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?
Lioresal contains the active ingredient baclofen. Lioresal belongs to a group of medicines
called muscle relaxants.
Lioresal is used to reduce the stiffness or spasms in your muscles to help make you
more mobile and able to manage your daily activities.
2. What should I know before I use Lioresal?
Do not use if you have ever had an allergic reaction to Lioresal 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?
Some medicines may interfere with Lioresal and affect how it works.
4. How do I use Lioresal?
Your doctor will tell you exactly how many tablets of Lioresal to take.
Do not exceed the recommended dose prescribed by your doctor.
Treatment is usually started in hospital with small doses of Lioresal. The dose is
then gradually increased to an amount that works best for you
5. What should I know while using Lioresal?
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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.
Keep all doctor's appointments, so that your progress can be checked.
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Things you should not do
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Do not stop using this medicine suddenly, unless your doctor tells you to
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how Lioresal
affects you.
Lioresal may cause sleepiness in some people, especially when you start taking it
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Drinking alcohol
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Tell your doctor if you drink alcohol.
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Looking after your medicine
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Store the tablets in a cool dry place
Keep out of reach of children
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6. Are there any side effects?
Common side effects include daytime sleepiness, lack of energy, tiredness, dizziness
or light-headedness, vertigo, confusion, headache, difficulty sleeping or nightmares,
nausea, retching or vomiting, constipation, stomach cramps or diarrhoea, loss of appetite,
stuffy nose, dry mouth, change in sense of taste, misuse, abuse and dependence, numbness,
muscle weakness or spasms, swelling of ankles, blurred vision, ringing in the ears,
frequent urination, excessive sweating, weight gain, impotence or inability to ejaculate,
increased blood sugar, low body temperature. For more information, including what
to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
Baclofen
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Lioresal tablets. 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.
Where to find information in this leaflet:
1. Why am I using Lioresal?
Lioresal contains the active ingredient baclofen. Lioresal belongs to a group of medicines called muscle relaxants.
Lioresal is used to
reduce the stiffness or spasms in your muscles to
help make you more mobile and able to manage your daily activities. These spasms happen in various illnesses such as multiple sclerosis and diseases or
injuries of the spinal cord.
2. What should I know before I use Lioresal?
Warnings
Do not use Lioresal 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.
Check with your doctor if you:
have any other medical conditions including mental illness, Parkinson's disease, seizures,
stiffness and restriction of movement in a group of muscles, stomach ulcers, stroke
or blood circulation problems, diabetes, a blood disorder known as porphyria, high
blood pressure, difficulty urinating
have problems with your heart, kidney, liver or lungs
have a history of alcoholism, drink large amounts of alcohol, or have a history of
drug abuse or dependence
have had thoughts of self-harm or and suicidal thoughts
take any medicines for any other condition
have any questions about why this medicine has been prescribed for you.
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.
Talk to your doctor if you are breastfeeding or 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 Lioresal and affect how it works. These include:
Any medicine that makes you sleepy such as medicines used to help you sleep or calm
you, pain relievers, and medicines for cold or allergies
medicines used to treat mood disorders, including tricyclic antidepressants, lithium
and monoamine oxidase inhibitors (MAOIs)
medicines used to treat diabetes
medicines that lower blood pressure including those used to treat high blood pressure
medicines used to treat Parkinson's disease, including selegiline and levodopa and
carbidopa.
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.
4. How do I use Lioresal?
How much to take
Your doctor will tell you exactly how many tablets of Lioresal to take.
Do not exceed the recommended dose prescribed by your doctor.
Treatment is usually started in hospital with small doses of Lioresal. The dose is
then gradually increased to an amount that works best for you
If you are under the age of 16 or over 65, or you have kidney disease, your doctor
may start you on a lower dose and increase it slowly to prevent unwanted side effects
Follow the instructions provided and use Lioresal until your doctor tells you to stop.
When to take Lioresal
Lioresal is usually taken in 3 divided doses throughout the day
Your doctor may tell you to take it more or less often, depending on your situation.
