Consumer medicine information

Oxycodone Sandoz

Oxycodone hydrochloride

BRAND INFORMATION

Brand name

Oxycodone Sandoz

Active ingredient

Oxycodone hydrochloride

Schedule

S8

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Oxycodone Sandoz.

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Oxycodone Sandoz.

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 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

Long-term use of oxycodone tablets may result in a decrease in sex hormone levels which may affect sperm production in men and the menstrual cycles in females. Talk to your doctor if you have concerns.

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, respiratory depression (breathing slows or weakens) or other obstructive airways disease
  • 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 or any condition that obstructs the stomach/bowel or affects bowel transit (movement of food or ingested material along the bowel)
  • have swallowing difficulties of narrowing of the oesophagus
  • 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 or recent abdominal surgery
  • diverticulitis (inflammation of bowel wall)
  • 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
  • oesophageal, stomach or intestinal disorders (including cancer in these areas) resulting in narrowing of the oesophagus, stomach or intestines
  • 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.
  • antidepressants e.g. fluoxetine, paroxetine
  • 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 stomach ulcers or heartburn
  • medicines to relieve stomach cramps or spasms, to prevent travel sickness
  • medicines to treat Parkinson's disease
  • medicines to treat urinary incontinence
  • 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, rifampin
  • medicines used to treat convulsions e.g. carbamazepine, phenytoin
  • medicine to treat HIV infection and AIDs e.g. ritonavir
  • St. John's wort (a herbal preparation)
  • alcohol
  • grapefruit and grapefruit juice
  • medicines to thin the blood e.g. coumarin derivatives such as warfarin
  • medicines to treat epilepsy, pain and anxiety e.g. gabapentin and pregabalin.

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.

There are no data on rectal administration of Oxycodone Sandoz tablets, therefore rectal administration of Oxycodone Sandoz is not recommended.

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.

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

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 (nausea), loss of appetite or constipation
  • muscle problems such as spasms or twitching or tremors
  • sore throat, dry mouth, hiccups, trouble swallowing or changes in voice
  • excessive sweating
  • skin rash, itching, fever, chills or sweating
  • feeling anxious or nervous, trouble sleeping or abnormal dreams
  • trouble with your balance
  • new problems with your eyesight
  • swelling of legs or ankles.
  • absence of menstrual periods
  • impotence
  • decreased sexual drive

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
  • choking, gaging, regurgitation, tablets stuck in throat or trouble swallowing the tablets
  • 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
  • fatigue, feeling of tiredness drowsiness or lack or energy
  • 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:

  • your breathing slows or weakens
  • 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 5 mg - blue, round, biconvex modified release tablets.

Oxycodone Sandoz 10 mg - white, round, biconvex modified release tablets.

Oxycodone Sandoz 20 mg - pink, round, biconvex modified release tablets.

Oxycodone Sandoz 40 mg - yellow, round, biconvex modified release tablets.

Oxycodone Sandoz 80 mg - green, round, biconvex modified release tablets.

Available in blister packs of 28 tablets.

Ingredients

Active ingredients:

  • Oxycodone Sandoz 5 mg - 5 mg oxycodone hydrochloride
  • Oxycodone Sandoz 10 mg - 10 mg oxycodone hydrochloride
  • Oxycodone Sandoz 20 mg - 20 mg oxycodone hydrochloride
  • Oxycodone Sandoz 40 mg - 40 mg oxycodone hydrochloride
  • Oxycodone Sandoz 80 mg - 80 mg oxycodone hydrochloride

Inactive ingredients:

Excipients core:

  • maize starch
  • behenoyl polyoxylglycerides
  • lactose monohydrate
  • 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 (20 mg tablets only)
  • iron oxide yellow (40 mg tablets only)
  • iron oxide black (80 mg 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 726 369

Novartis New Zealand Limited
PO Box 99102
Newmarket, Auckland 1149
New Zealand
Tel: 0800 354 335

This leaflet was prepared in February 2020.

Australian Register Numbers

5 mg tablets: AUST R 153605 (blister packs)

10 mg tablets: AUST R 153597 (blister packs)

20 mg tablets: AUST R 153615 (blister packs)

40 mg tablets: AUST R 153611 (blister packs)

80 mg tablets: AUST R 153591 (blister packs)

Published by MIMS March 2020

BRAND INFORMATION

Brand name

Oxycodone Sandoz

Active ingredient

Oxycodone hydrochloride

Schedule

S8

 

1 Name of Medicine

Oxycodone hydrochloride.

6.7 Physicochemical Properties

Oxycodone hydrochloride is a white or almost white, hygroscopic powder that is freely soluble in water, sparingly soluble in anhydrous ethanol and practically insoluble in toluene.
Chemical name: 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. Molecular formula: C18H21NO4.HCl. Molecular weight: 351.87.

