NOVACODONE 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:

Novacodone 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. Novacodone modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances. Novacodone 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: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2017-05-08

Patient Information leaflet

NOVACODONE
® TABLETS
_Oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide)_
CONSUMER MEDICINE INFORMATION
WARNING:
LIMITATIONS OF USE
Novacodone 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
Novacodone 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
Novacodone 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 Novacodone
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 NOVACODONE
Using Novacodone 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), canna-
bis and alcohol may result in severe drowsiness, decreased awareness,
breathing problems, coma and death. Your doctor will
minimise 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 Novacodone.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Novacodone 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 NOVACODONE
TABLETS ARE TAKEN FOR

Summary of Product characteristics

Novacodone
®
modified release tablets 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, 80mg
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION
NOVACODONE
® (OXYCODONE HYDROCHLORIDE)
MODIFIED RELEASE TABLETS
1
NAME OF THE MEDICINE
Oxycodone hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Novacodone
®
modified release tablets contain the following quantities of oxycodone
hydrochloride:
Novacodone
®
10 mg contains oxycodone hydrochloride 10 mg
Novacodone
®
15 mg contains oxycodone hydrochloride 15 mg
Novacodone
®
20 mg contains oxycodone hydrochloride 20 mg
Novacodone
®
30 mg contains oxycodone hydrochloride 30 mg
Novacodone
®
40 mg contains oxycodone hydrochloride 40 mg
Novacodone
®
60 mg contains oxycodone hydrochloride 60 mg
Novacodone
®
80 mg contains oxycodone hydrochloride 80 mg
The inactive ingredients in the reformulated Novacodone 10 to 80 mg
tablets are: polyethylene
oxide and magnesium stearate. The tablets’ film coating also
contains:
10mg - Opadry White Y-5R-18024-A
15mg - Opadry complete film coating system 05B97512 Gray
20mg - Opadry complete film coating system YS-1R-14518-A Pink
30mg - Opadry complete film coating system YS-1-16518-A Brown
40mg - Opadry Yellow YS-1R-12525-A
60mg - Opadry complete film coating system 15B25501 Red
80mg - Opadry Green Y-5R-11167-A
3
PHARMACEUTICAL FORM
Novacodone tablets are modified release tablets designed to provide
delivery of oxycodone over
12 hours.
Novacodone 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg
1
and 80 mg tablets have been
reformulated, and comprise a matrix formulation with a hydrogelling
property (i.e. particles or
whole tablets become highly viscous (gel-like) in water), intended to
be crush-deterrent and to
reduce the rapid release of oxycodone upon accidental or intentional
misuse. The tablets have
been heat-treated to increase the mechanical strength of the tablet.
Novacodone
®
modified release tablets 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, 80mg
Page 2 of 19
The physical properties of the reformulated Novacodone tablets were
examined following an
ext