Oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide)
Consumer Medicine Information
What is in this leaflet As with all strong painkillers, your • have a head injury, a brain
body may become used to you taking tumour or have raised pressure
This leaflet answers some common OXYCONTIN tablets. Taking it may within the head, brain or spinal
questions about OXYCONTIN result in physical dependence. cord
tablets. Physical dependence means that you • have severe abdominal pain with
may experience withdrawal bloating, cramps, vomiting or
It does not contain all the available
symptoms if you stop taking constipation
information. It does not take the
oxycodone suddenly, so it is • have a condition where your
place of talking to your doctor or
important to take it exactly as stomach empties more slowly
directed by your doctor. than it should, your small bowel
All medicines have risks and
This medicine is only available with does not work properly or you
benefits. Your doctor has weighed
a doctor's prescription. have just had an operation on
the risks of you taking this medicine
against the benefits they expect it
• have severe liver or kidney
will have for you.
If you have any concerns about Before you take it • are about to have an operation
taking this medicine, ask your including surgery on your spine
doctor or pharmacist.
for pain relief in the next 24 hours
Keep this leaflet with the medicine. When you must not take it or have had an operation within
You may need to read it again. the last 24 hours
Do not take OXYCONTIN tablets
if you: • take medicine for depression
called a 'monoamine oxidase
• suffer from shallow breathing or
inhibitor' or have taken any in the
have any breathing problems such
What OXYCONTIN as acute asthma, chronic
last two weeks
tablets are taken for • have been given the 80 mg
bronchitis or impaired lung
strength and you have not used
OXYCONTIN tablets contain any opioid medicine before.
• are severely drowsy or have a
oxycodone hydrochloride. Do not take OXYCONTIN tablets
reduced level of consciousness
Oxycodone belongs to a group of if you are allergic to oxycodone,
medicines called opioid analgesics. • suffer from irregular or fast
opioid painkillers, or any of the
heartbeats or changes in the way ingredients listed at the end of this
OXYCONTIN tablets are used to the heart beats
relieve moderate to severe persistent leaflet.
• have heart problems or heart This medicine contains lactose so
pain when other forms of treatment
disease including if due to long consider this if you are lactose
have not been effective.
term lung disease intolerant.
Opioid analgesics such as oxycodone • have just drunk a large amount of
hydrochloride have been used to treat Do not take this medicine after the
alcohol, regularly drink large expiry date (EXP) printed on the
pain for many years. amounts of alcohol or have pack.
Your doctor, however, may prescribe confusion and shaking due to If you take it after the expiry date has
it for another purpose. stopping drinking alcohol passed, it may not work very well.
Ask your doctor if you have any • suffer from convulsions, fits or
Do not take it if the packaging is
questions about why it has been seizures
torn or shows signs of tampering.
prescribed for you.
OXYCONTIN® Tablets Published by MIMS/myDr May 2011 1
Do not take this medicine if you Tell your doctor if you are breast These medicines or alcohol may be
are pregnant or intend to become feeding or planning to breast-feed. affected by OXYCONTIN tablets,
pregnant whilst taking this Oxycodone can pass into the breast may affect how well OXYCONTIN
medicine. milk and can affect the baby. Your tablets work or may increase side
Like most medicines of this kind, doctor can discuss with you the risks effects. You may need to use
OXYCONTIN tablets are not and benefits involved. different amounts of your medicines,
recommended to be taken during or take different medicines.
If you have not told your doctor
pregnancy. Your doctor will discuss
about any of the above, tell them Your doctor or pharmacist has more
the risks and benefits of taking it if
before you take any OXYCONTIN information on medicines to be
you are pregnant.
tablets. careful with or avoid while taking
Do not give this medicine to a child this medicine.
younger than 12 years of age. Taking other medicines
Safety and effectiveness in children
younger than 12 years of age have Tell your doctor if you are taking
not been established. any other medicines, including any
that you buy without a How to take
prescription from your pharmacy, OXYCONTIN tablets
Before you start to take it supermarket or health food shop.
