TARGIN oxycodone hydrochloride / naloxone hydrochloride 30/15mg modified release tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

23-09-2022

Summary of Product characteristics (SPC)

06-09-2022

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

oxycodone hydrochloride, Quantity: 30 mg; naloxone hydrochloride dihydrate, Quantity: 16.48 mg (Equivalent: naloxone hydrochloride?, Qty 15 mg)

Available from:

Mundipharma Pty Ltd

INN (International Name):

naloxone hydrochloride dihydrate,oxycodone hydrochloride

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: povidone; ethylcellulose; stearyl alcohol; lactose monohydrate; purified talc; magnesium stearate; titanium dioxide; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black

Administration route:

Oral

Units in package:

60, 28, 20

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

TARGIN modified release tablet is indicated for the management of severe pain where:,- other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain, and,- the pain is opioid-responsive; and,- requires daily, continuous, long term treatment.,TARGIN modified release tablet is not indicated for use in chronic non-cancer pain other than in exceptional circumstances.,TARGIN modified release tablet is not indicated as an as-needed (PRN) analgesia,The naloxone component in a fixed combination with oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.,TARGIN is indicated as a second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.

Product summary:

Visual Identification: Brown, capsule shaped tablet, OXN marked on one side and 30 on other.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-09-24

Patient Information leaflet

TARGIN®TABLETS MFCTARGI10820 (SUPERSEDES MFCTARGI11219)
1
TARGIN
®
tablets
Oxycodone hydrochloride and naloxone hydrochloride
Consumer Medicine Information
WARNING:
Limitations of use
TARGIN should only be used when your doctor decides that other
treatment options are not able to effectively manage your
pain or you cannot tolerate them.
Hazardous and harmful use
TARGIN poses risks of abuse, misuse and addiction which can lead to
overdose and death. Your doctor will monitor you
regularly during treatment.
Life threatening respiratory depression
TARGIN can cause life-threatening or fatal breathing problems (slow,
shallow, unusual or no breathing) even when used as
recommended. These problems can occur at any time during use, but the
risk is higher when first starting Targin and after a
dose increase, if you are older, or have an existing problem with your
lungs. Your doctor will monitor you and change the
dose as appropriate.
Use of other medicines while using TARGIN
Using TARGIN with other medicines that can make you feel drowsy such
as sleeping tablets (e.g. benzodiazepines), other
pain relievers, antihistamines, antidepressants, antipsychotics,
gabapentinoids (e.g. gabapentin and pregabalin), cannabis
and alcohol may result in severe drowsiness, decreased awareness,
breathing problems, coma and death. Your doctor will
minimise the dose and duration of use; and monitor you for signs and
symptoms of breathing difficulties and sedation. You
must not drink alcohol while using TARGIN
What is in this leaflet
This leaflet answers some common
questions about TARGIN 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 TARGIN tablets
are t

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Summary of Product characteristics

TARGIN
®
Modified Release Tablets
Page 1 of 36
AUSTRALIAN PRODUCT INFORMATION – TARGIN
®
MODIFIED RELEASE
TABLETS
WARNINGS
Limitations of use
Because of the risks associated with the use of opioids, TARGIN
modified release tablets
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
TARGIN modified release tablets 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 TARGIN
modified release tablets. 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 TARGIN modified release tablets.
1
NAME OF THE MEDICINE
Oxycodone hydrochloride and naloxone hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TARGIN

2.5/1.25 modified release tablets contains oxycodone hydrochloride 2.5
mg/naloxone
hydrochl

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