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DEPODUR 10MG/ML SUSPENSION FOR INJECTION

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Patient Information Leaflet

Depodur 10mg/ml
Suspension for Injection

2 Before you are given Depodur

You should not be given Depodur:
■ if you are allergic (hypersensitive) to morphine or
any of the other ingredients in Depodur (see list
of ingredients in Section 6)
■ if you are receiving epidural anaesthesia
(Morphine sulfate pentahydrate)
■ if you have severe problems with your breathing
■ if you have medical condition that makes an
The name of this medicine is Depodur 10mg/ml
epidural injection unsafe, such as a blood
Suspension for Injection, which will be referred to as
infection or abnormal blood clotting
Depodur throughout this leaflet.
■ if you have an acute, severe abdominal condition
called paralytic ileus.
Read all of this leaflet carefully before you start
taking this medicine.
Depodur is not recommended for patients under
18 years of age.
■ Keep this leaflet. You may need to read it again.
Your doctor will take special care when giving
■ If you have further questions, please ask your
you Depodur:
doctor or your pharmacist.
■ This medicine has been prescribed for you. Do not ■ if you have increased pressure inside your head
(symptoms of which are headache, feeling being
pass this medicine on to others; it may harm them,
sick, dislike of bright lights)
even if their symptoms are the same as yours.
■ if you have low blood pressure associated
■ If any of the side effects gets serious, or if you
with fluid loss
notice any side effects not listed in this leaflet,
■ if you are male and have difficulty in
please tell your doctor or pharmacist.
passing urine
■ if you are addicted to heroin or other drugs
In this leaflet:
like this
1. What Depodur is and what it is given for
■ if you have severe lung disease
2. Before you are given Depodur
■ if you have severe liver disease
3. How Depodur is given
■ if you have inflammation of your pancreas
4. Possible side effects
■ if you have inflammatory bowel disease e.g.
5. How to store Depodur
Crohn’s or ulcerative colitis
6. Further information
■ if you breath slowly and erratically when asleep.
1 What Depodur is and what it is given for Depodur can occasionally cause breathing to
become too slow, which can be delayed, profound
Depodur is a potent pain-killer.
and of sudden onset. Because this could be
dangerous if unrecognised and untreated, close
It is used to provide pain relief immediately
following a surgical operation. It is injected into the monitoring and observation for 48 hours following
epidural space in the spine. The morphine sulfate in administration is mandatory.
Depodur will be released over time to provide pain
Taking other medicines
relief for up to 48 hours, decreasing the need for
Please inform your doctor or pharmacist if you are
other pain medication.
taking or using any of these or other medicines,
even those not prescribed.

You should not receive Depodur if you are taking
a class of medicines called monoamine oxidase
inhibitors (MAOIs), e.g. tranilcypromine,
phenelzine etc, or within 14 days of stopping
treatment with MAOIs.
■ Make sure the anaesthetist is aware if you are
taking sedative or tranquilliser medicines, other
strong pain killers or any medicines that may
cause sedation as a side effect, or if you have
recently drunk alcohol, as they may react badly
with your medicine.
If you have been given a local epidural anaesthetic
e.g. bupivacaine, your Depodur will be given at least
30 minutes afterwards.


Pregnancy
Depodur can be given to women undergoing
caesarean section after the umbilical cord has been
clamped, where adequate monitoring facilities are
available. It should not be given to women for
vaginal labour and delivery, or to women who have
received epidural local anaesthetics for pain relief
during labour.
Breast-feeding
Small amounts of morphine sulfate may pass into
breast milk after administration of any morphine
formulation. If you are breast-feeding ask your
doctor or anaesthetist for advice before being
given Depodur.
Driving and using machines
Depodur is given prior to or during a surgical
operation and typically stays in your body for
approximately 48 hours. Therefore, you should not
drive or operate heavy equipment for at least 48
hours after receiving it.

