Oxycodone Controlled Release Tablets

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Oxycodone hydrochloride 30 mg;  
Available from:
Boucher & Muir (New Zealand) Limited t/a BNM Group
INN (International Name):
Oxycodone hydrochloride 30 mg
Dosage:
30 mg
Pharmaceutical form:
Modified release tablet
Composition:
Active: Oxycodone hydrochloride 30 mg   Excipient: Ammonio methacrylate copolymer Ferrous oxide Hypromellose Iron oxide black Lactose monohydrate Macrogol 400 Magnesium stearate Povidone Purified talc   Purified water Stearyl alcohol Titanium dioxide Triacetin
Prescription type:
Class B3 Controlled Drug
Manufactured by:
Siegfried Ltd
Therapeutic indications:
Management of moderate to severe chronic pain unresponsive to non-narcotic analgesia.
Product summary:
Package - Contents - Shelf Life: Blister pack, PVC/PVDC film with aluminium foil - 20 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC film with aluminium foil - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC film with aluminium foil - 100 tablets - 36 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-9155/1d
Authorization date:
2015-01-05

Read the complete document

Oxycodone Controlled Release Tablets (Matrix Formulation)

06072018

Consumer Medicine Information

OXYCODONE

CONTROLLED RELEASE TABLETS

Oxycodone hydrochloride

C

ontrolled release tablets (Matrix Formulation)

5mg, 10 mg, 20 mg, 40 mg & 80 mg

What is in this leaflet

Please read this leaflet carefully before you start taking Oxycodone Controlled Release

Tablets.

This leaflet answers some common questions about Oxycodone Controlled Release

Tablets. It does not contain all the available information. The most up-to-date Consumer

Medicine Information can be downloaded from www.medsafe.govt.nz.

Reading this leaflet 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

Oxycodone Controlled Release Tablets against the benefits this medicine is expected to

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 want to read it again.

What Oxycodone Controlled Release Tablets are

used for

Oxycodone Controlled Release Tablets contain oxycodone hydrochloride. Oxycodone

belongs to a group of medicines called opioid analgesics which are strong medicines used

to treat or prevent pain.

Oxycodone Controlled Release Tablets are used to relieve moderate to severe persistent

pain when other forms of treatment have not been effective.

Your doctor may have prescribed this medicine for another reason.

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

you.

Oxycodone Controlled Release Tablets (Matrix Formulation)

06072018

Oxycodone Controlled Release Tablets are only available with a doctor's prescription.

As with all strong painkillers, your body may become used to you taking Oxycodone

Controlled Release 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.

Before you take Oxycodone Controlled Release

Tablets

Oxycodone Controlled Release Tablets are not suitable for everyone.

When you must not take it

Do not take Oxycodone Controlled Release Tablets if you:

suffer from shallow breathing or have any breathing problems such as acute asthma,

chronic bronchitis or impaired lung function

are severely drowsy or have a reduced level of consciousness

suffer from irregular or fast heartbeats or changes in the way the heart beats

have heart problems or heart disease, including if this is due to long term lung disease

have just drunk a large amount of alcohol, regularly drink large amounts of alcohol or

have confusion and shaking due to stopping drinking alcohol

suffer from convulsions, fits or seizures

have a head injury, a brain tumour or have raised pressure within the head, brain or

spinal cord

have severe abdominal pain with bloating, cramps, vomiting or constipation

have a condition where your stomach empties more slowly than it should, your small

bowel does not work properly or you have just had an operation on your abdomen

have severe liver or kidney disease

are about to have an operation including surgery on your spine for pain relief in the

next 24 hours or have had an operation within the last 24 hours

are taking a medicine for depression called a monoamine oxidase inhibitor (MAOI) or

have taken any in the last two weeks

have been given the 80 mg strength and you have not used any opioid medicine

before.

Do not take Oxycodone Controlled Release Tablets if you are allergic to any

medicine containing oxycodone, opioid painkillers, or any of the ingredients listed

at the end of this leaflet.

Do not take it if you are pregnant or intend to become pregnant.

Like

most

medicines of this kind,

Oxycodone Controlled

Release Tablets

recommended

taken

during

pregnancy.

Extended

oxycodone

during

pregnancy can cause withdrawal symptoms in newborns. Your doctor will discuss the risks

and benefits of taking it if you are pregnant.

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Do not take it after the expiry date (EXP) printed on the pack.

If you take it after the expiry date has passed, it may not work as well.

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

If you are not sure whether you should start taking Oxycodone Controlled Release

Tablets, talk to your doctor or pharmacist.

Before you start to take it

Tell your doctor or pharmacist if you have allergies to any other medicines, foods,

preservatives or dyes.

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

following:

low blood pressure including from having low blood volume

increased prostate size or difficulty passing urine

chronic lung, liver or kidney disease

problems with or recent surgery on your gall bladder or bile duct

inflammation of the pancreas

adrenal glands not working properly

underactive thyroid gland

inflammatory bowel disease or recent abdominal surgery

severe mental condition involving losing contact with reality, hearing voices or an

inability to think clearly

an addiction or history of abuse of alcohol, opioids or other drugs.

This medicine is not recommended to be taken during labour.

Oxycodone given to the mother during labour can cause breathing problems in the

newborn.

Tell your doctor if you are breast-feeding or planning to breast-feed.

The active ingredient in Oxycodone Controlled Release Tablets passes into breast milk

and there is a possibility that your baby may be affected. Your doctor can discuss with you

the risks and benefits involved.

Tell your doctor if you intend to become pregnant.

Extended use of oxycodone can cause problems conceiving, irregular periods and sexual

problems.

Do not give Oxycodone Controlled Release Tablets to a child aged 12 years and

under.

There is not enough information to recommend the use of this medicine for children under

12 years old.

If you have not told your doctor or pharmacist about any of the above, tell them

before you start taking Oxycodone Controlled Release Tablets.

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.