Tell your doctor if you have Some medicines and OXYCONTIN
allergies to any other medicines,
How much to take
tablets may interfere with each other.
foods, preservatives or dyes. These include: Your doctor will tell you exactly
Tell your doctor if you have or • medicines to treat depression, how much to take.
have had any medical conditions, psychiatric or mental disorders. Follow the instructions given to
especially the following: Medicines to treat depression you by your doctor and pharmacist
• low blood pressure including belonging to a group called exactly.
from having low blood volume monoamine oxidase inhibitors
• increased prostate size or must be stopped 14 days before How to take it
difficulty passing urine OXYCONTIN tablets are taken.
• chronic lung, liver or kidney • medicines to help you sleep Swallow OXYCONTIN tablets
whole with a full glass of water or
disease • medicines to put you to sleep
• problems or recent surgery of during an operation or procedure
your gall bladder or bile duct • medicines to relax your muscles Do not break, chew, crush or
dissolve the tablets.
• inflammation of the pancreas • medicines to lower blood
• adrenal glands not working pressure OXYCONTIN tablets are only
properly • quinidine and other medicines to designed to work properly if
swallowed whole. The tablets may
• underactive thyroid gland treat the heart
• medicines to thin the blood e.g. release all their contents at once if
• lactose intolerance
coumarin derivatives such as broken, chewed, crushed or dissolved
• inflammatory bowel disease or which can be dangerous and cause
recent abdominal surgery serious problems, such as an
• cimetidine, a medicine to treat
• severe mental condition involving overdose or even death.
losing contact with reality,
• medicines to relieve stomach If you have trouble swallowing your
hearing voices or an inability to
cramps or spasms, to prevent tablets whole, talk to your doctor.
travel sickness or to treat
• an addiction or history of abuse You must only take OXYCONTIN
Parkinson's disease tablets by mouth.
of alcohol, opioids or other drugs.
• medicines to stop nausea or Taking this medicine in a manner
This medicine is not recommended
vomiting e.g. metoclopramide other than that prescribed by your
to be taken during labour.
Oxycodone given to the mother • other pain relievers including doctor can be harmful to your health.
during labour can cause breathing other opioids
problems in the newborn. • ketoconazole, a medicine to treat When to take it
• alcohol. Take OXYCONTIN tablets every
OXYCONTIN® Tablets Published by MIMS/myDr May 2011 2
Take OXYCONTIN tablets If you take too much Keep all of your doctor's
regularly to control the pain. (overdose) appointments so that your progress
can be checked.
Taking them at the same time each
Immediately telephone your Tell your doctor if your pain is
day will have the best effect and will
doctor, or the Poisons Information getting worse or you are having more
mean that the onset of pain is
Centre (telephone 13 11 26) for frequent breakthrough pain. Also tell
prevented. If however, you begin to advice, or go to Accident and your doctor if you are having any
experience pain ('breakthrough pain') Emergency at your nearest problems or difficulties while you are
and you are taking your hospital, if you think you or
being treated with OXYCONTIN
OXYCONTIN tablets as prescribed, anyone else may have taken too
contact your doctor as your dosage many OXYCONTIN tablets.
may have to be reviewed. Do this even if there are no signs of Tolerance to oxycodone may develop
discomfort or poisoning. which means that the effect of the
How long to take it You may need urgent medical medicine may decrease. If this
attention. happens, your doctor may increase
Continue taking your medicine for the dose so that you get adequate
as long as your doctor tells you. Keep telephone numbers for these pain relief.
If you stop taking this medicine Keep enough OXYCONTIN
If someone takes an overdose they
suddenly, your pain may worsen and tablets with you to last over
may experience difficulties in
you may experience withdrawal weekends and holidays.
symptoms such as: breathing, become drowsy and tired,
lack muscle tone, have cold or
• body aches clammy skin, have constricted pupils, Things you must not do
• loss of appetite, nausea, stomach have very low blood pressure or slow Do not drink alcohol while you are
cramps or diarrhoea heart rate and may even become taking OXYCONTIN tablets.
• fast heart rate unconscious or die. Alcohol use could increase serious
• sneezing or runny nose When seeking medical attention, take side effects of oxycodone, such as
• chills, tremors, shivering or fever this leaflet and any remaining tablets sleepiness, drowsiness, and slow or
• trouble sleeping with you to show the doctor. Also tell shallow breathing.
• increased sweating and yawning them about any other medicines or Do not take OXYCONTIN tablets
• weakness alcohol which have been taken. to treat any other complaint unless
• nervousness or restlessness. your doctor tells you to.
Do not give your medicine to
If you forget to take it anyone else, even if they have the
While you are taking it same condition as you.
