OxyNorm_R_ Capsules

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					OxyNorm(R) Capsules
Oxycodone hydrochloride

Consumer Medicine Information

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What is in this leaflet                 taking OxyNorm capsules, so if you     *   depression
                                        suddenly stop taking OxyNorm           *   DTs (confusion and shaking due
Please read this leaflet carefully      capsules, you may experience some          to stopping drinking alcohol)
before you start taking OxyNorm         symptoms of withdrawal. It is          *   a condition where you have high
capsules.                               important to discuss this issue with       levels of carbon dioxide in your
                                        your doctor.                               blood
This leaflet answers some of the
common questions about OxyNorm          This medicine is available only with   *   severe kidney disease
capsules. It does not contain all the   a doctor's prescription.               3. If you are taking medicine for
available information. It does not      Be careful driving or operating           depression called monoamine
take the place of talking to your       machinery until you know how              oxidase inhibitor, or you have
doctor or pharmacist.                   OxyNorm capsules affect you.              taken any in the last two weeks.
All medicines have risks and                                                   4. If you regularly drink large
benefits. Your doctor has weighed                                                 amounts of alcohol.
the risks of you taking OxyNorm                                                5. If you are about to have an
capsules against the benefits they      Before you take                           operation.
expect it will have for you.            OxyNorm(R) capsules                    Do not take OxyNorm capsules
Use OxyNorm capsules as instructed,                                            after the expiry date (exp) printed
and follow the advice given in this                                            on the pack.
leaflet.                                When you must not take it              If you take this medicine after the
                                        1. If you have allergies to:           expiry date has passed, it may not
If you have any concerns about
taking this medicine, ask your          * oxycodone hydrochloride              work as well.
doctor or pharmacist.                   *   any other medicines known as       Do not take OxyNorm capsules if
                                            opioid analgesics, e.g. morphine   the packaging is torn or shows any
Keep this leaflet with your
medicine.                                   or codeine                         signs of tampering, or if the
                                        *   any of the ingredients in          capsules show any visible signs of
You may need to read it again.                                                 deterioration.
                                            OxyNorm capsules which are
                                            listed under the heading
                                            "Ingredients" at the end of this   Before you start to take it
What OxyNorm(R)                         2. If you have or have had any of
                                                                               You must tell your doctor if:
capsules are used for                      the following medical               1. You have or have had any
                                           conditions:                            other medical conditions
OxyNorm capsules are used to                                                      including:
                                        * severe breathing problems such
relieve moderate to severe pain when       as asthma                           * stomach pains or constipation
other forms of treatment have not                                              *   kidney or liver disease
                                        *   irregular or rapid heartbeats
been effective.
                                        *   heart disease                      *   increased prostate size
OxyNorm capsules belong to a class                                             *   narrowing of the urinary tract
                                        *   fits or convulsions
of drugs known as opioid analgesics.                                           *   bile-duct increase or
                                        *   head injury or brain tumour
Opioid analgesics such as OxyNorm                                                  inflammation of the pancreas
                                        *   severe headaches
capsules have been used to treat pain                                          *   disorientation, hallucination,
                                        *   non-functioning small bowel or
for many years. In most cases                                                      dizziness standing up or severe
                                            delayed stomach emptying
addiction does not occur. However,                                                 headaches
over time your body becomes used to     *   severe stomach pain

