Contains the active ingredient morphine sulfate pentahydrate
Consumer Medicine Information
What is in this leaflet
Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about MORPHINE MR APOTEX. It does not contain
all the available information. It does not take the place of talking to your doctor
The information in this leaflet was last updated on the date listed on the last page.
More recent information on this medicine may be available.
Ask your doctor or pharmacist:
if there is anything you do not understand in this leaflet,
if you are worried about taking your medicine, or
to obtain the most up-to-date information.
All medicines have risks and benefits. Your doctor has weighed the risks of you using
this medicine against the benefits they expect it will have for you.
Pharmaceutical companies cannot give you medical advice or an individual diagnosis.
Keep this leaflet with your medicine. You may want to read it again.
What this medicine is used for
The name of your medicine is MORPHINE MR APOTEX. It contains the active ingredient
morphine sulfate pentahydrate
It is used to treat:
chronic severe pain.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
How it works
Opioid analgesics such as morphine sulphate have been used to treat chronic cancer
pain for many years. In most cases addiction does not occur. However, over time your
body becomes used to taking morphine, so if you suddenly stop taking your MORPHINE
MR APOTEX tablets you may experience some symptoms of withdrawal.
It is important that you discuss this issue with your doctor.
Use in children
This medicine must not be used in children under one year of age or weighing less
than 25 kg. Safety and effectiveness has not been established in children under one
year of age or weighing less than 25kg.
Before you take this medicine
When you must not take it
Do not take this medicine if:
You have or have had any of the following:
shallow breathing or other breathing problems, such as severe asthma, impaired lung
function or chronic bronchitis
severely drowsy or a reduced level of consciousness
irregular or rapid heart beats
regularly drinking large amounts of alcohol or have confusion and shaking due to stopping
long lasting pain not due to disease progression and have a history of substance and
fits or convulsions
head injury, brain tumour, increased pressure in your head or spine
are about to have an operation or have had one within the last 24 hours
severe kidney or liver disease or a disease of the brain caused by liver disease
severe abdominal pain with bloating, cramps or vomiting
a condition where your stomach empties more slowly than it should, your small bowel
does not work properly or you have just had an operation on your abdomen
taking medicine for depression called a 'monoamine oxidase inhibitor' or have taken
any in the last two weeks
You are pregnant.
MORPHINE MR APOTEX may affect your developing baby if you take it during pregnancy.
Like most medicines of this kind, MORPHINE MR APOTEX is not recommended to be taken
during pregnancy. Your doctor will discuss the risks and benefits of using it if you
The expiry date (EXP) printed on the pack has passed.
The packaging is torn, shows signs of tampering or it does not look quite right.
You are hypersensitive or have had an allergic reaction to MORPHINE MR APOTEX, other
opioid analgesics, or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include cough, shortness of breath, wheezing
or difficulty breathing; swelling of the face, lips, tongue, throat or other parts
of the body; rash, itching or hives on the skin; fainting or hayfever-like symptoms.
If you think you are having an allergic reaction do not take any more of the medicine
and contact your doctor immediately or go to the Accident and Emergency department
at the nearest hospital.
Please note if you are lactose intolerant that some of the strengths of this medicine
also contain lactose (except for 100 mg).
Before you start to take it
Before you start taking this medicine, tell your doctor if:
1. You have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
2. You have or have had any medical conditions, especially the following:
low blood pressure including from having low blood volume
increased prostate size or difficulty passing urine
problems or recent surgery of your gall bladder or bile duct
inflammation of the pancreas
adrenal glands not working properly
underactive thyroid gland
acute abdominal pain
inflammatory bowel disease or recent abdominal surgery.
3. This medicine is not recommended to be taken during labour.
Morphine given to the mother during labour can cause breathing problems in the newborn.
4. You are currently breast-feeding or you plan to breastfeed.
Morphine can pass into the breast milk and can affect the baby. Your doctor can discuss
with you the risks and benefits involved.