Chemical structure.

Its chemical structure is:

CAS number.

124-90-3.

2 Qualitative and Quantitative Composition

Oxycodone Sandoz tablets contain 5 mg, 10 mg, 20 mg, 40 mg or 80 mg oxycodone hydrochloride.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Oxycodone Sandoz 5 mg.

Round, blue, biconvex, modified release tablets containing 5 mg oxycodone hydrochloride.

Oxycodone Sandoz 10 mg.

Round, white, biconvex, modified release tablets containing 10 mg oxycodone hydrochloride.

Oxycodone Sandoz 20 mg.

Round, pink, biconvex, modified release tablets containing 20 mg oxycodone hydrochloride.

Oxycodone Sandoz 40 mg.

Round, yellow, biconvex, modified release tablets containing 40 mg oxycodone hydrochloride.

Oxycodone Sandoz 80 mg.

Round, green, biconvex, modified release tablets containing 80 mg oxycodone hydrochloride.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Oxycodone is a full opioid agonist with no antagonist properties whose principal therapeutic action is analgesia. It has an affinity for kappa, mu and delta opiate receptors in the brain and spinal cord. Oxycodone is similar to morphine in its action. Other pharmacological actions of oxycodone are in the CNS (respiratory depression, antitussive, anxiolytic, sedative and miosis), smooth muscle (constipation, reduction in gastric, biliary and pancreatic secretions, spasm of sphincter of Oddi and transient elevations in serum amylase) and cardiovascular system (release of histamine and/or peripheral vasodilation, possibly causing pruritus, flushing, red eyes, sweating and/or orthostatic hypotension).
Opioids may influence the hypothalamic pituitary adrenal or gonadal axes. Some changes that can be seen include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes.

Clinical trials.

A recent study assessed the effects of a standard high fat meal on the pharmacokinetics of oxycodone 160 mg (not marketed in Australia) in 30 healthy males and found that the Cmax was increased by a mean of 25% (range 8 to 52%), and the overall bioavailability (AUCinf) by an average of 14%. As the Mean Residence Time (MRT) was unchanged in the presence of food (9.4 hours fasting, 9.3 hours fed), the change in Cmax may have been partly due to an increase in the extent of absorption, rather than solely due to an increased rate of absorption. There was no evidence of dose dumping, and the 90% CIs around the AUC ratios were within the range 80 to 125%.
A second recent study compared the effects of a high fat meal on two 5 mg oxycodone tablets taken by 24 healthy males. The Cmax was increased by a mean of 29% and the AUCinf by an average of 14.5%. Again, there was no evidence of dose dumping.

5.2 Pharmacokinetic Properties

Absorption.

Following single dose oral administration of Oxycodone Sandoz tablets to healthy subjects under fasting conditions, mean peak plasma concentrations of oxycodone were achieved within 2-4 hours.
Oxycodone Sandoz tablets 5, 10, 20, 40 and 80 mg are dose proportional in terms of both rate and extent of absorption.
Earlier bioequivalence studies indicated that ingestion of a standard high fat meal does not alter the peak oxycodone concentration or the extent of oxycodone absorption, however, two later studies on the lowest (5 mg) and highest (160 mg not marketed in Australia) oxycodone strengths suggested that a high fat meal increased the AUC by up to 20% and the Cmax by up to 29%.

Distribution.

Compared with morphine, which has an absolute bioavailability of approximately 30%, oxycodone has a high absolute bioavailability of up to 87% following oral administration.
Oxycodone Sandoz tablets are expected to provide onset of analgesia within one hour in most patients with a 12 hour duration of action. Steady state is achieved in about one day.
Release of oxycodone from Oxycodone Sandoz tablets is independent of pH under physiological conditions.

Metabolism.

It is metabolised principally to noroxycodone and oxymorphone. Oxymorphone has some analgesic activity but is present in plasma in low concentrations and is not considered to contribute to oxycodone's pharmacological effect.
Oxycodone hydrochloride is metabolised in the liver to form noroxycodone, oxymorphone, noroxymorphone, 6alpha and beta oxycodol and conjugated glucuronides. CYP3A4 and CYP2D6 are involved in the formation of noroxycodone and oxymorphone, respectively (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). The contribution of these metabolites to the analgesic effect is insignificant.

Excretion.

Oxycodone has an elimination half-life of approximately three hours.

5.3 Preclinical Safety Data

Genotoxicity.

Oxycodone was not genotoxic in bacterial gene mutation assays, but was positive in the mouse lymphoma assay. In assays of chromosomal damage, genotoxic effects occurred in the human lymphocyte chromosomal aberration assay in vitro, but not in the in vivo bone marrow micronucleus assay in mice.