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Tell any health professional who is prescribing a new medicine for you that you are

taking Oxycodone Controlled Release Tablets.

Some medicines and Oxycodone Controlled Release Tablets may interfere with each

other. These include:

medicines to treat depression, psychiatric or mental disorders. Medicines to treat

depression belonging to a group called monoamine oxidase inhibitors (MAOIs) must

be stopped 14 days before Oxycodone Controlled Release Tablets are taken.

medicines to relieve allergy symptoms

medicines to help you sleep

medicines to put you to sleep during an operation or procedure

medicines to relax your muscles

medicines to lower blood pressure

quinidine and other medicines to treat the heart

medicines to thin the blood, e.g. coumarin derivatives such as warfarin

cimetidine, a medicine used to treat ulcers

medicines to relieve stomach cramps or spasms, to prevent travel sickness or to treat

Parkinson’s disease

medicines to stop nausea or vomiting e.g. metoclopramide

other pain relievers including other opioids

ketoconazole, a medicine to treat fungal infections

alcohol.

The above medicines may be affected by Oxycodone Controlled Release Tablets, or may

affect how well they work. You may need different amounts of Oxycodone Controlled

Release Tablets, or take them at different times, 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 Oxycodone Controlled Release Tablets.

How to take Oxycodone Controlled Release Tablets

Read the label carefully and follow all directions given to you by your doctor and

pharmacist.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist

for help.

How much to take

Your doctor will tell you exactly how much Oxycodone Controlled Release Tablets

you should take.

If you take the wrong dose, Oxycodone Controlled Release Tablets may not work as well

and your problem may not improve.

Oxycodone Controlled Release Tablets (Matrix Formulation)

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Ask your doctor or pharmacist if you are unsure of the correct dose for you.

This depends on your condition and whether or not you are taking any other medicines.

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

How to take it

Swallow the tablet(s) with a full glass of water or other fluid. Take them with or

without food.

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

The tablets may release all their contents at once if broken, chewed, crushed or dissolved,

which can be dangerous and cause serious problems, such as an overdose or even death.

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

You must only take Oxycodone Controlled Release Tablets by mouth.

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

to your health.

When to take it

Take Oxycodone Controlled Release Tablets every 12 hours.

Take Oxycodone Controlled Release Tablets regularly to control the pain.

Taking them at the same time each day will have the best effect and will mean that the

onset of pain is prevented. If, however, you begin to experience pain (‘breakthrough pain’)

and you are taking your Oxycodone Controlled Release Tablets as prescribed, contact

your doctor as your dosage may have to be reviewed.

How long to take it

Continue taking the medicine for as long as your doctor tells you.

If you stop taking this medicine suddenly, your pain may worsen and you may experience

withdrawal symptoms such as:

body aches

loss of appetite, nausea, stomach cramps or diarrhoea

fast heart rate

sneezing or runny nose

chills, tremors, shivering or fever

trouble sleeping

increased sweating and yawning

weakness

nervousness or restlessness.

If you are unsure whether you should stop taking Oxycodone Controlled Release

Tablets, talk to your doctor or pharmacist.

Oxycodone Controlled Release Tablets (Matrix Formulation)

06072018

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take the next

dose when you are meant to.

Do not try to make up for missed doses by taking more than one dose at a time.

This may increase the chance of getting an unwanted side effect.

If there is still a long time to go before your next dose, take it as soon as you

remember, and then go back to taking it as you would normally.

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

hints.

While

you

are

taking

Oxycodone

Controlled

Release Tablets

Things you must do

Take Oxycodone Controlled Release Tablets exactly as your doctor has prescribed.

If you are about to be started on any new medicine, tell your doctor and pharmacist

that you are taking Oxycodone Controlled Release Tablets. Likewise, tell any other

doctors, dentists and pharmacists who are treating you that you are taking this

medicine.

If you are going to have surgery, tell the surgeon and anaesthetist that you are

taking this medicine.

It may affect other medicines used during surgery.

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

Keep all of your doctor’s appointments so that your progress can be checked.

Tell your doctor if your pain is getting worse or you are having more frequent breakthrough

pain.

Tolerance to oxycodone may develop, which means that the effect of the medicine may

decrease. If this happens, your doctor may increase the dose so that you get adequate

pain relief.

See your doctor if you feel that your condition is not improving or is getting worse.

Keep

enough

Oxycodone

Controlled

Release

Tablets

with

you

to

last

over

weekends and holidays.

Oxycodone Controlled Release Tablets (Matrix Formulation)

06072018

Things you must not do

Do not give your medicine to anyone else, even if they have the same condition as

you.

This medicine is only intended for the person it has been prescribed for.

Do not take Oxycodone Controlled Release Tablets to treat any other complaints

unless your doctor tells you to.

Do not stop taking Oxycodone Controlled Release Tablets or change the dosage

without checking with your doctor.

Over time your body may become used to you taking oxycodone so if you stop taking it

suddenly, your pain may worsen and you may have unwanted side effects such as

withdrawal symptoms. This is called physical dependence. If you need to stop taking this

medicine, your doctor will gradually reduce the amount you take each day, if possible,

before stopping the medicine completely.

Do not drink alcohol while you are taking Oxycodone Controlled Release Tablets.

Alcohol use could increase serious side effects of oxycodone, such as sleepiness,

drowsiness and slow or shallow breathing.

Things to be careful of

Do not drive or operate machinery until you know how Oxycodone Controlled

Release Tablets affect you.

It 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.

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

standing up. You may feel light-headed when you begin to take these tablets.

This is because your blood pressure is falling suddenly. Standing up slowly, especially

when you get up from bed or chairs, 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.

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.

Tell your doctor if you suffer from nausea or vomiting when taking Oxycodone

Controlled Release Tablets.

If you vomit after your dose, your pain may come back, as you may not have absorbed

your medicine. If this happens, speak to your doctor. Your doctor may prescribe some

medicine to help you stop vomiting.

