NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
OXYNORM®CAPSULES 5MG, 10MG, 20MG MFCOXYNO10720
Oxycodone hydrochloride (ox-ee-code-own hi-dro-klor-ide)
Consumer Medicine Information
|
WARNING:
Limitations of use
OxyNorm 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
OxyNorm 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
OxyNorm 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 OxyNorm 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 OxyNorm
Using OxyNorm 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 OxyNorm.
|
What is in this leaflet
This leaflet answers some common questions about OxyNorm capsules.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What OxyNorm capsules are taken for
OxyNorm capsules contain oxycodone hydrochloride. Oxycodone belongs to a group of medicines called opioid analgesics.
OxyNorm capsules are used to provide the short-term management of severe pain for which other treatment options have failed or are otherwise inappropriate to provide sufficient management of pain.
Your doctor, however, may prescribe it for another purpose.
Ask your doctor if you have any questions about why it has been prescribed for you.
As with all strong painkillers, your body may become used to you taking OxyNorm capsules. 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.
This medicine is only available with a doctor’s prescription.
Before you take it
Long-term use of OxyNorm capsules may result in a decrease in sex hormone levels which may affect sperm production in men and the menstrual cycle in females. Talk to your doctor if you have any concerns.
When you must not take it
Do not take OxyNorm capsules 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 due to long-term lung disease
have just consumed a large amount of alcohol, regularly consume large amounts of alcohol or have confusion and shaking due to alcohol withdrawal
suffer from convulsions, fits or seizures
have a head injury, brain tumour or have raised pressure within the head, brain or spinal cord
have sudden severe abdominal pain
have a condition where your stomach empties more slowly than it should, or your small bowel does not work properly
are about to have an operation (including surgery on your spine for pain relief in the next 6 hours)
have severe kidney or liver disease
take a medicine for depression called a ‘monoamine oxidase inhibitor’ or have taken any in the last two weeks.
Do not take OxyNorm capsules if you are allergic to oxycodone, opioid painkillers, or any of the ingredients listed at the end of this leaflet.
Do not take this medicine after the expiry date (EXP) printed on the pack.
If you take it after the expiry date has passed, it may not work very well.
Do not take it if the packaging is torn or shows signs of tampering.
Do not give this medicine to a child younger than 18 years of age.
Safety and effectiveness in children younger than 18 years of age have not been established.
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 medical conditions, especially the following:
Have sleep apnoea (temporarily stopping breathing while you sleep)
low blood pressure
increased prostate size or difficulty passing urine
chronic lung, liver or kidney disease
disease of your gall bladder or bile duct
inflammation of the pancreas
underactive adrenal glands
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.
Pregnancy and breastfeeding
This medicine is not recommended to be taken during labour.
Oxycodone given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn.
Tell your doctor if you are breastfeeding or planning to breastfeed.
Oxycodone can pass into the breast milk and can harm the baby. Your doctor can discuss with you the risks involved.
If you have not told your doctor about any of the above, tell them before you take any OxyNorm capsules.
Do not take this medicine if you are pregnant or intend to become pregnant whilst taking this medicine.
Like most medicines of this kind, OxyNorm capsules are not recommended to be taken during pregnancy. Your doctor will discuss the risks of taking them if you are pregnant.
Addiction
You can become addicted to OxyNorm even if you take it exactly as prescribed. OxyNorm 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 OxyNorm. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking OxyNorm suddenly, so it is important to take it exactly as directed by your doctor.
Tolerance
Tolerance to OxyNorm 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 having 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.
Taking other medicines
Tell your doctor if you are taking any other medicines or dietary substances, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines, dietary supplements and OxyNorm capsules 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 must be stopped 14 days before OxyNorm capsules are taken
antidepressants e.g. fluoxetine, paroxetine
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 treat convulsions, e.g. phenytoin and carbamazepine
medicines to thin the blood e.g. coumarin derivatives such as warfarin
cimetidine, a medicine to treat stomach ulcers and heartburn
medicines to relieve stomach cramps or spasms, or to prevent travel sickness and the symptoms of allergies
medicines to treat Parkinson’s disease
medicines to treat urinary incontinence
medicines to stop nausea or vomiting e.g. metoclopramide
other pain relievers including other opioids
medicines to treat fungal infections, e.g. ketoconazole
antibiotics, e.g. clarithromycin, rifampin
medicines to treat HIV infection and AIDS, e.g. ritonavir
alcohol
St John’s wort (a herbal preparation)
grapefruit and grapefruit juice.
medicines to treat epilepsy, pain, and anxiety e.g. gabapentin and pregabalin.
These medicines, dietary supplements or alcohol may be affected by OxyNorm capsules, may affect how well OxyNorm capsules work or may increase side effects. You may need to use different amounts of your medicines, or take different medicines.
Your doctor or pharmacist has more information on medicines and dietary supplements to be careful with or avoid while taking this medicine.
How to take OxyNorm capsules
How much to take
Your doctor will tell you exactly how much to take.
Follow the instructions given to you by your doctor or pharmacist exactly.
How to take it
Swallow OxyNorm capsules whole with a full glass of water or other fluid.
Do not open, chew or crush them.
OxyNorm capsules are only designed to work properly if swallowed whole.
You must only take OxyNorm capsules by mouth.
If you have trouble swallowing your capsules whole, talk to your doctor.
Taking this medicine in a manner other than that prescribed by your doctor can be harmful to your health.
When to take it
Take OxyNorm capsules every 4 to 6 hours or as directed by your doctor.
If you begin to experience pain and you are taking your OxyNorm capsules as prescribed, contact your doctor as your dosage may have to be reviewed.
How long to take it
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 withdrawal symptoms such as:
body aches
loss of appetite, nausea, stomach cramps or diarrhoea
fast heart rate
sneezing or runny nose
chills, tremors, shivering or fever
trouble sleeping
increased sweating and yawning
weakness
nervousness or restlessness.
If you forget to take it
If you forget to take your capsules, contact your doctor or pharmacist for advice.
Do not take a double dose to make up for the dose you have missed.
This will increase the chance of you getting unwanted side effects.
If you take too much (overdose)
If you or someone else receive too much (overdose), and experience one or more of the symptoms below, 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 steps even if someone other than you have accidentally used OxyNorm 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 taken too much OxyNorm, you should immediately telephone your doctor, or the Poisons Information Centre (Australia: telephone 13 11 26, New Zealand: telephone 0800 POISON or 0800 764 766), or go to 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 capsules with you to show the doctor. Also tell them about any other medicines or alcohol which have been taken.
While you are taking it
Things you must do
Take OxyNorm capsules exactly as your doctor has prescribed.
Before you start on a new medicine, remind your doctor and pharmacist that you are taking OxyNorm capsules.
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.
Tell your doctor if your pain is getting worse. Always discuss any problems or difficulties you have while you are taking OxyNorm capsules.
Tolerance to oxycodone may develop which means that the effect of the medicine may decrease. If this happens, your doctor may review your dose so that you get adequate pain relief.
Keep enough OxyNorm capsules with you to last over weekends and holidays.
Things you must not do
Do not drink alcohol while you are taking OxyNorm capsules.
Drinking alcohol whilst taking OxyNorm capsules may make you feel more sleepy and increase the risk of serious side effects such as shallow breathing with the risk of stopping breathing and loss of consciousness.
Do not take OxyNorm capsules to treat any other complaint 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, exceed the dose recommended or change the dosage without checking with your doctor.
Over time your body may become used to oxycodone. 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.
Things to be careful of
Do not drive or operate machinery until you know how OxyNorm capsules affect you.
OxyNorm capsules may cause drowsiness, dizziness, hallucinations, disorientation, blurred vision or other vision problems or may affect alertness. If you are affected you should not drive or operate machinery. Discuss these effects with 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.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.
Standing up slowly will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.
Tell your doctor if you suffer from nausea or vomiting when taking OxyNorm capsules.
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 OxyNorm capsules causes constipation.
Your doctor can advise about your diet, the proper use of laxatives and suitable exercise you can do to help manage this.
There is potential for abuse of oxycodone and the development of dependence. It is important that you discuss this issue with your doctor.
Side effects
All medicines may have some unwanted side effects. Sometimes they are serious but most of the time they are not. As for other medicines of this type, that is opioid analgesics, side effects tend to reduce over time, with the exception of constipation. This means that the longer you take this medicine, the less it may cause problems for you. Your doctor has weighed the risks of this medicine against the benefits they expect it will have for you.
Do not be alarmed by this list of possible side effects.
Not everybody experiences them.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking OxyNorm capsules.
This medicine helps people with moderate to severe pain, but it may have unwanted side effects in some people. Other side effects not listed here may also occur in some people.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
mild abdominal symptoms such as diarrhoea, feeling sick (nausea), decreased appetite or constipation
dry mouth, hiccups, sore throat, trouble swallowing or changes in voice
excessive sweating
feeling anxious or nervous, trouble sleeping or abnormal dreams
trouble with your balance, vertigo
new problems with your eyesight
skin rash, itching, chills or fever
muscle problems, such as spasms, twitching or tremors
swelling of legs or ankles
absence of menstrual periods
impotence
decreased sexual drive.
Tell your doctor as soon as possible if you notice any of the following and they worry you:
stomach discomfort, vomiting, indigestion or abdominal pain
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 or loss of strength or trouble walking
fatigue, feeling of tiredness, drowsiness or lack of energy
changes in passing urine such as the volume passed, pain or feeling the need to urinate urgently.
The above list includes serious side effects that may require medical treatment.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
your breathing slows or weakens
you have an allergic reaction: shortness of breath, wheezing, shallow or difficult breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin
seizures, fits or convulsions
fast or irregular heartbeats
chest pain or chest tightness.
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
When seeking medical attention, take this leaflet and any remaining capsules with you to show the doctor.
After taking it
Storage
Keep your capsules in the blister pack until it is time to take them.
If you take the capsules out of the blister pack they may not keep as well.
Keep your capsules in a cool, dry place, where the temperature stays below 30°C.
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 on hot days.
Heat and damp 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 you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
Product description
What it looks like
OxyNorm® capsules come in three strengths:
5 mg – orange and beige, printed with “ONR 5”
10 mg – white and beige, printed with “ONR 10”
20 mg – pink and beige, printed with “ONR 20”.
OxyNorm® capsules 5mg, 10 mg and 20mg come in boxes containing blister packs of 10 and 20 capsules.
Ingredients
Active ingredients:
5 mg capsules contain 5 mg oxycodone hydrochloride
10 mg capsules contain 10 mg oxycodone hydrochloride
20 mg capsules contain 20 mg oxycodone hydrochloride
Inactive ingredients:
microcrystalline cellulose
magnesium stearate
Empty Hard Gelatin Capsules 4722-1 (5mg only)
Empty Hard Gelatin Capsules 4723-1 (10mg only)
Empty Hard Gelatin Capsules 4724-1 (20mg only)
OPACODE monogramming ink S-1-277002 BLACK.
In addition, the capsules also contain the colourants listed below:
5 mg – E110 (sunset yellow), E132 (indigo carmine), E171 (titanium dioxide), E172 (iron oxide red and yellow)
10 mg & 20 mg – E132 (indigo carmine), E171 (titanium dioxide), E172 (iron oxide red and yellow).
This medicine does not contain lactose, sucrose, gluten or tartrazine.
Supplier
OxyNorm® capsules are supplied in Australia by:
Mundipharma Pty Limited
ABN 87 081 322 509
88 Phillip Street
Sydney, NSW, 2000
Phone: 1800 188 009
OxyNorm® capsules are supplied in New Zealand on behalf of Mundipharma New Zealand Limited by:
Pharmaco (NZ) Ltd
PO BOX 4079
Auckland 1140
Phone: (09) 377-3336
Medical enquiries: 0800 773 310
® OXYNORM is a trade mark of MUNDIPHARMA
This leaflet was updated in July 2020.
Please check with your pharmacist that this is the latest version of the leaflet available.
Australian Registration Numbers for OxyNorm® capsules:
5 mg: AUST R 74145
10 mg: AUST R 74143
20 mg: AUST R 74141
Orbis RA-0282-015
Source: Read Full Article