Prodeine 15

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

Codeine phosphate; Paracetamol

Предлага се от:

Sanofi-Aventis Australia Pty Ltd

Клас:

Medicine Registered

Листовка

PRODEINE
®
 15

_Paracetamol and codeine phosphate_
CONSUMER MEDICINE INFORMATION (CMI)

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Prodeine 15.
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 this medicine
against the benefits they expect it
will 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 PRODEINE 15 IS
USED FOR
Prodeine 15 is used to relieve
moderate to severe pain.
Prodeine 15 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 help reduce fever.
Your doctor, however, may prescribe
Prodeine 15 for another purpose.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
IT HAS BEEN PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PRODEINE 15 IF YOU
HAVE:
•
unstable asthma or emphysema
•
bronchitis
•
glucose-6-phosphate-
dehydrogenase deficiency (an
enzyme deficiency)
•
diarrhoea caused by antibiotics or
poisoning
DO NOT TAKE PRODEINE 15 IF YOU
HAVE ALCOHOL DEPENDENCE.
DO NOT TAKE PRODEINE 15 DURING THE
THIRD TRIMESTER OF PREGNANCY.
DO NOT TAKE IT IF YOU ARE IN LABOUR,
ESPECIALLY IF THE BABY IS PREMATURE.
Prodeine 15 contains codeine, which
may produce withdrawal effects in
the newborn baby.
DO NOT TAKE PRODEINE 15 IF YOU ARE
ALLERGIC TO IT OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cause
difficulty in swallowing or breathing.
DO NOT GIVE PRODEINE 15 TO CHILDREN
UNDER 7 YEARS.
There is no experience with its u

Данни за продукта

Prodeine 15 PI 
GLUv1 GLUv2 PIv6 18 Jul 12 
 Page 1 

PRODUCT INFORMATION 
PRODEINE 15 
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Paracetamol and codeine phosphate. 
CHEMICAL STRUCTURE 
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 
CAS NUMBERS 
Paracetamol: CAS No. 103-90-2 
Codeine Phosphate hemihydrate: CAS No. 1444-62-6 
DESCRIPTION 
Each capsule-shaped tablet contains  paracetamol 500 mg  and codeine phosphate
15 mg  and 
maize starch, purified talc, pregelatinised maize starch,
povidone, stearic acid, potassium sorbate, 
magnesium stearate and microcrystalline cellulose. 
PHARMACOLOGY 
Analgesic and antipyretic. 
Paracetamol's analgesic mechanism of action has not been fully elucidated but may involve 
blocking impulse generation at the bradykinin-sensitive chemoreceptors, that evoke pain.  The 
antipyretic effect of paracetamol rises from its ability to
block the action of prostaglandin synthetase 
and so prevent the synthesis of prostaglandins in response
to the pyrogen stimulus in the region of 
the anterior hypothalamus. 
Codeine acts centrally.  It produces analgesia by dulling the
response to painful stimuli at several 
loci in the CNS.  This causes an alteration in the sensation and
affective response of pain. 
There is evidence to suggest that a combination of paracetamol with codeine is superior in 
analgesic action to either drug administered alone. 
PHARMACOKINETICS 
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
paracetam