Carcinogenicity.

Studies of oxycodone in animals to evaluate its carcinogenic potential have not been conducted.

4 Clinical Particulars

4.1 Therapeutic Indications

Oxycodone Sandoz is indicated for the management of moderate to severe chronic pain unresponsive to non-narcotic analgesia.

4.3 Contraindications

Hypersensitivity to opioids or to any of the constituents of Oxycodone Sandoz tablets, acute respiratory depression, cor pulmonale, cardiac arrhythmias, acute asthma or other obstructive airways disease, paralytic ileus, suspected surgical abdomen, severe renal impairment (creatinine clearance < 10 mL/minute) or severe hepatic impairment (see Section 4.4 Special Warnings and Precautions for Use, Special risk groups), delayed gastric emptying, acute alcoholism, brain tumour, increased cerebrospinal or intracranial pressure, head injury (due to risk of raised intracranial pressure), severe CNS depression, convulsive disorders, delirium tremens, hypercarbia, concurrent administration of monoamine oxidase inhibitors or within two weeks of discontinuation of their use. Not recommended for preoperative use or for the first 24 hours postoperatively. Pregnancy.

4.4 Special Warnings and Precautions for Use

The major risk of opioid excess is respiratory depression including subclinical respiratory depression. As with all opioids, a reduction in dosage may be advisable in hypothyroidism. Use with caution in opioid dependent patients and in patients with raised intracranial pressure, hypotension, hypovolaemia, diseases of the biliary tract, pancreatitis, inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency (Addison's disease), toxic psychosis, chronic respiratory, renal and hepatic disease, myxoedema and debilitated elderly or infirm patients or patients taking benzodiazepines, other CNS depressants (including alcohol) or MAO inhibitors. As with all opioid preparations, patients who are to undergo cordotomy or other pain relieving surgical procedures should not receive Oxycodone Sandoz tablets for 24 hours before surgery. Pain in the immediate preoperative period, and any symptoms of opioid withdrawal, should be managed with short acting analgesic agents. If further treatment with Oxycodone Sandoz tablets is then indicated, the dosage should be adjusted to the new postoperative requirement.
Concurrent use of oxycodone and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concurrent prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe oxycodone concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depressions and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Hyperalgesia that will not respond to a further dose increase of oxycodone may very rarely occur in particular at high doses. An oxycodone dose reduction or change in opioid may be required.
As with all opioid preparations, oxycodone tablets should be used with caution following abdominal surgery as opioids are known to impair intestinal motility and should not be used until the doctor is assured of normal bowel function. Should paralytic ileus be suspected or occur during use, Oxycodone Sandoz tablets should be discontinued immediately.
Use caution when prescribing Oxycodone Sandoz tablets for patients who have any underlying GI disorders that may predispose them to intestinal obstruction. Patients with underlying GI disorders such as oesophageal cancer or colon cancer with a small gastrointestinal lumen are at greater risk.
Oxycodone Sandoz tablets should not be taken by patients with difficulty in swallowing or who have been diagnosed with narrowing of the oesophagus. If patients experience swallowing difficulties (e.g. choking, gagging, discomfort, regurgitation, tablets stuck in the throat) after taking Oxycodone Sandoz tablets, they should be advised to seek immediate medical attention.
Opioids such as oxycodone hydrochloride, may influence the hypothalamic-pituitary-adrenal or -gonadal axes. Some changes that can be seen include an increase in serum prolactin and decreases in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes.

Use in chronic, non-malignant pain.