Tell

your

doctor

if

taking

Oxycodone

Controlled

Release

Tablets

causes

constipation.

Your doctor can advise you about your diet, the proper use of laxatives and suitable

exercise you can do to help you manage this.

Oxycodone Controlled Release Tablets (Matrix Formulation)

06072018

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.

In case of overdose

If you take too much

Immediately telephone your doctor, or the Poisons Information Centre (telephone

0800 POISON or 0800 764 766), or go to Accident and Emergency at your nearest

hospital, if you think that you or anyone else may have taken too much Oxycodone

Controlled Release Tablets.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Symptoms of an overdose may include difficulties in breathing, becoming drowsy and tired,

lack of muscle tone, having cold or clammy skin, constricted pupils, very low blood

pressure or slow heart rate, becoming unconscious or death.

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 that have been taken.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you

are taking Oxycodone Controlled Release Tablets.

Like all medicines, Oxycodone Controlled Release Tablets may occasionally cause side

effects in some people. Sometimes they are serious, most of the time they are not. You

may need medical attention if you get some of the side effects.

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

diarrhoea,

feeling

sick,

loss

appetite

constipation

dry mouth, hiccups, sore throat, trouble swallowing or changes in voice

sweating and flushing

feeling anxious or nervous, trouble sleeping or abnormal dreams

trouble with your balance

new problems with your eyesight

skin rash, itching, chills or fever

fatigue

muscle problems such as spasms or twitching

impotence

decreased sexual drive

changes in menstrual bleeding

swelling of legs or ankles.

Oxycodone Controlled Release Tablets (Matrix Formulation)

06072018

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

worry you:

stomach discomfort, vomiting, indigestion or abdominal pain

abnormal thinking, changes in mood or feeling deep sadness

drowsiness, fainting or dizziness especially when standing up

slow or noticeable heartbeats

headache or confusion

unusual weakness, loss of strength or trouble walking

changes in passing urine such as the volume passed, pain or feeling the need to

urinate urgently.

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

Tell your doctor immediately, or go to Accident and Emergency at your nearest

hospital if you notice any of the following:

serious 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.

These

very

serious

side

effects;

need

urgent

medical

attention

hospitalisation.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

After taking Oxycodone Controlled Release Tablets

Storage

Keep your tablets in the pack until it is time to take them.

If you take the tablets out of the pack they may not keep well.

Keep

Oxycodone

Controlled

Release

Tablets

in

a

cool

dry

place

where

the

temperature stays below 25°C.

Oxycodone Controlled Release Tablets (Matrix Formulation)

06072018

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

sill.

Do not leave it in the car.

Heat and damp can destroy some medicines.

Keep it and any other medicine 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.

Do not keep Oxycodone Controlled Release Tablets past their expiry date.

Disposal

Return any unused medicine, and any medicine past its expiry date (as shown on

the labelling) to your pharmacy.

Product description

What it looks like

Oxycodone Controlled Release Tablets are available in blister packs of 20 tablets. There

are 5 different strengths:

The 5 mg tablets are light blue, round, biconvex controlled release tablets with black

imprint ‘5’ on one side and a diameter of approximately 7.1 mm.

The 10 mg tablets are white, round, biconvex controlled release tablets with black imprint

‘10’ on one side and a diameter of approximately 7.1 mm.

The 20 mg tablets are light pink, round, biconvex controlled release tablets with black

imprint ‘20’ on one side and a diameter of approximately 7.1 mm.

The 40 mg tablets are light orange to ochre, round, biconvex controlled release tablets

with black imprint ‘40’ on one side and a diameter of approximately 7.1 mm.

The 80 mg tablets are green, round, biconvex controlled release tablets with white imprint

‘80’ on one side and a diameter of approximately 8.8 mm.

Ingredients

Active ingredient:

oxycodone hydrochloride

Inactive ingredients:

lactose monohydrate

ammonio methacrylate copolymer Type B

povidone

talc

triacetin

stearyl alcohol

Oxycodone Controlled Release Tablets (Matrix Formulation)

06072018

magnesium stearate

hypromellose

macrogol 400

titanium dioxide

brilliant blue FCF (5 mg tablets only)

iron oxide red (20 mg and 40 mg tablets only)

iron oxide yellow (40 mg and 80 mg tablets only)

indigo carmine aluminium lake (80 mg tablets only)

printing ink

Oxycodone Controlled Release Tablets contain lactose. They do not contain tartrazine or

any other azo dyes.

Sponsor details

Distributed in New Zealand by:

BNM Group

39 Anzac Road

Browns Bay

Auckland 0753

Ph: 0800 565 633

Date of preparation

This leaflet was prepared on 06 July 2018

Read the complete document

OXYCODONE CONTROLLED RELEASE TABLETS (MATRIX FORMULATION)

Oxycodone Hydrochloride modified release tablets 5mg, 10mg, 15mg, 20mg, 30mg, 40mg, 60mg & 80mg

06072017

Page 1 of 18

New Zealand Data Sheet

1

PRODUCT NAME

OXYCODONE CONTROLLED RELEASE TABLETS (MATRIX FORMULATION)

5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg & 80 mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Oxycodone hydrochloride 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg & 80 mg

Excipient with known effect: lactose monohydrate

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Oxycodone Controlled Release Tablets 5 mg – Light blue, round, biconvex, controlled

release tablets with black imprint ‘5’ on one side and a diameter of approx. 7.1 mm.

Oxycodone Controlled Release Tablets 10 mg – White, round, biconvex, controlled

release tablets with black imprint ‘10’ on one side and a diameter of approx. 7.1 mm.

Oxycodone Controlled Release Tablets 15 mg* – Grey, round, biconvex, controlled

release tablets with a diameter of approx. 7.1 mm.

Oxycodone Controlled Release Tablets 20 mg – Light pink, round, biconvex controlled

release tablets with black imprint ‘20’ on one side and a diameter of approx. 7.1 mm.

