NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
OXYCODONE MYLAN
oxycodone hydrochloride
Consumer Medicine Information
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WARNING
Limitations of use
OXYCODONE MYLAN should only be used when your doctor decides that other treatment options are not able to effectively manage your pain or you cannot tolerate them. Hazardous and harmful use OXYCODONE MYLAN poses risks of abuse, misuse and addiction which can lead to overdose and death. Your doctor will monitor you regularly during treatment. Life threatening respiratory depression
OXYCODONE MYLAN can cause life-threatening or fatal breathing problems (slow, shallow, unusual or no breathing), even when used as recommended. These problems can occur at any time during use, but the risk is higher when first starting OXYCODONE MYLAN and after a dose increase, if you are older or have an existing problem with your lungs. Your doctor will monitor you and change the dose as appropriate. Use of other medicines while using OXYCODONE MYLAN
Using OXYCODONE MYLAN with other medicines that can make you feel drowsy such as sleeping tablets (e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants, antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin), cannabis and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death. Your doctor will minimise the dose and duration of use; and monitor you for signs and symptoms of breathing difficulties and sedation. You must not drink alcohol while using OXYCODONE MYLAN.
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What is in this leaflet
This leaflet answers some common questions about OXYCODONE MYLAN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking OXYCODONE MYLAN against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What OXYCODONE MYLAN is used for
This medicine is used for the short-term management of moderate to severe pain.
This medicine belongs to a group of medicines called narcotic analgesics.
The active ingredient in this medicine works by binding to receptors called opioid receptors, which are in your central nervous system. This binding action changes your body’s perception of pain throughout the central nervous system producing the pain relieving (analgesic) effect.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor’s prescription.
ADDICTION
You can become addicted to OXYCODONE MYLAN even if you take it exactly as prescribed. OXYCODONE MYLAN 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 OXYCODONE MYLAN. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking OXYCODONE MYLAN suddenly, so it is important to take it exactly as directed by your doctor.
TOLERANCE
Tolerance to OXYCODONE MYLAN may develop, which means that the effect of the medicine may decrease. If this happens, more may be needed to maintain the same effect. Speak to your doctor if this occurs.
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
OXYCODONE MYLAN given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn.
Before you take OXYCODONE MYLAN
When you must not take it
Do not take OXYCODONE MYLAN if you have an allergy to:
any medicine containing oxycodone hydrochloride
any other narcotic analgesics such as morphine, codeine or opium
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Do not take this medicine if you are pregnant.
It may affect your developing baby if you take it during pregnancy.
Do not breast-feed if you are taking this medicine.
The active ingredient in OXYCODONE MYLAN passes into breast milk and there is a possibility that your baby may be affected.
Do not give this medicine to children.
Safety and effectiveness in children have not been established.
Do not take this medicine if you have or have had any of the following:
head injury
brain tumour
epilepsy or other convulsive disorders
heart problems, such as an irregular and/or rapid heartbeat
chronic obstructive pulmonary disease, asthma or other respiratory diseases
severe headaches, or headaches due to increased pressure in the head
a history of alcohol or drug abuse
a history of mental illness
Do not take this medicine if you are taking or have taken medicines for depression called Monoamine Oxidase Inhibitors (MAOIs) within the last 14 days.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
muscle weakness
underactive thyroid
kidney disease
liver disease
low blood pressure
prostate problems, or difficulty in passing urine
bowel disorders
prescription or illicit drug addiction
If you have not told your doctor about any of the above, tell them before you start taking OXYCODONE MYLAN.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and OXYCODONE MYLAN may interfere with each other. These include:
anaesthetics
anticoagulants, medicines used to thin the blood
medicines used to treat epilepsy
medicines used to help with sleeping
medicines used to help lower blood pressure
medicines used to treat anxiety
medicines used to treat depression
medicines used to treat cold and flu symptoms
other medicines used to relieve pain
medicines used to relieve nausea and vomiting
atropine-like medicines, used to prevent travel sickness and for stomach cramps and spasms
medicines used to treat chronic obstructive pulmonary disorder
antipsychotic medicines, used to treat psychosis, schizophrenia or bipolar disorder
antihistamine medicines, used to treat allergic skin conditions or hay fever
any medicine containing naloxone and/or naltrexone, used to reverse the effects of narcotic analgesics
These medicines may be affected by OXYCODONE MYLAN or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.
