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 using Lioresal Intrathecal?
Lioresal Intrathecal contains the active ingredient baclofen. Lioresal Intrathecal
is used as a muscle relaxant and to reduce tension in your muscles which may cause
spasms. For more information, see Section
1. Why am I using Lioresal Intrathecal? in the full CMI.
2. What should I know before I use Lioresal Intrathecal?
Do not use if you have ever had an allergic reaction to baclofen 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?
4. How do I use Lioresal Intrathecal?
Lioresal Intrathecal is given by experienced doctors using special medical equipment.
A small amount of Lioresal Intrathecal is injected into your spinal cord to see if
it improves your muscle spasms. You will need to stay in hospital, at least at the
beginning of treatment.
If this medicine improves your condition, a special pump will be implanted under the
skin of your abdomen. The pump will deliver a constant amount of Lioresal Intrathecal
into your spinal cord through a tiny tube.
You or the person caring for you will be shown how to look after the pump at home
and how to keep the skin where it has been implanted free from infection.
5. What should I know while using Lioresal Intrathecal?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Lioresal Intrathecal.
See your doctor regularly and keep all appointments to refill the pump.
Tell your doctor immediately if you have problems with the pump.
Tell your doctor immediately if you have thoughts of suicide or self-harm.
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Things you should not do
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Do not stop using this medicine suddenly or allow the pump to run out of medicine.
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Driving or using machines
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Lioresal Intrathecal may cause dizziness, sleepiness or blurred vision in some people.
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Drinking alcohol
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Drinking alcohol while on Lioresal Intrathecal may make you feel more sleepy or dizzy
than normal.
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Looking after your medicine
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If you are keeping a supply of Lioresal Intrathecal at home, keep the ampoules in
a cool dry place below 30°C (room temperature), away from moisture, heat or sunlight.
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6. Are there any side effects?
There can be serious side effects that need immediate medical attention. These include
allergic reactions, infections, thoughts of suicide or self-harm, unusual changes
to mood, feeling anxious, convulsions.
Active ingredient:
baclofen
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Lioresal Intrathecal. 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 Lioresal Intrathecal.
Where to find information in this leaflet:
1. Why am I using Lioresal Intrathecal?
Lioresal Intrathecal contains the active ingredient baclofen. Lioresal Intrathecal is a muscle relaxant that is given as an injection when medicines
taken by mouth do not work well enough or when they cause too many side effects.
Lioresal Intrathecal is used to reduce tension in your muscles which causes spasms.
These spasms happen in various illnesses such as multiple sclerosis, cerebral palsy
and other diseases or injuries of the spinal cord or brain. Lioresal Intrathecal reduces
spasms and the pain that goes with them. It helps make you more mobile and improve
your ability to manage your daily activities.
2. What should I know before I use Lioresal Intrathecal?
Warnings
Do not use Lioresal Intrathecal if:
you are allergic to baclofen, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Epilepsy that is not responding to treatment.
Check with your doctor if you have any other medical conditions, including:
Thoughts of suicide or self-harm at any time
Speak to your doctor immediately or go to the Emergency Department of the nearest
hospital for help if you have thoughts of self-harm. Ask your family, a friend or
carer to monitor your behaviour and tell you if they are worried about any changes
in your behaviour. Ask them to read this leaflet.
Infections of any kind
Epilepsy, any history of seizures
Parkinson's disease
Mental illness such as schizophrenia, psychotic disorders, conditions that cause confusion
Scoliosis, a sideways curve in the spine
Blood circulation problems
Heart problems
Breathing problems
Stomach ulcers
Kidney problems
History of sudden episodes of anxiety, excessive sweating, "goose-flesh", a pounding
headache, an unusually slow heartbeat, stiff muscles.
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. Lioresal
Intrathecal should not be used during pregnancy unless the expected benefit outweighs
the possible risk.
Talk to your doctor if you are breastfeeding or intend to breastfeed. It is not known
if the medicine passes into breast milk.
Use in children
The safe use of Lioresal Intrathecal in children under 4 years of age has not been
established.
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 Lioresal Intrathecal and affect how it works, including:
Levodopa, a medicine used to treat Parkinson's disease
General anesthetics used during surgery
Tricyclic antidepressants, a class of medicine used to treat depression
Medicines used to lower blood pressure
Some medicines used to reduce pain, including morphine
Certain medicines used to help you sleep, improve your mood.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking, and if these affect Lioresal Intrathecal.
4. How do I use Lioresal Intrathecal?
How Lioresal Intrathecal is used
This medicine can only be given by experienced doctors using special medical equipment.
You will need to stay in hospital, at least at the beginning of treatment.
Your doctor will inject a small amount of Lioresal Intrathecal into your spinal cord
to see if it improves your muscle spasms.
If it does, then a special pump will be implanted under the skin of your abdomen.
From the pump, a constant amount of baclofen goes into your spinal cord through a
tiny tube. The pump will give you a small amount of medicine all the time.
