OXYCONTIN® Tablets

Oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about OXYCONTIN tablets.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

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

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

Keep this leaflet with the medicine. You may need to read it again.

What OXYCONTIN tablets are taken for

OXYCONTIN tablets contain oxycodone hydrochloride. Oxycodone belongs to a group of medicines called opioid analgesics.

OXYCONTIN tablets are used to relieve moderate to severe persistent pain when other forms of treatment have not been effective.

Opioid analgesics such as oxycodone hydrochloride have been used to treat pain for many years.

Your doctor, however, may prescribe it for another purpose.

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

As with all strong painkillers, your body may become used to you taking OXYCONTIN tablets. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking oxycodone suddenly, so it is important to take it exactly as directed by your doctor.

This medicine is only available with a doctor's prescription.

Before you take it

When you must not take it

Do not take OXYCONTIN tablets if you:

• suffer from shallow breathing or have any breathing problems such as acute asthma, chronic bronchitis or impaired lung function
• are severely drowsy or have a reduced level of consciousness
• suffer from irregular or fast heartbeats or changes in the way the heart beats
• have heart problems or heart disease including if due to long term lung disease
• have just drunk a large amount of alcohol, regularly drink large amounts of alcohol or have confusion and shaking due to stopping drinking alcohol
• suffer from convulsions, fits or seizures
• have a head injury, a brain tumour or have raised pressure within the head, brain or spinal cord
• have severe abdominal pain with bloating, cramps, vomiting or constipation
• have a condition where your stomach empties more slowly than it should, your small bowel does not work properly or you have just had an operation on your abdomen
• have severe liver or kidney disease
• are about to have an operation including surgery on your spine for pain relief in the next 24 hours or have had an operation within the last 24 hours
• take medicine for depression called a 'monoamine oxidase inhibitor' or have taken any in the last two weeks
• have been given the 80 mg strength and you have not used any opioid medicine before.

Do not take OXYCONTIN tablets if you are allergic to oxycodone, opioid painkillers, or any of the ingredients listed at the end of this leaflet. This medicine contains lactose so consider this if you are lactose intolerant.

Do not take this medicine after the expiry date (EXP) printed on the pack. If you take it after the expiry date has passed, it may not work very well.

Do not take it if the packaging is torn or shows signs of tampering.

Do not take this medicine if you are pregnant or intend to become pregnant whilst taking this medicine. Like most medicines of this kind, OXYCONTIN tablets are not recommended to be taken during pregnancy. Your doctor will discuss the risks and benefits of taking it if you are pregnant.

Do not give this medicine to a child younger than 12 years of age. Safety and effectiveness in children younger than 12 years of age have not been established.

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 have or have had any medical conditions, especially the following:

• low blood pressure including from having low blood volume
• increased prostate size or difficulty passing urine
• chronic lung, liver or kidney disease
• problems or recent surgery of your gall bladder or bile duct
• inflammation of the pancreas
• adrenal glands not working properly
• underactive thyroid gland
• lactose intolerance
• inflammatory bowel disease or recent abdominal surgery
• severe mental condition involving losing contact with reality, hearing voices or an inability to think clearly
• an addiction or history of abuse of alcohol, opioids or other drugs.

This medicine is not recommended to be taken during labour. Oxycodone given to the mother during labour can cause breathing problems in the newborn.

Tell your doctor if you are breast feeding or planning to breast-feed. Oxycodone can pass into the breast milk and can affect the baby. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you take any OXYCONTIN tablets.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and OXYCONTIN tablets may interfere with each other. These include:

• medicines to treat depression, psychiatric or mental disorders. Medicines to treat depression belonging to a group called monoamine oxidase inhibitors must be stopped 14 days before OXYCONTIN tablets are taken.
• medicines to help you sleep
• medicines to put you to sleep during an operation or procedure
• medicines to relax your muscles
• medicines to lower blood pressure
• quinidine and other medicines to treat the heart
• medicines to thin the blood e.g. coumarin derivatives such as warfarin
• cimetidine, a medicine to treat ulcers
• medicines to relieve stomach cramps or spasms, to prevent travel sickness or to treat Parkinson's disease
• medicines to stop nausea or vomiting e.g. metoclopramide
• other pain relievers including other opioids
• ketoconazole, a medicine to treat fungal infections
• alcohol.

These medicines or alcohol may be affected by OXYCONTIN tablets, may affect how well OXYCONTIN tablets work or may increase side effects. You may need to use different amounts of your medicines, or take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking this medicine.

How to take OXYCONTIN tablets

How much to take

Your doctor will tell you exactly how much to take.

Follow the instructions given to you by your doctor and pharmacist exactly.

How to take it

Swallow OXYCONTIN tablets whole with a full glass of water or other fluid.

