OXYCODONE BNM oxycodone hydrochloride 5mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

oxycodone hydrochloride, Quantity: 5 mg

Available from:

Boucher & Muir Pty Ltd

INN (International Name):

oxycodone hydrochloride

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: Gelatin; microcrystalline cellulose; iron oxide red; sodium laureth sulfate; titanium dioxide; indigo carmine; iron oxide yellow; magnesium stearate

Administration route:

Oral

Units in package:

10, 20, 60

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Oxycodone BNM is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Product summary:

Visual Identification: Dark pink body brown cap, printed with 5 on body OXY on cap; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-11-18

Patient Information leaflet

OXYCODONE BNM
1
OXYCODONE BNM
_Oxycodone hydrochloride _
_Capsules 5 mg, 10 mg and 20 mg _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Oxycodone
BNM.
This leaflet answers some common
questions about Oxycodone BNM.
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 Oxycodone
BNM 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 OXYCODONE BNM
IS USED FOR
Oxycodone BNM contain oxycodone
hydrochloride.
Oxycodone belongs to a group of
medicines called opioid analgesics.
Oxycodone BNM is used for short-
term management of severe pain for
which other treatment options 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
Oxycodone BNM. 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
OXYCODONE BNM
Long-term use of Oxycodone BNM
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.
Oxycodone BNM is not suitable for
everyone.
_WHEN YOU MUST NOT TAKE IT _
Do not take Oxycodone BNM if you:
•
suffer from shallow breathing or
have any breathing problems such
WARNING:
LIMITATIONS OF USE
Oxycodone BNM should only be used when your doctor decides t

Summary of Product characteristics

OXYCODONE BNM
1
AUSTRALIAN PRODUCT INFORMATION
OXYCODONE BNM
OXYCODONE HYDROCHLORIDE
CAPSULE
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, Oxycodone BNM
capsules
should only be used in patients for whom other treatment options,
including non-
opioid analgesics, are ineffective, not tolerated or otherwise
inadequate to provide
appropriate
management
of
pain
(see
Section
4.4
Special
Warnings
and
Precautions for Use).
_HAZARDOUS AND HARMFUL USE _
Oxycodone BNM capsules poses risks of hazardous and harmful use which
can
lead to overdose and death. Assess the patient’s risk of hazardous
and harmful use
before prescribing and monitor the patient regularly during treatment
(see Section
4.4 Special Warnings and Precautions for Use).
_LIFE THREATENING RESPIRATORY DEPRESSION _
Serious, life-threatening or fatal respiratory depression may occur
with the use of
Oxycodone BNM capsules. Be aware of situations which increase the risk
of
respiratory depression, modify dosing in patients at risk and monitor
patients
closely, especially on initiation or following a dose increase (see
Section 4.4
Special Warnings and Precautions for Use).
_CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS) _
_DEPRESSANTS, INCLUDING ALCOHOL _
Concomitant
use
of
opioids
with
benzodiazepines,
gabapentinoids,
antihistamines, tricyclic antidepressants, antipsychotics, cannabis or
other central
nervous system (CNS) depressants, including alcohol, may result in
profound
sedation, respiratory depression, coma, and death. Limit dosages and
durations to
the minimum required; and monitor patients for signs and symptoms of
respiratory
depression and sedation. Caution patients not to drink alcohol while
taking
Oxycodone BNM capsules.
OXYCODONE BNM
2
1
NAME OF THE MEDICINE
Oxycodone hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxycodone BNM capsules contain 5 mg, 10 mg or 20 mg oxycodone
hydrochloride,
respectively.
For the full list of excipients, see Section 6.1 List of excipients.