OxyContin

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Achète-le

Ingrédients actifs:

Oxycodone hydrochloride

Disponible depuis:

Mundipharma Pty Ltd

classe:

Medicine Registered

Notice patient

                                OXYCONTIN
®
 TABLETS
 
_Oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide)_
CONSUMER MEDICINE INFORMATION
   
 
 
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OxyContin 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 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 OXYCONTIN
TABLETS ARE TAKEN FOR
OxyContin tablets contain
oxycodone hydrochloride.
Oxycodone belongs to a group of
medicines called opioid analgesics.
OxyContin tablets are used to relieve
moderate to severe chronic pain
when other forms of treatment have
not been effective.
Your doctor, however, may prescribe
it for another purpose.
Ask your doctor if you have any
questions about why it has been
prescribed for you.
As with all strong painkillers, your
body may become used to you taking
OxyContin tablets. Taking it may
result in physical dependence.
Physical dependence means that you
may experience withdrawal
symptoms if you stop taking
OxyContin tablets suddenly, so it is
important to take it exactly as
directed by your doctor.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE OXYCONTIN TABLETS IF
YOU:
•
have any breathing problems such
as acute asthma, respiratory
depression (breathing slows or
weakens) or other obstructive
airways disease
•
are severely drowsy or have a
reduced level of consciousness
•
suffer from irregular heartbeats or
changes in the way the heart beats
•
have heart disease due to long
term lung disease
•
have just consumed a large
amount of alcohol, regularly
consume large amounts of
alcohol, or have confusion and
shaking due to alcohol
withdrawal
•
suffer from convulsi
                                
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Résumé des caractéristiques du produit

                                OxyContin
®
 Tablets PI (03 November 11) 
 
Supersedes PI (17 February 11) 
mfpoxyco21111 
 
Page 1 of 14 
_ _
PRODUCT INFORMATION 
 
OXYCONTIN
® 
TABLETS 
(5 MG, 10 MG, 15 MG, 20 MG, 30 MG, 40 MG, 60 MG, 80 MG, 120
MG, 160 MG) 
 
 
NAME OF THE MEDICINE 
Oxycodone hydrochloride USP 
 
 
DESCRIPTION 
Oxycodone hydrochloride is a white, crystalline,  odourless powder readily soluble
in water, 
sparingly soluble in ethanol and nearly insoluble in
ether.  The chemical name is 4,5
a-epoxy-
14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride (CAS No.: 124-90-3).
 The 
molecular formula is C
18
H
21
NO
4
. HCl and molecular weight  is 351.83.    The  structural 
formula for oxycodone hydrochloride is: 
 
 
 
The inactive ingredients in OxyContin
®
  tablets are: lactose, povidone, Eudragit RS 30D 
(solids), glycerol triacetate, stearyl alcohol, talc
and magnesium stearate.  All of the tablets are 
coated with hypromellose, titanium dioxide and macrogol 400.
 The tablet coatings also 
contain: hydroxypropylcellulose (10 & 80
mg tablets),  polysorbate 80 (20 & 40, 60, 120 & 
160 mg tablets), iron oxide red CI 77491 (15, 20, 30, 60
& 120 mg tablets), iron oxide yellow 
CI 77492 (15, 30, 40 & 80 mg tablets), indigo carmine CI 73015
aluminium lake (80 & 160 
mg tablets),  brilliant blue CI 42090 (5
mg tablets)  and iron oxide black E172 (15,  30, 60 & 
120 mg tablets). 
 
 
PHARMACOLOGY 
Actions 
Oxycodone is a full opioid agonist with no
antagonist properties whose principal therapeutic 
action is analgesia.  It has an affinity for kappa, mu and
delta opiate receptors in the brain and 
spinal cord.  Oxycodone is similar to morphine in its action.
 Other pharmacological actions of 
oxycodone are in
the central nervous system (CNS:  respiratory depression,
antitussive, 
anxiolytic, sedative 
                                
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