Coxa 500 Tablet

Ülke: Malezya

Dil: İngilizce

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

şimdi satın al

Indir Ürün özellikleri (SPC)
08-12-2021

Aktif bileşen:

Paracetamol

Mevcut itibaren:

Alpharme Plc Sdn. Bhd.

INN (International Adı):

Paracetamol

Paketteki üniteler:

10 Tablets; 100 Tablets; 500 Tablets; 1000 Tablets

Tarafından üretildi:

Farmalabor - Produtos Farmaceuticos, S.A.

Bilgilendirme broşürü

                                COXA 500 TABLET
Paracetamol 500mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Coxa 500 Tablet is used for
2.
How Coxa 500 Tablet works
3.
Before you use Coxa 500 Tablet
4.
How to use Coxa 500 Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Coxa 500
Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT COXA 500 TABLET IS USED FOR
Coxa 500 tablets is used for the relief of
fever and reduce pain.
HOW COXA 500 TABLET WORKS
Coxa
Tablet
contains
Paracetamol
which has analgesic (pain relief) and
antipyretic (anti-fever) properties.
BEFORE YOU USE COXA 500 TABLET
-
_When you must not use it _
Do not take Coxa 500 Tablet if:
•
You
have
ever
had
an
allergic
reaction to Paracetamol or to any of
the other ingredients
•
You
are
taking
other
medicines
containing paracetamol.
_ _
If you are not sure whether you should
take this medicine, ask your doctor or
pharmacist for advice before taking any
medicine.
_ _
-
_Before you start use it _
Tell your doctor or pharmacist if
•
You have liver or kidney disease.
•
You are pregnant or breastfeeding.
Ill effects in human have not been
reported when taking paracetamol
during pregnancy or breastfeeding.
•
You are taking other medicine that
affect the liver
-
_Taking other medicines _
Tell your doctor or pharmacist if you are
taking any other medicines, including
any that you buy without a prescription
from a pharmacy, supermarket or health
food shop.
Inform your doctor or pharmacist if you
are
taking
if
you
are
taking
cholestyramine,
metoclopramide,
domperidone, warafin, chloramphenicol,
non-steroidal
anti-inflammatory
drug
(NSAIDs),
alcohol,
hepatic
enzyme
inducers, hepatotoxic medications.
HOW TO USE COXA 500 TABLET
-
_How much to use _
•
Adults and children over 12 years: 1
- 2 tablets three to four times daily
as required. Not more than 8 tablets
in 24 hours unless instructed by a
doctor.
•
Children
under
12
years:
Not
recommended.
Follow all directions 
                                
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Ürün özellikleri

                                COXA 500 TABLET
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Coxa 500 Tablet
Each tablet contains paracetamol 500mg.
PRODUCT DESCRIPTION
Coxa 500 tablet is a white round, uniform and scored on one side. The
score line is not intended to divide the
tablet into equal doses.
PHARMACODYNAMIC
Paracetamol has analgesic and antipyretic effects. It may produce
analgesia by inhibiting prostaglandin
synthesis in the central nervous system and through a peripheral
action by blocking pain impulse generation.
The peripheral action may also be due to inhibition of prostaglandin
synthesis or to inhibition of the synthesis or
actions of other substances that sensitise pain receptors to
mechanical or chemical stimulation.
Paracetamol probably produces antipyresis by acting centrally on the
hypothalamic heat regulating centre to
produce peripheral vasodilation resulting in increased blood flow
through skin, sweating and heat loss. The central
action probably involves the inhibition of prostaglandin synthesis in
the hypothalamus.
PHARMACOKINETIC
Absorption
The oral absorption of paracetamol is rapid and almost completely
absorbed from the gastro-intestinal tract with
peak plasma concentration occurring about 0.5 to 2 hours after
ingestion and may be decreased if taken after a
high carbohydrate meal.
Distribution
Paracetamol is distributed rapidly throughout all tissues.
Concentrations are comparable in blood, saliva and
plasma. The volume of distribution of Paracetamol is approximately 1
L/kg bodyweight. At therapeutic doses
protein binding is negligible.
Metabolism
Protein binding is not significant with doses producing plasma
concentration below 60mcg/ml but may reach
moderate level with high or toxic doses. Approximately 90% - 95% of a
dose is metabolized in the liver, primarily
by conjugation with glucuronic acid, sulphuric acid and cysteine. An
intermediate metabolite, which may
accumulate in overdosage after the primary metabolic pathways become
saturated, is hepatotoxic and possibly
nephrotoxic. The half -life is 1-4 hours and does
                                
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