Consumer medicine information

Proladone

Oxycodone

BRAND INFORMATION

Brand name

Proladone

Active ingredient

Oxycodone

Schedule

What is in this leaflet

This leaflet answers some common questions about Proladone.

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 using Proladone against the benefits they expect it will have for you.

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

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

What Proladone is used for

Proladone is a suppository containing oxycodone. It belongs to a group of medicines called opioid analgesics and acts to relieve pain.

Proladone is used to relieve pain after surgery or for treating cancer pain.

Your doctor may have prescribed Proladone for another reason.

Ask your doctor if you have any questions about why Proladone has been prescribed for you. Proladone is only available with a doctor’s prescription.

Addiction
You can become addicted to Proladone even if you take it exactly as prescribed. Proladone may become habit forming causing mental and physical dependence. If abused it may become less able to reduce pain.

Dependence
As with all other opioid containing products, your body may become used to you taking Proladone. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking Proladone suddenly, so it is important to take it exactly as directed by your doctor.

Tolerance
Tolerance to Proladone may develop, which means that the effect of the medicine may decrease. If this happens, more may be needed to maintain the same effect.

Withdrawal
Continue taking your medicine for as long as your doctor tells you. If you stop taking this medicine suddenly, your pain may worsen and you may experience some or all of the following withdrawal symptoms:

nervousness, restlessness, agitation, trouble sleeping or anxiety
body aches, weakness or stomach cramps
loss of appetite, nausea, vomiting or diarrhoea
increased heart rate, breathing rate or pupil size
watery eyes, runny nose, chills or yawning
increased sweating.

Proladone given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn.

Before you use Proladone

When you must not use it

Do not use Proladone if you have an allergy to Proladone or any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction are:

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
discolouration of the skin.

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

head injury, or increased pressure in the head
brain tumour
epilepsy (also known as fits or convulsions)
are taking, or have taken in the last 14 days, medicine for depression especially Monoamine Oxidase Inhibitors (MAOIs)
heart problems such as irregular and/or rapid heartbeat
asthma
any difficulty in breathing
alcoholism.

Do not use this medicine for children as there have been no studies of its effects in children.

Do not use this medicine after the expiry date printed on the packet.

Do not use this medicine if the packaging is torn or shows signs of tampering.

If you are not sure whether you should be using Proladone contact your doctor.

Before you start to use Proladone

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you are pregnant or intend to become pregnant. Your doctor or pharmacist will discuss the possible risks and benefits of using Proladone during pregnancy.

Tell your doctor if you are breast-feeding or plan to breast-feed. Like most opioid medicines, Proladone is not recommended while you are breast-feeding.

Tell your doctor if you have, or have had, any medical conditions, especially the following:

myasthenia gravis, a disease of the muscles
an underactive thyroid gland
kidney disease
liver disease
if male, prostate problems or difficulty passing water
bowel disorders
asthma or breathing problems.

If you have not told your doctor about any of the above, tell them before you start using Proladone.

Taking other medicines

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

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

medicines used to treat hyperactivity
medicines used to produce calmness or to help you sleep
medicines called anaesthetics which are used to put you to sleep during an operation or procedure
barbiturates, medicines used to treat epilepsy, to produce calmness or to help you sleep
other opioid medicines used to treat pain
medicines used to treat depression, psychiatric or mental disorder
medicines used to treat certain mental and emotional conditions e.g. depression
medicines used to treat high blood pressure or other heart conditions
medicines used to prevent blood clots
medicines used to prevent or relieve the symptoms of allergy (such as hay fever)
medicines used to treat nausea or vomiting.

These medicines may be affected by Proladone or they may affect how well it works.

Tell your doctor if you regularly drink alcohol. Alcohol may interfere with this medicine. Your doctor may advise you to stop drinking alcohol while using this medicine.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while using Proladone.

How to use Proladone

How much to use

Your doctor will tell you how many suppositories you need to use each day.

How to use it

If possible, go to the toilet and empty your bowels before using your suppository. Suppositories work best if your bowels are empty.

