Comfarol 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

 
Comfarol Forte CMI 
CMIv4 GLUv1 GLUv2 Jul12 
Page 1

_ _
COMFAROL FORTE TABLETS  
_PARACETAMOL & CODEINE PHOSPHATE _
CONSUMER MEDICINE INFORMATION (CMI) 

WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about Comfarol 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 Comfarol 
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 COMFAROL 
FORTE USED FOR 
Comfarol Forte is used to relieve 
moderate to severe pain and fever.

Comfarol 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 
COMFAROL FORTE  
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE COMFAROL 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 
ANTIBIOTICS OR POISONING 
DO NOT TAKE COMFAROL FORTE IF 
YOU HAVE A

Данни за продукта

PRODUCT INFORMATION 
COMFAROL 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 derivatives, and mercapturic acid 
compounds via oxidation.  Paracetamol is
metabolised differently by infants and children 
compared to adults, the sulfate conjugate being predom