Oxycodone Controlled Release Tablets 30 mg* – Brown, round, biconvex, controlled

release tablets with a diameter of approx. 7.1 mm.

Oxycodone Controlled Release Tablets 40 mg

Light

orange

to ochre, round,

biconvex, controlled release tablets with black imprint ‘40’ on one side and a diameter

approx. 7.1 mm.

Oxycodone Controlled Release Tablets 60 mg* – Pink-red, round, biconvex, controlled

release tablets with a diameter of approx. 8.8 mm.

Oxycodone Controlled Release Tablets 80 mg – Green, round, biconvex, controlled

release tablets with white imprint ‘80’ on one side and a diameter of approx. 8.8 mm.

*Not available in New Zealand.

OXYCODONE CONTROLLED RELEASE TABLETS (MATRIX FORMULATION)

Oxycodone Hydrochloride modified release tablets 5mg, 10mg, 15mg, 20mg, 30mg, 40mg, 60mg & 80mg

06072017

Page 2 of 18

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Management of moderate to severe chronic pain unresponsive to non-narcotic

analgesia.

4.2

Dose and method of administration

Oxycodone Controlled Release Tablets 80 mg should only be used in opioid-

tolerant

patients. In patients not previously exposed to opioids (opioid naïve),

this tablet

strength may cause fatal respiratory depression.

Oxycodone Controlled Release Tablets are to be swallowed whole, and are not to

be

broken, chewed or crushed. Taking broken, chewed or crushed Oxycodone

Controlled Release Tablets could lead to the rapid release and absorption of

a

potentially toxic dose of oxycodone.

Alcoholic

beverages

should

avoided

while

patient

being

treated

with

Oxycodone

Controlled Release Tablets.

Dose

Adults, elderly and children over 12 years:

Prior to initiation and titration of doses, refer to the section 4.4 Special warnings and

precautions for use for

information on special risk groups such as females and the

elderly.

Oxycodone Controlled Release Tablets should be taken at 12-hourly intervals. The

dosage

is dependent on the severity of the pain, and the patient’s previous history

of analgesic

requirements.

Increasing

severity

pain

will

require

increased

dosage

Oxycodone

Controlled

Release Tablets using the 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60

mg 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

ceiling

dose

patients

should

titrated

pain

relief

unless

unmanageable adverse drug reactions prevent this. If

higher doses are necessary,

increases should be made, where possible, in 25% -

50% increments. The need for

escape medication more than twice a day indicates

that the dosage of Oxycodone

Controlled Release Tablets should be increased.

The usual starting dose for opioid-naïve 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.

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.

OXYCODONE CONTROLLED RELEASE TABLETS (MATRIX FORMULATION)

Oxycodone Hydrochloride modified release tablets 5mg, 10mg, 15mg, 20mg, 30mg, 40mg, 60mg & 80mg

06072017

Page 3 of 18

Patients transferring from other opioid formulations:

Patients

receiving

other

oral

oxycodone

formulations

transferred

Oxycodone

Controlled Release Tablets at the same total daily dosage, equally

divided into two 12-

hourly Oxycodone Controlled Release Tablets doses.

Patients

receiving oral morphine before Oxycodone

Controlled

Release

Tablets

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

only a guide to the

dose of Oxycodone Controlled Release Tablets required. Inter-

patient variability requires

that each patient is carefully titrated to the appropriate dose.

For patients who are receiving an alternative opioid, the “oral oxycodone equivalent” of

analgesic presently being used should be determined. Having determined the

total daily

dosage of the present analgesic, the following equivalence table 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 Controlled Release Tablets doses.

Multiplication factors for converting the daily dose of prior

opioids to the daily dose of oral oxycodone*

(mg/day prior opioid x factor = mg/day oral oxycodone)

Oral prior opioid

Parenteral opioid

Oxycodone

Codeine

0.15

Fentanyl TTS

See below**

See below**

Hydromorphone

Pethidine

Methadone

Morphine

* To be used for conversion to oral oxycodone. For patients receiving high-dose parenteral

opioids,

a more conservative conversion is warranted. For example, for high-dose

parenteral morphine, use 1.5 instead of 3 as a multiplication factor.

** Conversion from transdermal fentanyl to Oxycodone Controlled Release Tablets: 18

hours following the removal of the transdermal fentanyl patch, Oxycodone Controlled

Release

Tablet

treatment can be initiated. Although there has been no systematic

assessment of such conversion, a conservative oxycodone dose, approximately 10 mg

12-hourly of Oxycodone Controlled Release Tablets, should be initially substituted for

each 25 µg/hr fentanyl transdermal patch. The patient should be monitored closely.

Paediatric population

Children under 12 years:

Not recommended.

Method of administration

Oxycodone Controlled Release Tablets consist of a dual-polymer matrix, intended for

oral

use only. The controlled release tablets must be swallowed whole, and not be

broken,

chewed

crushed.

administration

broken,

chewed

crushed

controlled release

oxycodone tablets leads to a rapid release and absorption of a

potentially

fatal

dose

oxycodone.

Parenteral

venous

injection

tablet

constituents, especially talc, can be

expected

result

local

tissue

necrosis,

pulmonary granulomas and serious adverse

reactions which may be fatal.

OXYCODONE CONTROLLED RELEASE TABLETS (MATRIX FORMULATION)

Oxycodone Hydrochloride modified release tablets 5mg, 10mg, 15mg, 20mg, 30mg, 40mg, 60mg & 80mg

06072017

Page 4 of 18

4.3

Contraindications

Hypersensitivity to opioids or to any of the ingredients of Oxycodone

Controlled

Release Tablets listed in section 6.1

Acute respiratory depression

Cor pulmonale

Cardiac arrhythmias

Acute asthma or other obstructive airways disease

Paralytic ileus

Suspected surgical abdomen

Severe hepatic impairment (refer to Special risk groups in s e c t i o n

4 . 4 S p e c i a l warnings and

precautions for use)

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

discontinuation of their use

Pregnancy

Not recommended for pre-operative use or for the first 24 hours post-operatively.

