Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before taking this medicine.
1. Why am I taking ENDONE?
ENDONE contains the active ingredient oxycodone hydrochloride. ENDONE is used for
the short-term management of severe pain. For more information, see Section
1. Why am I taking ENDONE? in the full CMI.
2. What should I know before I take ENDONE?
Do not take if you have ever had an allergic reaction to ENDONE or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I take ENDONE? in the full CMI.
3. What if I am taking other medicines?
4. How do I take ENDONE?
The usual dose is one tablet every six hours. Your doctor may prescribe a different
dose for you. Be sure to follow your doctor’s directions about when and how to take
ENDONE.
Swallow the tablets whole with a full glass of water after food or with milk.
5. What should I know while taking ENDONE?
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Things you should do
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If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
Remind any doctor, dentist or pharmacist you visit that you are taking ENDONE.
If you become pregnant while taking this medicine, tell your doctor immediately.
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Things you should not do
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Do not take ENDONE to treat any other complaints 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 lower the dosage without first checking with your
doctor.
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Driving or using machines
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Do not drive or operate machinery until you know how ENDONE affects you.
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Drinking alcohol
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Do not drink alcohol while you are taking this medicine.
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Looking after your medicine
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Keep your tablets in the pack until it is time to take them.
Keep your tablets in a cool, dry place where the temperature stays below 30°C.
Keep it where young children cannot reach it.
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6. Are there any side effects?
Speak to your doctor if you have any of these: dizziness, light-headedness and confusion; drowsiness; nausea.
Call your doctor as soon as possible if you notice any of these: difficulty passing urine; dry mouth; irregular heart beat; decrease in body temperature;
hallucinations; muscle rigidity; severe headache due to increased pressure in the
head.
Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if you notice any of these: loss of consciousness; difficulty or an inability to breathe properly; severe dizziness,
drowsiness or disorientation; symptoms of an allergic reaction (itchy skin rash, skin
blisters or discolouration of skin upon exposure to sunlight).
This is not a complete list of all possible side effects. For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
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WARNING:
Limitations of use
ENDONE should only be used when your doctor decides that other treatment options are
not able to effectively manage your pain or you cannot tolerate them.
Hazardous and harmful use
ENDONE poses risks of abuse, misuse and addiction which can lead to overdose and death.
Your doctor will monitor you regularly during treatment.
Life threatening respiratory depression
ENDONE can cause life-threatening or fatal breathing problems (slow, shallow, unusual
or no breathing), even when taken as recommended. These problems can occur at any
time during use, but the risk is higher when first starting ENDONE and after a dose
increase, if you are older or have an existing problem with your lungs. Your doctor
will monitor you and change the dose as appropriate.
Use of other medicines while taking ENDONE
Using ENDONE with other medicines that can make you feel drowsy such as sleeping tablets
(e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants, antipsychotics,
gabapentinoids (e.g. gabapentin and pregabalin), cannabis and alcohol may result in
severe drowsiness, decreased awareness, breathing problems, coma and death.
Your doctor will minimise the dose and duration of use; and monitor you for signs
and symptoms of breathing difficulties and sedation. You must not drink alcohol while
taking ENDONE.
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Active ingredient(s):
oxycodone hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking ENDONE. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking ENDONE.
Where to find information in this leaflet:
1. Why am I taking ENDONE?
ENDONE contains the active ingredient oxycodone hydrochloride. This medicine belongs to a group of medicines called narcotic analgesics.
ENDONE is used
for the short-term management of severe pain.
The active ingredient in this medicine works by binding to receptors called opioid
receptors, which are in your central nervous system. This binding action changes your
body's perception of pain throughout the central nervous system producing the pain
relieving (analgesic) effect.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
Addiction
You can become addicted to ENDONE even if you take it exactly as prescribed. ENDONE
may become habit forming causing mental and physical dependence. If abused it may
become less able to reduce pain.
Dependence
As with all other opioid containing products, your body may become used to you taking
ENDONE. Taking it may result in physical dependence. Physical dependence means that
you may experience withdrawal symptoms if you stop taking ENDONE suddenly, so it is
important to take it exactly as directed by your doctor.