OXYNORM(R) CAPSULES                                                                                                   1
*   low activity of the adrenal gland   How to take                              If you forget to take it
    (Addison's disease)                 OxyNorm(R) capsules                      If you forget to take a dose, contact
*   inflammatory bowel disease
                                                                                 your doctor or pharmacist for
*   under-active thyroid                                                         advice.
2. You are pregnant or plan to          How much to take
                                                                                 If you have trouble remembering
   become pregnant.                     The dose of OxyNorm capsules may         when to take your medicine, ask
Your doctor will discuss the possible   be different for each person. Your       your doctor or pharmacist for
risks and benefits of taking            doctor will decide the right dose for    some hints.
OxyNorm capsules during                 you.                                     An example is taking your medicine
                                        The amount of OxyNorm capsules           at the same time each day, such as 6
3. You are breastfeeding or plan        needed to give good pain relief          am, 10 am, 2 pm, 6 pm and 10 pm.
   to breastfeed.                       varies. The doctor will take into
Your doctor will discuss the risks      account your age, weight, level of       If you take too much
and benefits of taking OxyNorm          pain and medical history when            (overdose)
capsules when breastfeeding. The        choosing your dose.
active ingredient from OxyNorm                                                   Immediately telephone your
capsules passes into breast milk and                                             doctor, or the Poisons Information
                                        How to take it                           Centre (telephone 131 126), or go
is generally not recommended while
                                                                                 to the Emergency Department at
you are breastfeeding.                  Swallow OxyNorm capsules whole
                                                                                 your nearest hospital, if you think
                                        with a full glass of water or other
If you have not told your doctor                                                 you or anyone else may have taken
about any of the above, tell them                                                too many OxyNorm capsules. Do
before you take any OxyNorm             Do not open, chew or crush               this even if there are no signs of
capsules.                               OxyNorm capsules.                        discomfort or poisoning. Also
                                                                                 report any other medicines or
OxyNorm capsules are not                                                         alcohol which have been taken.
recommended for children under          When to take it                          You may need urgent medical
18 years of age.                                                                 attention. Keep telephone
                                        Take this medicine as directed by
                                        your doctor.                             numbers for these places handy.
Taking other medicines                                                           If someone takes too many capsules,
                                        OxyNorm capsules should be taken
                                        at 4 to 6 hourly intervals.              they will probably become drowsy,
Tell your doctor if you are taking
                                                                                 tired, confused, have very low blood
any other medicines, including any      Take your capsules at the times you
that you buy without a                                                           pressure, experience difficulties in
                                        have been told. If, however, you         breathing and possibly become
prescription from your pharmacy,
                                        begin to experience pain, and you are    unconscious.
supermarket or health food shop.
                                        taking your OxyNorm capsules as
Some medicines may interfere with       prescribed (breakthrough pain)
OxyNorm capsules. These include:        contact your doctor, as your dosage
*   medication for depression           may have to be reviewed.
                                                                                 While you are taking
*   medication to help you sleep        OxyNorm capsules must be taken           OxyNorm(R) capsules
*   medication for allergy              regularly to control the pain. Taking
*   pain relievers                      OxyNorm capsules at regular time
*   alcohol                             intervals means that the onset of pain   Things you must do
                                        is prevented.
*   medicines used to treat blood                                                Take OxyNorm capsules exactly as
    clots.                              Do not take any alcohol while you        your doctor has prescribed.
These medicines or alcohol may          are being treated with OxyNorm
                                        capsules.                                Visit your doctor regularly for a
increase the side effects of OxyNorm                                             check-up, and always discuss any
capsules. Your doctor or pharmacist                                              problems or difficulties during or
can tell you what to do if you are      How long to take it                      after taking OxyNorm capsules.
taking any of these medicines.
                                        Continue taking OxyNorm capsules         Tell your doctor if your pain is
Your doctor has more information on     until you finish the pack or until       getting worse, or if you are having
medicines to be careful with, or to     your doctor recommends.                  frequent breakthrough pain.
avoid, while taking OxyNorm                                                      Keep enough OxyNorm capsules
capsules.                                                                        with you to last over weekends and

OXYNORM(R) CAPSULES                                                                                                     2
Tell all the doctors, dentists and      Things to be careful of                 *   abnormal thoughts and dreams
pharmacists who are treating you                                                *   trouble sleeping
that you are taking OxyNorm             Be careful driving or operating
                                        machinery until you know how            *   dizziness standing up
                                        OxyNorm capsules affect you.            *   headache
If you become pregnant while you
                                                                                *   twitching
are taking OxyNorm capsules, tell       You may feel drowsy when you
your doctor.                            begin to take OxyNorm capsules.         *   sore throat
                                        If you drink alcohol the drowsiness     *   fever, chills
If you plan to have any type of         may be worse.
surgery, tell your doctor or                                                    *   dry mouth
anaesthetist or dentist that you are    Be careful if you are elderly,          *   anorexia
taking OxyNorm capsules.                unwell or taking other medicines.       *   difficulties in breathing,
                                        Some people may experience side             increased cough, wheezing or
Things you must not do                  effects such as drowsiness,                 chest pain
                                        confusion, dizziness and                *   sweating.
Do not drive or operate machinery       unsteadiness, which may increase the
until you know how OxyNorm                                                      Other less common side effects
                                        risk of a fall.                         include:
capsules affect you.
                                        You may suffer from nausea or
OxyNorm capsules may cause                                                      *   stomach pain and excessive gas
                                        vomiting when taking OxyNorm
drowsiness or dizziness in some                                                     in the stomach or bowel
                                        capsules. If you vomit two to three
people and therefore may affect         hours after your dose, your pain may    *   difficulty in swallowing and sore
alertness. Ask your doctor's advice                                                 mouth
                                        come back, as you will not have
about whether or not it will be safe    absorbed your medicine. If this         *   dehydration, fluid retention and
for you to drive a car, operate any     happens, speak to your doctor. Your         thirst
machinery while taking OxyNorm          doctor may prescribe some medicine      *   ringing of the ears
capsules or anything else that may be   to help you stop vomiting.              *   urination problems
dangerous if you are drowsy.
                                        OxyNorm capsules can cause              *   skin trouble, such as rash,
Make sure you know how you react        constipation. You should speak to           itching, dryness, peeling, lumps
to OxyNorm capsules before you          your doctor about your diet, and            or hives
drive a car, operate machinery, or do   proper use of laxatives.                *   flushing of the face
anything else that could be
dangerous if you are drowsy, dizzy                                              *   loss of memory, depression,
or not alert.                                                                       disorientation, faintness,
                                                                                    agitation, mood changes, speech
Do not take OxyNorm capsules for        Side effects                                difficulties, hallucinations,
a longer time than your doctor has
                                                                                    unconsciousness, fits or
                                        Tell your doctor as soon as possible        convulsions and restlessness
Do not take alcohol while being         if you do not feel well while you are   *   changes in heart beat rate
treated with OxyNorm capsules.          taking OxyNorm capsules.
                                                                                *   low muscle strength, abnormal
Do not change your dose without         OxyNorm capsules help most people           manner of walking, muscle
first checking with your doctor.        with moderate to severe pain, but it        rigidity, shaking
                                        may have unwanted side effects in
Do not give OxyNorm capsules to                                                 *   general feeling of being unwell,
                                        some people.
anyone else even if they have, or                                                   pain and neck pain
you think they may have, the same       All medicines can have side effects.
                                                                                *   increase in appetite and changes
condition as you.                       Sometimes they are serious, most of
                                                                                    in taste
                                        the time they are not. You may need
Do not use OxyNorm capsules to                                                  *   impotence
                                        medical treatment if you get some of
treat other complaints unless your      the side effects.                       *   pins and needles
doctor tells you to.                                                            *   vision abnormalities.
                                        Ask your doctor to answer any of
Do not stop taking OxyNorm              the questions you may have.             *   swelling of the face, arms and
capsules or lower your dosage,                                                      legs
without first checking with your        The most common side effects are:
                                                                                Tell your doctor if you notice any
doctor.                                 *   stomach problems, such as pain,     other effect, even if it is not on this
OxyNorm capsules should be taken            nausea, constipation, diarrhoea     list. Some people may get other
strictly according to your doctor's         and vomiting                        side effects while taking OxyNorm
instructions.                           *   dizziness, drowsiness, confusion,   capsules.
                                            nervousness and weakness

OXYNORM(R) CAPSULES                                                                                                    3
Ask your doctor if you do not           Disposal                                 Identification
understand anything in this list.
                                        If your doctor tells you to stop         The Australian Registration numbers
Do not be alarmed by this list of
                                        taking OxyNorm capsules, or the          can be located on the front of the
possible side effects. You may not      capsules have passed their expiry        carton.
experience any of them.                 date, return the unused medicine to
                                                                                 Blister pack
                                        your pharmacist.
Habit forming effects                                                            OxyNorm 5mg - AUST R 74145

Opioid analgesics such as OxyNorm       Product description                      OxyNorm 10mg - AUST R 74143
capsules have been used to treat pain   What it looks like                       OxyNorm 20mg - AUST R 74141
for many years. In most cases
addiction does not occur. However,      OxyNorm capsules come in three
                                        strengths:                               Supplier
over time your body becomes used to
taking OxyNorm capsules, so if you      OxyNorm 5 mg - orange/beige              Mundipharma Pty Limited
suddenly stop taking OxyNorm            capsules, printed ONR 5 mg.              ABN 87 081 322 509
capsules, you may experience some       OxyNorm 10 mg - white/beige              Level 26, 6 O'Connell Street
symptoms of withdrawal. It is                                                    Sydney, NSW, 2000
                                        capsules, printed ONR 10 mg.
important to discuss this issue with
you doctor.                             OxyNorm 20 mg - pink/beige
                                        capsules, printed ONR 20 mg.             Date of preparation:
                                                                                 April 2006
                                        OxyNorm capsules come in blister
                                        packs containing 20 capsules.
After using
OxyNorm(R) capsules                     Ingredients
                                        OxyNorm capsules contain either 5
Storage                                 mg or 10 mg or 20 mg, of oxycodone
                                        hydrochloride, as the active
Keep your capsules in the blister       ingredient.
pack until it is time to take them.
                                        The inactive ingredients in OxyNorm
If you take the capsules out of the     capsules are microcrystalline
blister they may not keep as well.      cellulose and magnesium stearate.
OxyNorm capsules should be kept         In addition, the capsules also contain
in a cool, dry place, where the         the ingredients and colourants listed
temperature stays below 30              below:
degrees C. Do not store it or any
other medicine in the bathroom or       E172 (iron oxide), E132 (indigo
near a sink. Do not leave it in the     carmine), E171 (titanium dioxide),
car on hot days.                        sodium lauryl sulfate and gelatin.
                                        The 5 mg OxyNorm capsules also
Heat and dampness can destroy some
                                        contain E110 (sunset yellow FCF).
                                        The capsules are printed in black ink
Keep it where children cannot           which contains industrial methylated
reach it.                               spirit, shellac, iron oxide black
A locked cupboard at least              (E172), soya lecithin and butyl
one-and-a-half metres above the         alcohol.
ground is a good place to store

OXYNORM(R) CAPSULES                                                                                                4

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