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ENDONE(R)

CLICK TO BUY ENDONE TAB 5MG 20

Oxycodone hydrochloride
Consumer Medicine Information

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What is in this leaflet

This leaflet answers some common questions asked about ENDONE. It does not contain all the available information about this medicine. It does not take the place of talking to your doctor or pharmacist.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed up the risks of you taking ENDONE against the benefits they expect it will have for you.

Keep this leaflet with the medicine.

You may want to read it again later.

What ENDONE is used for

This medicine contains oxycodone hydrochloride.

ENDONE belongs to a group of medicines called narcotic analgesics. Narcotic analgesics act to relieve pain.

Ask your doctor if you have any questions about why ENDONE has been prescribed for you.

Your doctor may prescribe ENDONE for another reason.

ENDONE is only available with a doctor`s prescription.

WARNING:
ENDONE can be addictive. If used for a long time ENDONE may become habit forming causing mental and physical dependence. If abused it may become less able to reduce pain.

Before you take ENDONE

When you must not take it

Do not take ENDONE if you have an allergy to:

any medicine containing oxycodone hydrochloride
any of the ingredients listed at the end of this leaflet
any other similar medicine (such as other narcotic analgesics, like morphine)

Some of the symptoms of an allergic reaction may be an itchy skin rash, skin blisters or discolouration of the skin upon exposure to sunlight.

Do not use ENDONE if you currently have or have had any of the following:

head injury
brain tumour
alcoholism
epilepsy (also known as fitting)
are taking or have taken in the last 14 days medicines for depression called Monoamine Oxidase Inhibitors (MAOIs).
heart problems such as an irregular and/or rapid heartbeat
asthma
any difficulty breathing
depression
severe headaches due to raised pressure in the head

Your doctor will need to know about all of these before prescribing ENDONE for you.

Do not take ENDONE during pregnancy or during breastfeeding as it may cause difficulty in breathing in an unborn or newborn child.

Women who are pregnant, planning to become pregnant or who are breastfeeding should discuss this with their doctor.

Do not give this medicine to children.

There is not enough information available to recommend the use of ENDONE in children.

Do not take ENDONE after the expiry date (EXP) printed on the packet or if the packaging is torn or shows signs of tampering.

It may not work as well if you take it after the expiry date. Return it to your pharmacist for disposal.

If you are not sure whether you should be taking ENDONE, consult your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you currently have or have had any of the following health problems/medical conditions.

muscle weakness
underactive thyroid
kidney disease
liver disease
low blood pressure
if a male, prostate problems or difficulty passing water
bowel disorders

It may not be safe for you to take ENDONE if you have these conditions. Your doctor will need to consider all these factors when advising you about taking ENDONE.

If you have not told your doctor about any of the above, tell him/her before you start taking ENDONE.

Taking other medicines

You must tell your doctor about all the medicines you are taking, including any that you may buy from pharmacies, health food shops or supermarkets.

Some medicines may interfere with ENDONE and these include:

anaesthetics
medicines used to thin the blood
medicines used to treat epilepsy
medicines used to help with sleeping
blood pressure lowering medicines
medicines used to treat mental problems
medicines used to reduce anxiety
medicines used to treat depression
medicines used to treat “flu” symptoms
pain relievers

These medicines may be affected by ENDONE or they may affect how well ENDONE works. You may need to take different amounts of these medicines, or you may need to take different medicines.

Your doctor or pharmacist has a more complete list of medicines to avoid while taking ENDONE.

If you have not told your doctor about any of the above, tell him/her before you take ENDONE.

How to 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 bottle, 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.

How to take it

Swallow ENDONE with a full glass of water.

ENDONE should be taken after meals or with milk.

How long to take it

The length of treatment will depend on your condition. Your doctor will advise you when to stop taking ENDONE.

If you have been using ENDONE for a long period of time and it is no longer needed to control pain DO NOT suddenly stop taking ENDONE. 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 it

If you forget to take a dose of ENDONE, take the dose as soon as you remember and then go back to taking it as you would normally. However, if it is almost time for your next dose, for example within 2 or 3 hours, skip the missed dose and take the next dose when you are meant to.

Do not take a double dose to make up for the dose that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take ENDONE, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to the Casualty Department at your nearest hospital, if you think that you or anyone else may have taken too much ENDONE, even if there are no signs of discomfort or poisoning.

Keep the telephone numbers for your doctor, the Poisons Information Centre and your nearest hospital handy so that they are accessible in case of an emergency.

If you are not sure what to do, contact your doctor or pharmacist.

