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.
1. Why am I being treated with DBL Promethazine Hydrochloride Injection BP?
2. What should I know before treatment with DBL Promethazine Hydrochloride Injection
BP?
Do not use if you have ever had an allergic reaction to promethazine hydrochloride,
phenothiazine-derivative medicines 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 Promethazine Hydrochloride Injection BP 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.
4. How is DBL Promethazine Hydrochloride Injection BP given?
5. What should I know during treatment with DBL Promethazine Hydrochloride Injection
BP?
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Things you should do
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Remind any doctor, nurse, pharmacist or dentist who treat you that you are being given
this medicine. Remind them before starting a new medicine, before surgery and blood
tests.
Use a sunscreen on exposed skin or remain covered if you go outdoors after being given
this medicine. DBL Promethazine Hydrochloride Injection BP may cause you to sunburn
more easily.
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Things to be careful of
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Be careful before you drive or use any machines or tools until you know how DBL Promethazine
Hydrochloride Injection BP affects you.
Children should be careful when riding bicycles or climbing trees.
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Drinking alcohol
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Be careful when drinking alcohol while being given this medicine.
If you drink alcohol, dizziness or drowsiness may be worse.
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6. Are there any side effects?
Side effects include:
dry mouth, nose or throat, injection site reaction, nausea and vomiting, constipation
or diarrhoea, loss of appetite, unusual tiredness or weakness, clumsiness or unsteadiness,
feeling faint, difficulty in sleeping, increased sensitivity of the skin to the sun,
and skin itch.
Serious side effects include: sore throat and fever, blurred vision, difficult or
painful urination, fast or slow heartbeat, severe drowsiness, confusion, tremors or
convulsions, muscle spasms in the neck and back, jerky movements of the head and face,
shuffling walk, trembling and shaking of hands, ringing or buzzing in ears, unusual
excitement, nervousness, restlessness or irritability, hallucinations, trouble breathing,
flushing or redness of face, allergic reaction symptoms, severe pain in the stomach
with bloating, gut cramps and vomiting, unusual bleeding or bruising, and yellowing
of the skin or eyes.
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.
Active ingredient(s):
Promethazine hydrochloride (Proe-METH-a-zeen)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Promethazine Hydrochloride
Injection BP. 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 Promethazine Hydrochloride
Injection BP.
Where to find information in this leaflet:
1. Why am I being treated with DBL Promethazine Hydrochloride Injection BP?
DBL Promethazine Hydrochloride Injection BP contains the active ingredient promethazine
hydrochloride. DBL Promethazine Hydrochloride Injection BP belongs to a group of antihistamines
called phenothiazines (fen-oh-THY-ah-zines). It works by preventing the effects of
histamine in the body.
DBL Promethazine Hydrochloride Injection BP is used to treat:
allergic reactions,
to relieve nausea, vomiting and dizziness
as a sedative (to help people go to sleep and control their anxiety) before and after
surgery, and during labour.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
This medicine is not addictive.
2. What should I know before treatment with DBL Promethazine Hydrochloride Injection
BP?
Warnings
You must not be given DBL Promethazine Hydrochloride Injection BP if:
any medicine containing promethazine hydrochloride
any other phenothiazine-derivative medicines or
any of the ingredients listed at the end of this leaflet, such as sulfites.
Some of the symptoms of an allergic reaction may include: shortness of breath, wheezing
or difficulty breathing; swelling of the face, lips or 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.
2. the expiry date printed on the pack or if the packaging is torn or shows signs of
tampering.
If it has expired or is damaged return it to your pharmacist for disposal.
If you are not sure whether you should be given this medicine, talk to your doctor.
Check with your doctor if you:
have any allergies to any other medicines, foods, preservatives or dyes.
have or have had any other medical conditions, especially the following:
asthma or breathing difficulties
bone-marrow depression
enlarged prostate
epilepsy
heart or blood pressure disease
irregular heart beat
glaucoma, an eye condition
liver problems
ulcer of the stomach or duodenum
kidney or bladder problems
take any medicines for any other condition, including sedatives
If you have not told your doctor about any of the above, tell them before you are
given promethazine.
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.
DBL Promethazine Hydrochloride Injection BP is not recommended for use during later
stages of pregnancy. If there is a need to consider promethazine during pregnancy,
your doctor will discuss with you the benefits and risks of being given it.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Promethazine passes into breast milk and there is a possibility that your baby may
be affected.
Your doctor or pharmacist will discuss the possible risks and benefits of being given
promethazine while you are breastfeeding.
Use in Children
This medicine must not be given to children under the age of 2 years.
Safety and effectiveness in children under the age of 2 years have not been established.
In general, children are more sensitive to the effects of antihistamines, and DBL
Promethazine Hydrochloride Injection BP should be administered with caution.
Serious side effects, such as convulsions, are more likely to occur in younger patients
and would be of greater risk to infants than to older children or adults. Also, nightmares
or unusual excitement, nervousness, restlessness, or irritability may be more likely
to occur in children.
The use of this medicine is not recommended in children who have a history of difficulty
in breathing while sleeping or a family history of sudden infant death syndrome (SIDS),
or in children under 2 years of age.
Children or adolescents who show signs of Reye’s syndrome should not be given this
medicine.
Uncontrolled movements that may occur with promethazine may be mistakenly confused
with symptoms of Reye’s syndrome.
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 Promethazine Hydrochloride Injection BP and
affect how it works.
