TARGIN oxycodone hydrochloride / naloxone hydrochloride 30/ 15mg modified release tablets blister pack
Main information
- Trade name:
- TARGIN oxycodone hydrochloride / naloxone hydrochloride 30/ 15mg modified release tablets blister pack
- Active ingredient:
- naloxone hydrochloride dihydrate, oxycodone hydrochloride
- Available from:
- Mundipharma Pty Ltd
- INN (International Name):
- naloxone hydrochloride dihydrate, oxycodone hydrochloride
- Medicine domain:
- Humans
- Medicine type:
- Allopathic drug
Documents
- for the general public:
- Patient Information leaflet
-
- for healthcare professionals:
- Summary of Product characteristics
-
- for the general public:
- Public Assessment Report
-
Localization
- Available in:
-
Australia
- Language:
- English
Status
- Source:
- Dept. of Health,Therapeutic Goods Administration - Australia
- Authorization status:
- Registered
- Authorization number:
- 216280
- Last update:
- 20-05-2019
Public Assessment Report
Public Summary
Summary for ARTG Entry:
216280
TARGIN oxycodone hydrochloride / naloxone hydrochloride 30/15mg modified release tablets blister pack
ARTG entry for
Medicine Registered
Sponsor
Mundipharma Pty Ltd
Postal Address
GPO Box 5214,SYDNEY, NSW, 2001
Australia
ARTG Start Date
24/09/2014
Product category
Medicine
Status
Active
Approval area
Drug Safety Evaluation Branch
Conditions
Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods
Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered
or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Products
1. TARGIN oxycodone hydrochloride / naloxone hydrochloride 30/15mg modified release tablets blister pack
Product Type
Single Medicine Product
Effective date
11/10/2017
Warnings
See Product Information and Consumer Medicine Information for this product
Standard Indications
Specific Indications
1- The management of moderate to severe chronic pain unresponsive to non-narcotic analgesia. The naloxone component in a fixed combination with
oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.,2- Second line symptomatic treatment of patients with severe to
very severe idiopathic restless legs syndrome after failure of dopaminergic therapy
The management of moderate to severe chronic pain unresponsive to non-narcotic analgesia. The naloxone component in a fixed combination with
oxycodone is indicated for the therapy and/or prophylaxis of opioid-induced constipation.
Additional Product information
Container information
Type
Material
Life Time
Temperature
Closure
Conditions
Blister Pack
PVC/Al
3 Years
Store below 25
degrees Celsius
Not recorded
Not recorded
Pack Size/Poison information
Pack Size
Poison Schedule
(S8) Controlled Drug
(S8) Controlled Drug
(S8) Controlled Drug
Components
1. TARGIN oxycodone hydrochloride / naloxone hydrochloride anhydrous 30/15mg modified release tablets blister pack
Dosage Form
Tablet, modified release
Route of Administration
Oral
Visual Identification
Brown, capsule shaped tablet, OXN marked on one side and 30 on other.
Active Ingredients
naloxone hydrochloride dihydrate
16.48 mg
oxycodone hydrochloride
30 mg
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
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Public Summary
Page 1 of
Produced at 26.11.2017 at 07:29:51 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information
Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation
TARGIN
®
tablets
Oxycodone hydrochloride and naloxone hydrochloride
Consumer Medicine Information
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 taken for
TARGIN tablets contain two
different medicines called oxycodone
hydrochloride and naloxone
hydrochloride anhydrous.
Oxycodone belongs to a group of
medicines called opioid analgesics.
Naloxone is a medicine which, when
taken orally, can block some of the
effects of opioids in the gut, such as
constipation.
Pain relief:
TARGIN tablets are used to relieve
moderate to severe persistent pain
when other forms of treatment have
not been effective. The naloxone in
TARGIN tablets will help prevent
and treat opioid-induced
constipation.
Restless legs syndrome:
TARGIN tablets are also used to
relieve the symptoms of severe to
very severe restless legs syndrome in
people who can't be treated with
dopamine medicines. People with
restless legs syndrome have
unpleasant sensations in their limbs.