4.4

Special warnings and precautions for use

major

risk

opioid

excess

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 hypotension,

hypovolaemia,

diseases

biliary

tract,

pancreatitis,

inflammatory

bowel

disorders,

prostatic

hypertrophy,

adrenocortical

insufficiency

(Addison’s

disease),

toxic

psychosis,

chronic pulmonary, renal or hepatic disease, myxoedema and

debilitated elderly or infirm

patients.

As with all opioid preparations, patients who are to undergo cordotomy or other

pain-relieving surgical procedures should not receive Oxycodone Controlled Release

Tablets

for 24 hours before surgery. Pain in the immediate pre-operative period, and

symptoms of opioid withdrawal, should be managed with short-acting analgesic

agents.

further treatment with Oxycodone Controlled Release Tablets is then

indicated, the dosage

should be adjusted to the new post-operative requirement.

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.

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As with all opioid preparations, Oxycodone Controlled Release Tablets should be

used

with caution following abdominal surgery, as opioids are known to impair intestinal

motility

and should not be used until the physician is assured of normal bowel

function.

Should

paralytic

ileus

suspected

occur

during

use,

Oxycodone

Controlled Release Tablets

should be discontinued immediately.

Use with CNS Depressants

Profound sedation, respiratory depression, coma, and

death may result from the

concomitant use

of Oxycodone Controlled Release Tablets with benzodiazepines or

other CNS

depressants (e.g., non-benzodiazepine

sedatives/hypnotics,

anxiolytics,

tranquilizers, muscle relaxants, general anaesthetics, medicines

with antihistamine-

sedating actions such as antipsychotics, other opioids, alcohol). Because of these risks,

reserve concomitant prescribing of these drugs for use in patients for whom alternative

treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and

benzodiazepines increases the risk of medicine-related mortality compared to use of

opioid analgesics alone. Because of similar pharmacological properties, it is reasonable

to expect similar risk with the concomitant use of other CNS depressant drugs with opioid

analgesics [see

Section 4.5 Interactions with other medicines and other forms of

interaction].

If the decision is made to prescribe a benzodiazepine or

other CNS depressant

concomitantly

with an opioid analgesic, prescribe the lowest effective dosages and

minimum durations of concomitant use. In patients already receiving an opioid analgesic,

prescribe a lower initial dose

of the benzodiazepine or other CNS depressant than

indicated in the absence of an opioid, and titrate based on clinical response. If an opioid

analgesic is initiated in a patient already taking a

benzodiazepine or other CNS

depressant, prescribe a lower initial dose of the opioid analgesic,

and titrate based on

clinical response.

Follow patients

closely for

signs and symptoms

respiratory

depression and sedation.

Advise both patients and caregivers about the risks of respiratory depression and

sedation when Oxycodone Controlled Release Tablets are used with benzodiazepines

or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive

or operate heavy machinery until the effects of

concomitant use of the benzodiazepine

or other CNS depressant have been determined. Screen

patients for risk of substance

use disorders, including opioid abuse and misuse, and warn them of the risk for overdose

and death associated with the use of additional CNS depressants including alcohol and

illicit drugs [see Section 4.5 Interactions with other medicines and other forms of

interaction].

Use in chronic, non-malignant pain

The use of Oxycodone Controlled Release Tablets 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

the pain is having a significant impact on the patient’s quality of life

there is no psychological contraindication, drug-seeking behaviour or history

drug misuse.

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Opioids, where clinically indicated, are one component of, and should be integrated into,

comprehensive management approach to chronic, non-malignant pain. Appropriate

patient

selection is the key to successful treatment of moderate to severe 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 –

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

before consideration of other treatment options such as physiotherapy/exercise/

rehabilitation

approaches,

psychosocial

interventions

such

(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 prescribing, a trial of Oxycodone Controlled Release Tablets or

shorter-acting opioid should be undertaken. Long-term administration of Oxycodone

Controlled

Release Tablets should only occur if this trial demonstrates that the pain is

opioid

sensitive.

Opioid-naïve

patients

require

rapid

dose

escalation

with

concomitant

pain relief within the trial period should generally be considered

inappropriate for long-term

therapy.

One doctor only should be responsible for the prescribing 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;167:30-4).

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 medicine

development of strong psychological dependence. Oxycodone Controlled

Release Tablets

should therefore be prescribed and handled with a high degree of

caution appropriate to

the use of a medicine with strong abuse potential.

Withdrawal symptoms may occur following abrupt discontinuation of oxycodone therapy

upon administration of an opioid antagonist. Therefore, patients on prolonged

therapy

should be withdrawn gradually from the medicine 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

essential

prescribing

doctor should

consider whether the benefit of treatment outweighs the risk of abuse.

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Formulation

Oxycodone Controlled Release Tablets contain lactose.

Oxycodone Controlled Release Tablets consist of a dual-polymer matrix, intended for

oral

use only. The controlled release tablets must be swallowed whole, and not be

broken,

chewed

crushed.

administration

broken,

chewed

crushed

controlled release

oxycodone tablets leads to a rapid release and absorption of a

potentially

fatal

dose

oxycodone.

Parenteral

venous

injection

tablet

constituents, especially talc, can be

expected

result

local

tissue

necrosis,

pulmonary granulomas and serious adverse

reactions which may be fatal.

Special risk groups

Renal and hepatic impairment

renal

hepatic

impairment,

administration

Oxycodone

Controlled

Release

Tablets 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 or hepatic function. Therefore, initiation of

dosing in patients

with renal impairment (CLcr < 60 mL/min) or hepatic impairment

should be reduced to ⅓ to ½ of the usual dose with cautious titration.

Elderly

The plasma concentrations of oxycodone are only nominally affected by age, being

approximately 15% greater in elderly as compared with young subjects. There were

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 to ⅓ to ½ of the usual doses.

