OxyContin

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Oxycodone hydrochloride 10mg

Tilgængelig fra:

Mundipharma New Zealand Ltd

INN (International Name):

Oxycodone hydrochloride 10 mg

Dosering:

10 mg

Lægemiddelform:

Modified release tablet

Sammensætning:

Active: Oxycodone hydrochloride 10mg Excipient: Magnesium stearate Opadry white Y-5R-18024-A Polyethylene oxide

Recept type:

Class B3 Controlled Drug

Fremstillet af:

Rhodes Technologies Inc

Terapeutiske indikationer:

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

Produkt oversigt:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al in outer cardboard carton - 20 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC/Al in outer cardboard carton - 28 tablets - 36 months from date of manufacture stored at or below 25°C

Autorisation dato:

2012-09-12

Indlægsseddel

OxyContin
®
tablets Feb 2022
1
OXYCONTIN
® TABLETS
_Oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide) _
CONSUMER MEDICINE INFORMATION
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 chronic pain
when other forms of treatment have
failed or are otherwise inappropriate
to provide sufficient management of
pain.
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
OxyContin tablets 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 any
concerns.
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE OXYCONTIN TABLETS IF
YOU:

have any breathing problems
such as acute asthma, respiratory
depression (breathing slows or
weakens) or other obstructive
airways disease

are severely drowsy or have a
reduced level of consciousness

suffer from irre

Produktets egenskaber

NEW ZEALAND DATA SHEET
OXYCONTIN®MODIFIED RELEASE TABLETS– OXYCONT018
Feb 2022
Page 1 of 22
OXYCONTIN® modified release tablets
Oxycodone hydrochloride
1 PRODUCT NAME
OXYCONTIN® 10mg modified release tablet
OXYCONTIN® 15mg modified release tablet
OXYCONTIN® 20mg modified release tablet
OXYCONTIN® 30mg modified release tablet
OXYCONTIN® 40mg modified release tablet
OXYCONTIN® 60mg modified release tablet
OXYCONTIN® 80mg modified release tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
OxyContin® 10 mg contains oxycodone hydrochloride 10 mg
OxyContin® 15 mg contains oxycodone hydrochloride 15 mg
OxyContin® 20 mg contains oxycodone hydrochloride 20 mg
OxyContin® 30 mg contains oxycodone hydrochloride 30 mg
OxyContin® 40 mg contains oxycodone hydrochloride 40 mg
OxyContin® 60 mg contains oxycodone hydrochloride 60 mg
OxyContin® 80 mg contains oxycodone hydrochloride 80 mg
The inactive ingredients in the reformulated OXYCONTIN 10 to 80 mg
tablets are: polyethylene
oxide, butylated hydroxytoluene (BHT) and magnesium stearate. The
tablets’ film coating also
contain:
10mg - Opadry Y-5R-18024-A White
15mg - Opadry complete film coating system 05B97512 Grey
20mg - Opadry 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 Y-5R-11167-A Green
For the full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
OXYCONTIN_ _10 MG TABLETS – Round, unscored, biconvex, white,
film-coated tablet with ’ON’ on one
side and 10 on the other.
OXYCONTIN_ _15 MG TABLETS - Round, unscored, biconvex, grey,
film-coated tablet with ‘ON’ on one
side and 15 on the other.
OXYCONTIN_ _20 MG TABLETS – Round, unscored, biconvex, pink,
film-coated tablet with ‘ON’ on one
side and 20 on the other.
OXYCONTIN_ _30 MG TABLETS - Round unscored, biconvex, brown,
film-coated tablet with ‘ON’ on one
side and 30 on the other.
NEW ZEALAND DATA SHEET
OXYCONTIN®MODIFIED RELEASE TABLETS