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.
1. Why am I being treated with DBL Fentanyl Injection?
DBL Fentanyl Injection contains the active ingredient fentanyl citrate. DBL Fentanyl
Injection is a short-term pain reliever that belongs to a group of medicines called
opioid analgesics. It is most commonly used to relieve severe pain. It may also be
used just before, or during, an operation, to help the anaesthetic work better.
2. What should I know before treatment with DBL Fentanyl Injection?
Do not use if you have ever had an allergic reaction to fentanyl 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.
3. What if I am taking other medicines?
Some medicines may interfere with DBL Fentanyl Injection and affect how it works.
4. How is DBL Fentanyl Injection given?
Your doctor will decide what dose of fentanyl you will receive. This depends on your
age, physical condition and other factors, such as your weight.
5. What should I know during treatment with DBL Fentanyl Injection?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are being given fentanyl.
If you become pregnant while you are being treated with fentanyl, tell your doctor
immediately.
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Things you should not do
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Do not stop using this medicine suddenly. If you have been using fentanyl for more
than two weeks, you may experience unpleasant feelings if you stop fentanyl suddenly.
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Driving or using machines
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Do not drive a car, operate machinery, or do anything else that could be dangerous
until you know how fentanyl affects you. Fentanyl may cause drowsiness and impair
coordination.
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Drinking alcohol
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Do not drink alcohol while you are being treated with fentanyl.
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Looking after your medicine
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If you are being given DBL Fentanyl Injection while in hospital, it will be stored
in the pharmacy or on the ward. Store below 25°C.
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6. Are there any side effects?
Common side effects include sweating, dizziness, faintness, nausea or vomiting. Tell
your doctor immediately if you notice slow or troubled breathing, muscle stiffness,
slowed heart rate, blurred vision, spasm of the larynx (voice box) or itching. If
you experience serious side effects such as allergic reactions, agitation, hallucinations,
twitching or loss of coordination, severe dizziness and weakness, irregular heart
rate, changes in blood pressure, skin turning blue or unconsciousness, you may need
urgent medical attention or hospitalisation.
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WARNING:
Limitations of use
DBL Fentanyl Injection 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
DBL Fentanyl Injection poses risks of abuse, misuse and addiction which can lead to
overdose and death. Your doctor will monitor you regularly during treatment.
Life threatening breathing problems
DBL Fentanyl Injection 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 fentanyl
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 fentanyl
Using fentanyl 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 fentanyl.
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Active ingredient(s):
fentanyl citrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Fentanyl Injection. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using DBL Fentanyl Injection.
Where to find information in this leaflet:
1. Why am I being treated with DBL Fentanyl Injection?
DBL Fentanyl Injection contains the active ingredient fentanyl citrate. DBL Fentanyl Injection is a short-term pain reliever that belongs to a group of medicines
called opioid analgesics. Fentanyl acts in the brain and spinal cord. It works quickly
to reduce pain and its effects wear off quickly.
Fentanyl may be used alone but is usually used in hospital with other anaesthetics
or with a sedative such as droperidol before an operation to provide an anaesthetic
effect and during an operation to help continue the anaesthesia.
Your doctor may have prescribed it for another reason.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
2. What should I know before treatment with DBL Fentanyl Injection?
If you are not sure whether you should be given this medicine, talk to your doctor
or pharmacist.
Warnings
Do not use DBL Fentanyl Injection if you:
are allergic to fentanyl, or any of the ingredients listed at the end of this leaflet.
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.
Always check the ingredients to make sure you can use this medicine.
have bronchial asthma or severe disease relating to the lungs
have breathing difficulties or shallow breathing
are undergoing treatment with monoamine oxidase (MAO) inhibitors (e.g. phenelzine,
tranylcypromine, moclobemide or selegiline) or have stopped MAO inhibitor treatment
during the last fourteen days
have myasthenia gravis (severe muscle weakness)
have long-standing pain not related to cancer.
Check with your doctor if you:
have or have had any other medical conditions, especially the following:
kidney or liver problems
lung or breathing problems
slow or irregular heartbeats; heart problems
snoring or sleep apnoea (you temporarily stop breathing or have difficulty breathing
while asleep)
recent head injury
mental health conditions (e.g. depression, anxiety or personality disorder)
or anyone in your family have abused or are dependent on alcohol, prescription medicine
or other illegal substances (addiction)
are a smoker
take any medicines for any other condition
have allergies to any other medicines, foods, preservatives or dyes.