If you forget to take your tablets,
take your next dose as soon as you Do not stop taking your medicine,
remember, unless it is almost time Things you must do exceed the dose recommended or
for your next dose, then go on as change the dosage without
before. Take OXYCONTIN tablets exactly checking with your doctor.
as your doctor has prescribed. Over time your body may become
Do not take a double dose to make used to you taking oxycodone so if
up for the dose you have missed. Before you start on a new
medicine, remind your doctor and you stop taking it suddenly, your
This will increase the chance of you pain may worsen and you may have
pharmacist that you are taking
getting unwanted side effects. unwanted side effects such as
If you are not sure what to do, ask withdrawal symptoms. This is called
Tell any other doctors, dentists and physical dependence.
your doctor or pharmacist.
pharmacists who treat you that
If you have trouble remembering you are taking this medicine. If you need to stop taking this
when to take your medicine, ask medicine, your doctor will gradually
If you are going to have surgery,
your pharmacist for hints. reduce the amount you take each day,
tell the surgeon or anaesthetist that
For example, take your medicine at if possible, before stopping the
you are taking this medicine.
the same time each morning and medicine completely.
It may affect other medicines used
evening such as 8 a.m. and 8 p.m.
If you become pregnant while
taking this medicine, tell your
OXYCONTIN® Tablets Published by MIMS/myDr May 2011 3
Things to be careful of Side effects • stomach discomfort, vomiting,
indigestion or abdominal pain
Do not drive or operate machinery
All medicines may have some • abnormal thinking, changes in
until you know how OXYCONTIN
unwanted side effects. Sometimes mood or feeling deep sadness
tablets affect you.
OXYCONTIN tablets may cause
they are serious but most of the time • drowsiness, fainting or dizziness
they are not. As for many other especially when standing up
drowsiness, dizziness, hallucinations,
medicines of this type, that is opioid • slow or noticeable heartbeats
disorientation, blurred vision or other
analgesics, many side effects tend to
vision problems or may affect • headache or confusion
reduce over time, with the exception
alertness. Discuss these aspects and
of constipation. This means that the • unusual weakness, loss of
any impact on your driving or strength or trouble walking
longer you take this medicine, the
operating machinery with your • changes in passing urine such as
less it may cause problems for you.
Your doctor has weighed the risks of the volume passed, pain or
Be careful if you are elderly, this medicine against the benefits feeling the need to urinate
unwell or taking other medicines. they expect it will have for you. urgently.
Some people may experience side The above list includes serious side
effects such as drowsiness, Do not be alarmed by this list of
possible side effects. effects that may require medical
confusion, dizziness and treatment.
You may not experience any of them.
unsteadiness, which may increase the
risk of a fall. Tell your doctor or pharmacist as If any of the following happen, tell
soon as possible if you do not feel your doctor immediately or go to
If you feel light-headed, dizzy or Accident and Emergency at your
well while you are taking
faint when getting out of bed or nearest hospital:
standing up, get up slowly.
This medicine helps most people • you have an allergic reaction:
Standing up slowly will help your
with moderate to severe pain, but it shortness of breath, wheezing,
body get used to the change in
may have unwanted side effects in a shallow or difficult breathing;
position and blood pressure. If this
few people. Other side effects not swelling of the face, lips, tongue,
problem continues or gets worse, talk
listed here may also occur in some throat or other parts of the body;
to your doctor.
people. rash, itching or hives on the skin
Tell your doctor if you suffer from
Ask your doctor or pharmacist to • seizures, fits or convulsions
nausea or vomiting when taking • fast or irregular heartbeats
answer any questions you may
have. • chest pain or chest tightness.
If you vomit after your dose, your
pain may come back, as you may not Tell your doctor if you notice any The above list includes very serious
have absorbed your medicine. If this of the following and they worry side effects. You may need urgent
happens, speak to your doctor. Your you: medical attention or
doctor may prescribe some medicine • mild abdominal problems such as
to help you stop vomiting. diarrhoea, feeling sick, loss of Tell your doctor or pharmacist if
appetite or constipation you notice anything that is making
Do not be alarmed if you see
• dry mouth, hiccups, sore throat, you feel unwell.
remnants or the whole tablet in
your stool. trouble swallowing or changes in Other side effects not listed above
The active substances have already voice may also occur in some people.
been released in the stomach and gut, • sweating When seeking medical attention,
and absorbed into your body. • feeling anxious or nervous, take this leaflet and any remaining
trouble sleeping or abnormal tablets with you to show the
Tell your doctor if taking
OXYCONTIN tablets causes
constipation. • trouble with your balance
Your doctor can advise you about • new problems with your eyesight
your diet, the proper use of laxatives
• skin rash, itching, chills or fever
and suitable exercise you can do to
• muscle problems such as spasms
help you manage this.
