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.
Why am I being treated with DBL Morphine Sulfate Injection?
DBL Morphine Sulfate Injection contains the active ingredient morphine sulfate pentahydrate.
DBL Morphine Sulfate Injection is a pain reliever that belongs to a group of medicines
called opioid analgesics. It is most commonly used for short-term relief of severe
pain. It may also be used just before or during an operation to help the anaesthetic
work better.
What should I know before treatment with DBL Morphine Sulfate Injection?
You should not be given DBL Morphine Sulfate Injection if you have ever had an allergic
reaction to morphine 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.
What if I am taking other medicines?
Some medicines may interfere with DBL Morphine Sulfate Injection and affect how it
works.
How is DBL Morphine Sulfate Injection given?
Your doctor will decide what dose of morphine you will receive. This depends on your
condition and other factors, such as your weight.
What should I know during treatment with DBL Morphine Sulfate Injection?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you have been given morphine.
If you become pregnant while you are being treated with morphine, 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 morphine for more
than two weeks, you may experience unpleasant feelings if you stop morphine suddenly.
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Driving or using machines
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Do not drive a car, operate machine, or do anything else that could be dangerous until
you know how morphine affects you. Morphine 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 morphine.
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Looking after your medicine
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If you are being given DBL Morphine Sulfate Injection while in hospital, it will be
stored in the pharmacy or on the ward. Store below 25°C.
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Are there any side effects?
Common side effects are mild and usually short lived. These include drowsiness, dizziness
or unsteadiness, light-headedness, sweating or flushing, nausea or vomiting, constipation,
mood changes. If you experience any signs of an allergic reaction, severe drowsiness,
slow or troubled breathing, severe weakness, agitation, hallucinations, unconsciousness,
seizures, slow or rapid heart beat, difficulty in urinating, you may need urgent medical
attention or hospitalisation.
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WARNING:
Limitations of use
Morphine 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
Morphine 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 respiratory depression
Morphine 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 morphine 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 morphine
Using morphine 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 morphine.
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Active ingredient(s):
morphine sulfate pentahydrate
Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Morphine Sulfate 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 Morphine Sulfate Injection.
Where to find information in this leaflet:
Why am I being treated with DBL Morphine Sulfate Injection?
DBL Morphine Sulfate Injection contains the active ingredient morphine sulfate pentahydrate. DBL Morphine Sulfate Injection is a pain reliever that belongs to a group of medicines
called opioid analgesics. Morphine acts in the brain and spinal cord.
DBL Morphine Sulfate Injection is used most commonly for short-term relief of severe
pain. It may also be used just before or during an operation to help the anaesthetic
work better.
Ask your doctor if you have any questions about why morphine has been prescribed for
you.
Your doctor may have prescribed morphine for another reason.
What should I know before treatment with DBL Morphine Sulfate Injection?
Warnings
Do not use DBL Morphine Sulfate Injection if you:
are allergic to any medicine containing morphine, any of the ingredients listed at
the end of this leaflet, or any other similar medicines.
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 severe bronchial asthma or severe disease relating to the lungs
have shallow or difficulty breathing
are suffering from acute alcoholism
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 an irregular heart beat (arrhythmia)
have severe liver problems
have severe central nervous system depression
have diabetic acidosis where there is danger of coma
have had recent biliary tract surgery or biliary colic
have obstruction of the gastrointestinal tract
have a condition where the small bowel does not work properly (paralytic ileus)
have diarrhoea caused by antibiotic-induced large bowel inflammation or by poisoning
have a rare adrenal gland tumour near the kidney (phaeochromocytoma)
have heart failure after lung disease
have a head injury, brain tumour or increased pressure in the head or are comatose.
Check with your doctor if you:
have or have had any other medical conditions, especially the following:
epilepsy, convulsions, fits or seizures
underactive thyroid gland (hypothyroidism) and/or adrenal gland (Addison's disease)
enlarged prostate or problems with urination
fast heart beat (tachycardia)
liver problems
kidney problems
any bowel disorders or ulcerative colitis
biliary tract disease or inflammation of the pancreas
myasthenia gravis
snoring or sleep apnoea (you temporarily stop breathing or have difficulty breathing
while asleep)
long-standing pain not related to cancer
unexplained increase in pain, increased levels of pain with increasing opioid medication
or sensitivity not associated with the original pain.
