OxyNorm

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Oxycodone hydrochloride 5mg;  

Available from:

Mundipharma New Zealand Ltd

INN (International Name):

Oxycodone hydrochloride 5 mg

Dosage:

5 mg

Pharmaceutical form:

Capsule

Composition:

Active: Oxycodone hydrochloride 5mg   Excipient: Gelatin Indigo carmine Iron oxide red Iron oxide yellow Magnesium stearate Microcrystalline cellulose Sodium laurilsulfate Sunset yellow FCF Titanium dioxide

Units in package:

Blister pack, PVDC/PVC/Al, 20 capsules

Class:

Class B3 Controlled Drug

Prescription type:

Class B3 Controlled Drug

Manufactured by:

Macfarlan Smith Ltd

Therapeutic indications:

The management of opioid responsive, moderate to severe pain.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVDC/PVC/Al - 20 capsules - 48 months from date of manufacture stored at or below 30°C - Bottle, plastic, HDPE with PP lid or PP with PE lid - 100 capsules - 48 months from date of manufacture stored at or below 30°C

Authorization date:

1999-12-22

Patient Information leaflet

OxyNorm
®
capsules 5mg. 10mg, 20mg
OxyncapCMI211202
1
OXYNORM
® CAPSULES
_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 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
oxycodone hydrochloride.
Oxycodone belongs to a group of
medicines called opioid analgesics.
OxyNorm capsules are used to
relieve moderate to severe 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
OxyNorm capsules. 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 OxyNorm capsules
may result in a decrease in sex
hormone levels which may affect
sperm production in men and the
menstrual cycle in females. Talk to
your doctor if you have any
concerns.
_WHEN YOU MUST NOT TAKE IT _
Do not take OxyNorm capsules 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 heart problems due to long-
term lung disease

have

Summary of Product characteristics

NEW ZEALAND DATA SHEET
_ _
OxyNorm® Capsules & Oral Liquid (OXYNORM016)
May 2023
Page 1 of 19
OXYNORM® CAPSULES
OXYNORM® ORAL SOLUTION
Oxycodone hydrochloride
1 PRODUCT NAME
OXYNORM® 5mg Capsules
OXYNORM® 10mg Capsules
OXYNORM® 20mg Capsules
OXYNORM® 5mg/5mL Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
OXYNORM capsules contain Oxycodone hydrochloride 5 mg, 10 mg or 20 mg.
Each 5 mg capsule contains 4.5 mg of oxycodone as 5 mg of oxycodone
hydrochloride
Each 10 mg capsule contains 9.0 mg of oxycodone as 10 mg of oxycodone
hydrochloride
Each 20 mg capsule contains 18.0 mg of oxycodone as 20 mg of oxycodone
hydrochloride
OXYNORM oral solution contains Oxycodone hydrochloride 5 mg/5 mL.
Each 1 mg/ml oral solution contains 1 mg of oxycodone hydrochloride
per 1 ml.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
OXYNORM capsules 5 mg
Each 5 mg capsule is a size 4, hard gelatin, orange/beige, opaque
capsule printed with ONR and 5.
OXYNORM capsules 10mg
Each 10 mg capsule is a size 4, hard gelatin, white/beige, opaque
capsule printed with ONR and 10.
OXYNORM capsules 20 mg
Each 20 mg capsule is a size 4, hard gelatin, pink/beige, opaque
capsule printed with ONR and 20.
OXYNORM liquid 5 mg/5 mL is a clear, colourless to straw-coloured
solution
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The management of opioid-responsive moderate to severe pain.
4.2
DOSE AND METHOD OF ADMINISTRATION
The dose should be adjusted to the intensity of the pain and the
sensitivity of the individual
patient. The patient's previous history of analgesic requirements,
their body weight, and sex (higher
plasma
concentrations
are
produced
in
females),
should
also
be
taken
into
account
when
determining the dose.
Generally, the lowest effective dose for analgesia should be selected.
If higher doses are necessary,
increases should be made in 25% - 50% increments where possible.
It is recommended that patients take the medication in a consistent
manner in relation to the timing
of meals. (See section 5.2)