This can start as soon as they sit or
lie down and is only relieved by an
irresistible urge to move the legs,
sometimes the arms and other parts
of the body. It makes sitting still and
sleeping very difficult.
TARGIN tablets helps to relieve the
unpleasant sensations and so reduces
the urge to move the limbs.
Your doctor, however, may prescribe
it for another purpose.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
As with all strong painkillers, your
body may become used to you taking
TARGIN tablets. Taking it may
result in physical dependence.
Physical dependence means that you
may experience withdrawal
symptoms if you stop taking
TARGIN 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
TARGIN
Long-term use of TARGIN tablets
may affect your fertility. If you have
any concerns about taking this
medicine, ask your doctor.
When you must not take it
Do not take TARGIN tablets if
you:
have moderate or severe liver
disease
have any breathing problems such
as severe asthma, respiratory
depression (breathing slows or
weakens) or other obstructive
airways disease
are severely drowsy or have a
reduced level of consciousness
have a condition where your
stomach empties more slowly
than it should or any condition
that obstructs the stomach/bowel
or affects bowel transit
(movement of food or ingested
material along the bowel)
have sudden severe abdominal
pain
have irregular heart beats or
changes in the way the heart beats
have a head injury, brain tumour
or have raised pressure within the
head, brain or spinal cord
suffer from uncontrolled
convulsions, fits or seizures
have heart problems due to long-
term lung disease
have just consumed and/or
regularly consume large amounts
of alcohol or have confusion and
shaking due to alcohol
withdrawal
take a medicine for depression
called a 'monoamine oxidase
inhibitor' or have taken any in the
last two weeks
are about to have an operation
(including surgery on your spine
for pain relief in the next 24
TARGIN
TABLETS MFCTARGI11017 (SUPERSEDES MFCTARGI10716)
hours) or have had an operation
within the last 24 hours
have a history of opioid abuse.
Do not take TARGIN tablets if you
are allergic to oxycodone,
naloxone, opioid painkillers, or any
of the ingredients listed at the end
of this leaflet.
Some of the symptoms of an allergic
reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or
other parts of the body
rash, itching or hives on the skin
Do not take this medicine if you
are pregnant or intend to become
pregnant whilst taking this
medicine.
Like most medicines of this kind,
TARGIN tablets are not
recommended to be taken during
pregnancy. Your doctor will discuss
the risks of taking it if you are
pregnant.
Do not breastfeed if you are taking
this medicine.
The active ingredients in TARGIN
tablets may pass into breast milk and
there is a possibility that your baby
may be affected. Your doctor can
discuss with you the risks involved.
Do not give this medicine to a child
younger than 12 years of age.
Safety and effectiveness in children
younger than 12 years of age have
not been established.
Do not take this medicine after the
expiry date (EXP) printed on the
pack.
If you take it after the expiry date has
passed, it may not work very well.
Do not take it if the packaging is torn
or shows signs of tampering.
Before you start to take it
Tell your doctor if you have
allergies to any other medicines,
foods, preservatives or dyes.
Tell your doctor if you have or
have had any medical conditions,
especially the following:
chronic kidney, liver or lung
disease
high or low blood pressure
problems with your heart and
blood circulation
underactive thyroid gland
disease of your gall bladder or
bile duct
inflammation of the pancreas
inflammatory bowel disease or
recent abdominal surgery
enlarged prostate
underactive adrenal glands
epileptic disorders or are prone to
having convulsions
galactose intolerance, lactose
deficiency or glucose-galactose
malabsorption
some cancers of the digestive
tract or pelvis
severe mental condition involving
losing contact with reality,
hearing voices or an ability to
think clearly
an addiction or history of abuse
of alcohol, opioids or other drugs
sleep apnoea, a condition
characterised by frequent
breathing stops during the night
which may make you feel very
sleepy during the daytime
episodes of suddenly falling
asleep or sleepiness occur.
