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 given DBL Ergometrine Injection?
DBL Ergometrine Injection contains the active ingredient ergometrine maleate. DBL
Ergometrine Injection is used to prevent and/or treat excessive bleeding in the mother
after delivery of a baby or a miscarriage. It works by contracting the uterus and
blood vessels.
2. What should I know before I am given DBL Ergometrine Injection?
You should not be given DBL Ergometrine Injection if you have ever had an allergic
reaction to ergometrine, or other medicines belonging to the ergot alkaloid class
of medicines (e.g., ergotamine, dihydroergotamine), or any of the ingredients listed
at the end of the CMI.
Tell your doctor if you have any other medical conditions, take any other medicines,
or plan to breastfeed.
3. What if I am taking other medicines?
Some medicines may interfere with DBL Ergometrine Injection and affect how it works.
4. How is DBL Ergometrine Injection given?
Your doctor will decide what dose you will receive. This depends on your condition.
Usually only a single dose is required for the treatment and prevention of excessive
bleeding.
Ergometrine is generally given as an injection into a large muscle. In an emergency
situation it may be given as a slow injection into a vein. It must only be given by
a doctor or nurse.
5. What should I know while being given DBL Ergometrine Injection?
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Things you should do
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Tell your doctor or nurse straight away if you experience numbness, coldness or tingling
in the fingers or toes during treatment with ergometrine.
Tell any other doctors, dentists and pharmacists who are treating you that you have
been given DBL Ergometrine Injection.
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Looking after your medicine
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DBL Ergometrine Injection will be stored in the hospital pharmacy or in the ward.
It is kept in the refrigerator (between 2°C and 8°C) and away from light.
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6. Are there any side effects?
Side effects include mild headache, nausea, leg cramps, nasal congestion, unusual
sweating, unpleasant taste, abdominal pain, mild pain and/or inflammation at the injection
site and ringing in the ears. These are usually mild and short-lived. Serious side
effects include signs of an allergic reaction (such as difficulty breathing, sudden
and/or severe headache, chest pain, palpitations, slow heartbeat, dizziness or faintness),
numbness, coldness or tingling in the fingers or toes, sudden, severe headache or
pressure in the head, chest pain, angina or palpitations, decreased, increased or
irregular heart rate, spasm of the oesophagus (food pipe), convulsions or seizures,
blood in the urine, severe pain and/or inflammation at the injection site, gangrene,
drowsiness or confusion, nausea, vomiting, diarrhoea, decrease or increase in heart
rate, constriction of pupils, unusual thirst, difficulty in breathing, loss of consciousness,
severe cramping of the uterus.
Active ingredient(s):
ergometrine maleate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Ergometrine 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 being given DBL Ergometrine Injection.
Where to find information in this leaflet:
1. Why am I being given DBL Ergometrine Injection?
DBL Ergometrine Injection contains the active ingredient ergometrine maleate. Ergometrine is an ergot alkaloid. Ergot alkaloids are usually given to stop excessive
bleeding that sometimes occurs after delivery of a baby. They work by causing the
muscle of the uterus to contract.
DBL Ergometrine Injection is used to
prevent and/or treat excessive bleeding in the mother after delivery of a baby or
a miscarriage. It works by contracting the uterus and blood vessels.
2. What should I know before I am given DBL Ergometrine Injection?
Warnings
You must not be given DBL Ergometrine Injection if you:
are in the first or second stages of labor
have any retained placenta
have eclampsia or pre-eclampsia (very high blood pressure during pregnancy)
are at risk of miscarriage
have severe or persistent infection
have impaired circulation in blood vessels (peripheral vascular disease)
have heart disease, high blood pressure or a history of high blood pressure
have impaired liver or kidney function
are allergic to ergometrine, or to other medicines belonging to the ergot alkaloid
class of medicines (e.g., ergotamine, dihydroergotamine), or to any of the ingredients
listed at the end of this leaflet.
Some of the 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. Other symptoms of an allergic reaction
to ergometrine may include sudden and/or severe headache, chest pain, palpitations,
slow heartbeat, dizziness and/or faintness.
Always check the ingredients to make sure you can use this medicine.
