start to use it_
_Pregnancy and lactation_

Talk to you doctor before taking this
medicine if you are pregnant, might
become pregnant or are breastfeeding.

Should
only
be
taken
if
clearly
needed.

Use
during
the
third
trimester
of
pregnancy should be avoided.

Avoid
usage
in
nursing
mother.
Salicylate is excreted in breast milk.
_-Taking o
                                
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Preparatomtale

                                WINSPIRIN
ACETYLSALICYLIC ACID DISPERSIBLE TABLET 300MG
Each tablet contains:
Aspirin ………………………….. 300 mg
DESCRIPTION:
PRODUCT DESCRIPTION
White, circular, biconvex, uncoated tablets with score line.
Dispersible tablet gives a cloudy liquid after dispersion in water.
PHARMACODYNAMICS
At higher doses, aspirin is an effective anti-inflammatory agent,
partially due to inhibition of inflammatory mediators via
cyclo-oxygenase
inhibition in peripheral tissues. Acetyl salicylic acid affects
platelet aggregation by irreversibly inhibiting prostaglandin
cyclo-oxygenase. This
effect lasts for the life of the platelet and prevents the formation
of the platelet aggregating factor thromboxane A
2
. Non-acetylated salicylates
do not inhibit this enzyme and have no effect on platelet aggregation.
At somewhat higher doses, aspirin reversibly inhibits the formation of
prostaglandin I
2
(prostacyclin), which is an arterial vasodilator and inhibits platelet
aggregation.
PHARMACOKINETICS
ABSORPTION:
Aspirin after oral administration is generally well absorbed from the
gastrointestinal (GI) tract. Following absorption, aspirin is
hydrolyzed to salicylic acid with peak plasma levels of salicylic acid
occurring within 1-2 hours of dosing. The rate of absorption from the
GI
tract is dependent upon the dosage form, the presence or absence of
food, gastric pH and other physiologic factors.
DISTRIBUTION:
Salicylic acid is widely distributed to all tissues and fluids
in the
body including the central nervous system (CNS), breast milk
and fetal tissues. The highest concentrations are found in the plasma,
liver, renal cortex, heart and lungs. The protein binding of
salicylate is
concentration-dependent, i.e., non-linear. At low concentrations (<100
micrograms/milliliter (mcg/ml)), approximately 90 percent of plasma
salicylate is bound to albumin while at higher concentrations (> 400
mcg/ml), only about 75 percent is bound. The early signs of salicylic
overdose (salicylism), including tinnitus (ringing in the ears), occur
a
                                
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