5. You are planning to have surgery or an anaesthetic.
6. You are currently receiving or are planning to receive dental treatment.
7. You are taking or are planning to take any other medicines. This includes vitamins
and supplements that are available from your pharmacy, supermarket or health food
Some medicines may interact with MORPHINE MR APOTEX. These include:
medicines to treat depression, psychiatric or mental disorders. Medicines for depression
belonging to a group called monoamine oxidase inhibitors must be stopped 14 days before
MORPHINE MR APOTEX tablets are taken.
medicines to help you sleep
medicines to put you to sleep during an operation or procedure
medicines to relax your muscles
medicines to prevent or relieve the symptoms of allergy such as antihistamines
propranolol or other medicines to lower blood pressure
gabapentin or barbiturates to treat seizures
medicines to thin the blood e.g. coumarin derivatives such as warfarin
medicines used to relieve heartburn or treat stomach ulcers such as cimetidine or
antacids (take antacids at least 2 hours after taking MORPHINE MR APOTEX tablets)
medicines to treat Parkinson's disease
medicines to stop nausea or vomiting e.g. metoclopramide
rifampicin, a medicine to treat tuberculosis
other pain relievers including other opioids
medicines to treat HIV infection
If you are taking any of these you may need a different dose or you may need to take
Other medicines not listed above may also interact with MORPHINE MR APOTEX.
How to take this medicine
Follow carefully all directions given to you by your doctor or pharmacist. Their instructions
may be different to the information in this leaflet.
How much to take
Your doctor or pharmacist will tell you how much of this medicine you should take.
This will depend on your condition and whether you are taking any other medicines.
Do not stop taking your medicine or change your dosage without first checking with
How to take it
MORPHINE MR APOTEX tablets must be swallowed whole. MORPHINE MR APOTEX tablets must
not be chewed, crushed or dissolved.
MORPHINE MR APOTEX tablets are only designed to work properly if swallowed whole.
The tablets may release all their contents at once if broken, chewed, crushed or dissolved
which can be dangerous and cause serious problems, such as an overdose or even death.
If you have trouble swallowing your tablets whole, talk to your doctor.
You must only take MORPHINE MR APOTEX tablets by mouth.
Taking this medicine in a manner other than that prescribed by your doctor can be
harmful to your health.
When to take it
MORPHINE MR APOTEX tablets should be taken every 12 hours. MORPHINE MR APOTEX tablets
must be taken regularly to control the pain. Taking MORPHINE MR APOTEX tablets at
regular time intervals means that the onset of pain is prevented.
It is important to take the tablets at the times you have been told to. If, however,
you begin to experience pain and you are taking your MORPHINE MR APOTEX as prescribed
('breakthrough pain'), contact your doctor as your dosage may have to be reviewed.
How long to take it for
Continue taking your medicine for as long as your doctor tells you.
If you stop taking this medicine suddenly, your pain may worsen and you may experience
withdrawal symptoms such as:
loss of appetite, nausea, stomach cramps or diarrhoea
fast heart rate
sneezing or runny nose
chills, tremors, shivering or fever
increased sweating and yawning
nervousness or restlessness
Make sure you have enough to last over weekends and holidays.
If you forget to take it
If you forget to take a dose, contact your doctor for advice.
Do not take a double dose to make up for missed doses.
This may increase the chance of you experiencing side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints to help you remember.
If you take too much (overdose)
If you think that you or anyone else may have taken too much of this medicine, immediately
telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia)
for advice. Alternatively go to the Accident and Emergency Department at your nearest
Do this even if there are no signs of discomfort or poisoning. You may need urgent
If someone takes an overdose they may become drowsy, tired, confused, lack muscle
tone, have cold or clammy skin, have constricted pupils, have a very low blood pressure
or slow heart rate, experience difficulties in breathing and possibly become unconscious
or even die.
When seeking medical attention, take this leaflet and any remaining tablets with you
to show the doctor. Also, tell them about any other medicines or alcohol which have
While you are taking this medicine
Things you must do
Tell your doctor that you are taking this medicine if:
you are about to be started on any new medicine
you become pregnant while taking this medicine, tell your doctor immediately
you are about to have any blood tests
you are going to have surgery or an anaesthetic or are going into hospital.
your pain is getting worse or you are having more frequent breakthrough pain.
Your doctor may occasionally do tests to make sure the medicine is working and to
prevent side effects. Go to your doctor regularly for a check-up.
