OXYCODONE SANDOZ oxycodone hydrochloride 20 mg 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:

Sandoz Pty Ltd

INN (International Name):

oxycodone hydrochloride

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: hypromellose; copovidone; microcrystalline cellulose; medium chain triglycerides; titanium dioxide; magnesium stearate; maize starch; stearic acid; lactose monohydrate; colloidal anhydrous silica; behenoyl polyoxyglycerides; hydrogenated castor oil; iron oxide red

Administration route:

Oral

Units in package:

60, 28, 20

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Oxycodone Sandoz 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. Oxycodone Sandoz modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. Oxycodone Sandoz modified release tablet is not indicated as an as-needed (PRN) analgesia.

Product summary:

Visual Identification: Pink, round, biconvex film coated tablets; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-01-20

Patient Information leaflet

OXYCODONE SANDOZ
®
1
OXYCODONE SANDOZ
®
_Oxycodone hydrochloride modified release tablet _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Oxycodone Sandoz.
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 OXYCODONE
SANDOZ IS USED
FOR
This medicine is used to relieve
severe pain when other forms of
treatment have failed or are
otherwise inappropriate to provide
sufficient management of pain.
It contains the active ingredient
oxycodone hydrochloride.
Oxycodone hydrochloride belongs to
a class of drugs known as opioid
analgesics.
As with all strong painkillers, your
body may become used to you taking
Oxycodone Sandoz tablets. Taking it
may result in physical dependence.
Physical dependence means that you
may experience withdrawal
symptoms if you stop taking
Oxycodone Sandoz suddenly, so it is
important to take it exactly as
directed by your doctor.
There is not enough information to
recommend the use of this medicine
for children under the age of 12
years.
This medicine is available only with
a doctor's prescription.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
BEFORE YOU TAKE
OXYCODONE
SANDOZ
Long-term use of oxycodone tablets
may result in a decrease in sex
WARNING:
LIMITATIONS OF USE
Oxycodone Sandoz should only be used when you doctor decides that
other treatment options are not able to effectively
manage your pain or you cannot tolerate them.
HAZARDOUS AND HARMFUL USE
Oxycodone Sandoz poses risks of abuse, misuse and addiction which can
lead to overdose and death. Your

Summary of Product characteristics

200923-Oxycodone Sandoz-pi
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
OXYCODONE SANDOZ
® (OXYCODONE HYDROCHLORIDE) MODIFIED
RELEASE TABLETS
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Oxycodone
Sandoz 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 _
Oxycodone Sandoz 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 Oxycodone
Sandoz 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 Oxycodone Sandoz modified release tablet.
1.
NAME OF THE MEDICINE
Oxycodone hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxycodone Sandoz modified release tablets contain 5