How to take Lioresal
Swallow the tablets whole during meals with a glass of water or other liquid.
If you forget to take Lioresal
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Otherwise, take it as soon as you remember and then go back to taking it as you would
normally.
Do not take a double dose to make up for the dose you missed.
If you take too much Lioresal
If you think that you have taken too much Lioresal, 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.
Symptoms of overdose include:
Main symptoms such as drowsiness, breathing difficulties, and being unconscious (coma)
Other symptoms such as feeling confused, hallucinations, agitation, convulsions, blurred
vision, unusual low muscle tone, sudden and involuntary muscle spasm, poor or absent
reflexes, high or low blood pressure, slow, fast or irregular heartbeat, low body
temperature, nausea, vomiting, diarrhoea, excessive salivation, trouble breathing
during sleep (sleep apnoea), severe muscle pain with fever and dark urine (rhabdomyolysis),
and ringing in the ears
If you have kidney disease and have accidentally taken more tablets than your doctor
has prescribed, you may feel drowsy, confused, have hallucinations.
5. What should I know while using Lioresal?
Things you should do
Keep all doctor's appointments, so that your progress can be checked.
Call your doctor straight away if you:
Become pregnant or think you might be pregnant.
Remind any doctor, dentist or pharmacist you visit that you are using Lioresal.
Call your doctor straight away if you have symptoms such as increased sleepiness,
new onset of drowsiness, confusion or muscle jerks.
These may be signs of a condition known as encephalopathy and your doctor may decide
to stop treatment with Lioresal tablets.
Call your doctor straight away or go to a hospital if you have thoughts of harming
or killing yourself.
Some people treated with Lioresal have had suicidal thoughts. Ask a relative or close
friend to tell you if they are worried about any changes in your behaviour.
Things you should not do
Do not stop using this medicine suddenly unless your doctor tells you to.
Stopping Lioresal suddenly may make your condition worse. You may experience the following:
nervousness, feeling confused, hallucinations, abnormal thinking or behaviour, convulsions,
uncontrollable twitching, jerking or writhing movements, fast heartbeat, high body
temperature, pain in muscles, fever, dark urine. The excessive stiffness (spasms)
in your muscles may also get worse.
Do not use this medicine to treat any other problems unless your doctor tells you
to
Do not give this medicine to anyone else. Even if they have the same condition as
you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Lioresal
affects you.
Lioresal may cause sleepiness and decreased alertness in some people, especially when
you start taking it.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may make you feel more sleepy when taking Lioresal.
Looking after your medicine
Keep your tablets in the original container until it is time to take them.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place 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.
When to discard your medicine
If your doctor tells you to stop taking Lioresal or the expiry date on the medicine
has passed, ask your pharmacist what to do with any tablets you have left over.
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.
Side effects happen mainly at the start of treatment with Lioresal or if the dose
is too high or increased too quickly. Your doctor will adjust your dose if necessary.
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 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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Colloidal anhydrous silica
Microcrystalline cellulose
Magnesium stearate
Povidone
Wheat starch
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Potential allergens
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Tell your doctor if you have an intolerance to gluten.
This medicine contains wheat starch.
Lioresal tablets do not contain lactose, sucrose, tartrazine or any other azo dyes.
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Do not take this medicine if you are allergic to any of these ingredients.
What Lioresal looks like
Lioresal 10 mg: white, round, flat tablets marked with KJ and a score line on one
side and CG on the other side. Bottles of 100 tablets; AUST R 11038.
Lioresal 25 mg: white, round, flat tablets marked with UR and a score line on one
side and CG on the other side. Blister packs of 100 tablets; AUST R 68365.
Who distributes Lioresal
Lioresal is supplied in Australia by:
NOVARTIS Pharmaceuticals Australia Pty Limited
ABN 18 004 244 160
54 Waterloo Road
Macquarie Park NSW 2113
Telephone 1800 671 203
® = Registered trademark
This leaflet was prepared in September 2024.
Internal document code
(lrst240924c is based on PI lrst240924i).