Tell any other doctors, dentists and pharmacists who are treating you that you take
Things you must not do
Give this medicine to anyone else, even if their symptoms seem similar to yours
Take your medicine to treat any other condition unless your doctor or pharmacist tells
Stop taking your medicine, or change the dosage, without first checking with your
Over time your body may become used to you taking morphine so if you stop taking it
suddenly, your pain may worsen and you may experience withdrawal symptoms. This is
called physical dependence.
If you need to stop taking this medicine, your doctor will gradually reduce the amount
you take each day, if possible, before stopping the medicine completely.
Things to be careful of
Be careful when driving or operating machinery until you know how this medicine affects
Ask your doctor's advice about whether or not it will be safe for you to drive or
operate any machinery whilst taking MORPHINE MR APOTEX.
You may feel drowsy when you begin to take MORPHINE MR APOTEX tablets. If you drink
alcohol, the drowsiness may be worse.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
Standing up slowly 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.
You may suffer from nausea or vomiting when taking MORPHINE MR APOTEX tablets. If
you vomit 2-3 hours after your dose your pain may come back as you will not have absorbed
your morphine. If this happens speak to your doctor. Your doctor may prescribe some
medicine to help stop you vomiting.
Constipation can be caused by morphine. You should speak to your doctor about your
diet and the proper use of laxatives.
There is potential for abuse of morphine and the development of addiction to morphine.
It is important that you discuss this issue with your doctor.
Possible side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking MORPHINE MR APOTEX tablets or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any
of them. All medicines can have side effects. Sometimes they are serious but most
of the time they are not.
Tell your doctor or pharmacist if you notice any of the following.
This list includes the more common side effects.
nausea or vomiting
Other possible side effects are listed below. Tell your doctor or pharmacist as soon
as possible if you notice any of the following:
loss of appetite
dry mouth or changes in taste
new problems with your eyesight
skin rash, redness in the face or itching
irregular periods or sexual problems
muscle twitching or muscle tightness
swelling of legs or ankles
stomach discomfort or cramps, indigestion or abdominal pain
abnormal thinking or changes in mood
slow or noticeable heartbeats
headache, confusion or hallucinations
unusual weakness or loss of strength
changes in passing urine such as the volume passed, pain or feeling the need to urinate
seizures, fits or convulsions
Other side effects not listed above may occur in some patients.
If you think you are having an allergic reaction to MORPHINE MR APOTEX tablets, do
not take any more of this medicine and tell your doctor immediately or go to the Accident
and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
cough, 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
Storage and disposal
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, 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
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
If your doctor or pharmacist tells you to stop taking this medicine or it has passed
its expiry date, your pharmacist can dispose of the remaining medicine safely.
What MORPHINE MR APOTEX looks like
10 mg tablets
Buff coloured, biconvex, smooth, round, film coated tablets with 10 on one face
30 mg tablets
Violet coloured, biconvex, smooth, round, film coated tablets with 30 on one face
60 mg tablets
Orange coloured, biconvex, smooth, round, film coated tablets with 60 on one face
100 mg tablets
Grey coloured, biconvex, smooth, round, film coated tablets with 100 on one face
Available in blister packs of 20, 28 or 60 tablets.
* Not all strengths, pack types and/or pack sizes may be available.
Each tablet contains 10, 30, 60 or 100 mg of morphine sulfate pentahydrate as the
It also contains the following inactive ingredients:
lactose (except the 100 mg)
talc - purified,
The tablet coatings contain a different colourant for each strength, as follows:
Opadry buff OY-3607
Opadry violet OY-6708
Opadry orange OY-3533
Opadry grey OY-8238
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo
dyes. The 100 mg strength is lactose-free.
Australian Registration Numbers
MORPHINE MR APOTEX 10 mg tablets (blisters): AUST R 132251.
MORPHINE MR APOTEX 30 mg tablets (blisters): AUST R 132254.
MORPHINE MR APOTEX 60 mg tablets (blisters): AUST R 132256.
MORPHINE MR APOTEX 100 mg tablets (blisters): AUST R 132258.
Southern Cross Pharma Pty Ltd
Suite 5/118 Church St HAWTHORN VIC 3122
Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park, NSW 2113
APO and APOTEX are registered trademarks of Apotex Inc.
This leaflet was last updated in: