Panadeine Forte

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

Paracetamol; Codeine phosphate

Предлага се от:

Sanofi-Aventis Australia Pty Ltd

Клас:

Medicine Registered

Листовка

PANADEINE FORTE
®
TABLETS

_Paracetamol and codeine phosphate_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Panadeine Forte
tablets. It does not contain all the
available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Panadeine
Forte against the benefits this
medicine is expected to have for you.
KEEP THIS INFORMATION WITH THE
TABLETS.
You may need to read it again.
WHAT IS PANADEINE
FORTE USED FOR
Panadeine Forte is used to relieve
moderate to severe pain and fever.
Panadeine Forte contains
paracetamol and codeine.
Paracetamol and codeine work
together to stop the pain messages
from getting through to the brain.
Paracetamol also acts in the brain to
reduce fever.
Your doctor may have prescribed this
medicine for another use.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
THE MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE
PANADEINE FORTE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PANADEINE FORTE IF YOU
ARE ALLERGIC TO PARACETAMOL OR
CODEINE OR ANY OF THE INGREDIENTS
LISTED UNDER "PRODUCT DESCRIPTION"
AT THE END OF THIS LEAFLET.
THE SYMPTOMS OF AN ALLERGIC
REACTION MAY INCLUDE A RASH,
ASTHMA ATTACK OR HAY FEVER.
DO NOT TAKE THIS MEDICINE IF YOU
HAVE OR HAVE HAD ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
Acute breathing difficulties such
as bronchitis, unstable asthma or
emphysema
•
Glucose-6-phosphate
dehydrogenase deficiency (an
enzyme deficiency)
•
Diarrhoea caused by poisoning or
antibiotics
DO NOT TAKE PANADEINE FORTE IF YOU
HAVE ALCOHOL DEPENDENCE.
DO NOT TAKE PANADEINE FORTE
DURING THE THIRD TRIMESTER OF
PREGNANCY.
DO NOT TAKE PANADEINE FORTE
DURING LABOUR ESPECIALLY IF THE
BABY IS PREMATURE.
This medicine contains codeine,
which may produce withdrawal
effects in the newborn baby.
DO NOT USE PANADEINE FORTE IF YOU
ARE BREASTFEE

Данни за продукта

Panadeine Forte PI 
GLUv1 GLUv2 PIv6 18 Jul 12 
_ _
_Page 1 _

PRODUCT INFORMATION 
PANADEINE FORTE 
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Paracetamol and codeine phosphate 
DESCRIPTION 
Each capsule-shaped tablet contains Paracetamol 500 mg, Codeine
phosphate 30 mg. 
Other ingredients are maize starch, povidone, potassium sorbate, microcrystalline cellulose, 
stearic acid, magnesium stearate, purified talc, pregelatinised
maize starch, and croscarmellose 
sodium. 
CAS - 103-90-2 (paracetamol). CAS 41444-62-6 (codeine phosphate
hemihydrate) 

O
H
NH
CH
3
O

O
OH
H
N
CH
3
H
H
3
CO
.H
3
PO
4
. 
1/2
H
2
0

paracetamol MW 151.17 

codeine phosphate  MW 406.37 
PHARMACOLOGY 
Analgesic and antipyretic:  There is evidence to
suggest that a combination of paracetamol with 
codeine is superior in analgesic action to either drug
administered alone. 
Absorption 
After oral administration, paracetamol is absorbed
rapidly and completely from the small intestine; 
peak plasma levels occur 30 to 120
minutes after administration. 
Food intake delays paracetamol absorption.  Codeine has about one-sixth of morphine's 
analgesic activity.  It is well absorbed from the
gastrointestinal tract and does not interfere with 
paracetamol absorption. 
Distribution 
Paracetamol is uniformly distributed throughout most body fluids; the apparent volume of 
distribution is 1 to 1.2 L/kg.  Paracetamol can cross the placenta
and is excreted in milk.  Plasma 
protein binding is negligible at usual therapeutic concentrations but increases with increasing 
concentrations. 
Metabolism 
Paracetamol is metabolised by the hepatic microsomal enzyme
system.  In adults at therapeutic 
doses, paracetamol is mainly conjugated with glucuronide
(45-55%) or sulfate (20-30%).  A minor 
proportion (less than 20%) is metabolised
to catechol derivati