OxyContin

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Oxycodone hydrochloride 80mg;  ;  

Available from:

Mundipharma New Zealand Ltd

INN (International Name):

Oxycodone hydrochloride 80 mg

Dosage:

80 mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Oxycodone hydrochloride 80mg     Excipient: Ammonio methacrylate copolymer Lactose monohydrate Magnesium stearate Opadry green Y-5-11167-A Povidone Purified talc Stearyl alcohol Triacetin

Units in package:

Blister pack, PVC/Al, 20 tablets

Class:

Class B3 Controlled Drug

Prescription type:

Class B3 Controlled Drug

Manufactured by:

Rhodes Technologies Inc

Therapeutic indications:

The management of moderate to severe chronic pain unresponsive to non-narcotic analgesia

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/Al - 20 tablets - 60 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al - 60 tablets - 60 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE, PP caps - 60 tablets - 60 months from date of manufacture stored at or below 25°C

Authorization date:

1999-12-10

Patient Information leaflet

OXYCONTIN
 TABLETS
_Oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide) _
CONSUMER MEDICINE INFORMATION
OXYCONTIN
®
Tablets
Page 1 of 5
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 persistent
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 oxycodone 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
Long-term use of OxyContin tablets
may result in a decrease in sex
hormone levels which may affect
sperm production in men and the
menstrual cycles in females. Talk to
your doctor if you have concerns.
_WHEN YOU MUST NOT TAKE IT _
Do not take OXYCONTIN tablets if
you:

suffer from shallow breathing or
have any breathing problems such
as acute asthma, chronic bronchitis
or impaired lung function

are severely drowsy or have a
reduced level of consciousness

suffer from irregular or fast
heartbeats or changes in the way
the heart beats

have hear

Summary of Product characteristics

NEW ZEALAND DATA SHEET
OxyContin® Tablets OXYCONTIN016
29 June 2017
Page 1 of 16
OXYCONTIN® CONTROLLED RELEASE TABLETS
Oxycodone hydrochloride
1 PRODUCT NAME
OXYCONTIN® 5mg tablets
OXYCONTIN® 10mg tablets
OXYCONTIN® 15mg tablets
OXYCONTIN® 20mg tablets
OXYCONTIN® 30mg tablets
OXYCONTIN® 40mg tablets
OXYCONTIN® 60mg tablets
OXYCONTIN® 80mg tablets
OXYCONTIN® 120mg tablets
Note: Not all strengths are available in NZ
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
OXYCONTIN 5mg tablets – each tablet contains Oxycodone hydrochloride
5mg
OXYCONTIN 10mg tablets – each tablet contains Oxycodone
hydrochloride 10mg
OXYCONTIN 15mg tablets – each tablet contains Oxycodone
hydrochloride 15mg
OXYCONTIN 20mg tablets – each tablet contains Oxycodone
hydrochloride 20mg
OXYCONTIN 30mg tablets – each tablet contains Oxycodone
hydrochloride 30mg
OXYCONTIN 40mg tablets – each tablet contains Oxycodone
hydrochloride 40mg
OXYCONTIN 60mg tablets – each tablet contains Oxycodone
hydrochloride 60mg
OXYCONTIN 80mg tablets – each tablet contains Oxycodone
hydrochloride 80mg
OXYCONTIN 120mg tablets – each tablet contains Oxycodone
hydrochloride 120mg
Excipient with known effect: lactose
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
OXYCONTIN 5 mg tablets – Round, biconvex, pale blue, film-coated
tablet with OC on one side and 5
on the other.
OXYCONTIN_ _10 mg tablets – Round, biconvex, white, film-coated
tablet with OC on one side and 10
on the other.
OXYCONTIN_ _15 mg tablets - Round, biconvex, grey, film-coated tablet
with OC on one side and 15 on
the other.
OXYCONTIN_ _20 mg tablets – Round, biconvex, pink, film-coated
tablet with OC on one side and 20 on
the other.
OXYCONTIN_ _30 mg tablets - Round biconvex, brown, film-coated tablet
with OC on one side and 30
on the other.
NEW ZEALAND DATA SHEET
OxyContin® Tablets OXYCONTIN016
29 June 2017
Page 2 of 16
OXYCONTIN_ _40 mg tablets – Round, biconvex, yellow, film-coated
tablet with OC on one side and 40
on the other.
OXYCONTIN_ _60 mg t