Tell your doctor if you have used
an opioid before.
Using TARGIN tablets after using
doses of other opioids may lead to
withdrawal symptoms or diarrhoea.
If you have not told your doctor
about any of the above, tell them
before you take any TARGIN
tablets.
Taking other medicines
Tell your doctor if you are taking
any other medicines or dietary
supplements, including any that
you buy without a prescription
from your pharmacy, supermarket
or health food shop.
Some medicines, alcohol and
TARGIN tablets may interfere with
each other. These medicines include:
medicines used to treat
depression, psychiatric or mental
disorders
medicines used to treat
depression belonging to a group
called monoamine oxidase
inhibitors must be stopped 14
days before TARGIN tablets are
taken
medicines to help you sleep
other pain relievers including
other opioids
medicines used to prevent or
relieve the symptoms of allergy
medicines to stop nausea or
vomiting e.g. metoclopramide or
prochlorperazine
cimetidine, a medicine used to
treat stomach ulcers or heartburn
medicines to put you to sleep
during an operation or procedure
medicines used to thin the blood
e.g. coumarin derivatives such as
warfarin
medicines used to lower blood
pressure
quinidine and other medicines
used to treat the heart
medicines to treat convulsions
e.g. phenytoin, carbamazepine
antifungals e.g. ketoconazole
antibiotics e.g. clarithromycin,
rifampicin
medicines to treat HIV infection
and AIDS e.g. ritonavir
medicines used to relieve
stomach cramps or spasms, to
prevent travel sickness
medicines to treat Parkinson's
disease
medicines to treat urinary
incontinence
medicines used to relax muscles
St John's wort (a herbal
preparation)
TARGIN
TABLETS MFCTARGI11017 (SUPERSEDES MFCTARGI10716)
grapefruit and grapefruit juice.
These medicines, dietary
supplements or alcohol may affect
how well TARGIN tablets work, or
may increase side effects. You may
need to avoid these or use different
amounts, or take different medicines.
While you are taking this medicine
for restless legs syndrome your
doctor may reduce your dose if you
are taking TARGIN tablets and
Rotigotine, a medicine used to treat
Parkinson's disease.
Your doctor or pharmacist has more
information on medicines and dietary
supplements to be careful with or
avoid while taking this medicine.
How to take TARGIN
tablets
How much to take
Your doctor will tell you exactly how
much to take.
Follow the instructions given to
you by your doctor or pharmacist
exactly.
How to take it
Swallow TARGIN tablets whole
with a full glass of water.
Do not chew, crush, break or
dissolve the tablets.
TARGIN tablets are only designed to
work properly if swallowed whole.
The tablets may release all their
contents at once if chewed, crushed,
broken or dissolved which can be
dangerous and cause serious
problems, such as an overdose which
may be fatal.
If you have trouble swallowing your
tablets whole, talk to your doctor.
You must only take TARGIN
tablets by mouth.
Taking this medicine in a manner
other than that prescribed by your
doctor can be harmful to your health.
When to take it
Take TARGIN tablets every 12
hours.
Take TARGIN tablets regularly to
control the pain or to relieve the
symptoms of restless legs syndrome.
Taking them at the same time each
day will assist in ensuring the best
effect in improving your pain. If
however, you begin to experience
worsening pain or symptoms and
you are taking your TARGIN
tablets as prescribed, contact your
doctor as your dosage may need to
be reviewed.
You may take this medicine with or
without food.
How long to take it
Continue taking your medicine for
as long as your doctor tells you.
If you stop taking this medicine
suddenly, your pain or symptoms
may worsen and you may experience
withdrawal symptoms such as:
body aches
loss of appetite, nausea, stomach
pain or diarrhoea
fast heart rate
sneezing or runny nose
chills, tremors, shivering or fever
trouble with sleeping
increased sweating and yawning
weakness
nervousness or restlessness.
If you forget to take it
If you forget to take your tablets,
contact your doctor or pharmacist
for advice.
Do not take a double dose to make
up for the dose that you missed.
