OXYCONTIN Tablets.pdf by liningnvp


									OXYCONTIN® Tablets
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
                                                                                 your abdomen
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
                                                                                  other fluid.
• 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.
  think clearly
                                           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
                                           fungal infections
                                         • alcohol.                               Take OXYCONTIN tablets every
                                                                                  12 hours.

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.
                                         places handy.
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
                                         OXYCONTIN tablets.
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.
                                         during surgery.
                                         If you become pregnant while
                                         taking this medicine, tell your
                                         doctor immediately.

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:
                                          OXYCONTIN tablets.
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
OXYCONTIN tablets.
                                          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
                                            dreams                                  doctor.
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.
                                            or twitching
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
                                        oxycodone hydrochloride
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
                                      Inactive ingredients:
                                      • lactose
                                      • povidone
Product description                   • Eudragit RS 30D (solids)
                                      • glycerol triacetate
                                      • stearyl alcohol
What it looks like
                                      • talc
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

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