OXYCONTIN oxycodone hydrochloride 20mg modified release tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxycodone hydrochloride, Quantity: 20 mg

Available from:

Mundipharma Pty Ltd

INN (International Name):

oxycodone hydrochloride

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: polyethylene oxide; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80; iron oxide red; macrogol 400

Administration route:

Oral

Units in package:

20, 28

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

OxyContin modified release tablet is indicated for the management of severe pain where: ? other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and ? the pain is opioid-responsive; and ? requires daily, continuous, long term treatment. OxyContin modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. OxyContin modified release tablet is not indicated as an as-needed (PRN) analgesia.

Product summary:

Visual Identification: Round, unscored, pink-coloured, bi-convex tablets debossed with ON (underscored) on one side and 20 on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2013-10-22

Patient Information leaflet

OXYCONTIN
® TABLETS
_Oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide)_
CONSUMER MEDICINE INFORMATION
WARNING:
LIMITATIONS OF USE
OxyContin should only be used when your doctor decides that other
treatment options are not able to effectively manage
your pain or you cannot tolerate them.
HAZARDOUS AND HARMFUL USE
OxyContin poses risks of abuse, misuse and addiction which can lead to
overdose and death. Your doctor will monitor you
regularly during treatment.
LIFE THREATENING RESPIRATORY DEPRESSION
OxyContin can cause life-threatening or fatal breathing problems
(slow, shallow, unusual or no breathing) even when used
as recommended. These problems can occur at any time during use, but
the risk is higher when first starting OxyContin and
after a dose increase, if you are older, or have an existing problem
with your lungs. Your doctor will monitor you and change
the dose as appropriate.
USE OF OTHER MEDICINES WHILE USING OXYCONTIN
Using OxyContin with other medicines that can make you feel drowsy
such as sleeping tablets (e.g. benzodiazepines), other
pain relievers, antihistamines, antidepressants, antipsychotics,
gabapentinoids (e.g. gabapentin and pregabalin), cannabis and
alcohol may result in severe drowsiness, decreased awareness,
breathing problems, coma and death. Your doctor will mini-
mise the dose and duration of use; and monitor you for signs and
symptoms of breathing difficulties and sedation. You must
not drink alcohol while using OxyContin.
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

Summary of Product characteristics

OxyContin® Modified Release Tablets 10mg, 15mg, 20mg, 30mg, 40mg,
60mg, 80mg
Page 1 of 22
AUSTRALIAN PRODUCT INFORMATION – OXYCONTIN
® (OXYCODONE
HYDROCHLORIDE) MODIFIED RELEASE TABLETS
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, OxyContin
modified release tablets
should only be used in patients for whom other treatment options,
including non-opioid
analgesics, are ineffective, not tolerated or otherwise inadequate to
provide appropriate
management of pain (see Section 4.4 Special Warnings and Precautions
for Use).
_HAZARDOUS AND HARMFUL USE _
OxyContin modified release tablets poses risks of hazardous and
harmful use which can
lead to overdose and death. Assess the patient’s risk of hazardous
and harmful use before
prescribing and monitor the patient regularly during treatment (see
Section 4.4. Special
Warnings and Precautions for Use).
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious,
life-threatening
or
fatal
respiratory
depression
may
occur
with
the
use
of
OxyContin modified release tablets. Be aware of situations which
increase the risk of
respiratory depression, modify dosing in patients at risk and monitor
patients closely,
especially on initiation or following a dose increase (see Section 4.4
Special Warnings and
Precautions for Use).
_CONCOMITANT _
_USE _
_OF _
_BENZODIAZEPINES _
_AND _
_OTHER _
_CENTRAL _
_NERVOUS _
_SYSTEM _
_(CNS) _
_DEPRESSANTS, INCLUDING ALCOHOL _
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants,
antipsychotics,
cannabis
or
other
central
nervous
system
(CNS)
depressants, including alcohol, may result in profound sedation,
respiratory depression,
coma, and death. Limit dosages and durations to the minimum required;
and monitor
patients for signs and symptoms of respiratory depression and
sedation. Caution patients
not to drink alcohol while taking OxyContin modified release tablet.
1
NAME OF THE MEDICINE
Oxycodone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OxyCo