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Oxycodone Sandoz

Oxycodone hydrochloride modified release tablet
Consumer Medicine Information (CMI)

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Oxycodone Sandoz. It does not contain all the information that is known about Oxycodone Sandoz. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

WHAT OXYCODONE SANDOZ IS USED FOR

This medicine is used to relieve moderate to severe persistent pain when other forms of treatment have not been effective.
It contains the active ingredient oxycodone hydrochloride.
Oxycodone hydrochloride belongs to a class of drugs known as opioid analgesics.
Opioid analgesics such as oxycodone hydrochloride have been used to treat pain for many years. As with all strong painkillers, your body may become used to you taking Oxycodone Sandoz 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.
There is not enough information to recommend the use of this medicine for children under the age of 12 years.
This medicine is available only with a doctor's prescription.
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.

BEFORE YOU TAKE OXYCODONE SANDOZ

When you must not take it

Do not take this medicine if you have an allergy to:
oxycodone hydrochloride, or to any of the other ingredients listed at the end of this leaflet under Product Description
any other similar medicines known as opioid analgesics, e.g. morphine or codeine.
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.
Do not take this medicine if you have or have had any of the following medical conditions:
suffer from shallow breathing or have any breathing problems such as acute asthma, chronic bronchitis or impaired lung function
severe drowsiness or have a reduced level of consciousness
irregular or rapid heartbeats or changes in the way the heart beats
heart problems or heart disease including if due to long term lung disease
fits, convulsions or seizures
head injury, brain tumour, severe headaches or have raised pressure within the head, brain or spinal cord
severe abdominal pain with bloating, cramps, vomiting or constipation
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
severe liver or kidney disease
severe depression
a condition where you have high levels of carbon dioxide in your blood.
Do not take this medicine if:
you are taking a medicine for depression called monoamine oxidase inhibitor, or you have taken any in the last two weeks
you have just drunk a large amount of alcohol, regularly drink large amounts of alcohol or have confusion and shaking due to stopping drinking alcohol
you 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
you have been given the 80mg strength and have not used any opioid medicine before.
Do not take this medicine if you are pregnant or intend to become pregnant whilst taking this medicine.
It may affect your developing baby if you take it during pregnancy.
Do not take this medicine after the expiry date printed on the pack 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 start taking this medicine, talk to 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 have or have had any of the following medical conditions:
low blood pressure including from having low blood volume
chronic lung, liver or kidney disease
stomach pains or constipation or inflammatory bowel disease
recent abdominal surgery
increased prostrate size or difficulty passing urine
narrowing of the urinary tract
problems or recent surgery of your gall bladder or bile duct
inflammation of the pancreas
disorientation, hallucination, dizziness standing up or severe headaches
adrenal glands not working properly
under-active thyroid gland
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 breastfeeding or plan to breastfeed.
Your doctor can discuss with you the risks and benefits involved.
Oxycodone Sandoz contains lactose. If you have been told by your doctor that you have intolerance to some sugars, tell your doctor before taking it.
If you have not told your doctor about any of the above, tell him/her before you start taking Oxycodone Sandoz.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Oxycodone Sandoz may interfere with each other. These include:
medication for depression, psychiatric or mental disorders.
Medicines to treat depression belonging to a group called monoamine oxidase inhibitors must be stopped 14 days before Oxycodone Sandoz tablets are taken.
medication 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
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
ritonavir, an antiviral medication
macrolide antibiotics, e.g. clarithromycin
medicines used to treat epilepsy e.g. carbamazepine, phenytoin
St. John's wort
alcohol
grapefruit juice
medicines to thin the blood e.g. coumarin derivatives such as warfarin.
These medicines or alcohol may be affected by Oxycodone Sandoz or may affect how well it works. They may increase the side effects of Oxycodone Sandoz. 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.

HOW TO TAKE OXYCODONE SANDOZ

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, ask your doctor or pharmacist for help.

How much to take

The dose of this medicine may be different for each person. Your doctor will decide the right dose for you.
The amount of this medicine needed to give good pain relief varies. The doctor will take into account your age, weight, level of pain and medical history when choosing your dose.
Ask your doctor or pharmacist if you are unsure of the correct dose for you.
They will tell you exactly how much to take.
Follow the instructions they give you.
If you take the wrong dose, Oxycodone Sandoz may not work as well and your problem may not improve.

How to take it

Swallow Oxycodone Sandoz tablets whole with a full glass of water or other fluid.
Do not break, chew, crush or dissolve the tablets. This medicine was designed to work properly only if swallowed whole. They may release all their contents at once if broken, chewed, crushed or dissolved, resulting in a risk of overdose or even death.
If you have trouble swallowing your tablets whole, talk to your doctor.
You must only take Oxycodone Sandoz tablets by the mouth.
Taking this medicine in a manner other than prescribed by your doctor can be harmful to your health.

When to take Oxycodone Sandoz

Take this medicine as directed by your doctor.
This medicine should be taken every twelve hours.
Take your tablets at the times you have been told. If, however, you begin to experience pain (breakthrough pain), and you are taking your Oxycodone Sandoz tablets as prescribed, contact your doctor, as your dosage may have to be reviewed.
This medicine must be taken regularly to control the pain. Taking this medicine at regular time intervals means that the onset of pain is prevented. This medicine should not be taken when you feel you need it, as this will cause some pain to be experienced.
Do not take any alcohol while you are being treated with Oxycodone Sandoz.