Follow these steps to use a suppository:

Wash your hands thoroughly with soap and water.
Feel the suppository while it is still in the foil.
If it feels soft, keep it in the foil and chill it in the fridge or by holding it under cold water for a few minutes. Do not remove the foil wrapper while you are chilling it.
Put on a disposable glove, if desired. They are available from pharmacies.
Remove all of the foil wrapper from the suppository.
Moisten the suppository by dipping it briefly in cool water.
Lie on your side and raise your knee to your chest.
Push the suppository gently, pointed end first, into your rectum (back passage).
Remain lying down for a few minutes while the suppository dissolves.
Throw away the disposable glove and any used material and wash your hands thoroughly to reduce the risk of infection.

Try not to go to the toilet and open your bowels for at least an hour after using the suppository. The suppository takes about one hour to be completely absorbed and do its work.

If you are not sure how to use a suppository, ask your doctor or pharmacist.

If you forget to use Proladone

If it is almost time for your next suppository (within 2 or 3 hours), skip the suppository you missed and use your next suppository when you are meant to.

Otherwise, use it as soon as you remember, and then go back to using the suppositories as you would normally.

Do not use two suppositories to make up for the one 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 use your medicine, ask your pharmacist for some hints.

How long to use it

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

Do not suddenly stop using Proladone. Your doctor may want you to gradually reduce the amount of Proladone you are using before stopping completely. Stopping gradually will lessen the risk of unwanted side effects.

If you use too much (overdose)

If you or someone else receive too much (overdose), and experience one or more of the symptoms below, immediately call triple zero (000) for an ambulance. Keep the person awake by talking to them or gently shaking them every now and then. You should follow the above steps even if someone other than you have accidentally used Proladone that was prescribed for you. If someone takes an overdose they may experience one or more of the following symptoms:

Slow, unusual or difficult breathing
Drowsiness, dizziness or unconsciousness
Slow or weak heartbeat
Nausea or vomiting
Convulsions or fits

If you think you or someone else may have used too much Proladone, you should immediately:

phone the Poisons Information Centre by calling 13 11 26 (Australia), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning. When seeking medical attention, take this leaflet and remaining medicine with you to show the doctor. Also tell them about any other medicines or alcohol which have been taken.

While you are using Proladone

Things you must do

Tell any other doctors, dentists, and pharmacists who are treating you that you are using Proladone.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are using Proladone.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are using Proladone.

If you become pregnant while using Proladone, tell your doctor.

Things you must not do

Do not give Proladone to anyone else, even if they have the same condition as you.

Do not use Proladone to treat any other complaints unless your doctor tells you to.

Do not stop using Proladone or lower or increase the dose without checking with your doctor.

Do not run out of this medicine over the weekend or on holidays.

Your doctor may want you to gradually reduce the amount of Proladone you are using before stopping completely. This may help reduce the possibility of withdrawal symptoms such as nausea, diarrhoea, body aches (see Side effects).

Things to be careful of

Be careful when drinking alcohol while you are using Proladone. Drinking alcohol while using this medicine could make you feel more dizzy, sleepy or light-headed than usual. Your doctor may suggest you avoid alcohol while you are using Proladone.

Be careful driving or operating machinery until you know how Proladone affects you. Proladone may cause drowsiness, sleepiness or dizziness in some people and affect alertness. Make sure you know how you react to Proladone before you drive or operate machinery or do anything else that could be dangerous if you are sleepy or dizzy. If this occurs do not drive.

Be careful using the suppositories for people over 65 years. Families and carers should be aware that these people may become confused while using Proladone. Special care may be needed.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Proladone. Proladone helps most people with pain, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

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

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

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

confusion
drowsiness
constipation
vomiting
nausea.

These are the more common side effects of Proladone.

Other side effects are:

difficulty passing water (urine)
decreased frequency passing water (urine)
dry mouth
sweating
redness of the face
loss of appetite
faintness or feeling weak
slow heart rate
abnormal or fast heart rate
irregular heart beat
dizziness on standing
restlessness
constriction of pupils
changes of mood
decrease in body temperature
muscle stiffness
itchy rash or other forms of itchiness
severe headache.