The use of Oxycodone Sandoz for the treatment of chronic pain which is not due to malignancy should be restricted to situations where: all other conservative methods of analgesia have been tried and have failed or are insufficient; the pain is having a significant impact on the patient's quality of life; there is no psychological contraindication, drug seeking behaviour or past and current personal or family history of alcohol, prescription/illicit drug abuse or misuse.
Opioids, where clinically indicated, should only be prescribed as one component of a comprehensive multimodal management approach to chronic, non-malignant pain. Appropriate patient selection is the key to successful treatment of moderate to severe chronic pain with opioid analgesics.
An initial comprehensive assessment should be conducted using a biopsychosocial approach to identify a cause for the pain and the appropriateness of opioid therapy, and to identify psychosocial factors that may exacerbate pain or magnify overall distress (e.g. depression, anxiety, post-traumatic stress disorder, borderline personality disorder, marked family stressors, history of sexual abuse). In the absence of a clear indication for a strong opioid analgesic, drug seeking behaviour must be suspected and resisted, particularly in individuals with a history of, or propensity for, drug abuse. Factors that may put the patient at increased risk of opioid abuse/ addiction include a personal/ family history of substance, prescription medication and alcohol abuse, and major psychosocial issues (e.g. psychological/ psychiatric disorder). The use of opioids to treat predominant emotional distress should be avoided.
Generally, opioid analgesics are not initiated prior to a full initial clinical assessment and before consideration of other treatment options such as physiotherapy/ exercise/ rehabilitation approaches, psychosocial interventions such as CBT (cognitive behavioural therapy) self management approaches, involvement of a psychologist or psychiatrist to address psychological co-morbidities which may be impacting on pain coping and trials of other non-opioid pharmacotherapeutic or interventional strategies.
Prior to long-term prescription, a trial of Oxycodone Sandoz or a shorter acting opioid should be undertaken. Long-term administration of Oxycodone Sandoz should only occur if this trial demonstrates that the pain is opioid sensitive. Opioid naive patients who require rapid dose escalation with no concomitant pain relief within the trial period should generally be considered inappropriate for long-term therapy.
One doctor only should be responsible for the prescription and monitoring of the patient's opioid use.
Prescribers should consult appropriate clinical guidelines on the use of opioid analgesics in such patients (e.g. those published by the Australian Pain Society in The Medical Journal of Australia 1997; 167: 30-34).

Drug dependence.

As with other opioids, tolerance and physical dependence tend to develop upon repeated administration of oxycodone. There is potential for abuse of the drug and for development of strong psychological dependence. Oxycodone tablets should therefore be prescribed and handled with a high degree of caution appropriate to the use of a drug with strong abuse potential.
Withdrawal symptoms may occur following abrupt discontinuation of oxycodone therapy or upon administration of an opioid antagonist. Therefore, patients on prolonged therapy should be withdrawn gradually from the drug if it is no longer required for pain control.
Oxycodone should be used with caution and under close supervision in patients with pain not due to malignancy who have a prior history of substance abuse. However, in such cases, prior psychological assessment is essential and the prescribing doctor should consider whether the benefit of treatment outweighs the risk of abuse.

Formulation.

Oxycodone Sandoz modified release tablets are intended for oral use only. The modified release tablets must be swallowed whole, and not broken, chewed or crushed. The administration of broken, chewed or crushed modified release oxycodone tablets leads to a rapid release and absorption of a potentially fatal dose of oxycodone. Parenteral venous injection of the tablet constituents can be expected to result in local tissue necrosis, pulmonary granulomas and serious adverse reactions which may be fatal.

Special risk groups.

Gender.

Female subjects have, on average, plasma oxycodone concentrations up to 25% higher than males on a bodyweight adjusted basis. The reason for this difference is unknown. There were no significant male/ female differences detected for efficacy or adverse events in clinical trials.

Use in hepatic impairment.

In hepatic impairment, the administration of oxycodone does not result in significant levels of active metabolites. However, the plasma concentration of oxycodone in this patient population may be increased compared with patients having normal hepatic function. Therefore, initiation of dosing in patients with hepatic impairment should be reduced to one-third to one-half of the usual dose with cautious titration.

Use in renal impairment.

In renal impairment, the administration of oxycodone does not result in significant levels of active metabolites. However, the plasma concentration of oxycodone in this patient population may be increased compared with patients having normal renal function. Therefore, initiation of dosing in patients with renal impairment (creatinine clearance < 60 mL/minute) should be reduced to one-third to one-half of the usual dose with cautious titration.

Use in the elderly.

The plasma concentrations of oxycodone are only nominally affected by age, being approximately 15% greater in elderly as compared to young subjects. There were no differences in adverse event reporting between young and elderly subjects.

Elderly, debilitated patients.

As with other opioid initiation and titration, doses in elderly patients who are debilitated should be reduced one-third to one-half of the usual doses.

Paediatric use.

Oxycodone Sandoz modified release tablets are not recommended for use in children below the age of 12 years due to insufficient data on safety and efficacy.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Anticholinergic agents.

Concurrent use with oxycodone with anticholinergics or medications with anticholinergics activity (e.g. tricyclic antidepressants, antihistamines, antipsychotics, muscle relaxants, anti-Parkinson medications) may result in increased anticholinergic effects, including an increased risk of severe constipation and/or urinary retention.

Antihypertensive agents.

Hypotensive effects of these medications may be potentiated when used concurrently with oxycodone, leading to increased risk of orthostatic hypotension.

CNS depressants include, but are not limited to: sedatives (including benzodiazepines, antipsychotics, antidepressants, anxiolytics, hypnotics, general anaesthetics, phenothiazines, other tranquillizers, alcohol, other opioids, gabapentinoids such as pregabalin, benzodiazepines and neuroleptic drugs, etc.).

