CODAPANE FORTE paracetamol 500mg and codeine phosphate hemihydrate 30mg tablet blister pack

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

codeine phosphate hemihydrate,paracetamol

Saadav alates:

Alphapharm Pty Ltd

Volitamisolek:

Registered

Infovoldik

CODAPANE FORTE
_Paracetamol and codeine phosphate hemihydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Codapane Forte.
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 Codapane
Forte against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CODAPANE FORTE
IS USED FOR
Codapane Forte is used to relieve
moderate to severe pain, and fever.
Codapane Forte contains paracetamol
and codeine. These ingredients work
together to stop the pain messages
from reaching the brain.
Paracetamol also acts in the brain to
reduce fever.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CODAPANE
FORTE HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Codapane Forte for another reason.
This medicine may be addictive after
repeated administration.
Codapane Forte is not recommended
for children under 12 years of age.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
CODAPANE FORTE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CODAPANE FORTE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
paracetamol or codeine
•
any of the ingredients listed at the
end of this leaflet
•
any other similar medicines, such
as morphine and oxycodone.
•
Aspirin or any other NSAID
medicine.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE CODAPANE FORTE IF YOU
HAVE:
•
breathing difficulties, such as
asthma, bronchitis or emphysema
•
Glucose-6-phosphate
dehydrogenase deficiency (an
enzyme deficiency)
•
Ultra-rapid metaboliser of
CYP2D6
•
diarrhoe

Toote omadused

PRODUCT INFORMATION
CODAPANE FORTE
_Paracetamol and codeine phosphate hemihydrate _
NAME OF THE MEDICINE
Active ingredient
:
Paracetamol
Chemical name
:
N-(4-Hydroxyphenyl)acetamide
Structural formula
:
Molecular formula
:
C
8
H
9
NO
2
Molecular weight
:
151.17
CAS Registry no.
:
103-90-2
Active ingredient
:
Codeine phosphate hemihydrate
Chemical name
:
7,8-Didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol
phosphate
hemihydrate
Structural formula
:
Molecular formula
:
C
18
H
24
NO
7
P, ½H
2
O
Molecular weight
:
406.37
CAS Registry no.
:
41444-62-6
CODAPANE FORTE – Product Information
2
DESCRIPTION
Paracetamol is a white crystalline powder, sparingly soluble in water,
freely soluble in alcohol, very slightly
soluble in ether and in methylene chloride. Codeine phosphate
hemihydrate appears as white, crystalline powder
or small colourless crystals, freely soluble in water, slightly
soluble in alcohol, practically insoluble in ether.
Codapane Forte tablets contain 500 mg of paracetamol (present as
“Compap L”) and 30 mg of codeine phosphate
hemihydrate as the active ingredients. Codapane Forte tablets also
contain the following inactive ingredients:
crospovidone, colloidal anhydrous silica, sodium lauryl sulfate,
stearic acid and magnesium stearate.
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.
PHARMACOKINETICS
PARACETAMOL
ABSORPTION
After oral administration, paracetamol is absorbed rapidly and
completely from the small intestine; peak plasma
levels occur 15 to 75 minutes after administration. These results are
not significantly different to those of
Panadeine
®
Forte. Food intake delays 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 concentra