Gender

Female subjects have, on average, plasma oxycodone concentrations up to 25%

higher

than males on a body weight 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.

Paediatric population

Not recommended for children under 12 years.

4.5

Interaction with other medicines and other forms of interaction

Anticholinergic agents

Concurrent

oxycodone

with

anticholinergics

medications

with

anticholinergic

activity (e.g. tricyclic antidepressants, antihistamines, antipsychotics,

muscle relaxants,

anti-Parkinson medications) may result in increased anticholinergic

adverse

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.

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CNS

depressants

(including

sedatives

or

hypnotics,

general

anaesthetics,

phenothiazines,

other

tranquillisers,

alcohol,

other

opioids

and

neuroleptic

medicines, etc.).

Concurrent

with

oxycodone

result

increased

respiratory

depression,

hypotension, profound sedation or coma. Caution is recommended and the dosage of

or both agents should be reduced. Intake of alcoholic beverages while being

treated with

Oxycodone Controlled Release Tablets should be avoided because this

may lead to more

frequent undesirable effects such as somnolence and respiratory

depression. Oxycodone

hydrochloride

containing

products

should

avoided

patients with a history of or

present alcohol, drug or medicines abuse.

Benzodiazepines and other Central Nervous System (CNS) Depressants

Clinical

Impact

Due to additive

pharmacologic effect, the concomitant

benzodiazepines or other

CNS depressants including alcohol,

increases the risk of respiratory depression,

profound sedation,

coma, and death.

Intervention

Reserve concomitant prescribing of these drugs for use in patients

whom

alternative

treatment

options

inadequate.

Limit

dosages and durations to the

minimum required. Follow patients

closely for signs of respiratory depression and

sedation [see Section

4.4 Special warnings and precautions for use].

Examples

Benzodiazepines

other

sedatives/hypnotics,

anxiolytics,

tranquilizers, muscle

relaxants, general anaesthetics, drugs with

antihistamine-sedating

actions

such

antipsychotics,

other

opioids, alcohol.

Coumarin derivatives

Although there is little substantiating evidence, opiate agonists have been reported

potentiate the anticoagulant activity of coumarin derivatives.

CYP2D6 and CYP3A4 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

dietary

elements,

which

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

quinidine

does

alter

pharmacodynamic

effects

oxycodone.

CYP3A4

inhibitors

such

macrolide

antibiotics

(e.g.

clarithromycin),

azole

antifungal

agents

(e.g.

ketoconazole),

protease inhibitors (e.g. ritonavir) and grapefruit juice may cause decreased clearance

oxycodone

which

could

lead

increase

oxycodone

plasma

concentrations.

Oxycodone metabolism may be blocked by a variety of medicines (e.g. cimetidine,

certain

cardiovascular drugs and antidepressants), although such blockade has not

yet been

shown to be of clinical significance with oxycodone tablets.

CYP3A4 inducers, such as rifampicin, carbamazepine, phenytoin and St John’s wort,

induce the metabolism of oxycodone and cause increased clearance of the drug,

resulting

in a decrease in oxycodone plasma concentrations.

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Oxycodone did not inhibit the activity of P450 isozymes 2D6, 3A4, 1A2, 2A6, 2C19 or

human

liver

microsomes

in

vitro.

Nonclinical

data

in

vitro

in

vivo

indicate

that

oxycodone

P-glycoprotein substrate

induce

overexpression of P-glycoprotein in rats.

Metoclopramide

Concurrent use with oxycodone may antagonise the effects of metoclopramide on

gastrointestinal motility.

Monoamine Oxidase Inhibitors (MAOIs)

Non-selective

MAOIs

intensify

the effects

of opioid

medicines which can

cause

anxiety,

confusion and significant respiratory depression. Severe and sometimes

fatal reactions

have

occurred

patients

concurrently

administered

MAOIs

pethidine. Oxycodone

should not be given to patients taking non-selective 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 medicine 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

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.

Paediatric population

Not recommended for children under 12 years.

4.6

Fertility, pregnancy and lactation

Pregnancy

Australian

Pregnancy

Category

Drugs

which,

owing

their

pharmacological

effects,

have caused or may be suspected of causing, harmful effects on the human

foetus or

neonate without causing malformations. These effects may be reversible.

Oxycodone

used

during

pregnancy

labour

cause

withdrawal

symptoms

and/or

respiratory depression in the newborn infant. Oral administration of oxycodone

during the

period

organogenesis

elicit

teratogenicity

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.

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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 pre-natal oxycodone on the hypothalamic-pituitary-adrenal

axis in adolescent

rats,

intravenous

administration

oxycodone

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

adequate

well-controlled

studies

with

oxycodone

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

result

neonatal

opioid

withdrawal syndrome.

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.

Breastfeeding

Oxycodone accumulates in human milk, with a median maternal milk:plasma ratio of

recorded in one study. Oxycodone (7.5 ng/mL) was detected in the plasma of one

of forty-

one infants 72 hours after Caesarean section. Opioids may cause respiratory

depression

in the newborn and withdrawal symptoms can occur in breastfeeding infants

when

maternal administration of an opioid analgesic is stopped. Oxycodone Controlled

Release

Tablets 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.

Fertility

In reproductive toxicology studies, no evidence of impaired fertility was seen in male

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

reproductive

function,

including

fertility

sexual

dysfunction

both sexes, and

irregular menses in women.

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.

4.8

Undesirable effects

a. Summary of the safety profile

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.

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

associated with low

histamine release although urticaria and pruritus may occur.