Concurrent use of oxycodone with sedative medicine such as benzodiazepines or related drugs increases the risk of profound sedation, respiratory depression, hypotension, death or coma because of additive CNS depressant effect. Caution is recommended with a reduction in dosage for one or both agents and a reduction in duration of concurrent use. Intake of alcoholic beverages while being treated with oxycodone tablets should be avoided because this may lead to more frequent undesirable effects such as somnolence and respiratory depression. Oxycodone hydrochloride containing products should be avoided in patients with a history of or present alcohol, drug or medicines abuse.

Coumarin derivatives.

Although there is little substantiating evidence, opiate agonists have been reported to potentiate the anticoagulant activity of coumarin derivatives.

Metoclopramide.

Concurrent use with oxycodone may antagonise the effects of metoclopramide on gastrointestinal motility.

Monoamine oxidase inhibitors (MAOIs).

Nonselective MAOIs intensify the effects of opioid drugs which can cause anxiety, confusion and significant respiratory depression. Severe and sometimes fatal reactions have occurred in patients concurrently administered MAOIs and pethidine. Oxycodone should not be given to patients taking nonselective MAOIs or within 14 days of stopping such treatment. As it is unknown whether there is an interaction between selective MAOIs (e.g. selegiline) and oxycodone, caution is advised with this drug combination.

Neuromuscular blocking agents.

Oxycodone may enhance the effects of neuromuscular blocking agents resulting in increased respiratory depression.

Opioid agonist analgesics (including morphine, pethidine).

Additive CNS depressant, respiratory depressant and hypotensive effects may occur if two or more opioid agonist analgesics are used concurrently.

Opioid agonist/ antagonist analgesics (including pentazocine, butorphanol, buprenorphine).

Mixed agonist/ antagonist analgesics may reduce the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms.

CYP3A4 and CYP2D6 inhibitors and inducers.

Oxycodone is metabolised in part via the CYP2D6 and CYP3A4 pathways. The activities of these metabolic pathways may be inhibited or induced by various co-administered drugs or dietary elements, which may alter plasma oxycodone concentrations. Oxycodone doses may need to be adjusted accordingly. Drugs that inhibit CYP2D6 activity, such as paroxetine and quinidine, may cause decreased clearance of oxycodone which could lead to an increase in oxycodone plasma concentrations. Concurrent administration of quinidine does not alter the pharmacodynamic effects of oxycodone. CYP3A4 inhibitors such as macrolide antibiotics (e.g. clarithromycin), azole antifungal agents (e.g. ketoconazole), protease inhibitors (e.g. ritonavir) and grapefruit juice may cause decreased clearance of oxycodone which could lead to an increase in oxycodone plasma concentrations. Oxycodone metabolism may be blocked by a variety of drugs (e.g. cimetidine, certain cardiovascular drugs and antidepressants), although such blockade has not yet been shown to be of clinical significance with Oxycodone Sandoz modified release tablets.
CYP3A4 inducers, such as rifampin, carbamazepine, phenytoin and St. John's wort, may induce the metabolism of oxycodone and cause increased clearance of the drug, resulting in a decrease in oxycodone plasma concentrations.
Oxycodone did not inhibit the activity of P450 isozymes 2D6, 3A4, 1A2, 2A6, 2C19 or 2E1 in human liver microsomes in vitro. Nonclinical data in vitro and in vivo indicate that oxycodone can act as a P-glycoprotein substrate and can induce overexpression of P-glycoprotein in rats.

Selective serotonin re-uptake inhibitor (SSRI) or a serotonin norepinephrine re-uptake inhibitor (SNRI).

Concurrent administration of oxycodone with serotonin agents, such as a Selective Serotonin Re-uptake Inhibitor (SSRI) or a Serotonin Norepinephrine Re-uptake Inhibitor (SNRI) may cause serotonin toxicity. The symptoms of serotonin toxicity may include mental-status changes (e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g. hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). Oxycodone should be used with caution and the dosage may need to be reduced in patients using these medications.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

