WINSPIRIN Acetylsalicylic Acid Dispersible Tablet 150mg

מדינה: מלזיה

שפה: אנגלית

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

קנה את זה

עלון מידע עלון מידע (PIL)
30-06-2022
מאפייני מוצר מאפייני מוצר (SPC)
30-06-2022

מרכיב פעיל:

Aspirin

זמין מ:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (שם בינלאומי):

Aspirin

יחידות באריזה:

30 Tablets; 100 Tablets; 500 Tablets; 1000 Tablets

תוצרת:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

עלון מידע

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
WINSPIRIN
ACETYLSALICYLIC
ACID
DISPERSIBLE
TABLET 150MG
Aspirin (150mg)
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
11.
Serial Number
WHAT WINSPIRIN IS USED FOR
WINSPIRIN
used
in
the
initial
treatment
of
cardiovascular
disorders
such as angina pectoris (temporary chest
pain) and myocardial infarction (heart
attack)
and
for
the
prevention
of
cardiovascular events in patients at risk.
Other such uses include the treatment
and
prevention
of
cerebrovascular
disorders such as stroke.
HOW WINSPIRIN WORKS
Acetylsalicylic
acid
belongs
to
the
group
of
acidic
nonsteroidal
anti-
inflammatory
drugs
with
analgesic,
antipyretic
and
anti-inflammatory
properties. Its mechanism of action is
based
on
irreversible
inhibition
of
cyclo-oxygenase
enzymes
involved
in
prostaglandin synthesis.
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 Acetylsalicylic
acid 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 other medicines _
Inform your doct
                                
                                קרא את המסמך השלם
                                
                            

מאפייני מוצר

                                WINSPIRIN ACETYLSALICYLIC ACID DISPERSIBLE TABLET 150MG
Each tablet contains:
Aspirin ………………………….. 150 mg
DESCRIPTION:
PRODUCT DESCRIPTION
White, circular, biconvex, uncoated dispersible tablets with top
scored. Dispersible tablets 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 
                                
                                קרא את המסמך השלם
                                
                            

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עלון מידע עלון מידע מלאית 30-06-2022

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