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b. Tabulated summary of adverse reactions

Key:

Very common

(

1/10)

Common

(≥ 1/100 to < 1/10)

Uncommon

(≥ 1/1,000 to < 1/100)

Rare

(≥ 1/10,000 to < 1/1,000)

Very rare

(< 1/10,000)

Not known

(cannot be estimated from the available data)

Cardiac disorders

Uncommon

bradycardia,

chest

pain,

palpitations

part

withdrawal

syndrome),

depression,

supraventricular tachycardia

Ear and labyrinth disorders

Uncommon

tinnitus, vertigo

Eye disorders

Uncommon

miosis, visual impairment, lacrimation disorder

Gastrointestinal disorders

Very common

nausea, vomiting, constipation

Common

abdominal pain, diarrhoea, dry mouth, dyspepsia, gastritis, hiccup

Uncommon

colic, dental caries, dysphagia, eructation, flatulence, gastrointestinal disorder,

ileus,

stomatitis

Rare

gum bleeding, tarry stool, tooth staining and damage

General disorders and administration site conditions

Common

sweating, asthenia, fatigue, chills, fever

Uncommon

accidental

injury,

drug

tolerance,

drug

withdrawal

syndrome

(with

without

seizures),

facial flushing, lymphadenopathy, malaise, muscular rigidity, neck pain,

oedema,

peripheral oedema, pain, thirst

Rare

weight changes (increase or decrease), cellulitis

Not known

drug withdrawal syndrome neonatal

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Hepatobiliary disorders

Uncommon

biliary spasm, cholestasis, hepatic enzyme increased

Immune system disorders

Uncommon

allergic reaction, anaphylactic reaction, anaphylactoid reaction, hypersensitivity

Metabolic and nutritional disorders

Common

anorexia, decreased appetite

Uncommon

increased appetite, dehydration, hyponatraemia

Nervous system disorders

Very common

dizziness, headache, somnolence

Common

faintness, asthenia, sedation, twitching, tremor

Uncommon

amnesia,

drowsiness,

abnormal

gait,

convulsion,

dysgeusia

(taste

perversion),

hyperkinesia, hypertonia, hypoaesthesia, hypothermia, raised intracranial pressure,

involuntary

muscle

contractions,

paraesthesia,

seizures,

speech

disorder,

stupor,

syncope,

coordination disturbances

Rare

seizures, in particular in epileptic patients or patients with tendency to convulsions,

muscle

spasm

Not known

hyperalgesia

Psychiatric disorders

Common

abnormal dreams, anxiety, confusional state, insomnia, nervousness, thinking

abnormal,

depression, lethargy

Uncommon

affect

emotional

lability,

agitation,

disorientation,

drug

dependence,

dysphoria,

euphoric

mood,

hallucination,

libido

decreased,

mood

altered,

restlessness,

hyperacousis,

depersonalisation

Not known

aggression

Renal and urinary disorders

Common

Micturition disturbances (increased urge to urinate)

Uncommon

ureteric spasm, urinary abnormalities, urinary retention, urinary tract infection

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Reproductive system and breast disorders

Uncommon

amenorrhoea, erectile dysfunction, hypogonadism, impotence

Respiratory, thoracic and mediastinal disorders

Common

bronchospasm, dyspnoea, pharyngitis, voice alteration

Uncommon

respiratory depression

Skin and subcutaneous tissue disorders

Very common

pruritus

Common

hyperhidrosis, rash

Uncommon

dry skin, exfoliative dermatitis, urticaria and other skin rashes

Rare

herpes simplex, urticaria

Vascular disorders

Common

orthostatic hypotension

Uncommon

hypotension accompanied by secondary symptoms such as palpitations &

syncope,

migraine, vasodilatation

c. Description of selected adverse reactions

No information held by the sponsor.

d. Paediatric population

Not recommended for children under 12 years.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important.

It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare

professionals are asked to report any suspected adverse reactions

https://nzphvc.otago.ac.nz/reporting/

4.9

Overdose

Symptoms

Acute overdosage with oxycodone

can be manifested by respiratory depression

(reduced

respiratory

rate

and/or

tidal

volume,

cyanosis),

extreme

somnolence

progressing to stupor

or coma, hypotonia, cold and/or clammy skin, miosis (dilated if

hypoxia

severe),

sometimes bradycardia, hypotension, and death. Severe

overdose may result in apnoea,

pulmonary oedema, circulatory collapse and death.

The features of overdose may be

delayed with a sustained release product such as

Oxycodone Controlled Release Tablets.

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Treatment of oxycodone overdosage

Primary

attention

should

given

immediate

supportive

therapy

with

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

contraindicated in patients with bowel obstruction, perforation, ileus,

haemodynamic

instability or compromised, unprotected airways, and should be used

cautiously

debilitated

patients

where

condition

further

compromised.

Concurrent

administration

activated

charcoal

whole

bowel

irrigation may decrease the

effectiveness of the charcoal (there may be competition

charcoal

binding

site

between

polyethylene

glycol

ingested

drugs) but the clinical relevance is

uncertain. Prolonged periods of observation (days)

required

patients

have

overdosed with long-acting oxycodone

preparations.

If there are signs of clinically significant respiratory or cardiovascular depression, the

of an opioid antagonist should

be considered. The

opioid antagonist naloxone

hydrochloride is a specific antidote for respiratory depression due to overdosage or as

result of unusual sensitivity to opioid. The usual intravenous adult dose of naloxone

is 0.4

mg or higher (please refer to naloxone Data Sheet 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,

exceed

that

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

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

treat

serious

respiratory

depression in the physically dependent patient, the

antagonist should be administered with

extreme

care

using

dosage

titration,

commencing with 10 to 20% of the usual

recommended initial dose.

OXYCODONE CONTROLLED RELEASE TABLETS (MATRIX FORMULATION)

Oxycodone Hydrochloride modified release tablets 5mg, 10mg, 15mg, 20mg, 30mg, 40mg, 60mg & 80mg

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Toxicity

Oxycodone toxicity may result from overdosage, but because of the great inter-individual

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 may 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.

Paediatric population

No information held by the sponsor. Not recommended for children under 12 years.

For advice on the management of overdose please contact the National Poisons Centre

on 0800 POISON (0800 764766).