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

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

These may be very serious side effects. You may need urgent medical attention or hospitalisation.

All of these side effects are very rare.

High doses of Proladone can cause:

heart failure
low blood pressure
inability to breathe properly.

The following side effects may occur when you stop using Proladone:

body aches
diarrhoea
gooseflesh or goose bumps
loss of appetite
nervousness
restlessness
runny nose
sneezing
shivering
stomach cramps
feeling sick, also called nausea
trouble sleeping
an increase in sweating and yawning
weakness
fast heart beat
unexplained fever.

These symptoms are usually mild if Proladone is stopped gradually.

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

After using Proladone

Storage

Keep your suppositories in the foil pack until it is time to use them. If you take the suppositories out of the pack they will not keep well.

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

Do not store Proladone or any other medicines in the bathroom or near a sink.

Do not leave it in the car on hot days or on window sills. 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 using the suppositories, if the medicine is damaged, you no longer need to use this medicine or you find that they have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What it looks like

Proladone is a smooth, off-white, oval/cone-shaped suppository for rectal use which will dissolve in the rectum (back passage). It is covered by a wax coating for easy insertion into the rectum.

Ingredients

Each Proladone suppository contains 30 mg of oxycodone.

Proladone suppositories also contain:

lactose monohydrate
maize starch
pectin
povidone
magnesium stearate
hard fat.

Proladone does not contain sucrose, gluten, tartrazine, alcohol, dyes or preservatives.

Supplier

Proladone is supplied in Australia by:

Phebra Pty Ltd,
19 Orion Road,
Lane Cove West, NSW 2066,
Australia.

Proladone 30 mg
12 suppositories per foil strip

AUST R 14965

Phebra Product Code - TAB007

Date of most recent amendment Apr 2020.

Phebra and the Phi symbol are trademarks of Phebra Pty Ltd, 19 Orion Road, Lane Cove West, NSW 2066, Australia.

Published by MIMS June 2020

BRAND INFORMATION

Brand name

Proladone

Active ingredient

Oxycodone

Schedule

1 Name of Medicine

Oxycodone.

2 Qualitative and Quantitative Composition

Proladone suppositories contain oxycodone 30 mg per suppository as the active ingredient.
Proladone suppositories also contain lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Proladone suppositories consist of an oval, 22 mm x 10 mm compressed cone, which will dissolve in use and which is covered by a wax coating to aid insertion, presented as a smooth, mottled, off-white product.

4 Clinical Particulars

4.1 Therapeutic Indications

Semisynthetic narcotic analgesic. Relief of post-operative pain following a wide range of major operative procedures such as major orthopaedic, abdominal, gynaecological and thoracic surgery, and for the relief of pain in malignant disease.

4.2 Dose and Method of Administration

One suppository every six to eight hours; in case of terminal disease, one suppository as required to control pain.

4.3 Contraindications

Hypersensitivity to opiate narcotics, severe respiratory disease, acute respiratory disease, acute respiratory depression, cor pulmonale, cardiac arrhythmias, bronchial asthma, acute alcoholism, brain tumour, head injuries, increased cerebrospinal or intracranial pressure, severe central nervous system (CNS) depression, convulsive disorders, delirium tremens, suspected surgical abdomen, and concomitant monoamine oxidase inhibitors (MAOIs) or within 14 days of such therapy.
The use of Proladone suppositories is contraindicated in chronic (long-term) non-cancer pain.