Do not break, chew, crush or dissolve the tablets.

OXYCONTIN tablets are only designed to work properly if swallowed whole. The tablets may release all their contents at once if broken, chewed, crushed or dissolved which can be dangerous and cause serious problems, such as an overdose or even death.

If you have trouble swallowing your tablets whole, talk to your doctor.

You must only take OXYCONTIN tablets by mouth.

Taking this medicine in a manner other than that prescribed by your doctor can be harmful to your health.

When to take it

Take OXYCONTIN tablets every 12 hours.

Take OXYCONTIN tablets regularly to control the pain.

Taking them at the same time each day will have the best effect and will mean that the onset of pain is prevented. If however, you begin to experience pain ('breakthrough pain') and you are taking your OXYCONTIN tablets as prescribed, contact your doctor as your dosage may have to be reviewed.

How long to take it

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 withdrawal symptoms such as:

• body aches
• loss of appetite, nausea, stomach cramps or diarrhoea
• fast heart rate
• sneezing or runny nose
• chills, tremors, shivering or fever
• trouble sleeping
• increased sweating and yawning
• weakness
• nervousness or restlessness.

If you forget to take it

If you forget to take your tablets, take your next dose as soon as you remember, unless it is almost time for your next dose, then go on as before.

Do not take a double dose to make up for the dose you have missed. This will increase the chance of you getting unwanted side effects.

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

If you have trouble remembering when to take your medicine, ask your pharmacist for hints. For example, take your medicine at the same time each morning and evening such as 8 a.m. and 8 p.m.

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too many OXYCONTIN tablets.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers for these places handy.

If someone takes an overdose they may experience difficulties in breathing, become drowsy and tired, lack muscle tone, have cold or clammy skin, have constricted pupils, have very low blood pressure or slow heart rate and may even become unconscious or die.

When seeking medical attention, take this leaflet and any remaining tablets with you to show the doctor. Also tell them about any other medicines or alcohol which have been taken.

While you are taking it

Things you must do

Take OXYCONTIN tablets exactly as your doctor has prescribed.

Before you start on a new medicine, remind your doctor and pharmacist that you are taking OXYCONTIN tablets.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

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.

If you become pregnant while taking this medicine, tell your doctor immediately.

Keep all of your doctor's appointments so that your progress can be checked. Tell your doctor if your pain is getting worse or you are having more frequent breakthrough pain. Also tell your doctor if you are having any problems or difficulties while you are being treated with OXYCONTIN tablets.

Tolerance to oxycodone may develop which means that the effect of the medicine may decrease. If this happens, your doctor may increase the dose so that you get adequate pain relief.

Keep enough OXYCONTIN tablets with you to last over weekends and holidays.

Things you must not do

Do not drink alcohol while you are taking OXYCONTIN tablets. Alcohol use could increase serious side effects of oxycodone, such as sleepiness, drowsiness, and slow or shallow breathing.

Do not take OXYCONTIN tablets to treat any other complaint 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, exceed the dose recommended or change the dosage without checking with your doctor. Over time your body may become used to you taking oxycodone so if you stop taking it suddenly, your pain may worsen and you may have unwanted side effects such as withdrawal symptoms. This is called physical dependence.

If you need to stop taking this medicine, your doctor will gradually reduce the amount you take each day, if possible, before stopping the medicine completely.

Things to be careful of

Do not drive or operate machinery until you know how OXYCONTIN tablets affect you. OXYCONTIN tablets may cause drowsiness, dizziness, hallucinations, disorientation, blurred vision or other vision problems or may affect alertness. Discuss these aspects and any impact on your driving or operating machinery with your doctor.

Be careful if you are elderly, unwell or taking other medicines. Some people may experience side effects such as drowsiness, confusion, dizziness and unsteadiness, which may increase the risk of a fall.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly 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.

Tell your doctor if you suffer from nausea or vomiting when taking OXYCONTIN tablets. If you vomit after your dose, your pain may come back, as you may not have absorbed your medicine. If this happens, speak to your doctor. Your doctor may prescribe some medicine to help you stop vomiting.

Do not be alarmed if you see remnants or the whole tablet in your stool. The active substances have already been released in the stomach and gut, and absorbed into your body.

Tell your doctor if taking OXYCONTIN tablets causes constipation. Your doctor can advise you about your diet, the proper use of laxatives and suitable exercise you can do to help you manage this.

There is potential for abuse of oxycodone and the development of addiction to oxycodone. It is important that you discuss this issue with your doctor.