If you have not told your doctor or pharmacist about any of the above, tell them before
you are given DBL Fentanyl Injection.
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.
As fentanyl crosses the placenta, your doctor or pharmacist will discuss the possible
risks and benefits of you being given DBL Fentanyl Injection during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
As fentanyl may pass into breast milk, breastfeeding is not recommended for 24 hours
following use of DBL Fentanyl Injection. Your doctor or pharmacist will discuss the
possible risks and benefits of being given DBL Fentanyl Injection during breastfeeding.
Children
DBL Fentanyl Injection should not be given to children under the age of 2 years. There
is not enough information to recommend the use of this medicine for children under
the age of 2 years.
Addiction
You can become addicted to fentanyl even if you use it exactly as prescribed. Fentanyl
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 using
fentanyl. Using it for a long time (i.e. more than two weeks) may result in physical
dependence (i.e. it can be habit-forming or addictive). Physical dependence means
that you may experience withdrawal symptoms if you stop using fentanyl suddenly, so
it is important to use it exactly as directed by your doctor.
However, it is also important to keep your pain under control. Your doctor can advise
you on how to manage this.
Tolerance
Tolerance to fentanyl 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 using your medicine for as long as your doctor tells you. If you stop using
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.
DBL Fentanyl Injection given to the mother during labour can cause breathing problems
and signs of withdrawal in the newborn.
3. 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 DBL Fentanyl Injection and affect how it works.
These include:
barbiturates
general and local anaesthetics (e.g. lidocaine)
strong pain killers (e.g. opioid analgesics)
sedating antipsychotics (e.g. droperidol, chlorpromazine, fluphenazine and thioridazine)
and centrally-active anti-emetics (e.g. metoclopramide and promethazine)
benzodiazepines (and other medicines) to treat anxiety, acute stress reactions, agitation,
tremor, such as diazepam, alprazolam, lorazepam or midazolam
other medicines which may make you drowsy such as sleeping tablets, tablets to calm
your nerves, sedatives, tranquilisers, hypnotics and muscle relaxants
antidepressants or medicines for anxiety disorders such as:
selective serotonin re-uptake inhibitors (SSRIs)
serotonin norepinephrine reuptake inhibitors (SNRIs)
monoamine oxidase (MAO) inhibitors (e.g. phenelzine, tranylcypromine and moclobemide)
MAO inhibitor used to treat Parkinson’s disease e.g. selegiline, rasagiline and safinamide.
medicines to treat mental disorders
medicines to treat seizures (gabapentinoids e.g. gabapentin, pregabalin)
Medicines that may
increase
the effect of DBL Fentanyl Injection include:
macrolide antibiotics (e.g. erythromycin)
azole-antifungal agents (e.g. ketoconizole)
protease inhibitors or medication for HIV (e.g. ritonavir)
Medicines that may
reduce
the effect of DBL Fentanyl Injection include:
rifampin (anti-tuberculosis medication)
carbamazepine and phenytoin, medicines used to control fits or seizures.
These medicines may be affected by DBL Fentanyl Injection or may affect how well it
works. You may need different amounts of your medicine, or different medicines. Your
doctor or pharmacist will advise you.
Your doctor and pharmacist may have more information on medicines to be careful with
or avoid while you are being given this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DBL Fentanyl Injection.
4. How is DBL Fentanyl Injection given?
How much is given
Your doctor will decide what dose you will receive. This depends on your age, physical
condition and other factors, such as your weight.
How is it given
Your doctor or nurse will usually give DBL Fentanyl Injection to you.
DBL Fentanyl Injection is given as an injection into a vein or muscle.
If you are given too much (overdose)
DBL Fentanyl Injection is administered under the care of a highly trained doctor so
overdose rarely occurs.
However, if you or someone else receive too much (overdose), and experience one or
more of the symptoms below, urgent medical attention is required. 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 DBL Fentanyl
Injection that was prescribed for you.
