2. What should I know before I am given DBL Naloxone Hydrochloride?
Do not start treatment if you have ever had an allergic reaction to naloxone or any
of the ingredients listed at the end of this CMI.
Talk to your doctor if you have an addiction to, or regularly use opioids (including
babies of mothers who fall into this category); have heart, lung, kidney or liver
disease, or 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, including some pain medicines and cold and cough medicines, may interfere
with DBL Naloxone Hydrochloride and affect how it works.
4. How is DBL Naloxone Hydrochloride given?
DBL Naloxone Hydrochloride is given as an injection into a muscle, under the skin
or as a slow injection into a vein.
Your dose depends on whether you are an adult, child or baby and how you are receiving
DBL Naloxone Hydrochloride.
5. What should I know while I am being given DBL Naloxone Hydrochloride?
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Things you should do
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Remind any doctor, nurse, pharmacist or dentist you visit that you are being given
this medicine.
Tell your doctor if you are pregnant, intend to become pregnant or are breastfeeding.
Tell your doctor if you have heart, lung, kidney or liver disease, or drug addiction.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly after being given DBL Naloxone Hydrochloride.
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Driving or using machines
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Be careful driving or using any machines or tools until you know how this medicine
affects you.
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Drinking alcohol
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Be careful when drinking alcohol while you are being given this medicine.
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Looking after your medicine
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DBL Naloxone Hydrochloride will usually be stored in the pharmacy or on the ward.
If you need to store this medicine, keep it in a cool, dry, dark place, below 25°C.
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6. Are there any side effects?
Symptoms of opioid withdrawal if you or your baby are dependent on opioids.
Side-effects not specific to opioid withdrawal may include: nausea/vomiting; sweating;
agitation; headache; light-headedness, dizziness; hyperventilating; tremors; seizures/fits;
fast or abnormal heartbeat; coughing up bloody or frothy mucus; coma; heart suddenly
stops beating which may lead to death.
Allergic reaction, which may be serious. Symptoms may include: shortness of breath,
wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts
of the body, and rash, itching or hives on the skin.
Active ingredient(s): naloxone hydrochloride dihydrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Naloxone Hydrochloride.
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 Naloxone Hydrochloride.
Where to find information in this leaflet:
1. Why am I being given DBL Naloxone Hydrochloride?
DBL Naloxone Hydrochloride contains the active ingredient naloxone hydrochloride dihydrate.
It belongs to a group of medicines known as opioid antagonists.
DBL Naloxone Hydrochloride is used to reverse the effects of opium-like substances
such as morphine, heroin, methadone or codeine.
It may also be used after surgical operations when powerful pain killers which have
been given during the operation are no longer required.
It acts very quickly, within one or two minutes when injected into a vein and can
be a life-saving measure in those people who have received an overdose of an opioid-like
drug.
DBL Naloxone Hydrochloride is not addictive.
2. What should I know before I am given DBL Naloxone Hydrochloride?
Warnings
You must not be given DBL Naloxone Hydrochloride if:
1. you are allergic to naloxone 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.
Check with your doctor if you:
Have or have had any other medical conditions, especially the following:
heart disease
lung disease
kidney disease
liver disease
drug addiction (including babies born to mothers with opioid addiction or regular
opioid use)
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 or pharmacist if you are pregnant or intend to become pregnant.
Naloxone crosses the placenta and can be absorbed by the unborn baby. This may result
in withdrawal symptoms in the baby as well as the mother, if the mother has regularly
taken opioids over the course of her pregnancy.
Your doctor or pharmacist will discuss the risks and benefits of being given naloxone
during pregnancy.
Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.
It is not known whether naloxone passes into breast milk.
Your doctor or pharmacist will discuss the possible risks and benefits of being given
naloxone when breast-feeding.
If you have not told your doctor about any of the above, tell them before you are
given this medicine.
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 Naloxone Hydrochloride and affect how it works.
These include:
Pain killers (e.g. codeine, buprenorphine or pentazocine)
Cough and cold remedies
Heart and blood pressure medication.
These medicines may be affected by DBL Naloxone Hydrochloride or may affect how well
it works. You may need different amounts of your medicine, or you may need to take/use
different medicines. Your doctor or pharmacist will advise you.
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 Naloxone Hydrochloride.