In reproductive toxicology studies, no evidence of impaired fertility was seen in male or female rats at oral oxycodone doses of 8 mg/kg/day, with estimated exposure (plasma AUC) equivalent to 8 mg/day in men and 17 mg/day in women.
Despite these fertility studies in animals, prolonged use of opioids may result in impairment of reproductive function, including fertility and sexual dysfunction in both sexes, and irregular menses in women.
(Category C)
Oxycodone used during pregnancy or labour, may cause withdrawal symptoms and/or respiratory depression in the newborn infant. Oral administration of oxycodone during the period of organogenesis did not elicit teratogenicity or embryofoetal toxicity in rats or rabbits at doses up to 8 mg/kg/day in rats (equivalent to 17 mg/day in women, based on estimated plasma AUC values) or 125 mg/kg/day in rabbits.
Oral administration of oxycodone to rats from early gestation to weaning did not affect postnatal development parameters at doses up to 6 mg/kg/day (equivalent to 9 mg/day in women, based on estimated AUC values). In a study designed specifically to investigate the effect of prenatal oxycodone on the hypothalamic pituitary adrenal axis in adolescent rats, intravenous administration of oxycodone 0.8 mg/kg/day (equivalent to 11 mg/day in pregnant women, based on estimated AUC values) had no effect on the corticosterone response, but delayed and enhanced the peak ACTH response to corticotrophin releasing hormone in males, but not females. The clinical significance of this observation is unknown.
There are no adequate and well controlled studies with oxycodone in pregnant women. Because animal reproduction studies are not always predictive of human responses, oxycodone should not be used during pregnancy unless clearly needed. Prolonged use of oxycodone during pregnancy can result in neonatal opioid withdrawal. Oxycodone is not recommended for use in women during or immediately prior to labour. Infants born to mothers who have received opioids during pregnancy should be monitored for respiratory depression.
Oxycodone accumulates in human milk, with a median maternal plasma:milk ratio of 3:1 recorded in one study. Oxycodone (7.5 nanogram/mL) was detected in the plasma of one of 41 infants 72 hours after Caesarean section. Opioids may cause sedation and respiratory depression in the newborn and withdrawal symptoms can occur in breastfeeding infants when maternal administration of an opioid analgesic is stopped. Oxycodone should not be used in breastfeeding mothers unless the benefits outweigh the risks. Breastfed infants should be monitored for respiratory depression, sedation, poor attachment and gastrointestinal signs.

4.8 Adverse Effects (Undesirable Effects)

Adverse drug reactions are typical of full opioid agonists, and tend to reduce with time, with the exception of constipation. Anticipation of adverse drug reactions and appropriate patient management can improve acceptability.

Cardiac disorders.

Uncommon: palpitations (as part of withdrawal syndrome), bradycardia, supraventricular tachycardia, blood pressure and heart rate reductions, ST depression, chest pain.

Ear and labyrinth disorders.

Uncommon: tinnitus, vertigo.

Eye disorders.

Uncommon: miosis, visual impairment.

Gastrointestinal disorders.

Very common: nausea, vomiting, constipation. Common: dry mouth, gastritis, hiccup, dyspepsia, abdominal pain, diarrhoea. Uncommon: colic, dental caries, stomatitis, dysphagia, eructation, flatulence, gastrointestinal disorders, ileus, regurgitation, retching.

General disorders and administration site conditions.

Common: asthenic conditions, sweating, fever, chills, fatigue. Uncommon: accidental injury, pain, neck pain, drug tolerance, drug withdrawal syndrome (with or without seizures), facial flushing, malaise, muscular rigidity, lymphadenopathy, oedema, peripheral oedema, thirst. Not known: drug withdrawal syndrome neonatal.

Hepatobiliary disorders.

Uncommon: biliary spasm, cholestasis, increased hepatic enzymes.

Immune system disorders.

Uncommon: allergic reaction, anaphylactic reaction, anaphylactoid reaction, hypersensitivity.

Injury, poisoning and procedural complications.

Uncommon: medication stuck in throat.

Metabolic and nutritional disorders.

Common: decreased appetite. Uncommon: anorexia, increased appetite, dehydration, hyponatraemia.

Nervous system disorders.

Very common: dizziness, headache, somnolence. Common: faintness, sedation, twitching, tremor, lethargy. Uncommon: drowsiness, raised intracranial pressure, hypothermia, abnormal gait, amnesia, hyperkinesia, hypoaesthesia, hypertonia, muscle contractions involuntary, paraesthesia, speech disorder, stupor, seizures, syncope, convulsion, dysgeusia (taste perversion). Not known: hyperalgesia.

Psychiatric disorders.

Common: abnormal dreams, anxiety, confusional state, insomnia, nervousness, thinking abnormal, depression. Uncommon: affect lability, agitation, decreased libido, disorientation, drug dependence, dysphoria, euphoric mood, hallucinations, altered mood, restlessness. Unknown: aggression.

Renal and urinary disorders.

Uncommon: ureteric spasm, urinary retention, urinary abnormalities, urinary tract infections.

Reproductive system and breast disorders.

Uncommon: amenorrhoea, erectile dysfunction, hypogonadism.

Respiratory, thoracic and mediastinal disorders.

Common: bronchospasm, dyspnoea, pharyngitis, voice alteration. Uncommon: respiratory depression, choking.

Skin and subcutaneous tissue disorders.

Very common: pruritus. Common: hyperhidrosis, rash. Uncommon: dry skin, exfoliative dermatitis, urticaria and other skin rashes.