4.4 Special Warnings and Precautions for Use

Oxycodone can produce drug dependence and, therefore, has the potential of being abused. Psychological dependence, physical dependence and tolerance may develop upon repeated administration. Abrupt withdrawal of oxycodone in those physically dependent may precipitate withdrawal symptoms. 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 extreme caution in patients with head injuries and raised intracranial pressure, as respiratory depression and ability to increase cerebrospinal fluid (CSF) pressure may be exaggerated, thereby complicating the clinical course.
Therapeutic doses of oxycodone may decrease respiratory drive and increase airways resistance in patients with acute asthma, chronic obstructive airways disease or those with substantially decreased pulmonary reserve or respiratory depression.
Oxycodone should be used only with caution and in reduced dosage during concomitant administration of other narcotic analgesics, general anaesthetics, phenothiazines and other tranquillisers, sedative/ hypnotics, some tricyclic antidepressants and other CNS depressants (including alcohol). Respiratory depression, hypotension and profound sedation or coma may result.
Administration of oxycodone may result in severe hypotension in patients whose ability to maintain adequate blood pressure is compromised by reduced blood volume, or concurrent administration of such drugs as phenothiazines or certain anaesthetics. Oxycodone may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
Opioid analgesics should be used with caution in patients with myasthenia gravis.
The euphoric activity of opioid compounds has led to their abuse. It should be given with caution or in reduced doses to patients with hypothyroidism, adrenocortical insufficiency, impaired kidney or liver function, prostatic hypertrophy or shock. It should be used with caution in patients with obstructive bowel disorders.

Hazardous and harmful use.

Proladone suppositories contains the opioid oxycodone and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed Proladone suppositories at recommended doses.
The risk of addiction is increased in patients with a personal or family history of substance abuse (including alcohol and prescription and illicit drugs) or mental illness. The risk also increases the longer the drug is used and with higher doses. Patients should be assessed for their risks for opioid abuse or addiction prior to being prescribed Proladone suppositories.
All patients receiving opioids should be routinely monitored for signs of misuse and abuse. Opioids are sought by people with addiction and may be subject to diversion. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the safe storage and proper disposal of any unused drug (see Section 6.4 Special Precautions for Storage; Section 6.6 Special Precautions for Disposal). Caution patients that abuse of oral or transdermal forms of opioids by parenteral administration can result in serious adverse events, which may be fatal.
Patients should be advised not to share Proladone suppositories with anyone else.

Respiratory depression.

Serious, life-threatening or fatal respiratory depression can occur with the use of opioids even when used as recommended. It can occur at any time during the use of Proladone suppositories but the risk is greatest during initiation of therapy or following an increase in dose. Patients should be monitored closely for respiratory depression at these times.
The risk of life-threatening respiratory depression is also higher in elderly, frail, or debilitated patients and in patients with existing impairment of respiratory function (e.g. chronic obstructive pulmonary disease; asthma) and in patients with hepatic or renal impairment (see Use in hepatic impairment, Use in renal impairment). Opioids should be used with caution and with close monitoring in these patients (see Section 4.2 Dose and Method of Administration). The use of opioids is contraindicated in patients with severe respiratory disease, acute respiratory disease and respiratory depression (see Section 4.3 Contraindications).
The risk of respiratory depression is greater with the use of high doses of opioids, especially high potency and modified release formulations, and in opioid naïve patients. Initiation of opioid treatment should be at the lower end of the dosage recommendations with careful titration of doses to achieve effective pain relief. Careful calculation of equianalgesic doses is required when changing opioids or switching from immediate release to modified release formulations, (see Section 4.2 Dose and Method of Administration), together with consideration of pharmacological differences between opioids. Consider starting the new opioid at a reduced dose to account for individual variation in response.

Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol.

Concomitant use of opioids and benzodiazepines or other CNS depressants, including alcohol, may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of Proladone suppositories with CNS depressant medicines, such as other opioid analgesics, benzodiazepines, gabapentinoids, cannabis, sedatives, hypnotics, tricyclic antidepressants, antipsychotics, antihistamines, centrally-active anti-emetics and other CNS depressants, should be reserved for patients for whom other treatment options are not possible. If a decision is made to prescribe Proladone suppositories concomitantly with any of the medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible. Patients should be followed closely for signs and symptoms of respiratory depression and sedation. Patients and their caregivers should be made aware of these symptoms. Patients and their caregivers should also be informed of the potential harms of consuming alcohol while taking Proladone suppositories.

Tolerance, dependence and withdrawal.