How to take OXYCODONE MYLAN
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How much to take
The usual dose is one tablet every six hours.
Your doctor may prescribe a different dose for you. Be sure to follow your doctor’s directions about when and how to take OXYCODONE MYLAN.
How to take it
Swallow the tablets whole with a full glass of water.
When to take it
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
OXYCODONE MYLAN should be taken after food or with milk.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
If you have been using this medicine for a long period of time and it is no longer needed to manage your pain, DO NOT stop taking OXYCODONE MYLAN suddenly.
Your doctor may want you to gradually reduce the amount of OXYCODONE MYLAN you are taking before stopping completely in order to lessen the risk of withdrawal symptoms.
If you forget to take it
If it is less than 3 hours before your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
If you or someone else receives 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 OXYCODONE MYLAN 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 OXYCODONE MYLAN, you should immediately:
phone the Poisons Information Centre (by calling 13 11 26), 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 any 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 OXYCODONE MYLAN
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking OXYCODONE MYLAN.
Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
Keep all of your doctor’s appointments so that your progress can be checked.
Things you must not do
Do not take OXYCODONE MYLAN to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
If you stop taking it suddenly, your condition may worsen, you may have unwanted side effects or you may experience withdrawal symptoms. Your doctor will gradually reduce the amount you take each day before stopping this medicine completely.
Do not drive or operate machinery until you know how OXYCODONE MYLAN affects you.
This medicine may impair the mental and physical ability needed to drive a car or operate heavy machinery. It may cause drowsiness. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Do not drink alcohol while you are taking this medicine.
Things to be careful of
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.
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.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking OXYCODONE MYLAN.
This medicine helps most people with their 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 attention if you get some of the side effects.
If you are over 65 years of age you may have an increased chance of getting side effects.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
dizziness, light-headedness, and confusion
drowsiness
constipation
vomiting
nausea
unusual tiredness or weakness
The above list includes the more common side effects of your medicine.
Tell your doctor as soon as possible if you notice any of the following:
difficulty passing urine
decreased frequency of passing urine
dry mouth
sweating
redness of the face
loss of appetite
fainting or feeling weak
slow heart rate
abnormal and fast heart rate
irregular heart beat
feeling light headed when standing up or when getting out of bed
decrease in body temperature
restlessness or nervousness
changes in mood
constriction of pupils
hallucinations
muscle rigidity
severe headache due to increased pressure in the head
The above list includes serious side effects that may require medical attention.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
loss of consciousness
difficulty or an inability to breathe properly
severe dizziness, drowsiness, or disorientation
symptoms of an allergic reaction (itchy skin rash, skin blisters, or discolouration of skin upon exposure to sunlight)
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
In long-term use, physical dependence and tolerance to the medicine may develop. The following withdrawal symptoms may be experienced after stopping treatment with OXYCODONE MYLAN:
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
After using OXYCODONE MYLAN
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 your tablets in a cool dry place where the temperature stays below 30°C.
Do not store OXYCODONE MYLAN or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
OXYCODONE MYLAN is available in blister packs of 20 tablets.
OXYCODONE MYLAN tablets are white and round, with one side embossed ‘O 5’ and a break bar on the other side.
Ingredients
OXYCODONE MYLAN contains 5 mg of oxycodone (as oxycodone hydrochloride) as the active ingredient.
The tablets also contain the following inactive ingredients:
lactose
microcrystalline cellulose
stearic acid
OXYCODONE MYLAN contains lactose.
Distributor
OXYCODONE MYLAN is distributed in Australia by:
Alphapharm Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.mylan.com.au
This leaflet was prepared in May 2020.
AUST R 224758
oxycodone_mylan_cmi\may20/00
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