Tell your doctor if you:
have disease of the blood vessels of the heart, or other heart problems
have hypertension (high blood pressure)
have calcium deficiency
have porphyria (a disease of the blood).
take any medicines for any other condition
have allergies to any other medicines, foods, preservatives or dyes
smoke (nicotine may alter the effects of ergometrine).
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
Talk to your doctor if you intend to breastfeed.
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 Ergometrine Injection and affect how it works.
These include:
medicines used to treat and/or prevent angina, such as glyceryl trinitrate
beta-blockers, medicines used to treat or prevent high blood pressure and other heart
disorders, e.g., angina, irregular heartbeats
bromocriptine, a medicine used to halt lactation, treat hormonal problems or to help
manage Parkinson’s Disease
dopamine, a medicine used to treat some heart conditions
some antibiotics used to treat infection, e.g., erythromycin, doxycyline or tetracycline
some general anaesthetics
some medicines used in migraine headaches, e.g., methysergide and sumatriptan.
These medicines may be affected by ergometrine 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 and pharmacist have 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 Ergometrine Injection.
4. How is DBL Ergometrine Injection given?
How much is given
Your doctor will decide what dose you will receive. This depends on your condition.
Usually only a single dose is required for the treatment and prevention of excessive
bleeding.
How it is given
Ergometrine is generally given as an injection into a large muscle. In an emergency
situation it may be given as a slow injection into a vein. It must only be given by
a doctor or nurse.
If you are given too much DBL Ergometrine Injection
As DBL Ergometrine Injection is given to you in a hospital under the supervision of
your doctor it is very unlikely that you will receive an overdose.
If you experience severe side effects and think that you or anyone else may have been
given too much DBL Ergometrine Injection you should immediately:
tell your doctor or nurse, 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.
5. What should I know while being given DBL Ergometrine Injection?
Things you should do
Tell your doctor straight away if you:
experience numbness, coldness or tingling in the fingers or toes during treatment
with ergometrine. Your doctor may decide to stop treatment with ergometrine.
Tell any doctor, dentist or pharmacist that is treating you that you have been given
DBL Ergometrine Injection.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DBL Ergometrine
Injection affects you.
Looking after your medicine
DBL Ergometrine Injection will be stored in the hospital pharmacy or in the ward.
It is kept in the refrigerator (between 2°C and 8°C) and away from light.
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.
Side effects
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Side effects
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What to do
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Administration site disorders:
mild pain and/or inflammation at the injection site
Ear disorders:
ringing in the ears
Gastrointestinal disorders:
nausea
abdominal pain
General disorders:
nasal congestion
Musculoskeletal and connective tissue disorders:
leg cramps
Nervous system disorders:
mild headache
unusual sweating
unpleasant taste
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Speak to your doctor or nurse if you have any of these side effects and they worry
you.
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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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Allergic reaction:
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
sudden and/or severe headache
chest pain, palpitations, slow heartbeat
dizziness or faintness
Administration site disorders:
severe pain and/or inflammation at the injection site
Cardiac disorders
chest pain, angina or palpitations
decreased, increased or irregular heart rate
Gastrointestinal disorders:
nausea, vomiting, diarrhoea
General disorders:
spasm of the oesophagus (food pipe)
convulsions or seizures
gangrene
drowsiness or confusion
constriction of pupils
unusual thirst
loss of consciousness
severe cramping of the uterus.
Nervous system disorders:
numbness, coldness or tingling in the fingers or toes
sudden, severe headache or pressure in the head
Renal and urinary disorders:
blood in the urine
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Tell your doctor or nurse straight away if you notice any of these serious side effects.
You may need urgent medical attention.
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Tell your doctor or nurse 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 that 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.
7. Product details
This medicine is only available with a doctor's prescription.
What DBL Ergometrine Injection contains
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Active ingredient
(main ingredient)
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ergometrine maleate
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Other ingredients
(inactive ingredients)
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maleic acid; water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
DBL Ergometrine Injection does not contain lactose, sucrose, gluten, tartrazine or
any other azo dyes.
What DBL Ergometrine Injection looks like
DBL Ergometrine Injection is a colourless or slightly yellowish solution.
DBL Ergometrine Injection: Aust R 58866.
Who distributes DBL Ergometrine Injection
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in April 2023.