This will increase the chance of you
getting unwanted side effects.
If you are not sure what to do, ask
your doctor or pharmacist.
If you have trouble remembering
when to take your tablets, ask your
pharmacist for some hints.
For example, take your medicine at
the same time each morning and
evening such as 8 a.m. and 8 p.m.
If you take too much
(overdose)
Immediately telephone your doctor
or the Poisons Information Centre
(Australia: telephone 13 11 26) for
advice, or go to Accident and
Emergency at your nearest
hospital, if you think that you or
anyone else may have taken too
many TARGIN tablets.
Do this even if there are no signs of
discomfort or poisoning.
You may need urgent medical
attention.
Keep telephone numbers for these
places handy.
You should also follow the above
steps if someone other than you has
taken the tablets that were prescribed
for you.
If someone takes an overdose they
may experience difficulties in
breathing, become drowsy and tired,
lack muscle tone, have cold or
clammy skin, have constricted pupils,
have very low blood pressure or slow
heart rate and may even become
unconscious or die.
When seeking medical attention, take
this leaflet and any remaining tablets
with you to show the doctor. Also
report any other medicines or alcohol
which have been taken.
While you are taking
TARGIN
Things you must do
Take TARGIN tablets exactly as
your doctor has prescribed.
Before you start on a new
medicine, remind your doctor and
pharmacist that you are taking
TARGIN tablets.
Tell any other doctors, dentists,
and pharmacists who treat you
that you are taking this medicine.
TARGIN
TABLETS MFCTARGI11017 (SUPERSEDES MFCTARGI10716)
If you are going to have surgery,
tell the surgeon or anaesthetist that
you are taking this medicine.
It may affect other medicines used
during surgery.
If you become pregnant while
taking this medicine, tell your
doctor immediately.
Keep all of your doctor's
appointments so that your progress
can be checked.
Tell your doctor if your pain is
getting worse, or if you are having
more frequent breakthrough pain.
Also tell your doctor if you are
having any problems or difficulties
while you are being treated with
TARGIN tablets.
Tolerance to oxycodone may develop
which means that the effect of the
medicine may decrease. If this
happens, your doctor may review
your dose so that you get adequate
pain relief.
Keep enough TARGIN tablets with
you to last over weekends and
holidays.
Things you must not do
Do not drink alcohol while you are
taking TARGIN tablets.
Drinking alcohol while taking
TARGIN tablets may make you feel
more sleepy and increase the risk of
serious side effects, such as shallow
breathing with the risk of stopping
breathing and loss of consciousness.
Do not take TARGIN tablets to
treat any other complaint unless
your doctor tells you to.
Do not give your medicine to
anyone else, even if they have the
same condition as you.
Do not stop taking your medicine
or change the dosage without
checking with your doctor.
Over time your body may become
used to you taking oxycodone so if
you stop taking it suddenly, your
pain may worsen and you may have
unwanted side effects such as
withdrawal symptoms. This is called
physical dependence.
If you need to stop taking this
medicine, your doctor will gradually
reduce the amount you take each day,
if possible, before stopping the
medicine completely.
Things to be careful of
Do not drive or operate machinery
until you know how TARGIN
tablets affect you.
TARGIN tablets may cause episodes
of suddenly falling asleep,
drowsiness, dizziness, hallucinations,
disorientation, blurred vision or other
vision problems or may affect
alertness. If you are affected, you
should not drive or operate
machinery. Discuss these effects with
your doctor.
If you have been switched to
TARGIN tablets from other opioid
pain medications and are taking
laxatives, you may need to reassess
your laxative treatment.
It may be appropriate to reduce your
laxative intake when you start taking
TARGIN tablets and throughout your
TARGIN tablet therapy.
Be careful if you are elderly,
unwell or taking other medicines.
Some people may experience side
effects such as drowsiness,
confusion, dizziness and unsteadiness
which may increase the risk of a fall.
If you feel light-headed, dizzy or
faint when getting out of bed or
standing up, get up slowly.