4. How is DBL Naloxone Hydrochloride given?
How much is given
For a known or suspected overdose in an adult, an initial dose of 1 to 5 ampoules
of DBL Naloxone Hydrochloride may be used. This may be repeated at 2 to 3 minute intervals,
up to a total of 25 DBL Naloxone Hydrochloride ampoules being used.
For a known or suspected overdose in a child, medical advice must be obtained to determine
how much is given.
Seek emergency services if delivered outside a hospital setting.
In hospital settings, your doctor will decide what dose you will receive and how often.
How it is given
DBL Naloxone Hydrochloride may be given either:
as an injection into a muscle (intramuscular)
just under your skin (subcutaneous) or
as a slow injection into a vein (intravenous).
Injection into a vein is the most common site in an emergency.
If you are given too much DBL Naloxone Hydrochloride
If you think that too much DBL Naloxone Hydrochloride has been given and/or if you
experience severe side effects, you should immediately:
contact your doctor, or
phone the Poisons Information Centre
(by calling
13 11 26), or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
Severe withdrawal symptoms can be produced in patients who are regular users of opioids
(or babies born to women who are regularly take opioids) if too much naloxone is used.
Ask your doctor or pharmacist if you have any concerns.
5. What should I know while I am being given DBL Naloxone Hydrochloride?
Things you should do
Remind any doctor, nurse, pharmacist or dentist you visit that you are receiving DBL
Naloxone Hydrochloride.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are receiving this medicine.
If you become pregnant while receiving DBL Naloxone Hydrochloride, tell your doctor
or pharmacist immediately.
Tell your doctor if you have heart disease, lung disease, kidney disease, liver disease
or drug addiction.
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.
Driving or using machines
Be careful driving or using any machines or tools until you know how DBL Naloxone
Hydrochloride affects you.
Drinking alcohol
Be careful when drinking alcohol while you are receiving this medicine.
Looking after your medicine
DBL Naloxone Hydrochloride will usually be stored in the pharmacy or on the ward.
However, if you need to store DBL Naloxone Hydrochloride, it should be kept in a cool
dry place, protected from light by keeping the ampoules in the box, and where the
temperature stays below 25°C.
For example, 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.
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.
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.
Abrupt reversal of the effects of opium-like substances may result in withdrawal symptoms,
which can be serious.
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Side effect
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What to do
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The symptoms of opioid withdrawal that may be experienced if you or your baby are
dependent on opioids may include:
body aches
diarrhoea, stomach cramps
fast heartbeat
fever
runny nose, sneezing
goose pimples, sweating, shivering
tremors
yawning
nausea or vomiting
nervousness, restlessness
irritability, abnormal excitability or violent behaviours
tingling, numbness, pins and needles
weakness
headache
seizures/fits.
Additional symptoms in babies may include:
excessive crying
abnormal movements.
General side effects not specific to opioid withdrawal may include:
nausea or vomiting
sweating
agitation
headache
light-headedness, dizziness
hyperventilating
tremors
coughing up bloody or frothy mucus
fast or abnormal heartbeat
seizures/fits
coma
heart suddenly stops beating which may lead to death.
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Tell your doctor or nurse or go immediately to Accident and Emergency if you notice
any of the following during treatment with DBL Naloxone Hydrochloride.
You may need urgent medical attention.
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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 in the skin.
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Tell your doctor or nurse immediately if you notice any of the following
These may be more serious side effects. You may need urgent medical attention.
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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.
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/safety/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
treatment with any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What DBL Naloxone Hydrochloride contains
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Active ingredient
(main ingredient)
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Naloxone hydrochloride dihydrate
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Other ingredients
(inactive ingredients)
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Hydrochloric acid
Sodium Chloride
Water for Injections
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Do not use this medicine if you are allergic to any of these ingredients.
DBL Naloxone Hydrochloride does not contain lactose, sucrose, gluten, tartrazine or
any other azo dyes.
What DBL Naloxone Hydrochloride looks like
DBL Naloxone Hydrochloride is a clear, colourless solution.
It should not be given if there are any crystals or particles visible in the solution.
DBL Naloxone Hydrochloride is available as follows:
400 microgram/mL, 5 x 1 mL ampoules
(AUST R 16282)
Who distributes DBL Naloxone Hydrochloride
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in September 2025.
™ Trademark