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 Morphine Sulfate 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?
Premature infants
DBL Morphine Sulfate Injection must not be given to premature infants or during labour
for delivery of premature infants.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed. As morphine
passes into breast milk, breastfeeding is not recommended while you are being given
morphine.
Your doctor or pharmacist can discuss with you the risks and benefits involved.
Addiction
You can become addicted to morphine even if you use it exactly as prescribed. Morphine
may become habit forming causing mental and physical dependence. If abused it may
become less able to reduce pain.
Physical dependency
As with all other opioid containing products, your body may become used to you using
morphine. Using it for a long time (i.e. more than two weeks) may result in physical
dependence. Physical dependence means that you may experience withdrawal symptoms
if you stop using morphine 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 morphine may develop, which means that the effect of the medicine may
decrease. If this happens, a higher dose of morphine 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.
Morphine injection given to the mother during labour can cause breathing problems
and signs of withdrawal in the newborn.
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 Morphine Sulfate Injection and affect how it
works. These include:
antidepressants or medicines for anxiety disorders, such as:
selective serotonin reuptake inhibitors (SSRIs)
serotonin and norepinephrine reuptake inhibitors (SNRIs)
tricyclic antidepressants (TCAs)
monoamine oxidase inhibitors (MAOIs) i.e. moclobemide, phenelzine, tranylcypromine
medicines use for migraine (triptans)
medicines used to prevent or treat nausea and vomiting (5-HT3 receptor antagonists)
selegiline, a monoamine oxidase inhibitor used to treat Parkinson's disease
cimetidine, a medicine used to treat stomach or duodenal ulcers, or reflux
diuretics (fluid tablets)
other medicines which may make you drowsy such as sleeping tablets, tablets to calm
your nerves, sedatives, tranquilisers, general anaesthetics, hypnotics and muscle
relaxants
benzodiazepines and other medicines to treat anxiety, acute stress reactions, agitation,
tremor e.g. diazepam, alprazolam or lorazepam
anti-diarrhoeal medications e.g. loperamide and kaolin
medicines to treat mental disorders (antipsychotics)
other opioid analgesics or strong painkillers
some antihistamines
some heart medications e.g. beta blocker
medicines that lower your blood pressure (antihypertensives)
warfarin, a medicine used to thin the blood
medicines used to reduce risk of blood clots or stroke e.g. clopidogrel, prasugrel
and ticagrelor
zidovudine or ritonavir, medicines used to treat HIV infection
medicines used for seizures such as gabapentinoids e.g. gabapentin and pregabalin
cannabis
atropine
some medicines used to treat infections e.g. rifampicin and ciprofloxacin.
Your doctor will minimise the dose and duration of use; and monitor you for signs
and symptoms of breathing difficulties and sedation.
These medicines may be affected by morphine 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 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 Morphine Sulfate Injection.
How is DBL Morphine Sulfate Injection given?
How much is given
Your doctor will decide what dose of morphine you will receive. This depends on your
condition and other factors, such as your weight.
How is it given
Your doctor or nurse will usually give DBL Morphine Sulfate Injection to you.
DBL Morphine Sulfate Injection can be given as:
an injection into a muscle
a slow injection into a vein
an injection under the skin, or
by a method called patient-controlled analgesia.
This method allows you, the patient, to control the amount of morphine you wish to
receive. On experiencing pain, you can press a button, which allows a dose of morphine
to be administered to you. To prevent you from receiving too much morphine, there
is a "lockout" period built into the pump which prevents continuous injection of morphine.
Your doctor will decide the most appropriate way for you to be given DBL Morphine
Sulfate Injection.
If you use too much (overdose)
If you think that you have received too much morphine, you may need urgent medical
attention.
If you or someone else receive too much (overdose), and experience one or more of
the symptoms below, call triple zero (000) for an ambulance. 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 has accidentally used morphine that was
prescribed for you.
Symptoms of an overdose may include:
slow, unusual or difficult breathing
drowsiness, dizziness or unconsciousness
severe weakness
slow or weak heart beat
nausea or vomiting
convulsions or fits
pale and cold skin.
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.
What should I know during treatment with DBL Morphine Sulfate Injection?
As morphine may cause nausea and vomiting, your doctor is likely to prescribe medicine
for you to take/receive before the morphine, to stop you feeling sick.
Morphine may also cause constipation, so your doctor is likely to prescribe laxatives
to prevent this happening.
Things you should do
If you are about to be started on any new medicine, tell your doctor, dentist and
pharmacist that you are being given morphine.
Tell any doctors, dentists and pharmacists who treat you that you are being given
morphine.
If you plan to have surgery that needs a general anaesthetic, tell the surgeon or
anaesthetist that you are being given morphine. It may affect other medicines used
during surgery.
If you become pregnant while you are being treated with morphine, tell your doctor
or pharmacist immediately.
Tell your doctor, pharmacist or nurse if you have any concerns about being given morphine.
Things you should not do
Do not use DBL Morphine Sulfate Injection to treat any other complaints unless your
doctor tells you to.
Do not give DBL Morphine Sulfate Injection to anyone else, even if they have the same
condition as you.
Do not stop using DBL Morphine Sulfate Injection or lower the dosage without checking
with your doctor or pharmacist. If you have been using DBL Morphine Sulfate Injection
for more than two weeks, you may experience unpleasant feelings if you stop suddenly.
Your doctor will probably want you to gradually reduce the amount of morphine you
are using, before stopping it completely.
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 given morphine.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how DBL Morphine
Sulfate Injection affects you.
DBL Morphine Sulfate Injection may cause drowsiness and impairment of coordination
in some people. Do not do anything else that could be dangerous if you are drowsy
or feeling uncoordinated.
Make sure you know how you react to morphine.
Drinking alcohol
Tell your doctor if you drink alcohol.
Do not drink alcohol while you are undergoing treatment with morphine, unless otherwise
advised by your doctor or pharmacist, as drowsiness and coordination may be worse.
Looking after your medicine
If you are being given DBL Morphine Sulfate Injection while in hospital, it will be
stored in the pharmacy or on the ward.
DBL Morphine Sulfate Injection should be stored in a cool, dry place, protected from
light, where the temperature stays below 25°C.
Do not store DBL Morphine Sulfate Injection or any other medicine in the bathroom
or near a sink.
Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
When to discard your medicine
Do not use this medicine after the expiry date.
If your doctor tells you to stop using DBL Morphine Sulfate Injection or the expiry
date has passed, take it to any pharmacy for safe disposal.
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.
If you are over 65 years of age you may have an increased chance of getting side effects.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Do not stop using morphine without first talking to your doctor or pharmacist.
Common side effects
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Common side effects
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What to do
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drowsiness, dizziness or unsteadiness
light-headedness
confusion
sweating or flushing
nausea and/or vomiting
constipation
reduced libido, erectile dysfunction or no menstrual periods
loss of appetite or taste changes
pain and irritation at the injection site
red, itchy skin
blurred vision
dry mouth
mood changes
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Speak to your doctor if you have any of these side effects and they worry you.
Mostly they are mild and short lived.
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Serious side effects
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/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.
Product details
This medicine is only available with a doctor's prescription.
What DBL Morphine Sulfate Injection contains
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Active ingredient
(main ingredient)
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Morphine sulfate pentahydrate
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Other ingredients
(inactive ingredients)
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Sodium chloride
Hydrochloric acid (to adjust pH)
Water for injections
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Do not use this medicine if you are allergic to any of these ingredients.
DBL Morphine Sulfate Injection does not contain lactose, sucrose, gluten, tartrazine
or any other azo dyes.
What DBL Morphine Sulfate Injection looks like
DBL Morphine Sulfate Injection is a clear slightly yellow to clear yellow solution
in a coloured glass ampoule.
It is available in the following strengths:
5 mg/1 mL AUST R 121754
10 mg/1 mL AUST R 101240
15 mg/1 mL AUST R 101243
30 mg/1 mL AUST R 121755
Not all presentations may be marketed.
Sponsor
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in August 2022.