Standing up slowly will help your
body get used to the change in
position and blood pressure. If this
problem continues or gets worse, talk
to your doctor.
Tell your doctor if you suffer from
nausea or vomiting when taking
TARGIN tablets.
If you vomit after your dose, your
pain may come back, as you will not
have absorbed your medicine. If this
happens, speak to your doctor. Your
doctor may prescribe some medicine
to help you stop vomiting.
Do not be alarmed if you see
remnants of the tablet in your
stool.
The active substances have already
been released in the stomach and gut,
and absorbed into your body.
There is potential for abuse of
oxycodone and the development of
addiction to oxycodone. It is
important that you discuss this
issue with your doctor.
Be aware that TARGIN tablets
may produce a positive result in
sports agency drug testing.
Side effects
All medicines may have some
unwanted side effects. Sometimes
they are serious, but most of the time
they are not. As for other medicines
of this type, that is opioid analgesics,
many side effects tend to reduce over
time. This means that the longer you
take this medicine, the less it may
cause problems for you. Your doctor
has weighed the risks of this
medicine against the benefits they
expect it will have for you.
Do not be alarmed by this list of
possible side effects.
Not everybody experiences them.
Tell your doctor or pharmacist as
soon as possible if you do not feel
well while you are taking TARGIN
tablets.
This medicine helps most people
with moderate to severe pain, but it
may have unwanted side effects in a
few people. Other side effects not
listed here may also occur in some
people.
Ask your doctor or pharmacist to
answer any questions you may
have.
Tell your doctor if you notice any
of the following and they worry
you:
mild abdominal problems such as
diarrhoea, feeling sick (nausea),
decreased appetite, constipation
TARGIN
TABLETS MFCTARGI11017 (SUPERSEDES MFCTARGI10716)
dry mouth, hiccups, sore throat,
thirst, trouble swallowing or
changes in voice
feeling anxious or nervous,
trouble sleeping or abnormal
dreams
trouble with your balance
excessive sweating, hot flushes
restlessness
muscle problems such as spasms,
twitching or tremors
fatigue and feeling of tiredness
skin rash, itching, chills, or fever
new problems with your eyesight
swelling of legs and ankles
absence of menstrual period
impotence
decreased sexual drive.
Tell your doctor as soon as possible
if you notice any of the following
and they worry you:
stomach discomfort, vomiting,
indigestion or abdominal pain
abnormal thinking or changes in
mood, or feeling deep sadness
slow or noticeable heart beats
headache or confusion
drowsiness, feeling faint or
fainting or dizziness especially
when standing up
unusual weakness, loss of
strength or trouble walking
urinary tract infections or change
in passing urine such as the
volume passed, pain or feeling
the need to urinate urgently.
The above list includes serious side
effects that may require medical
attention.
If any of the following happen, tell
your doctor immediately or go to
Accident and Emergency at your
nearest hospital:
you have an allergic reaction:
shortness of breath, wheezing,
shallow or difficulty breathing;
swelling of the face, lips, tongue,
throat or other parts of the body;
rash, itching or hives on the skin
your breathing slows or weakens
chest pain or chest tightness
fast or irregular heartbeats
seizures, fits or convulsions.
The above list includes very serious
side effects. You may need urgent
medical attention or hospitalisation.
After taking TARGIN
Storage
Keep your tablets in the blister
pack until it is time to take them.
If you take the tablets out of the
blister pack they may not keep as
well.
Keep your tablets in a cool, dry
place where the temperature stays
below 25°C.
Do not store it or any other
medicine in the bathroom, near a
sink or on a window sill.
Do not leave it in the car.
Heat and damp can destroy some
medicines.
Keep it where children cannot
reach it.
A locked cupboard at least one-and-
a-half metres above the ground is a
good place to store medicines.
Disposal
If your doctor tells you to stop
taking the tablets or the tablets
have passed their expiry date,
return any unused medicine to
your pharmacist.
