PARADEINE TABLET

Land: Malaysia

Sprache: Englisch

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

Wirkstoff:

Paracetamol; CODEINE PHOSPHATE

Verfügbar ab:

DYNAPHARM (M) SDN BHD

INN (Internationale Bezeichnung):

Paracetamol; CODEINE PHOSPHATE

Einheiten im Paket:

100 Tablets; 1000 Tablets

Hergestellt von:

DYNAPHARM (M) SDN BHD

Gebrauchsinformation

PARADEINE TABLET
Paracetamol / Codeine Phosphate (500mg / 8mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Paradeine Tablet is used for
2.
How Paradeine Tablet works
3.
Before you use Paradeine Tablet
4.
How to use Paradeine Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Paradeine
Tablet
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT PARADEINE TABLET IS USED FOR
For the relief of mild to moderately
severe pain.
HOW PARADEINE TABLET WORKS
Paracetamol and codeine phosphate are
painkillers that work together in different
ways to relieve pain.
BEFORE YOU USE PARADEINE TABLET
-
_When you must not use it _
-
Hypersensitivity to Paracetamol or
Codeine.
-
In children below the age of 12 years
for the symptomatic treatment of colds
due to an increased risk of developing
serious and life-threatening adverse
reactions.
-
In all paediatric patients (0-18 years of
age) who undergo tonsillectomy and/or
adenoidectomy for obstructive sleep
apnoea syndrome due to increased risk
of developing serious and life-
threatening adverse reactions.
-
In women who are breastfeeding.
-
In individuals for whom it is known
they are CYP2D6 ultra-rapid
metabolisers.
This preparation contains Paracetamol.
Do not take other Paracetamol
containing medicines at the same time.
_Pregnancy and lactation _
_ _
Do not take Paradeine Tablet if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take Paradeine Tablet if you are
breast-feeding. Ask your doctor or
pharmacist for advice before taking any
medicine.
-
_Before you start to use it _
Tell your doctor if:
- You are patients with impaired kidney
or liver function.
- You are taking other drugs which affect
the liver.
- You have underactive thyroid,
Addison’s disease and enlargement of
the prostate gland or constriction of the
urethra.
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy without a p

Fachinformation

PARADEINE TABLET
MAL19913256AZ
DESCRIPTION:
TABLET
Colour
: White
Shape
: Round, Flat and Scored
Marking
: “P”
EACH TABLET CONTAINS:
Paracetamol
....................................................................................
500 mg
Codeine Phosphate
...............................................................................
8 mg
PHARMACODYNAMICS:
Codeine Phosphate is a narcotic analgesic that acts in the central
nervous system to alter the perception of pain and emotional
response to pain. Codeine also has antitussive action by the
suppression of the cough reflex by a direct central action, probably
in the
medulla or pons. Codeine also has antidiarrhoeal action.
Paracetamol has analgesic and antipyretic actions.
PHARMACOKINETICS:
Codeine Phosphate is well absorbed after oral administration and after
injection. After an oral dose of 15 mg, peak plasma
concentrations of 30 ng/ml are attained within 2 hours. It is widely
distributed throughout the body and crosses the placenta. It is
metabolised in the liver by O-demethylation to form morphine,
N-demethylation to form narcodeine, and conjugation to form
glucuronides and sulphates of both unchanged drug and its metabolites.
After an oral dose, about 86% is excreted in the urine in 24
hours; of the excreted material, 40 to 70% is free or conjugated
Codeine, 5 to 15% is free or conjugated morphine, 10 to 20% is free or
conjugated normorphine; some of the dose is excreted in the bile and
trace amounts are found in the faeces; unchanged drug accounts
for 6 to 8% of the dose in urine in 24 hours which may be increased to
about 10% when the urinary pH is decreased; after an
intramuscular dose, 15 to 20% is excreted unchanged in acid urine in
24 hours.
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 glycoronide and sulphate conjugates. Less than 5%
is excreted as unchanged Paracetamol. The