Oxycodone Controlled Release Tablets

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Oxycodone hydrochloride 40mg;  

Available from:

Boucher & Muir (New Zealand) Limited t/a BNM Group

INN (International Name):

Oxycodone hydrochloride 40 mg

Dosage:

40 mg

Pharmaceutical form:

Modified release tablet

Composition:

Active: Oxycodone hydrochloride 40mg   Excipient: Colloidal silicon dioxide Ethylcellulose Hyprolose Hypromellose     Iron oxide red Iron oxide yellow Macrogol 6000   Magnesium stearate Microcrystalline cellulose Opacode black S-1-17860 Propylene glycol Purified talc   Sugar spheres Titanium dioxide

Units in package:

Blister pack, PVC/PVDC/Al, 20 tablets

Class:

Class B3 Controlled Drug

Prescription type:

Class B3 Controlled Drug

Manufactured by:

Siegfried Ltd

Therapeutic indications:

Management of moderate to severe chronic pain unresponsive to non-narcotic analgesia.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al - 20 tablets - 48 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 60 tablets - 48 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al - 100 tablets - 48 months from date of manufacture stored at or below 25°C - Bottle, HDPE with PP child-resistant closure - 20 tablets - 48 months from date of manufacture stored at or below 25°C - Bottle, HDPE with PP child-resistant closure - 60 tablets - 48 months from date of manufacture stored at or below 25°C - Bottle, HDPE with PP child-resistant closure - 100 tablets - 48 months from date of manufacture stored at or below 25°C

Authorization date:

2012-11-27

Patient Information leaflet

1
OXYCODONE CONTROLLED RELEASE TABLETS
13032014
Consumer Medicine Information
OXYCODONE CONTROLLED RELEASE
TABLETS
_OXYCODONE HYDROCHLORIDE _
Controlled release tablets 10 mg, 20 mg, 40 mg and 80 mg
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start taking Oxycodone
Controlled Release
Tablets.
This leaflet answers some common questions about Oxycodone Controlled
Release
Tablets. It does not contain all the available information. The most
up-to-date Consumer
Medicine Information can be downloaded from www.medsafe.govt.nz.
Reading this leaflet 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
Oxycodone Controlled Release Tablets against the benefits this
medicine is expected to
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 want to read it again.
WHAT OXYCODONE CONTROLLED RELEASE TABLETS ARE
USED FOR
Oxycodone Controlled Release Tablets contain oxycodone hydrochloride.
Oxycodone
belongs to a group of medicines called opioid analgesics which are
strong medicines
used to treat or prevent pain.
Oxycodone
Controlled
Release
Tablets
are
used
to
relieve
moderate
to
severe
persistent pain when other forms of treatment have not been effective.
Your doctor may have prescribed this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR
YOU.
Oxycodone Controlled Release Tablets are only available with a
doctor's prescription.
2
OXYCODONE CONTROLLED RELEASE TABLETS
13032014
As with all strong painkillers, your body may become used to you
taking Oxycodone
Controlled Release 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.
BEFORE YOU TAKE OXYCODONE CONTROLLED RELEASE
TABLETS
_ _
Ox

Summary of Product characteristics

OXYCODONE CONTROLLED RELEASE TABLETS
OXYCODONE HYDROCHLORIDE MODIFIED RELEASE TABLETS 10MG, 20MG, 40MG &
80MG
21072017
Page 1 of 17
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
OXYCODONE CONTROLLED RELEASE TABLETS
10 mg, 20 mg, 40 mg & 80 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxycodone hydrochloride 10 mg, 20 mg, 40 mg & 80 mg
Excipient with known effect: sucrose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Oxycodone Controlled Release Tablets 10 MG – Brown-red, oblong,
biconvex controlled
release tablets with a breakline on both sides and imprinted with
‘O1’ on one side
Oxycodone Controlled Release Tablets 20 MG – Pink, oblong, biconvex
controlled
release tablets with a breakline on both sides and imprinted with
‘O2’ on one side
Oxycodone Controlled Release Tablets 40 MG – Orange, oblong,
biconvex controlled
release tablets with a breakline on both sides and imprinted with
‘O4’ on one side
Oxycodone Controlled Release Tablets 80 MG – Yellow, oblong,
biconvex controlled
release tablets with a breakline on both sides and imprinted with
‘O8’ on one side
The tablets can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Management of moderate to severe chronic pain unresponsive to
non-narcotic analgesia.
4.2
DOSE AND METHOD OF ADMINISTRATION
OXYCODONE CONTROLLED RELEASE TABLETS 80 MG SHOULD ONLY BE USED IN
OPIOID-
TOLERANT
PATIENTS. IN PATIENTS NOT PREVIOUSLY EXPOSED TO OPIOIDS (OPIOID
NAÏVE),
THIS TABLET
STRENGTH MAY CAUSE FATAL RESPIRATORY DEPRESSION.
OXYCODONE CONTROLLED RELEASE TABLETS MUST NOT BE CHEWED OR CRUSHED.
TAKING
CHEWED OR CRUSHED OXYCODONE
CONTROLLED RELEASE TABLETS COULD LEAD TO THE
RAPID RELEASE AND ABSORPTION OF A
POTENTIALLY TOXIC DOSE OF OXYCODONE.
OXYCODONE CONTROLLED RELEASE TABLETS
OXYCODONE HYDROCHLORIDE MODIFIED RELEASE TABLETS 10MG, 20MG, 40MG &
80MG
21072017
Page 2 of 17
Alcoholic
beverages
should
be
avoided
while
the
patient
is
being
treated
with
Oxycodone
Controlled Release Tablets.
DOSE
_ADULTS, ELDERLY AN