There is potential for abuse of • swelling of legs or ankles.
oxycodone and the development of
addiction to oxycodone. It is Tell your doctor as soon as possible
important that you discuss this if you notice any of the following
issue with your doctor. and they worry you:
OXYCONTIN® Tablets Published by MIMS/myDr May 2011 4
After taking it • 40 mg - yellow, marked "OC" on • 30 mg - E172 (iron oxide red,
one side and 40 on the other yellow and black)
• 80 mg - green, marked "OC" on • 40 mg - polysorbate 80, E172
Storage one side and 80 on the other. (iron oxide yellow)
Keep your tablets in the blister OXYCONTIN® tablets come in • 80 mg - hydroxypropylcellulose,
pack until it is time to take them. boxes containing blister packs of 20 E172 (iron oxide yellow), E132
If you take the tablets out of the and 28 tablets. The 5 mg, 10 mg, 20 (indigo carmine)
blister pack they may not keep as mg, 40 mg and 80 mg strengths are This medicine does not contain
well. also available in blister packs of 60 sucrose, gluten or tartrazine.
Keep your tablets in a cool, dry
place, where the temperature stays Packs of 20 and 60 tablets will only Manufacturer / Sponsor
below 25°C. be available until current stocks are
OXYCONTIN® tablets are made in
Do not store it or any other the UK and supplied in Australia by:
medicine in the bathroom, near a Mundipharma Pty Limited
sink or on a window sill. Ingredients ABN 87 081 322 509
Do not leave it in the car on hot Active ingredients: 50 Bridge Street
days. Sydney, NSW, 2000
• 5 mg tablets contain 5 mg
Heat and damp can destroy some Phone: 1800 188 009
medicines. ®: OXYCONTIN is a Registered
• 10 mg tablets contain 10 mg
Keep it where children cannot oxycodone hydrochloride Trademark.
reach it. • 15 mg tablets contain 15 mg This leaflet was updated in
A locked cupboard at least one-and- oxycodone hydrochloride November 2010.
a-half metres above the ground is a
• 20 mg tablets contain 20 mg Australian Registration Numbers
good place to store medicines.
oxycodone hydrochloride for OXYCONTIN® tablets:
• 30 mg tablets contain 30 mg 5 mg: AUST R 93732
Disposal oxycodone hydrochloride 10 mg: AUST R 68187
If your doctor tells you to stop • 40 mg tablets contain 40 mg 15 mg: AUST R 143102
taking the tablets or the tablets oxycodone hydrochloride 20 mg: AUST R 68190
have passed their expiry date, ask • 80 mg tablets contain 80 mg 30 mg: AUST R 143173
your pharmacist how to dispose of oxycodone hydrochloride. 40 mg: AUST R 68191
medicines no longer required. 80 mg: AUST R 68193
Product description • Eudragit RS 30D (solids)
• glycerol triacetate
• stearyl alcohol
What it looks like
OXYCONTIN® tablets are round, • magnesium stearate
film-coated tablets. They are • coating with hypromellose, E171
available in seven strengths which (titanium dioxide) and macrogol
are as follows: 400.
• 5 mg - pale blue, marked "OC" In addition, the tablets also contain
on one side and 5 on the other the ingredients and colourants listed
• 10 mg - white, marked "OC" on below:
one side and 10 on the other • 5 mg - E133 (brilliant blue)
• 15 mg - grey, marked "OC" on • 10 mg - hydroxypropylcellulose
one side and 15 on the other
• 15 mg - E172 (iron oxide red,
• 20 mg - pink, marked "OC" on yellow and black)
one side and 20 on the other
• 20 mg - polysorbate 80, E172
• 30 mg - brown, marked "OC" on (iron oxide red)
one side and 30 on the other
OXYCONTIN® Tablets Published by MIMS/myDr May 2011 5