You will be monitored closely in a fully equipped and staffed environment during the
screening phase and dose-titration period immediately following pump implant. You
will regularly be assessed for your dosage requirements, for possible side effects
or evidence of infection. The functioning of the delivery system will also be checked.
It may take several days to find the amount of medicine that suits you best. Your
doctor will keep a close watch on you during this time.
How to monitor at home
You or the person caring for you will be shown how to look after the pump at home
and how to keep the skin where it has been implanted free from infection.
Your doctor will want to see you regularly to check your progress, adjust the dose
of Lioresal Intrathecal if needed, and make sure your pump is working well.
If you use too much Lioresal Intrathecal
If you think that you have received too much Lioresal Intrathecal, you may need urgent
medical attention.
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.
It is very important that you and those caring for you know the signs of overdose
that can happen. These are:
unusual muscle weakness
unusual sleepiness
unusual light-headedness or dizziness
unusual nausea or vomiting
excessive saliva
breathing problems
fainting or fits (seizures).
If you have any of the above signs, inform your doctor without delay.
Signs of overdose may happen suddenly or more slowly (for example, because the pump
is not working properly).
If the medicine must be stopped
If you need to stop using this medicine, your doctor will reduce the dose slowly to
avoid unwanted side effects. Stopping Lioresal Intrathecal suddenly or reducing the
dose quickly can cause serious side effects which in a few, rare cases have been fatal.
5. What should I know while using Lioresal Intrathecal?
Things you should do
Follow your doctor's instructions carefully. Make sure the pump and the site on the
skin are looked after properly.
If not, the pump may not work properly or you could get a serious skin infection.
See your doctor regularly and keep all appointments to refill the pump.
If you don't have the pump refilled when you are supposed to, you may suddenly run
out of medicine (see "Things you should not do" for more information).
If the flow rate (the amount of medicine you are given each day through the pump)
needs to be changed, make sure this is supervised by a trained health professional.
Errors in changing the flow rate could make the dose of medicine too high or low and
lead to serious side effects.
Call your doctor straight away if you:
Have any thoughts of suicide or unusual changes in behaviour;
Think your muscle spasms are returning or getting worse. Your doctor may be able to
change the dose of Lioresal Intrathecal to make it work better for you.
Feel pain in your back, shoulders, neck or bottom;
Become pregnant while taking this medicine. Your doctor can discuss with you the benefits
and risks of using this medicine while you are pregnant.
Tell any doctor, dentist or pharmacist you visit that you are using Lioresal Intrathecal.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are having Lioresal Intrathecal.
Things you should not do
Do not stop Lioresal Intrathecal suddenly or allow the pump to run out of medicine.
If it should happen, tell your doctor immediately and watch out for the following
symptoms.
Stopping this medicine suddenly may bring on severe and uncontrolled muscle spasms
and other unwanted symptoms, including difficulty in muscle movements, dizziness or
light-headedness due to low blood pressure, severe itching and numbness or tingling
in hands and feet, high fever, fast heartbeat, changes to your mental state, for example
anxiety, agitation, confusion, hallucination, abnormal thinking and behaviour, and
convulsions (seizures), persistent painful erection of the penis (priapism) and infection
(sepsis).
Problems with the pump, for example, due to battery problems, catheter problems, alarm
dysfunction or device malfunctions may also cause withdrawal symptoms.
If you have any of the above signs, tell your doctor immediately. These signs may
be followed by more serious side effects (including death) unless you are treated
immediately.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Lioresal
Intrathecal affects you.
Lioresal Intrathecal may cause dizziness, sleepiness or blurred vision in some people.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may make you feel more sleepy or dizzy than normal.
Looking after your medicine
If you are keeping a supply of Lioresal Intrathecal at home:
Keep your ampoules in the cardboard carton until it is time to use them.
Store the ampoules in a cool dry place below 30°C. (room temperature), away from moisture,
heat or sunlight; for example, do not store it in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
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.
Less serious side effects
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
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Lioresal Intrathecal contains
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Active ingredient
(main ingredient)
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baclofen
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Other ingredients
(inactive ingredients)
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sodium chloride
water for injection.
Lioresal Intrathecal does not contain preservatives.
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Potential allergens
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None.
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Do not take this medicine if you are allergic to any of these ingredients.
What Lioresal Intrathecal looks like
Lioresal Intrathecal is packaged in clear glass ampoules, each pack contains one ampoule.
There are different sizes of ampoule available:
1 mL ampoule containing 0.05 mg (50 micrograms) baclofen, Aust R 53837
5 mL ampoule containing 10 mg baclofen, Aust R 53836
20 mL ampoule containing 10 mg baclofen, Aust R 53835.
The 1 mL ampoule is used to test your response to Lioresal Intrathecal. The two larger
sizes are used to fill the pump, depending on the amount of medicine you need.
Who distributes Lioresal Intrathecal
Lioresal Intrathecal is supplied in Australia by:
Novartis Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone 1 800 671 203
®= Registered Trademark
This leaflet was prepared in February 2024.
Internal document code: (lrsi220224c) based on PI (lrsi220224i)