Tolerance
Tolerance to ENDONE may develop, which means that the effect of the medicine may decrease.
If this happens, more may be needed to maintain the same effect. Speak to your doctor
if this occurs.
Withdrawal
Continue taking your medicine for as long as your doctor tells you. If you stop taking
this medicine suddenly, your pain may worsen and you may experience some or all of
the following withdrawal symptoms:
nervousness, restlessness, agitation, trouble sleeping or anxiety
body aches, weakness or stomach cramps
loss of appetite, nausea, vomiting or diarrhoea
increased heart rate, breathing rate or pupil size
watery eyes, runny nose, chills or yawning
increased sweating
ENDONE given to the mother during labour can cause breathing problems and signs of
withdrawal in the newborn.
2. What should I know before I take ENDONE?
Warnings
Do not use ENDONE if:
you have any allergy to any medicine containing oxycodone hydrochloride, any other
narcotic analgesics such as morphine, codeine or opium 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
Always check the ingredients to make sure you can take this medicine.
you have or have had any of the following:
head injury
brain tumour
epilepsy or other convulsive disorders
heart problems such as an irregular and/or rapid heartbeat
chronic obstructive pulmonary disease, asthma or other respiratory diseases
severe headaches, or headaches due to raised pressure in the head
a history of alcohol or drug abuse
a history of mental illness
you are pregnant
you are breastfeeding
you are taking or have taken medicines for depression called Monoamine Oxidase Inhibitors
(MAOs) within the last 14 days.
the expiry date printed on the pack has passed or if the packaging is torn or shows
signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should be taking this medicine, consult your doctor.
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes
currently have or have had any of the following medical conditions:
muscle weakness
underactive thyroid
kidney disease
liver disease
low blood pressure
prostate problems, or difficulty in passing urine
bowel disorders
prescription or illicit drug addiction
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not take ENDONE if you are pregnant.
It may affect your developing baby if you take it during pregnancy.
Check with your doctor if you are pregnant or intend to become pregnant.
Do not breast-feed if you are taking ENDONE.
The active ingredient in ENDONE passes into breast milk and there is a possibility
that your baby may be affected.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Children
Do not give this medicine to children.
Safety and effectiveness in children have not been established.
If you have not told your doctor about any of the above, tell them before you start
taking ENDONE.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and ENDONE may interfere with each other. These include:
anaesthetics
anticoagulants, medicines used to thin the blood
medicines used to treat epilepsy
medicines used to help with sleeping
medicines used to help lower blood pressure
medicines used to treat anxiety
medicines used to treat depression
medicines used to treat cold and flu symptoms
other medicines used to relieve pain
medicines, used to relieve nausea and vomiting
atropine-like medicines, used to prevent travel sickness and for stomach cramps and
spasms
medicines used to treat chronic obstructive pulmonary disorder
antipsychotic medicines, used to treat psychosis, schizophrenia or bipolar disorder
antihistamine medicines, used to treat allergic skin conditions or hay fever
any medicine containing naloxone and/or naltrexone, used to reverse the effects of
narcotic analgesics.
These medicines may be affected by ENDONE or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ENDONE.
4. How do I take ENDONE?
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
How much to take
The usual dose is one tablet every six hours.
Your doctor may prescribe a different dose for you. Be sure to follow your doctor’s
directions about when and how to take ENDONE.
When to take ENDONE
Take ENDONE at about the same time each day. Taking it at the same time each day will
have the best effect. It will also help you remember when to take it.
ENDONE should be taken after food or with milk.
How to take ENDONE
Swallow the tablets whole with a full glass of water.
How long to take ENDONE
Continue taking your medicine for as long as your doctor tells you.
If you have been taking this medicine for a long period of time and it is no longer
needed to manage your pain, DO NOT stop taking ENDONE suddenly.
Your doctor may want you to gradually reduce the amount of ENDONE you are taking before
stopping completely in order to lessen the risk of withdrawal symptoms.