Product description
What it looks like
TARGIN
tablets are modified
release film-coated tablets. They are
available in seven strengths which
are as follows*:
2.5/1.25 mg - round, light yellow
with no markings
5/2.5 mg - oblong, blue, marked
"OXN" on one side and "5" on the
other
10/5 mg - oblong, white, marked
"OXN" on one side and "10" on the
other
15/7.5 mg - oblong, grey, marked
"OXN" on one side and "15" on the
other
20/10 mg - oblong, pink, marked
"OXN" on one side and "20" on the
other
30/15 mg - oblong, brown, marked
"OXN" on one side and "30" on the
other
40/20 mg - oblong, yellow, marked
"OXN" on one side and "40" on the
other.
60/30 mg - oblong, red, marked
"OXN" on one side and "60" on the
other
80/40 mg - oblong, brown, marked
"OXN" on one side and "80" on the
other
*Not all strengths are marketed in
Australia
TARGIN
tablets come in boxes
containing blister packs of 28 tablets.
Ingredients
Active ingredients:
2.5/1.25 mg contains 2.5 mg
oxycodone hydrochloride and
1.25 mg naloxone hydrochloride
5/2.5 mg contains 5 mg
oxycodone hydrochloride and 2.5
mg naloxone hydrochloride
10/5 mg contains 10 mg
oxycodone hydrochloride and 5
mg naloxone hydrochloride
15/7.5 mg contains 15 mg
oxycodone hydrochloride and 7.5
mg naloxone hydrochloride
20/10 mg contains 20 mg
oxycodone hydrochloride and 10
mg naloxone hydrochloride
30/15 mg contains 30 mg
oxycodone hydrochloride and 15
mg naloxone hydrochloride
TARGIN
TABLETS MFCTARGI11017 (SUPERSEDES MFCTARGI10716)
40/20 mg contains 40 mg
oxycodone hydrochloride and 20
mg naloxone hydrochloride.
60/30 mg contains 60 mg
oxycodone hydrochloride and 30
mg naloxone hydrochloride.
80/40 mg contains 80 mg
oxycodone hydrochloride and 40
mg naloxone hydrochloride.
Inactive ingredients:
lactose
hyprolose (2.5/1.25mg, 5/2.5mg
and 15/7.5mg tablets)
povidone (10/5mg, 20/10mg,
30/15mg, 40/20mg, 60/30 mg and
80/40 mg tablets)
ethylcellulose
stearyl alcohol
purified talc
magnesium stearate
polyvinyl alcohol
titanium dioxide
macrogol 3350
brilliant blue FCF (CI42090)
(5/2.5mg tablets)
iron oxide red (CI77491)
(2.5/1.25mg, 15/7.5mg, 20/10mg
30/15mg and 60/30 mg tablets)
iron oxide yellow (CI77492)
(2.5/1.25mg, 15/7.5mg, 30/15mg
40/20mg and 80/40 mg tablets )
iron oxide black (CI77499)
(15/7.5mg, 30/15mg, 60/30 mg
and 80/40 mg tablets).
This medicine does not contain
sucrose, gluten, tartrazine or any
other azo dyes.
Supplier
TARGIN
tablets are supplied in
Australia by:
Mundipharma Pty Limited
ABN 87 081 322 509
88 Phillip Street
Sydney NSW 2000
Phone: 1800 188 009
® TARGIN is a registered trade
mark.
This leaflet was updated in October
2017.
Please check with your pharmacist
that this is the latest version of the
leaflet available.
Australian Registration Numbers for
TARGIN
tablets are:
2.5/1.25 mg AUST R 216260
5/2.5 mg AUST R 156067
10/5 mg AUST R 156145
15/7.5 mg AUST R 216261
20/10 mg AUST R 156189
30/15 mg AUST R 216280
40/20 mg AUST R 156194
60/30 mg AUST R 243252
80/40 mg AUST R 243272
Orbis AU-4212
TARGIN
TABLETS MFCTARGI11017 (SUPERSEDES MFCTARGI10716)
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