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Active substance: BACLOFEN

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5. How to store Lioresal Tablets
6. Further information

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.
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.
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.
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

1. hat Lioresal Tablets are and what they
are used for
Lioresal Tablets contain 10 mg of the active ingredient
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. hings 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?
• 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.
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
• 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
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. ow 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,
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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.
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.

Patients with kidney problems
You will probably be given a much lower dose.
The doctor will decide what the dose should be.
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.
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. ossible 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:
More than 1 in 10 people have experienced:
Tiredness, sleepiness, nausea (feeling sick).
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 diarrhoea
Excessive sweating, rash
Increased need to pass urine or pain on passing urine.


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

5. ow to store Lioresal Tablets

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

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
The tablets come in PVC blister packs of 84, 100 and
200 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 manufactured by Novartis
Pharmaceuticals UK Limited, Wimblehurst Road,
Horsham, West Sussex, RH12 5AB and Frimley
Business Park, Frimley, Camberley, Surrey,
GU16 7SR, England.

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.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme (
uk/yellowcard). By reporting side effects you can help
provide more information on the safety of this medicine.

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.

6. urther information

This leaflet was revised in April 2015.
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
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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.