If you take an overdose of ENDONE you may start feeling sleepy and may experience difficulty in breathing which could lead to unconsciousness and loss of muscle control. Your heart may stop and death may occur.

While you are using ENDONE

Things you must do

Tell all of the doctors and pharmacists who are treating you that you are taking ENDONE.

Remind them that you are taking ENDONE if you are about to be started on any new medicine or before you have any kind of surgery.

Tell your doctor if you become pregnant while taking ENDONE.

Things you must not do

Do not take any other medicines while you are taking ENDONE unless you have discussed this with your doctor.

This includes medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.

Do not take ENDONE to treat any complaint other than that directed by your doctor.

It may not be safe to take ENDONE for another complaint.

Do not give ENDONE to anyone else, even if their symptoms seem similar.

It may not be safe for another person to take ENDONE.

Do not stop taking ENDONE or lower or increase the dose without first checking with your doctor. Do not let yourself run out of medicine over the weekend or on holidays.

Things to be careful of

Be careful when drinking alcohol while you are taking ENDONE.

The combination could make you more dizzy, sleepy or light-headed than usual. Your doctor may suggest you avoid alcohol while you are taking ENDONE.

Be careful driving or operating machinery until you know how ENDONE affects you.

ENDONE may cause drowsiness, sleepiness or dizziness in some people and affect alertness. Make sure you know how you react to ENDONE before you drive or operate machinery.

People over 65 years have a higher risk of getting side effects from medicines.

Families and carers should be aware that these people might become confused while taking ENDONE. Special care may be needed.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ENDONE even if you do not think the problems are connected with the medication or they are not listed in this leaflet.

All medicines can have side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and require medical attention.

If any of the following occur after taking ENDONE, stop taking it and contact your doctor or the Casualty Department at your nearest hospital:

unconsciousness
inability to breathe properly
severe dizziness, drowsiness or disorientation
symptoms of allergy (eg. itchy skin rash, skin blisters or discolouration of skin upon exposure to sunlight)

These are uncommon but serious side effects. Urgent medical attention may be required to deal with these effects.

The more common side effects are:

confusion
drowsiness
constipation
vomiting
nausea

Other side effects are:

difficulty passing urine
decreased frequency of passing urine
dry mouth
sweating
redness of the face
loss of appetite
faintness or feeling weak
dizziness
slow heart rate
abnormal and fast heart rate
irregular heat beat
fall in blood pressure on standing
decrease in body temperature
restlessness
changes of mood
constriction of pupils

Some of the less common side effects are:

muscle stiffness
itchy rash or other forms of itchiness
severe headache due to increased pressure within the head

High doses of ENDONE can cause:

unconsciousness
heart failure
low blood pressure
inability to breath properly

In long term use, physical dependence and tolerance may develop and the following withdrawal symptoms may be observed after ENDONE is discontinued:

body aches
loose bowel motions or diarrhoea
gooseflesh or goose bumps
loss of appetite
nervousness
restlessness
runny nose
sneezing
shivering
stomach cramps
nausea
trouble with sleeping
an increase in sweating and yawning
weakness
fast heart rate
unexplained fever

These symptoms are mild if withdrawal from ENDONE is gradual once it is no longer needed.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell while taking ENDONE.

Early consultation with your doctor can help prevent more serious complications by allowing prompt adjustments in your ENDONE therapy.

Ask your doctor or pharmacist to answer any questions you may have about side effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.

Storage

Keep ENDONE tablets in their container until it is time to take them.

If you take them out of their container, they may not keep well.

Do not store ENDONE tablets or any other medication in the bathroom or near a sink.

Heat and dampness can ruin some medicines.

Keep ENDONE tablets in a cool, dry place where the temperature stays below 30 degrees C.

Do not leave them in a car or on window sills on hot days.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-half-metres (5 feet) above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking ENDONE or you find that they have passed their expiry date, ask your pharmacist what to do with any unused medicine.

Product Description

What it looks like

ENDONE is a white, scored uncoated tablet engraved with the word “ENDONE” on one side and plain on the other side.

Ingredients

ENDONE contains 5 mg of oxycodone hydrochloride in each tablet.

The other ingredients in ENDONE tablets are:

lactose
microcrystalline cellulose
stearic acid

Sponsor

ENDONE is distributed in Australia by:

Sigma Pharmaceuticals Pty Ltd
(ACN 000 118 594)
96 Merrindale Drive
Croydon VIC 3136
The Australian Registration number fro ENDONE 5 mg tablets is:
AUST R 14945
This leaflet was prepared in September 1996 and updated April 2005.

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Endone Tablets 5MG Pack Of 20