Vascular disorders.

Common: orthostatic hypotension. Uncommon: hypotension, migraine, vasodilation.

Key.

Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
If nausea and vomiting are troublesome, oxycodone may be combined with an antiemetic. Constipation must be treated with appropriate laxatives. Overdose may produce respiratory depression. Compared with other opioids, oxycodone is associated with low histamine release although urticaria and pruritus may occur.

Post-marketing.

There have been rare post-marketing cases of intestinal obstruction, and exacerbation of diverticulitis, some of which have required medical intervention to remove the tablet.
There have been uncommon post-marketing reports of difficulty swallowing oxycodone 10 mg to 80 mg tablets, potentially due to the swelling and hydrogelling property of the tablets: choking, gagging, regurgitation, tablets stuck in the throat and difficulty swallowing the tablet.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Dosage.

Oxycodone Sandoz tablets 80 mg should only be used in opioid tolerant patients. In patients not previously exposed to opioids (opioid naive), this tablet strength may cause fatal respiratory depression.
Alcoholic beverages should be avoided while the patient is being treated with Oxycodone Sandoz tablets.

Adults, elderly and children over 12 years.

Prior to initiation and titration of doses, see Section 4.4 Special Warnings and Precautions for Use for information on special risk groups such as females and the elderly. Oxycodone Sandoz tablets should be taken at 12 hourly intervals. Appropriate pain management principles of careful assessment and ongoing monitoring should be followed at regular intervals, including reassessing the need for continued opioid therapy. The dosage is dependent on the severity of the pain, and the patient's previous history of analgesic requirements.
Increasing severity of pain will require an increased dosage of Oxycodone Sandoz tablets using the 10, 20, 40 or 80 mg tablet strengths, either alone or in combination, to achieve pain relief. The correct dosage for any individual patient is that which controls the pain and is well tolerated for a full 12 hours.
There is no ceiling dose and so patients should be titrated to pain relief unless unmanageable adverse drug reactions prevent this. If higher doses are necessary increases should be made, where possible, in 25 to 50% increments. The need for escape medication more than twice a day indicates that the dosage of Oxycodone Sandoz tablets should be increased.
The usual starting dose for opioid naive patients or patients presenting with severe pain uncontrolled by weaker opioids is 10 mg 12 hourly or 5 mg 12 hourly for patients with renal or hepatic impairment. The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief.
Patients receiving oral morphine before Oxycodone Sandoz tablet therapy should have their daily dose based on the following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral morphine. It must be emphasised that this is a guide to the dose of Oxycodone Sandoz tablets required. Interpatient variability requires that each patient is carefully titrated to the appropriate dose.
Controlled pharmacokinetic studies in elderly patients (aged over 65 years) have shown that compared with younger adults the clearance of oxycodone is only slightly reduced. No untoward adverse drug reactions were seen based on age, therefore adult doses and dosage intervals are appropriate.

Children under 12 years.

Not recommended.

Method of administration.

Oxycodone Sandoz tablets are to be swallowed whole, and are not to be cut, broken, chewed, crushed or dissolved. Taking cut, broken, chewed, crushed or dissolved Oxycodone Sandoz tablets could lead to the rapid release and absorption of a potentially toxic dose of oxycodone.
To avoid difficulty swallowing, Oxycodone Sandoz tablets should not be pre-soaked, licked or otherwise wetted prior to placing in the mouth and should be taken one tablet at a time with enough water to ensure complete swallowing immediately after placing it in the mouth.
There are no data on rectal administration of Oxycodone Sandoz tablets, therefore rectal administration of Oxycodone Sandoz tablets is not recommended.
Do not administer Oxycodone Sandoz tablets via nasogastric, gastric or other feeding tubes as it may cause obstruction of feeding tubes.

Dosage adjustment in.

Renal impairment.

The dose initiation should follow a conservative approach in these patients. The recommended adult starting dose should be reduced by 1/3 to 1/2, and each patient should be titrated to adequate pain control according to their clinical situation (see Section 4.4 Special Warnings and Precautions for Use, Special risk groups).

Hepatic impairment.

See above.

Patients transferring from other opioid formulations.

(For transfer from oral morphine, also see Adults, elderly and children over 12 years.) Patients receiving other oral oxycodone formulations may be transferred to Oxycodone Sandoz at the same total daily dosage, equally divided into two 12 hourly Oxycodone Sandoz doses.
For patients who are receiving an alternative opioid, the oral oxycodone equivalent of the analgesic presently being used should be determined. Having determined the total daily dosage of the present analgesic, the following equivalence table (see Table 1) can be used to calculate the approximate daily oral oxycodone dosage that should provide equivalent analgesia. The total daily oral oxycodone dosage should then be equally divided into two 12 hourly Oxycodone Sandoz doses.