If you forget to take ENDONE
If you miss your dose at the usual time and it is less than 3 hours before your next
dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you take too much ENDONE
If you or someone else receives too much (overdose), and experience one or more of
the symptoms below, immediately call triple zero (000) for an ambulance. Keep the
person awake by talking to them or gently shaking them every now and then. You should
follow the above steps even if someone other than you have accidentally taken ENDONE
that was prescribed for you.
If someone takes an overdose, they may experience one or more of the following symptoms:
slow, unusual or difficult breathing
drowsiness, dizziness or unconsciousness
slow or weak heartbeat
nausea or vomiting
convulsions or fits
clumsiness or loss of coordination
difficulty walking
facial drooping
loss of vision
personality changes
trouble speaking
weak muscles
If you think you or someone else have taken too much ENDONE, urgent medical attention
may be needed.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
When seeking medical attention, take this leaflet and any remaining medicine with
you to show the doctor. Also tell them about any other medicines or alcohol which
have been taken.
5. What should I know while taking ENDONE?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking ENDONE.
Remind any doctor, dentist or pharmacist you visit that you are taking ENDONE.
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.
Keep all of your doctor's appointments so that your progress can be checked.
Call your doctor straight away if you:
become pregnant while taking this medicine.
Things you should not do
Do not take ENDONE to treat any other complaints 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 lower the dosage without first checking with your
doctor.
If you stop taking it suddenly, your condition may worsen, you may have unwanted side
effects, or you may experience withdrawal symptoms. Your doctor will gradually reduce
the amount you take each day before stopping this medicine completely.
Driving or using machines
Do not drive or operate machinery until you know how ENDONE affects you.
This medicine may impair the mental and physical ability needed to drive a car or
operate heavy machinery. It may cause drowsiness. If you have any of these symptoms,
do not drive, operate machinery or do anything else that could be dangerous.
Drinking alcohol
Do not drink alcohol while you are taking this medicine. Tell your doctor if you drink alcohol.
Things to be careful of
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
Standing up slowly, especially when you get up from bed or chairs, 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.
Looking after your medicine
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack, they may not keep well.
Keep your tablets in a cool, dry place where the temperature stays below 30°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-half-metres above the ground is a good place to
store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking ENDONE.
This medicine helps most people with their pain, but it may have unwanted side effects
in a few people.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
If you are over 65 years of age you may have an increased chance of getting side effects.
Do not be alarmed by the following lists of side effects. You may not experience any
of them.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
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Serious side effects
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What to do
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difficulty passing urine
decreased frequency of passing urine
dry mouth
sweating
redness of the face
loss of appetite
fainting or feeling weak
slow heart rate
abnormal and fast heart rate
irregular heart beat
feeling light headed when standing up or when getting out of bed
decrease in body temperature
restlessness or nervousness
changes in mood
constriction of pupils
hallucinations
muscle rigidity
severe headache due to increased pressure in the head
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Call your doctor as soon as possible if you notice any of these serious side effects.
This list includes serious side effects that may require medical attention.
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Very serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
In long-term use, physical dependence and tolerance to the medicine may develop. The
following withdrawal symptoms may be experienced after stopping treatment with ENDONE:
nervousness, restlessness, agitation, trouble sleeping or anxiety
body aches, weakness or stomach cramps
loss of appetite, nausea, vomiting or diarrhoea
increased heart rate, breathing rate or pupil size
watery eyes, runny nose, chills or yawning
increased sweating
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What ENDONE contains
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Active ingredient
(main ingredient)
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5 mg of oxycodone hydrochloride per tablet
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Other ingredients
(inactive ingredients)
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lactose
microcrystalline cellulose
stearic acid
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Potential allergens
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sugars as lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What ENDONE looks like
ENDONE is a white, round, biconvex 10 mm tablet, one side embossed "O 5" with a break
bar on the other side (AUST R 14945).
Available in blister packs of 10 and 20 tablets.
Sponsor
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in July 2024.
ENDONE® is a Viatris company trade mark
ENDONE_cmi\Jul24/00