Neuroadaptation of the opioid receptors to repeated administration of opioids can produce tolerance and physical dependence. Tolerance is the need for increasing doses to maintain analgesia. Tolerance may occur to both the desired and undesired effects of the opioid.
Physical dependence, which can occur after several days to weeks of continued opioid usage, results in withdrawal symptoms if the opioid is ceased abruptly or the dose is significantly reduced. Withdrawal symptoms can also occur following the administration of an opioid antagonist (e.g. naloxone) or partial agonist (e.g. buprenorphine). Withdrawal can result in some or all of the following symptoms: dysphoria, restlessness/agitation, lacrimation, rhinorrhoea, yawning, sweating, chills, myalgia, mydriasis, irritability, anxiety, increasing pain, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhoea, increased blood pressure, increased respiratory rate and increased heart rate.
When discontinuing Proladone suppositories in a person who may be physically-dependent, the drug should not be ceased abruptly but withdrawn by tapering the dose gradually (see Ceasing opioids and see Section 4.2 Dose and Method of Administration).

Accidental ingestion/exposure.

Accidental ingestion or exposure of Proladone suppositories, especially by children, can result in a fatal overdose of oxycodone. Patients and their caregivers should be given information on safe storage and disposal of unused Proladone suppositories (see Section 6.4 Special Precautions for Storage; Section 6.6 Special Precautions for Disposal).

Hyperalgesia.

Hyperalgesia may occur with the use of opioids, particularly at high doses. Hyperalgesia may manifest as an unexplained increase in pain, increased levels of pain with increasing opioid dosages or diffuse sensitivity not associated with the original pain. Hyperalgesia should not be confused with tolerance (see Tolerance, dependence and withdrawal). If opioid induced hyperalgesia is suspected, the dose should be reduced and tapered off if possible. A change to a different opioid may be required.

Ceasing opioids.

Abrupt discontinuation or rapid decreasing of the dose in a person physically dependent on an opioid may result in serious withdrawal symptoms and uncontrolled pain (see Tolerance, dependence and withdrawal). Such symptoms may lead the patient to seek other sources of licit or illicit opioids. Opioids should not be ceased abruptly in a patient who is physically dependent but withdrawn by tapering the dose slowly. Factors to take into account when deciding how to discontinue or decrease therapy include the dose and duration of the opioid the patient has been taking, the type of pain being treated and the physical and psychological attributes of the patient. A multimodal approach to pain management should be in place before initiating an opioid analgesic taper. During tapering, patients require regular review and support to manage any increase in pain, psychological distress and withdrawal symptoms.
There are no standard tapering schedules suitable for all patients and an individualised plan is necessary. In general, tapering should involve a dose reduction of no more than 10 percent to 25 percent every 2 to 4 weeks (see Section 4.2 Dose and Method of Administration). If the patient is experiencing increased pain or serious withdrawal symptoms, it may be necessary to go back to the previous dose until stable before proceeding with a more gradual taper.
When ceasing opioids in a patient who has a suspected opioid use disorder, the need for medication assisted treatment and/or referral to a specialist should be considered.

Use in hepatic impairment.

Oxycodone should be given with caution or in reduced doses to patients with impaired liver function.

Use in renal impairment.

Oxycodone should be given with caution or in reduced doses to patients with impaired kidney function.

Use in the elderly.

Oxycodone should be administered with caution and in reduced dosages to elderly patients.

Paediatric use.

Oxycodone should not be administered to children.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Generally, the effects of oxycodone may be antagonised by acidifying agents and potentiated by alkalising agents.
The analgesic effect of oxycodone is potentiated by amphetamines, chlorpromazine and methocarbol. CNS depressants, such as other opioids, alcohol, anaesthetics, sedatives, benzodiazepines, hypnotics, barbiturates, phenothiazines, chloral hydrate, glutethimide, gabapentinoids, cannabis, tricyclic antidepressants, antipsychotics, antihistamines, centrally-active anti-emetics and other CNS depressants may enhance the depressant effects of oxycodone (see Section 4.4 Special Warnings and Precautions for Use, Risks from concomitant use of benzodiazepines or other CNS depressants, including alcohol). MAOIs (including procarbazine hydrochloride), pyrazolidone antihistamines, β-blockers and alcohol may also enhance the depressant effect of oxycodone.
Oxycodone may increase the anticoagulant activity of coumarin derivatives.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category C)
Oxycodone is Pregnancy Category C - Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
The only concern with oxycodone in pregnancy is with its use during labour when narcotic analgesics may cause respiratory depression in the newborn infant.
It is not known whether oxycodone is excreted in breast milk nor whether it has a harmful effect on the newborn. Therefore, oxycodone is not recommended for nursing mothers unless the expected benefits outweigh the potential risk.