4.7 Effects on Ability to Drive and Use Machines

Oxycodone may modify patients' reactions to a varying extent depending on the dosage and individual susceptibility. If their ability is impaired, patients should not drive or operate machinery.

4.9 Overdose

Symptoms.

Acute overdosage with oxycodone can be manifested by respiratory depression (reduced respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, hypotonia, skeletal muscle flaccidity, cold and/or clammy skin, miosis (dilated if hypoxia is severe), and sometimes bradycardia, hypotension, pulmonary oedema and death. Severe overdose may result in apnoea, pulmonary oedema, circulatory collapse and death. The features of overdose may be delayed with a modified release product such as Oxycodone Sandoz tablets.

Treatment.

Primary attention should be given to immediate supportive therapy with the establishment of adequate respiratory exchange through the provision of a patent airway and institution of assisted or controlled ventilation. Adequate body temperature and fluid balance should be maintained. Oxygen, intravenous fluids, vasopressors and other supportive measures should be used as indicated, to manage the circulatory shock accompanying an overdose. Cardiac arrest or arrhythmias may require cardiac massage or defibrillation.
Activated charcoal may reduce absorption of the drug if given within one to two hours after ingestion. Administration of activated charcoal should be restricted to patients who are fully conscious with an intact gag reflex or protected airway. A saline cathartic or sorbitol added to the first dose of activated charcoal may speed gastrointestinal passage of the product. In patients who are not fully conscious or have an impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.
Whole bowel irrigation (e.g. 1 or 2 litres of polyethylene glycol solution orally per hour until rectal effluent is clear) may be useful for gut decontamination. Whole bowel irrigation is contraindicated in patients with bowel obstruction, perforation, ileus, haemodynamic instability or compromised, unprotected airways and should be used cautiously in debilitated patients and where the condition may be further compromised. Concurrent administration of activated charcoal and whole bowel irrigation may decrease the effectiveness of the charcoal (there may be competition for the charcoal binding site between the polyethylene glycol and the ingested drugs) but the clinical relevance is uncertain. Prolonged periods of observation (days), may be required for patients who have overdosed with long acting oxycodone preparations.
If there are signs of clinically significant respiratory or cardiovascular depression, the use of an opioid antagonist should be considered. The opioid antagonist naloxone hydrochloride is a specific antidote for respiratory depression due to overdosage or as a result of unusual sensitivity to opioid. The usual intravenous adult dose of naloxone is 0.4 mg or higher (please refer to naloxone product information for further information). The onset of naloxone effect may be delayed by 30 minutes or more. Concomitant efforts at respiratory resuscitation should be carried out. Since the duration of action of oxycodone, particularly sustained release formulations, may exceed that of the antagonist, the patient should be under continued surveillance and doses of the antagonist should be repeated as needed, or an antagonist infusion established, to maintain adequate respiration.
In an individual physically dependent on, or tolerant to opioids, the administration of the usual dose of opioid antagonist can precipitate an acute withdrawal syndrome. This may lead to agitation, hypertension, tachycardia and risk of vomiting with possible aspiration. The severity of this syndrome will depend on the degree of physical dependence and the dose of antagonist administered. The use of opioid antagonists in such individuals should be avoided if possible. If an opioid antagonist must be used to treat serious respiratory depression in the physically dependent patient, the antagonist should be administered with extreme care by using dosage titration, commencing with 10 to 20% of the usual recommended initial dose.

Toxicity.

Oxycodone toxicity may result from overdosage but because of the great interindividual variation in sensitivity to opioids it is difficult to determine an exact dose of any opioid that is toxic or lethal. Crushing and taking the contents of a modified release dosage form leads to the release of oxycodone in an immediate fashion; this might result in a fatal overdose. The toxic effects and signs of overdosage may be less pronounced than expected, when pain and/or tolerance are manifest.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

S8.

6 Pharmaceutical Particulars

6.1 List of Excipients

Excipients core.

Maize starch, behenoyl polyoxylglycerides, lactose monohydrate, medium chain triglycerides, copovidone, hydrogenated castor oil, colloidal anhydrous silica, magnesium stearate.

Excipients coating.

Hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide, indigo carmine aluminium lake (5 mg tablets only), iron oxide red (20 mg tablets only), iron oxide yellow (40 mg tablets only), iron oxide black (80 mg tablets only) and 815063 Spectracol Green Lake (80 mg tablets only).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
For information on interactions with other medicines and other forms of interactions, see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Packaged in PVC/PE/PVDC/Al blister packs or HDPE bottles of 20, 28 or 60 tablets.
Not all presentations are marketed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

Summary Table of Changes