Symptoms of an overdose may include:
slow, unusual or difficult breathing causing skin to turn blue
severe drowsiness, dizziness or unconsciousness
confusion, memory loss, impairment of vision or coordination
slow or weak heartbeat, decreases in heart rate and blood pressure
nausea or vomiting
convulsions or fits
severe weakness or muscle stiffness
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.
5. What should I know during treatment with DBL Fentanyl Injection?
Things you should do
Tell any other doctors, dentists and pharmacists who are treating you that you are
being given DBL Fentanyl Injection.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist
that you are being given DBL Fentanyl Injection.
If you plan to have surgery that needs a local or general anaesthetic, tell your doctor
or dentist you are being given DBL Fentanyl Injection.
If you become pregnant while you are being treated with DBL Fentanyl Injection, tell
your doctor or pharmacist.
Tell your doctor, pharmacist or nurse if you have any concerns about being given DBL
Fentanyl Injection.
Things you should not do:
Do not give DBL Fentanyl Injection to anyone else, even if they have the same condition
as you.
Do not use DBL Fentanyl Injection to treat any other complaints unless your doctor
tells you to.
Do not stop using DBL Fentanyl Injection, or lower the dosage, without checking with
your doctor or pharmacist.
Do not take any other medicines, whether they are prescription or over-the-counter
medicines, unless they have been prescribed or recommended by a doctor or pharmacist
who knows you are being treated with DBL Fentanyl Injection.
Avoid smoking or taking other drugs unless your doctor tells you to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DBL Fentanyl
Injection affects you.
DBL Fentanyl Injection may cause feelings of weakness, dizziness, drowsiness and impairment
of coordination in some people. Do not drive a car, operate machinery, or do anything
else that could be dangerous if you are drowsy or feeling uncoordinated.
Drinking alcohol
Tell your doctor if you drink alcohol.
Do not drink alcohol while you are undergoing treatment with fentanyl unless otherwise
advised by your doctor or pharmacist as drowsiness and coordination impairment may
be worse.
Looking after your medicine
If you are being given DBL Fentanyl Injection while in hospital, it will be stored
in the pharmacy or on the ward.
DBL Fentanyl Injection should be stored in a cool, dry place, protected from light
where the temperature stays below 25°C.
Do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
When to discard your medicine
Do not use this medicine after the expiry date.
DBL Fentanyl Injection should not be given to you if the packaging is torn or shows
signs of tampering.
Getting rid of any unwanted medicine
If your doctor tells you to stop using this medicine or the expiry date as passed,
take it to any pharmacy for safe disposal.
6. 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.
Serious side effects
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Serious side effects
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What to do
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agitation, hallucinations
slow or troubled breathing
muscle stiffness, twitching or loss of coordination
severe dizziness and weakness
slow, fast or irregular heart rate
blurred vision
increase or decrease in blood pressure
skin turning blue and clammy
unconsciousness
spasm of the larynx (voice box)
allergic reactions
itching
The following side effects may occur when a sedating medicine (e.g. droperidol) is
used with DBL Fentanyl Injection
chills, shivering
restlessness
drowsiness
short periods of depression
imaginary events
uncontrolled movement of the body or eyes
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
Tell your doctor immediately if you experience any of these symptoms. You may need
urgent medical attention or hospitalisation.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Tell your doctor immediately if you have unwanted side effects which continue after
your treatment has stopped.
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 before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What DBL Fentanyl Injection contains
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Active ingredient
(main ingredient)
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Fentanyl citrate
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Other ingredients
(inactive ingredients)
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Sodium hydroxide
Sodium chloride
Hydrochloric acid
Water for injections
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Do not use this medicine if you are allergic to any of these ingredients.
DBL Fentanyl Injection does not contain lactose, sucrose, gluten, tartrazine or any
other azo dyes.
What DBL Fentanyl Injection looks like
DBL Fentanyl Injection is a sterile, aqueous, preservative-free, colourless or almost
colourless solution in glass ampoules.
It is available in the following strengths and pack sizes:
100 micrograms / 2 mL x 5 ampoules AUST R 107025
500 micrograms / 10 mL x 5 ampoules AUST R 107027
Who distributes DBL Fentanyl Injection
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in January 2024.