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Active substance: BACLOFEN

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LIORESAL® Tablets 10 mg
Patient Information Leaflet



What you need to know about Lioresal Tablets
Your doctor has decided that you or your child need this medicine to help
treat your condition.

Pharma Code to be read and run in this direction

Do you have Parkinson’s disease?
Do you suffer from any liver, kidney or lung disease?
Do you have diabetes?
Do you have difficulties in urinating?
Are you pregnant or breast feeding?
Do you have an intolerance to wheat flour? (The tablets contain small
amounts of wheat starch. They are suitable for people with coeliac
disease, however if you have a wheat allergy (different from coeliac
disease), you should not take this medicine.)
If the answer to any of these questions is YES, tell your doctor or pharmacist
because Lioresal Tablets might not be the right medicine for you.

If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.


Please read this leaflet carefully
before you start to take your
medicine. It contains important
information. Keep the leaflet in a safe
place because you may want to read
it again.
If you have any other questions, or if
there is something you don’t
understand, please ask your doctor
or pharmacist.
This medicine has been prescribed
for you. Never give it to someone else.
It may not be the right medicine for
them even if their symptoms seem to
be the same as yours.

In this leaflet:
1. What Lioresal Tablets are, and what they are used for
2. Things to consider before you start to take Lioresal Tablets
3. How to take Lioresal Tablets
4. Possible side effects
5. How to store Lioresal Tablets
6. Further information

1. What Lioresal Tablets are and what they are used for
Lioresal Tablets contain 10 mg of the active ingredient baclofen.
Baclofen is a muscle-relaxant drug. Lioresal Tablets are used to reduce and
relieve the excessive tension in your muscles (spasms) occurring in various
illnesses such as cerebral palsy, multiple sclerosis, cerebrovascular
accidents, spinal cord diseases and other nervous system disorders.

2. Things to consider before you start to take
Lioresal Tablets
Some people MUST NOT take Lioresal Tablets. Talk to your doctor if:
• you think you may be allergic to baclofen or to any of the other
ingredients of the tablets, (These are listed at the end of the leaflet.)
• you have ever had a stomach ulcer.
You should also ask yourself these questions before taking Lioresal Tablets:
• Have you had a stroke?
• Do you have epilepsy?
• Do you suffer from any mental illness?
• Are you being treated for high blood pressure?

Are you taking other medicines?
Some medicines can interfere with your treatment. Tell your doctor or
pharmacist if you are taking any of the following:
• Other medicines to relax muscles e.g. tizanidine
• Medicines to treat mood disorders such as lithium or tricyclic
antidepressants such as amitriptyline
• Medicines for high blood pressure e.g. diltiazem
• Other drugs which also affect the kidney, e.g. ibuprofen
• Medicines for Parkinson’s disease e.g. levodopa or carbidopa
• Medicines which slow down the nervous system, e.g. anti-histamines
such as promethazine, sedatives such as temazepam, opiates for pain
relief such as morphine and anti-convulsants (anti-epileptic medicines
such as carbamazepine).
Always tell your doctor or pharmacist about all the medicines you are
taking. This means medicines you have bought yourself as well as medicines
on prescription from your doctor.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.


You should not use Lioresal during pregnancy unless your doctor advises
you to do so. Tell your doctor if you are pregnant, or planning to
become pregnant.
Only a very small amount of Lioresal passes into breast milk. Your doctor
will discuss with you whether you should breast-feed whilst taking Lioresal.
Will there be any problems with driving or using machinery?
Some people may feel drowsy and/or dizzy or have problems with their
eyes while they are taking Lioresal Tablets. If this happens, you should not
drive or do anything that requires you to be alert (such as operate tools or
machinery) until these effects have worn off.
Other special warnings
• Be careful when drinking alcohol – it may affect you more than usual.
• Your doctor may want to give you a check up from time to time while
you are taking Lioresal Tablets.
• If you are going to have an operation of any kind, make sure that the
doctor knows that you are taking Lioresal Tablets.
Children and adolescents:
Lioresal Tablets are not suitable for use in children under 33 kg body weight.

