Tablets and oral liquid
Hydromorphone hydrochloride (hi-dro-morf-own hi-dro-klor-ide)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about DILAUDID tablets or oral liquid.
It does not contain all of the available information. It does not take the place of
talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the benefits of you
using DILAUDID tablets or oral liquid against the risks it may have for you.
If you have any concerns about this medicine, talk to your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What DILAUDID tablets & oral liquid are taken for
DILAUDID tablets and oral liquid contain hydromorphone hydrochloride. Hydromorphone
belongs to a group of medicines called opioid analgesics.
DILAUDID tablets or oral liquid are taken to relieve moderate to severe pain.
Opioid analgesics have been used to treat pain for many years. 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 hydromorphone.
Taking it may result in physical dependence. Physical dependence means that you may
experience withdrawal symptoms if you stop taking hydromorphone 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
When you must not take it
Do not take DILAUDID tablets or oral liquid if you:
suffer from shallow or difficult breathing or have any breathing problems such as
have severe abdominal pain with bloating, cramps or vomiting
have a condition where your small bowel does not work properly
take medicine for depression called a 'monoamine oxidase inhibitor' or have taken
any in the last two weeks.
Do not take DILAUDID tablets or oral liquid if you are allergic to hydromorphone,
opioid painkillers, or any of the ingredients listed at the end of this leaflet.
The tablets contain lactose so consider this if you are lactose intolerant.
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 damaged or shows signs of tampering.
Do not take this medicine during labour for the delivery of premature infants.
Hydromorphone given to the mother can cause breathing problems in the newborn, especially
Do not take this medicine if you are pregnant or intend to become pregnant whilst
taking this medicine.
Like most medicines of this kind, DILAUDID tablets or oral liquid are not recommended
to be taken during pregnancy. Your doctor will discuss the risks of taking it if you
Do not give this medicine to a child, and especially not to a premature newborn.
Safety and efficacy in children have not been established.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
Tell your doctor if you have or have had any medical conditions, especially the following:
are severely drowsy or have a reduced level of consciousness
heart problems or heart disease
chronic 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
convulsions, fits or seizures
head injury, brain tumour or increased pressure in your head
are about to have surgery or have had surgery in the last 24 hours
recent gastrointestinal surgery
chronic liver or kidney disease
low blood pressure including from having low blood volume
feeling faint or dizzy upon standing
increased prostate size or difficulty passing urine
problems with your gall bladder
problems with or recent surgery of your bile duct
inflammation of the pancreas
adrenal glands not working properly
underactive thyroid gland
severe mental condition involving losing contact with reality or an inability to think
an addiction or history of abuse of alcohol, opioids or other drugs.
Tell your doctor if you are breastfeeding or planning to breastfeed.
DILAUDID tablets or oral liquid should not be taken by breastfeeding women as hydromorphone
may pass into the breastmilk and can affect the baby.
If you have not told your doctor about any of the above, tell them before you take
DILAUDID tablets or oral liquid.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy
without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and DILAUDID tablets or oral liquid may interfere with each other.
medicines to treat depression, psychiatric or mental disorders. Medicines for depression
belonging to a group called 'monoamine oxidase inhibitors' must be stopped 14 days
before DILAUDID tablets or oral liquid are taken
medicines to help you sleep
medicines to put you to sleep during an operation or procedure
medicines to relax your muscles
medicines to stop nausea and vomiting e.g. metoclopramide or prochlorperazine
other pain relievers including other opioids
These medicines and alcohol may be affected by DILAUDID tablets or oral liquid, may
affect how well DILAUDID tablets or oral liquid 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 to be careful with or
avoid while taking this medicine.
How to take DILAUDID tablets or oral liquid
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.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How to take it
Swallow DILAUDID tablets with a glass of water.
Accurately measure the dose of DILAUDID oral liquid required.
Using a medicine measure such as a measuring glass or oral syringe, will make sure
that you get the correct dose. You can buy a medicine measure from a pharmacy.
Your doctor will choose the best DILAUDID preparation to give you. If you have trouble
swallowing your tablets, talk to your doctor.
You must only take DILAUDID tablets or oral liquid by mouth.
Taking these medicines in a manner other than that prescribed by your doctor can be
harmful to your health.
When to take it
Take DILAUDID tablets or oral liquid every 4 hours or as directed by your doctor.
Take these medicines at about the same times each day.
Take DILAUDID tablets or oral liquid either with or without food but take it the same
way every time. If you begin to experience pain, tell 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:
loss of appetite, nausea (feeling sick), stomach cramps or diarrhoea
fast heart rate
sneezing or runny nose
chills, tremor, shivering or fever
trouble sleeping, nervousness or restlessness
increased sweating and yawning
If you forget to take it
If you forget to take a dose, contact your doctor or pharmacist for advice.
Do not take a double dose to make up for the dose you have missed.
Taking extra medicine will increase the chance of unwanted side effects.
If you have trouble remembering when to take your medicine, ask your pharmacist for
If you take too much (overdose)
Immediately contact your doctor or the Poisons Information Centre (telephone 13 11
26) for advice, or go to Accident and Emergency at your nearest hospital, if you think
that you or anyone else may have taken too many DILAUDID tablets or taken too much
DILAUDID oral liquid. Keep telephone numbers for these places handy.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If someone takes an overdose they may experience difficulties in breathing, become
drowsy and tired, have constricted pupils, lack muscle tone, have cold or clammy skin,
have very low blood pressure or slow heart rate, and possibly may even become unconscious
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
While you are taking it
Things you must do
Take DILAUDID tablets or oral liquid exactly as your doctor has prescribed.
