OXYNORM oxycodone hydrochloride 10mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxycodone hydrochloride, Quantity: 10 mg

Available from:

Mundipharma Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; titanium dioxide; indigo carmine; iron oxide yellow; iron oxide red; Gelatin; sodium lauryl sulfate; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

20 capsules, 10 Capsules, 60 capsules

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

OxyNorm is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Product summary:

Visual Identification: Size 4 white/beige opaque capsules printed with ONR and 10 in black ink.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2000-11-08

Patient Information leaflet

OXYNORM
® CAPSULES
_Oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide)_
CONSUMER MEDICINE INFORMATION
WARNING:
LIMITATIONS OF USE
OxyNorm 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
OxyNorm 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
OxyNorm 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 OxyNorm 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 OXYNORM
Using OxyNorm 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 OxyNorm.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OxyNorm capsules.
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 OXYNORM
CAPSULES ARE TAKEN FOR
OxyNorm capsules contain
o

Summary of Product characteristics

OxyNorm
®
Capsules and Liquid
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION – OXYNORM
® (OXYCODONE
HYDROCHLORIDE) CAPSULES AND LIQUID
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, OxyNorm
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 _
OxyNorm 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
OxyNorm. 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 OxyNorm.
1
NAME OF THE MEDICINE
Oxycodone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OxyNorm 5 mg capsules contains 5 mg of Oxycodone hydrochloride
OxyNorm 10 mg capsules contains 10 mg of Oxycodone hydrochloride
OxyNorm 20 mg capsules contains 20 mg