How long to take Oxycodone Sandoz

Continue taking your medicine for as long as your doctor recommends.
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 a dose, contact your doctor or pharmacist for advice.
Do not take a double dose to make up for the dose that 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 (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone Australia 13 11 26 or New Zealand 0800 POISON or 0800 764766) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Oxycodone Sandoz. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Symptoms of an overdose may include drowsiness, tiredness, confusion, low blood pressure or slow heart rate, lack muscle tone, have cold or clammy skin, have constricted pupils, difficulty breathing and may even become unconsciousness 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 OXYCODONE SANDOZ

Things you must do

Take this medicine exactly as your doctor has prescribed.
Visit your doctor regularly for a check-up, and always discuss any problems or difficulties during or after taking this medicine.
Tell your doctor if your pain is getting worse, or if you are having more frequent breakthrough pain.
Keep enough of this medicine with you to last over weekends and holidays.
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.

Things you must not do

Do not give this medicine to anyone else, even if they have the same condition as you.
Do not use this medicine to treat other complaints unless your doctor tells you.
Do not take this medicine for a longer time than your doctor has prescribed.
Do not take alcohol while being treated with this medicine.
Alcohol use could increase serious side effects of oxycodone, such as sleepiness, drowsiness and slow or shallow breathing.
Do not stop taking this medicine, exceed the dose recommended or change 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.
Your doctor may want you to gradually reduce the amount you are taking before stopping completely.
This medicine should be taken strictly according to your doctor's instructions.

Things to be careful of

Do not drive or operate machinery until you know how Oxycodone Sandoz affects you.
Oxycodone 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.
Make sure you know how you react to this medicine before you drive a car, operate machinery, or do anything else that could be dangerous if you are drowsy, dizzy or not alert.
You may feel drowsy when you begin to take Oxycodone Sandoz tablets. If you drink alcohol the drowsiness may be worse.
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 Oxycodone Sandoz.
If you vomit two to three hours after your dose, your pain may come back, as you will not have absorbed your medicine. If this happens, speak to your doctor. Your doctor may prescribe some medicine to help you stop vomiting.
This medicine can cause constipation. Your doctor can advise you about your diet, the proper use of laxatives and 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

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Oxycodone Sandoz.
This medicine helps most people with moderate to severe pain, but they may have unwanted side effects in some people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
mild abdominal problems, such as diarrhoea, feeling sick, loss of appetite or constipation
abnormal thoughts and dreams, trouble sleeping
muscle problems such as spasms or twitching
sore throat, dry mouth, hiccups, trouble swallowing or changes in voice
skin rash, itching, fever, chills or sweating
feeling anxious or nervous
trouble with your balance
new problems with your eyesight
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 hospitalisation.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Ask your doctor if you don't understand anything in this list.

Habit forming effects

Opioid analgesics such as Oxycodone Sandoz have been used to treat pain for many years. In most cases addiction does not occur. However, over time your body becomes used to taking this medicine, so if you suddenly stop taking it, you may experience some symptoms of withdrawal. It is important to discuss this issue with you doctor.

AFTER TAKING OXYCODONE SANDOZ

Storage

Keep your medicine in the original container.
If you take it out of its original container it may not keep well.
Keep your medicine in a cool dry place where the temperature stays below 25°C.
Do not store Oxycodone Sandoz or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness 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 this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

PRODUCT DESCRIPTION

What it looks like

Oxycodone Sandoz comes in five strengths:
Oxycodone Sandoz 5mg - blue, round, biconvex modified release tablets.
Oxycodone Sandoz 10mg - white, round, biconvex modified release tablets.
Oxycodone Sandoz 20mg - pink, round, biconvex modified release tablets.
Oxycodone Sandoz 40mg - yellow, round, biconvex modified release tablets.
Oxycodone Sandoz 80mg - green, round, biconvex modified release tablets.
Available in blister packs of 28 tablets.

Ingredients

Active ingredients:
Oxycodone Sandoz 5mg - 5mg oxycodone hydrochloride
Oxycodone Sandoz 10mg - 10mg oxycodone hydrochloride
Oxycodone Sandoz 20mg - 20mg oxycodone hydrochloride
Oxycodone Sandoz 40mg - 40mg oxycodone hydrochloride
Oxycodone Sandoz 80mg - 80mg oxycodone hydrochloride
Inactive ingredients:
Excipients core:
maize starch
behenoyl polyoxylglycerides
lactose
medium chain triglycerides
copovidone
castor oil - hydrogenated
colloidal anhydrous silica
magnesium stearate
Excipients coating:
hypromellose
microcrystalline cellulose
stearic acid
titanium dioxide
indigo carmine aluminium lake (5mg tablets only)
815063 Spectracol Green Lake (80mg tablets only)
iron oxide red (20mg tablets only)
iron oxide yellow (40mg tablets only)
iron oxide black (80mg tablets only)
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Supplier

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Australia
Tel: 1800 634 500
Novartis New Zealand Limited
PO Box 99102
Newmarket, Auckland 1149
New Zealand
Tel: 0800 354 335
This leaflet was prepared in February 2016.
Australian Register Numbers
5mg tablets: AUST R 153605 (blister packs)
10mg tablets: AUST R 153597 (blister packs)
20mg tablets: AUST R 153615 (blister packs)
40mg tablets: AUST R 153611 (blister packs)
80mg tablets: AUST R 153591 (blister packs)