NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
DILAUDID® TABLETS
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before using this medicine.
Why am I using DILAUDID?
DILAUDID contains the active ingredient hydromorphone hydrochloride. DILAUDID is used for the short-term relief of severe pain for which other treatment options have failed or otherwise unsuitable to provide sufficient management of pain.
For more information, see Section 1. Why am I using DILAUDID? in the full CMI.
What should I know before I use DILAUDID?
Do not use if you have ever had an allergic reaction to hydromorphone or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use DILAUDID? in the full CMI.
What if I am taking other medicines?
Some medicines may interfere with DILAUDID and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
How do I use DILAUDID?
Your doctor will tell you exactly how much to take.
Follow the instructions given to you by your doctor or pharmacist exactly.
You must only take DILAUDID tablets by mouth.
More instructions can be found in Section 4. How do I use DILAUDID? in the full CMI.
What should I know while using DILAUDID?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using DILAUDID
Tell your doctor or pharmacist if you are taking any other medicines that you use to help you relax, anything that contains alcohol (like cough syrup) or other medicines that treat pain.
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Things you should not do
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Do not stop using this medicine suddenly.
Do not take more than your doctor tells you to
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Driving or using machines
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DILAUDID may cause drowsiness, if affected do not drive a vehicle or operate machinery
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Drinking alcohol
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Avoid alcohol
Alcohol may make you feel more sleepy, and could increase the risk of serious side effects, such as shallow breathing with the risk of stopping breathing and loss of consciousness.
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Looking after your medicine
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Store below 25°C and protect from light.
Keep it where young children cannot reach it.
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For more information, see Section 5. What should I know while using DILAUDID? in the full CMI.
Are there any side effects?
DILAUDID Tablets may cause constipation, nausea, dizziness, drowsiness and be habit forming if taken frequently or over long periods.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
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WARNING:
Limitations of use
DILAUDID 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
DILAUDID 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
DILAUDID 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 DILAUDID 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 DILAUDID
Using DILAUDID with other medicines that can make you feel drowsy such as sleepingtablets (e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants,antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin), cannabis and alcoholmay result in severe drowsiness, decreased awareness, breathing problems, coma anddeath. 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 DILAUDID.
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Active ingredient(s):Hydromorphone Hydrochloride
Consumer Medicine Information (CMI)
This leaflet provides important information about using DILAUDID. You should also speak to your doctor or pharmacist if you would like further informationor if you have any concerns or questions about using DILAUDID.
Where to find information in this leaflet:
1. Why am I using DILAUDID?
2. What should I know before I use DILAUDID?
3. How do I use DILAUDID?
4. What should I know while using DILAUDID?
5. Are there any side effects?
6. Product details
Why am I using DILAUDID?
DILAUDID contains the active ingredient hydromorphone hydrochloride. Hydromorphone belongs to a group of medicines called opioid analgesics.
DILAUDID is used to provide the short-term management of severe pain for which othertreatment options have failed or are otherwise inappropriate to provide sufficientmanagement of pain.
What should I know before I use DILAUDID?
Warnings
Do not use DILAUDID if:
you are allergic to hydromorphone hydrochloride, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you have acute breathing difficulties such as bronchitis or asthma
you have severe abdominal pain with bloating, cramps or vomiting
you have a condition where your small bowel does not work properly
you take medicine for depression called a ‘monoamine oxidase inhibitor’ or have taken any in the last two weeks.
you are pregnant or in labour
Check with your doctor if you:
are severely drowsy, have a reduced level of consciousness or are feeling faint or dizzy upon standing
have heart problems or heart disease
have low blood pressure
have chronic lung disease
suffer from sleep apnoea (temporarily stopping breathing while you sleep)
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, brain tumour or increased pressure in your head
are about to have surgery, had recent gastrointestinal surgery or have had other surgery in the last 24 hours,
have chronic liver or kidney disease
have increased prostate size or difficulty passing urine
have problems with your gall bladder
have problems with or recent surgery of your bile duct
have inflammation of the pancreas
have adrenal glands which are not working properly
have an underactive thyroid gland
have a severe mental condition involving losing contact with reality or an inability to think clearly
have an addiction or history of abuse of alcohol, opioids or other drugs
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.Low levels of opioid analgesics have been detected in human milk.
DILAUDID given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn.
Addiction
You can become addicted to DILAUDID even if you take it exactly as prescribed. DILAUDID 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 DILAUDID. Taking it may result in physical dependence. Physical dependence means that you may experience withdrawal symptoms if you stop taking DILAUDID suddenly, so it is important to take it exactly as directed by your doctor.
Tolerance
Tolerance to DILAUDID 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.
What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with DILAUDID and affect how it works.