Side effects

All medicines may have some unwanted side effects. Sometimes they are serious but most of the time they are not. As for many other medicines of this type, that is opioid analgesics, many side effects tend to reduce over time, with the exception of constipation. This means that the longer you take this medicine, the less it may cause problems for you. Your doctor has weighed the risks of this medicine against the benefits they expect it will have for you.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking OXYCONTIN tablets. This medicine helps most people with moderate to severe pain, but it may have unwanted side effects in a few people. Other side effects not listed here may also occur in some people.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

• mild abdominal problems such as diarrhoea, feeling sick, loss of appetite or constipation
• dry mouth, hiccups, sore throat, trouble swallowing or changes in voice
• sweating
• feeling anxious or nervous, trouble sleeping or abnormal dreams
• trouble with your balance
• new problems with your eyesight
• skin rash, itching, chills or fever
• muscle problems such as spasms or twitching
• swelling of legs or ankles.

Tell your doctor as soon as possible if you notice any of the following and they worry you:

• stomach discomfort, vomiting, indigestion or abdominal pain
• abnormal thinking, changes in mood or feeling deep sadness
• drowsiness, fainting or dizziness especially when standing up
• slow or noticeable heartbeats
• headache or confusion
• unusual weakness, loss of strength or trouble walking
• changes in passing urine such as the volume passed, pain or feeling the need to urinate urgently.

The above list includes serious side effects that may require medical treatment.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

• you have an allergic reaction: shortness of breath, wheezing, shallow or difficult breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin
• seizures, fits or convulsions
• fast or irregular heartbeats
• chest pain or chest tightness.

The above list includes very serious side effects. You may need urgent medical attention or hospitalization.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

When seeking medical attention, take this leaflet and any remaining tablets with you to show the doctor.

After taking it

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep as well.

Keep your tablets in a cool, dry place, where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom, near a sink or on a window sill.

Do not leave it in the car on hot days. Heat and damp can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking the tablets or the tablets have passed their expiry date, ask your pharmacist how to dispose of medicines no longer required.

Product description

What it looks like

OXYCONTIN® tablets are round, film-coated tablets. They are available in seven strengths which are as follows:

• 5 mg - pale blue, marked "OC" on one side and 5 on the other
• 10 mg - white, marked "OC" on one side and 10 on the other
• 15 mg - grey, marked "OC" on one side and 15 on the other
• 20 mg - pink, marked "OC" on one side and 20 on the other
• 30 mg - brown, marked "OC" on one side and 30 on the other
• 40 mg - yellow, marked "OC" on one side and 40 on the other
• 80 mg - green, marked "OC" on one side and 80 on the other.

OXYCONTIN® tablets come in boxes containing blister packs of 20 and 28 tablets. The 5 mg, 10 mg, 20 mg, 40 mg and 80 mg strengths are also available in blister packs of 60 tablets.

Packs of 20 and 60 tablets will only be available until current stocks are depleted.

Ingredients

Active ingredients:

• 5 mg tablets contain 5 mg oxycodone hydrochloride
• 10 mg tablets contain 10 mg oxycodone hydrochloride
• 15 mg tablets contain 15 mg oxycodone hydrochloride
• 20 mg tablets contain 20 mg oxycodone hydrochloride
• 30 mg tablets contain 30 mg oxycodone hydrochloride
• 40 mg tablets contain 40 mg oxycodone hydrochloride
• 80 mg tablets contain 80 mg oxycodone hydrochloride.

Inactive ingredients:

• lactose
• povidone
• Eudragit RS 30D (solids)
• glycerol triacetate
• stearyl alcohol
• talc
• magnesium stearate
• coating with hypromellose, E171 (titanium dioxide) and macrogol 400.

In addition, the tablets also contain the ingredients and colourants listed below:

• 5 mg - E133 (brilliant blue)
• 10 mg - hydroxypropylcellulose
• 15 mg - E172 (iron oxide red, yellow and black)
• 20 mg - polysorbate 80, E172 (iron oxide red)
• 30 mg - E172 (iron oxide red, yellow and black)
• 40 mg - polysorbate 80, E172 (iron oxide yellow)
• 80 mg - hydroxypropylcellulose, E172 (iron oxide yellow), E132 (indigo carmine)

This medicine does not contain sucrose, gluten or tartrazine.

Manufacturer / Sponsor

OXYCONTIN® tablets are made in the UK and supplied in Australia by:
Mundipharma Pty Limited
ABN 87 081 322 509
50 Bridge Street
Sydney, NSW, 2000
Phone: 1800 188 009

®: OXYCONTIN is a Registered Trademark.

This leaflet was updated in November 2010.

Australian Registration Numbers for OXYCONTIN® tablets:
5 mg: AUST R 93732
10 mg: AUST R 68187
15 mg: AUST R 143102
20 mg: AUST R 68190
30 mg: AUST R 143173
40 mg: AUST R 68191
80 mg: AUST R 68193

Published by MIMS/myDr May 2011

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