3 How Depodur is given
An anaesthetist will inject Depodur in the space
around the spinal cord. Depodur must not be given
any other way.
The anaesthetist may give a local anaesthetic /
adrenaline (epinephrine) test dose to make sure

the needle or catheter is in the right place before
■ skin redness and inflammation
it is given.
■ fever, with or without shaking
■ you may feel very tired due to changes in the
The dose depends on the type of surgery.
composition of your blood (which will be seen in
The following doses are usual:
the results of blood tests).
■ 10 – 15mg for hip and knee surgery and for
Common (affects less than 1 in 10 people):
lower abdominal or pelvic surgery
■ difficulty in sleeping
■ 10mg for caesarean sections.
■ feeling anxious with increased sweating and,
The maximum recommended dose in adults up to
possibly, increased blood pressure
65 years is 20mg. The maximum recommended dose ■ you may experience decreased sensitivity to
in elderly (65 years or older) or frail patients is 15mg.
stimulation from things such as light, touch or
pain, or encounter abnormal sensations such as
If you are given more Depodur than you
numbness, tingling or burning.
should receive
■ rapid heart beat
If you are given more Depodur than you should
■ flatulence
receive, there is an antidote. A type of drug called
■ a swollen abdomen
an opioid antagonist can be given to prevent the
effects of the morphine sulfate in Depodur. This
■ heartburn
may also reverse some of the pain killer effect.
■ back pain
■ you are likely to have difficulty passing urine
from the bladder or pass urine less often.
4 Possible side effects
If you notice any side effects either listed or not
As with all medicines, Depodur may also cause
listed in this leaflet, please notify a member of the
side effects, although not everyone gets them.
staff taking care of you.
Serious side effects
■ Importantly, you may develop poor breathing or
5 How to store Depodur
have difficulty in breathing, weakness, slowed
heart beat and dizziness when you stand up. You Keep out of reach and sight of children.
may be difficult to awaken, have dulled senses,
The vials should be kept in the original outer carton
feel more confused or less alert than usual or you and stored in a refrigerator (2°C to 8°C).
may become unconscious.
The product should not be used after the expiry
These symptoms may occur up to 48 hours after date stated on the vial.
you have received Depodur.
Vials of Depodur should be gently inverted to
If you experience any of the above you should
urgently draw this to the attention of hospital staff. re-suspend the particles immediately prior to
withdrawal from the vial.
After receiving Depodur you may experience
Any unused portion in the vial should be discarded.
the following:
Very common (affects more than 1 in 10 people):
■ headache
■ dizziness
■ feeling sick (or even vomit)
■ constipation
■ skin itching

6 Further information
What Depodur contains
The active substance is morphine sulfate
pentahydrate. The concentration of morphine
sulfate pentahydrate in Depodur is 10mg/ml.

Each vial of 1ml contains 10mg morphine sulfate
pentahydrate (10mg/ml).
The product also contains cholesterol, triolein,
tricaprylin, dioleoylphosphatidylcholine,
dipalmitoylphosphatidylglycerol, sodium chloride,
diluted (10%) hydrochloric acid, and water for
injections.
Depodur contains less than 1mmol sodium (23mg)
per 10ml, i.e. it is essentially ‘sodium-free.’
What Depodur looks like and contents of pack
Depodur is available in 10mg/ml single-use Type I
amber glass vials with ethylenetetrafluoroethylene
(ETFE) stoppers and aluminium caps.
Pack sizes are as follows:
10mg/1ml vials packaged in cartons of 5
15mg/1.5ml vials packaged in cartons of 5
20mg/2ml vials packaged in cartons of 5
Not all packs may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation Holder is:
Flynn Pharma Limited
Alton House
4 Herbert Street
Dublin 2
Ireland.
The manufacturer is:
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon
Co. Armagh
Northern Ireland
BT63 5QD.
This leaflet was last updated in
December 2010.

Bernard A Cope
49 Havering Drive
Romford Essex RM1 4BH
Tel 01708 763737
Mobile 07931 508402
Email bernard.cope@ntlworld.com

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Flynn Pharma Ltd
Depodur 10mg/ml Suspension for Injection
Leaflet
H 148mm x W 210mm
No
2 May 2008
Clinical variation
2a
22 July 2011
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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