Using DILAUDID with medicines that can make you feel drowsy may result in severe drowsiness, decreased awareness, breathing problems, coma and death.These medicines include:
sleeping tablets and other sedatives (including benzodiazepines and barbiturates)
gabapentinoids
cannabis
antihistamines
anxiolytics
general anaesthetics
antiemetics
antidepressants (including tricyclic antidepressants),
antipsychotics (including phenothiazines)
neuroleptics
other opioids
alcohol
DILAUDID may enhance the action of neuromuscular blocking agents and affect your breathing
DILAUDID should not be used if you are taking non-selective monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping such treatment
Check with your doctor or pharmacist if you are not sure about what medicines, vitaminsor supplements you are taking and if these affect DILAUDID.
How do I use DILAUDID?
How much to take
Your doctor will tell you how much to take
Follow the instructions provided and use DILAUDID until your doctor tells you to stop
When to take DILAUDID
Take DILAUDID every 4 hours or as directed by your doctor.
Take DILAUDID at about the same times each day.
How to take DILAUDID
DILAUDID can be taken either with or without food, but try to take it the same way every time.
If you begin to experience pain, tell your doctor as your dosage may have to be reviewed.
If you forget to use DILAUDID
If you are taking regular doses of DILAUDID, you should take it at the same times each day. If you miss your dose at the usual time you may take DILAUDID as soon as you remember or think you need it.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of getting unwanted side effects including severe drowsiness, decreased awareness, breathing problems, coma and death.
If you use too much DILAUDID
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 above steps even if someone other than you have accidentally used DILAUDID 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 DILAUDID 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 remaining medicine with you to show the doctor. Also tell them about any other medicines or alcohol which have been taken.
What should I know while using DILAUDID?
Things you should do
Call your doctor straight away if you:
become pregnant
feel your pain is getting worse.
Remind any doctor, dentist or pharmacist you visit that you are using DILAUDID.
If you are going to have surgery, tell the surgeon or anaesthetist that you are takingthis medicine
Things you should not do
Do not stop using this medicine suddenly.If you stop taking this medicine suddenly, your pain may worsen and you may experience withdrawal symptoms.
Do not take DILAUDID tablets or oral liquid to treat any other complaint unless your doctor tells you to.
Do not give this medicine to anyone else, even if they have the same condition as you
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DILAUDIDaffects you.
DILAUDID may cause drowsiness or impair mental and/or physical ability in some people.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may make you feel more sleepy, and could increase the risk of serious side effects, such as shallow breathing with the risk of stopping breathing and loss of consciousness.
Looking after your medicine
Store below 25°C
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on windowsills.
Keep it where young children cannot reach it.A locked cupboard at least one-and-a-halfmetres above the ground is a good place to store medicines.
Getting rid of any unwanted medicine
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.
Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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Gastrointestinal and urinary related:
constipation
nausea or vomiting
difficulty urinating
Neurological and behavior related:
dizziness
drowsiness
headache
Allergy related
sweating
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Speak to your doctor if you have any of these less serious side effects and they worryyou.
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Serious side effects
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Serious side effects
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What to do
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Breathing
difficulty breathing or shallow breathing
Neurological and behavior related:
light-headedness, fainting or dizziness especially when standing up
changes in mood
drowsiness or feeling extremely sedated
feeling disorientated and having nightmares
Heart related:
slow or noticeable heartbeats
Gastrointestinal and urinary related:
severe stomach pain with nausea or vomiting
difficulty urinating
Allergyrelated
shortness of breath, swelling of the face, lips, tongue or other parts of the body
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Call your doctor straight away, or go straight to the Emergency Department at yournearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making youfeel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist beforeyou decide to stop taking any of your medicines.
Product details
This medicine is only available with a doctor’s prescription.
What DILAUDID contains
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Active ingredient
(main ingredient)
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Hydromorphone hydrochloride
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Other ingredients
(inactive ingredients)
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magnesium stearate.Additionally;
the 2 mg tablet contains vat red 1 aluminium lake (CI73360) and quinoline yellow aluminium lake (CI47005)
the 4 mg tablet contains quinoline yellow aluminium lake (CI47005).
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Potential allergens
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Lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What DILAUDID looks like
DILAUDID 2 mg are light orange, round, flat-faced tablets, with bevelled edges, with the number “2” on one side and a “D” on the other side. (Aust R 67353)
DILAUDID 4 mg are light yellow, round, flat-faced tablets, with bevelled edges with the number “4” on one side and a “D” on the other side. (Aust R 67354)
DILAUDID 8 mg are white, triangular-shaped tablets, bisected on one face, with a “D” on each side of the bisecting line, and with the number “8” on the other face. (Aust R 67355)
Who distributes DILAUDID
Mundipharma Pty Limited
ABN 87 081 322 509
88 Phillip Street
SYDNEY NSW 2000
ABN 87 081 322 509
88 Phillip Street
SYDNEY NSW 2000
Phone: 1800 188 009
This leaflet was prepared in July 2020
® DILAUDID is a trademark of MUNDIPHARMA.
Orbis RA-0276-005
mfcdilao10720 supersedes mfcdilao11118
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