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Natural opium alkaloids

ATC-Code: N02A A05

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 central nervous system (CNS

respiratory

depression, antitussive, anxiolytic, sedative and miosis), smooth muscle

(constipation,

reduction

gastric,

biliary

pancreatic

secretions,

spasm

sphincter of Oddi and

transient elevations in serum amylase) and cardiovascular

system

(release

histamine

and/or

peripheral

vasodilatation,

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 be manifest from these

hormonal changes.

Paediatric population

Not recommended for children under 12 years.

5.2

Pharmacokinetic properties

Absorption

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 CONTROLLED RELEASE TABLETS (MATRIX FORMULATION)

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The absorption of oxycodone from Oxycodone Controlled Release Tablets is biphasic,

with

an initial absorption of approximately 40% of the active medicine (t

= 0.6 h)

providing

onset of analgesia within one hour in most patients, followed by a more

controlled

absorption, which determines the 12-hour duration of action (t

= 6.2

h). The mean

apparent half-life of Oxycodone Controlled Release Tablets is 6.5 hours

and steady-state

is achieved in about one day. The initial absorption occurs from the

surface of the tablet,

following dissolution of the film coat. The remaining drug

substance is absorbed from the

matrix either by dissolution or diffusion from or through

the tablet matrix.

Release of oxycodone from Oxycodone Controlled Release Tablets is independent of

under physiological conditions.

The relative bioavailability of oxycodone controlled release tablets is comparable to that

of rapid release oxycodone with maximum plasma concentrations being achieved after

approximately 3 to 4.5 hours after intake of the controlled-release tablets compared to

1 to 1.5 hours. Peak plasma concentrations and oscillations of the concentrations of

oxycodone from the controlled-release and rapid-release formulations are comparable

when given at the same daily dose at intervals of 12 and 6 hours, respectively.

Earlier bioequivalence studies indicated that ingestion of a standard high-fat meal does

alter the peak oxycodone concentration or the extent of oxycodone absorption from

oxycodone controlled release tablets, however, two later studies on the lowest (5 mg)

highest (160 mg not registered in New Zealand) oxycodone controlled release

tablet

strengths suggested that a high-fat meal increased the AUC by up to 20% and

the Cmax

by up to 29%.

The tablets must not be broken, crushed or chewed as this leads to rapid oxycodone

release and absorption of a potentially fatal dose of oxycodone due to the damage of

prolonged release properties.

Distribution

In steady state, the volume of distribution of oxycodone amounts to 2.6 L/kg and

plasma

protein binding to 38 - 45%; the elimination half-life to 4 to 6 hours and plasma

clearance

to 0.8 L/min.

Biotransformation

Oxycodone

hydrochloride

metabolised

liver

form

noroxycodone,

oxymorphone,

noroxymorphone, 6 α and β oxycodol and conjugated glucuronides.

CYP3A4

CYP2D6

involved

formation

noroxycodone

oxymorphone, respectively (see

Section 4.5

Interaction with other medicines and

other forms of interaction). The contribution of these metabolites to the analgesic effect

is insignificant.

Elimination

Oxycodone

elimination

half-life

approximately

three

hours

metabolised

principally to noroxycodone and oxymorphone. Oxymorphone has some

analgesic activity

present

plasma

concentrations

considered to contribute to

oxycodone’s pharmacological effect.

Oxycodone and its metabolites are excreted via urine and faeces. Oxycodone crosses

placenta and is found in breast milk.

OXYCODONE CONTROLLED RELEASE TABLETS (MATRIX FORMULATION)

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The elimination half-life of oxycodone from controlled-release tablets is 4 to 5 hours

with

steady state values being achieved after a mean of 1 day.

Linearity/non-linearity

Across the 5 - 80 mg dose range of controlled release oxycodone tablets, linearity

plasma concentrations was demonstrated in terms of rate and extent of absorption.

5.3

Preclinical safety data

Carcinogenicity

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

conducted.

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.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Oxycodone Controlled Release Tablets contain the following excipients: lactose

monohydrate, ammonio methacrylate copolymer Type B, povidone, talc, triacetin,

stearyl

alcohol, magnesium stearate, hypromellose, macrogol 400, titanium dioxide,

brilliant blue

FCF (5 mg tablets only), iron oxide black (15 mg and 30 mg tablets only),

iron oxide brown

(30 mg tablets only), iron oxide red (20 mg, 40 mg and 60 mg

tablets only), iron oxide

yellow (40 mg and 80 mg tablets only), erythrosine (60 mg

tablets only), indigo carmine

(80 mg tablets only) and printing ink (5 mg, 10 mg, 20 mg,

40 mg and 80 mg tablets only).

6.2

Incompatibilities

6.3

Shelf life

5 mg tablets:

2 years

10 mg/15 mg/20 mg/30 mg/40 mg/60 mg/80 mg tablets:

3 years

6.4

Special precautions for storage

Store below 25°C

6.5

Nature and contents of container

Blister packs of 20, 60 and 100 tablets

Not all pack sizes may be marketed.

OXYCODONE CONTROLLED RELEASE TABLETS (MATRIX FORMULATION)

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6.6

Special precautions for disposal and other handling

Any unused medicine or waste material should be disposed of in accordance with local

requirements.

7

MEDICINE SCHEDULE

Controlled Drug B3

8

SPONSOR

BNM Group

39 Anzac Road

Browns Bay

Auckland 0753

Phone 0800 565 633

9

DATE OF FIRST APPROVAL

Date of publication in the New Zealand Gazette of consent to distribute the medicine:

03 September 2015

10

DATE OF REVISION OF TEXT

06 July 2017

Summary table of changes

Section changed

Summary of new information

All sections

Text reformatted into new Medsafe data sheet format

4.4 Special warnings and

precautions for use

Information included on warnings for use with Central Nervous

System (CNS) Depressants

4.5 Interaction with other

medicines and other

forms of interaction

Information included on interactions between Benzodiazepines

and other Central Nervous System (CNS) Depressants

4.8 Undesirable effects

Inclusion of an additional undesirable effect under Psychiatric

disorders

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