4.7 Effects on Ability to Drive and Use Machines

Oxycodone may impair the mental and/or physical abilities needed for certain potentially hazardous activities, such as driving a car or operating machinery. Patients should be cautioned accordingly.

4.8 Adverse Effects (Undesirable Effects)

In normal doses, the most common side effects of opioid analgesics are nausea, vomiting, constipation, drowsiness and confusion. Micturition may be difficult and there may be ureteric or biliary spasm; there is also an antidiuretic effect. Dry mouth, sweating, facial flushing, anorexia, faintness, vertigo, bradycardia, supraventricular tachycardia, syncope, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood and miosis also occur. Raised intracranial pressure occurs in some patients. Due to the histamine-releasing effect, reactions such as urticaria and pruritus occur in some individuals. Muscle rigidity has been reported following the administration of opioids. Larger doses produce respiratory depression and hypotension, with circulatory failure and deepening coma. Convulsions may occur in infants and children. Death may occur from respiratory failure. Toxic doses vary considerably with the individual and regular users may tolerate large doses.
In long term use, physical dependence and tolerance may develop.
The following withdrawal symptoms may be observed after narcotics are discontinued: body aches, diarrhoea, gooseflesh, loss of appetite, nervousness, restlessness, runny nose, sneezing, tremors or shivering, stomach cramps, nausea, trouble with sleeping, unusual increase in sweating and yawning, weakness, tachycardia and unexplained fever. With appropriate medical use of narcotics and gradual withdrawal from the drug, these symptoms are usually mild.

Reporting suspected adverse reactions.

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.

4.9 Overdose

Symptoms.

Serious overdosage with oxycodone is characterised by respiratory depression and somnolence progressing to coma and skeletal muscle flaccidity. Cardiac arrest and death may occur.

Treatment.

Primary attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including oxycodone. Therefore, an appropriate dose of naloxone (usual adult dose: 0.4 mg) should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. Since the duration of action of oxycodone may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration.
An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression.
Oxygen, intravenous fluids, vasopressors and other supportive measures should be used as indicated.
Gastric emptying may be useful in removing unabsorbed drug.
In an individual physically dependent on narcotics, the administration of the usual dose of a narcotic antagonist will precipitate an acute withdrawal syndrome. The severity of this syndrome will depend on the degree of physical dependence and the dose of antagonist administered. The use of narcotic antagonists in such individuals should be avoided if possible. If a narcotic antagonist must be used to treat serious respiratory depression in the physically dependent patient, only 10 to 20% of the usual initial dose of the antagonist should be administered.
In severe toxicity, the cardiovascular system is usually depressed and requires supportive treatment. If hypotension is due to vasodilatation, plasma expansion or even vasopressors may be required. Additional measures include support of electrolyte balance, maintenance of normal temperature, catheterisation of the bladder to avoid distension and symptomatic treatment of itching, nausea, vomiting, headache and confusion during the recovery period.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

The effects of oxycodone when combined with pectin are of longer duration than those of oxycodone hydrochloride.
The suppository has been found to reduce the severity of intractable pain due to carcinomatosis for up to 8 hours.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

No data available.

Distribution.

No data available.

Metabolism.

No data available.

Excretion.

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Proladone suppositories also contain lactose monohydrate, maize starch, pectin, povidone, magnesium stearate and hard fat.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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)¹. The expiry date can be found on the packaging.
¹ AUST R 14965.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Proladone is presented as a strip pack of 12 suppositories.
Phebra product code - TAB007.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical name: 6-deoxy-7, 8-dihydro-14-hydroxy-3-O-methyl-6-oxomorphine.
The molecular weight of oxycodone is 315.4. The molecular formula is C₁₈H₂₁NO₄.

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