These include:
anticholinergic medicines, including medicines for stomach spasm
anticonvulsants or medicines for epilepsy/fits/seizures
beta blockers such as propranolol, medicines used to lower blood pressure
bromocriptine, a medicine used to treat Parkinson’s disease, acromegaly or to prevent
lactation
medicines that cause drowsiness or sleepiness such as sedatives, tranquillisers, barbiturates,
antihistamines, opioid analgesics (medicine to treat pain), general anaesthetics and
alcohol
levodopa (medicine for Parkinson’s disease)
metrizamide, a contrast agent, injected into the spinal cord before an x-ray
medicines used to treat depression, especially monoamine oxidase (MAO) inhibitors
and tricyclic antidepressants
phenothiazine-derivative medicines e.g. chlorpromazine (medicine for thought disorder)
quinidine, a medicine for rapid or irregular heartbeat
medicines to treat cold and flu
appetite suppressants
These medicines may be affected by promethazine or may affect how well it works. You
may need different amounts of your medicine, or you may need to take different medicines.
Your doctor or pharmacist has more information on medicines to be careful with or
avoid while being treated with 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 Promethazine Hydrochloride Injection
BP.
4. How is DBL Promethazine Hydrochloride Injection BP given?
How much is given
Your doctor will decide what dose you will receive. This depends on your condition
and other factors, such as your weight.
How it is given
DBL Promethazine Hydrochloride Injection BP is given as:
a deep injection into a large muscle or
as a slow injection into a vein.
It must only be given by a doctor or nurse.
If you receive too much DBL Promethazine Hydrochloride Injection BP
As DBL Promethazine Hydrochloride Injection BP is given to you under the supervision
of your doctor, it is unlikely that you will receive an overdose.
If you experience severe side effects or you think that you have been given too much
DBL Promethazine Hydrochloride Injection BP, you may need urgent medical attention.
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.
Symptoms of an overdose may include the side effects listed under Section
6. Are there any side effects? but are usually of a more severe nature.
Ask your doctor or pharmacist if you have any concerns.
5. What should I know during treatment with DBL Promethazine Hydrochloride Injection
BP?
Things you should do
Remind any doctor, nurse, pharmacist or dentist who treat you that you are being given
DBL Promethazine Hydrochloride Injection BP.
If you are about to start taking any new medicine, tell your doctor and pharmacist
that you are being given DBL Promethazine Hydrochloride Injection BP.
If you are going to have surgery, tell the surgeon or anaesthetist that you are being
given this medicine.
It may affect other medicines used during surgery.
If you are about to have any blood tests, tell your doctor that you are being given
this medicine.
It may interfere with the results of some tests including pregnancy, glucose and skin
allergen tests.
Use a sunscreen on exposed skin or remain covered if you go outdoors after being given
DBL Promethazine Hydrochloride Injection BP.
This medicine may cause you to sunburn more easily.
Things to be careful of
Be careful before you drive or use any machines or tools until you know how DBL Promethazine
Hydrochloride Injection BP affects you.
DBL Promethazine Hydrochloride Injection BP may cause drowsiness, dizziness or sleepiness
in some people. If you have any of these symptoms, do not drive, operate machinery
or do anything else that could be dangerous.
Children should be careful when riding bicycles or climbing trees.
Drinking alcohol
Tell your doctor if you drink alcohol.
Be careful when drinking alcohol while being given this medicine.
If you drink alcohol, dizziness or drowsiness may be worse.
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.
If you are over 65 years of age you may have an increased chance of getting side effects.
Side effects
Serious side effects
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Serious side effects
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What to do
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General
sore throat and fever
Eye issues
blurred vision
Urinary related issues
difficult or painful urination
Heart related issues
fast or slow heartbeat
Central nervous system
severe drowsiness
confusion
tremors or convulsions
muscle spasms in the neck and back
jerky movements of the head and face
shuffling walk
trembling and shaking of hands
ringing or buzzing in ears
Changes in behaviour, thinking or mood
unusual excitement, nervousness, restlessness or irritability
hallucinations
Respiratory issues
trouble breathing
Skin issues
flushing or redness of face
Allergic reaction symptoms
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips or tongue or other parts of the body
rash, itching or hives on the skin.
Stomach related issues
severe pain in the stomach with bloating, gut cramps and vomiting
Blood related issues
unusual bleeding or bruising
Liver related issues
yellowing of the skin or eyes (jaundice)
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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 side effects.
These may be 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. Some side effects may
only be found when your doctor does tests from time to time to check your progress.
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
treatment with any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What DBL Promethazine Hydrochloride Injection BP contains
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Active ingredient
(main ingredient)
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promethazine hydrochloride
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Other ingredients
(inactive ingredients)
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disodium edetate
glacial acetic acid
sodium acetate
sodium metabisulfite
water for injections
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DBL Promethazine Hydrochloride Injection BP contains 50 mg/ 2 mL of promethazine hydrochloride.
Do not use this medicine if you are allergic to any of these ingredients.
This medicine does not contain gluten, lactose, sucrose, tartrazine or any other azo
dyes.
What DBL Promethazine Hydrochloride Injection BP looks like
DBL™ Promethazine Hydrochloride Injection BP is a clear, colourless solution. (Aust
R 16255).
How DBL Promethazine Hydrochloride Injection BP is stored
DBL Promethazine Hydrochloride Injection BP will be stored in the pharmacy or on the
ward. The injection is kept in a cool dry place, protected from light, where the temperature
stays below 25°C.
Who distributes DBL Promethazine Hydrochloride Injection BP
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizermedinfo.com.au
This leaflet was prepared in January 2022.
™ Trademark
© Pfizer Australia Pty Ltd 2021