3. How to take Lioresal Tablets
The doctor will tell you how many Lioresal Tablets to take and when to take
them. Always follow his/her instructions carefully. The dose will be on the
pharmacist’s label. Check the label carefully. If you are not sure, ask your
doctor or pharmacist.
The doctor will tell you the best time to take the medicine. Some people
take it only at night or before doing a task such as washing, dressing,
shaving, etc.
The final dose of Lioresal depends on how each person responds to the
drug. You will be started on a low dose, and this will be increased gradually
over a few days, under the supervision of the doctor, until you are having

the dose which is right for you. If the starting dose is too high, or if the
dose is increased too quickly, you may experience side effects, particularly
if you are elderly, have kidney problems or have had a stroke.
You should not stop taking Lioresal Tablets suddenly. If the doctor decides
to stop your treatment with Lioresal Tablets, the dose will be reduced
gradually to prevent withdrawal symptoms such as muscle spasms and
increased muscle rigidity, fast heart rate, fever, confusion, hallucinations,
changes in mood and emotion, mental disorders, feeling persecuted or
convulsions (fits).
If you feel sick after taking Lioresal Tablets, you may find it helps to take
them with food or a milk drink.
• The usual dose is 20 mg (2 tablets) three times a day.
• The maximum daily dose is 100 mg (10 tablets) except if you are in
hospital when a higher dose may be used.

What if you take too much?
If you accidentally take too many Lioresal Tablets, tell your doctor at once
or contact your nearest hospital casualty department. Take your medicine
with you.

4. Possible side effects
Lioresal Tablets are suitable for most people, but, like all medicines, they
can sometimes cause side effects.
The side effects listed below have been reported:

Very rarely (less than 1 in 10,000) people have experienced:
Hypothermia (low body temperature).

More than 1 in 10 people have experienced:
Tiredness, sleepiness, nausea (feeling sick).

Patients with kidney problems
You will probably be given a much lower dose. The doctor will decide what
the dose should be.

Up to 1 in 10 people have experienced:
Excessively weak limbs or feeling tired and exhausted, aching muscles
Headache, dizziness or light-headedness
Breathing difficulties
Mood changes, confusion, hallucinations or nightmares
Dry mouth
Problems with their eyes
Unsteadiness, trembling or other problems with muscle control
Low blood pressure (fainting)
Stomach problems including retching, vomiting, constipation and
Excessive sweating, rash
Increased need to pass urine or pain on passing urine.

What if you forget to take a dose?
If you forget to take a dose, take the next dose at the usual time. DO NOT
take a double dose.

Up to 1 in 1,000 people have experienced:
Numbness or tingling in hands or feet
Increased muscle spasm

Children (0 to < 18 years)
Children’s treatment is adjusted to their body weight. Children’s treatment
usually starts with a very low dose (approximately 0.3 mg/kg/day), in
2–4 divided doses (preferably in 4 doses). The dosage is then gradually
increased until it becomes sufficient for the child’s individual requirements,
this may be between 0.75 and 2 mg/kg body weight. The total daily dose
should not exceed a maximum of 40 mg/day in children below 8 years of
age. In children over 8 years of age a maximum daily dose of 60 mg/day
may be given. Lioresal Tablets are not suitable for use in children below
33 kg body weight.

Disturbed sense of taste
Slurred or slow speech
Stomach ache
Liver problems
Difficulty in passing urine
Sexual problems in men, e.g. impotence
Convulsions (particularly in epileptics).

Other side-effects (how often they happen is not known)
Raised, itchy rash (urticaria – also known as nettle rash or hives).
Slow heart beat.
Increase in blood sugar.
Symptoms caused by stopping treatment suddenly (see ‘3. How to take
Lioresal Tablets’).
If any of the symptoms become troublesome, or if you notice anything
else not mentioned here, please go and see your doctor. He/she may
want to adjust the dose or give you a different medicine.

6. Further information
Lioresal Tablets are white or pale yellow and contain 10 mg of the active
ingredient, baclofen. They also contain the inactive ingredients silica,
microcrystalline cellulose, magnesium stearate, povidone and wheat starch.
The tablets come in blister packs of 84 and 100 and containers of 84 and
200. Some of the pack sizes may not be marketed.
The product licence holder is
Novartis Pharmaceuticals UK Limited, Frimley Business Park,
Frimley, Camberley, Surrey, GU16 7SR, England.
Lioresal Tablets are made by
Novartis Pharma S.p.A, 131 Via Provinciale Schito, Torre Annunziata, Italy.
This leaflet was revised in September 2012.
If you would like any more information, or would like the leaflet in a
different format, please contact Medical Information at Novartis
Pharmaceuticals UK Ltd, telephone number 01276 698370.
LIORESAL is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited

5. How to store Lioresal Tablets
Keep all medicines out of the reach and sight of children.
Store the tablets below 25ºC in a dry place.
Do not take the tablets after the expiry date which is printed on the outside
of the pack.
If your doctor tells you to stop taking Lioresal Tablets, please take any
which are left back to your pharmacist to be destroyed. Only keep them if
the doctor tells you to. Do not throw them away with your normal
household water or waste. This will help to protect the environment.



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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.