Before you start on a new medicine, remind your doctor and pharmacist you are taking
DILAUDID tablets or oral liquid.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
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 this medicine with your doctor.
Tolerance to hydromorphone may develop which means that the effect of the medicine
may decrease. If this happens, your doctor may review the dose so that you get adequate
Keep enough DILAUDID tablets or oral liquid with you to last over weekends and holidays.
Things you must not do
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
Do not stop taking this medicine, exceed the dose recommended or change the dose without
checking with your doctor.
Over time your body may become used to hydromorphone 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 this medicine.
Drinking alcohol while taking this medicine 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.
Things to be careful of
Tell your doctor if you find that you cannot concentrate or that you feel more sleepy
than normal when you start taking this medicine or when the dose is increased.
This feeling should wear off after a few days.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
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.
Do not drive or operate machinery until you know how DILAUDID tablets or oral liquid
As with other opioid analgesics, DILAUDID tablets or oral liquid 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.
Be careful if you are elderly, unwell or taking other medicines.
Some people may experience side effects such as unsteadiness, dizziness, drowsiness
or confusion which may increase the risk of a fall.
Tell your doctor if you suffer from nausea or vomiting when taking DILAUDID tablets
or oral liquid.
If you vomit after your dose, your pain may come back as you may not have absorbed
your medicine. Your doctor may be able to give you some medicine to help.
Tell your doctor if taking DILAUDID tablets or oral liquid causes constipation.
Your doctor can advise you about your diet, the proper use of laxatives and other
ways to help manage constipation.
There is potential for abuse of hydromorphone and the development of addiction to
hydromorphone. It is important that you discuss this issue with your doctor.
All medicines may have some unwanted side effects. Sometimes they are serious but
most of the time they are not. 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 as soon as possible if you do not feel well while you are taking
DILAUDID tablets or oral liquid.
This medicine helps most 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.
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 problems such as feeling nauseous (feeling sick), loss of appetite,
constipation or diarrhoea
dry mouth or changes in taste
feeling agitated, nervous or anxious
have trouble sleeping
trouble with your balance
problems with your eyesight
skin rash, itching or sweating
uncoordinated muscle movements and stiffness, tremor, tingling and numbness
swelling, including but not only, of the legs or ankles
Tell your doctor as soon as possible if you notice any of the following and they worry
stomach discomfort or cramps, vomiting, indigestion or abdominal pain
changes in mood
light-headedness, fainting or dizziness especially when standing up
drowsiness or feeling extremely sedated
feeling disorientated and having nightmares
slow or noticeable heartbeats
headache, confusion or hallucinations
unusual weakness or loss of strength
difficulty passing urine, 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 difficulty
breathing; swelling of the tongue, throat, face, lips or other parts of the body;
rash, itching, or hives on the skin
seizures, fits or convulsions
fast or irregular heartbeats.
The above list includes very serious side effects. You may need urgent medical attention
When seeking medical attention, take this leaflet and any remaining medicine with
you to show the doctor.
After taking it
Keep your medicine in its original container in a cool, dry place where the temperature
stays below 25°C and protected from light.
Do not store it or any other medicine in the bathroom, near a sink or on a window
Do not leave it in the car.
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.
If your doctor tells you to stop taking this medicine, or the expiry date has passed,
ask your pharmacist how to dispose of medicines no longer required.
What it looks like:
DILAUDID® tablets are available in three strengths:
2 mg tablets are round, light-orange tablets (marked with 2 on one side and a "D"
logo on the reverse)
4 mg tablets are round, light-yellow tablets (marked with 4 on one side and a "D"
logo on the reverse)
8 mg tablets are white, triangle-shaped tablets (one side marked with two small "D"
logos, one on each side of a break line and 8 on reverse).
DILAUDID® tablets are available in opaque plastic bottles containing 20 tablets.
DILAUDID® oral liquid is a clear, colourless to pale yellow, slightly viscous solution and
is available in one strength (1 mg/mL).
Each amber glass bottle contains 473 mL.
Each amber PET bottle contains 200 mL.
2 mg tablet contains 2 mg hydromorphone hydrochloride
4 mg tablet contains 4 mg hydromorphone hydrochloride
8 mg tablet contains 8 mg hydromorphone hydrochloride
In addition, the 2 mg and 4 mg tablets contain quinoline yellow aluminium lake (CI
47005) and the 2 mg tablet also contains vat red 1 aluminium lake (CI 73360).
DILAUDID® oral liquid
One mL contains 1 mg hydromorphone hydrochloride as the active ingredient.
Inactive ingredients are sucrose, glycerol, propyl hydroxybenzoate (preservative),
methyl hydroxybenzoate (preservative) and water.
DILAUDID® tablets and DILAUDID® oral liquid are supplied in Australia by:
Mundipharma Pty Limited
ABN 87 081 322 509
88 Phillip Street
SYDNEY NSW 2000
Phone: 1800 188 009
® DILAUDID is a trade mark of MUNDIPHARMA.
This leaflet was updated in
The Australian registration numbers are:
2mg: AUST R 67353
4mg: AUST R 67354
8mg: AUST R 67355
DILAUDID® oral liquid
1mg/mL: AUST R 67360