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LIORESAL 10MG TABLETS

Active substance(s): BACLOFEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

LIORESAL® 10MG TABLETS
(baclofen)
This product is available using the above name Lioresal 10mg
Tablets but will be referred to as Lioresal Tablets throughout this
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.
2.
3.
4.
5.
6.

What Lioresal Tablets are and what they are used for
Things to consider before you start to take Lioresal Tablets
How to take Lioresal Tablets
Possible side effects
How to store Lioresal Tablets
Further information

1. What Lioresal Tablets are and what they
are used for
Lioresal Tablets contain 10mg 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?
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 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 Tablets 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 Tablets passes into breast
milk. Your doctor will discuss with you whether you should breastfeed whilst taking Lioresal Tablets.

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.

Page 1 of 2

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 33kg
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 Tablets 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.

Adults



The usual dose is 20mg (2 tablets) three times a day.
The maximum daily dose is 100mg (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
0.3mg/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
2mg/kg body weight. The total daily dose should not exceed a
maximum of 40mg/day in children below 8 years of age. In
children over 8 years of age a maximum daily dose of 60mg/day
may be given. Lioresal Tablets are not suitable for use in children
below 33kg 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?

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’).

Manufacturer

This product is manufactured by: Novartis Farma S.p.A., Via
Provinciale Schito, 131, 80058 Torre Annunziata, Napoli, Italy.
Or
Novartis Farma, Estrada de Casais, Alto do Forte 2735 Rio de
Mouro, Portugal.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

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.

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.

Product Licence holder: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.

4. Possible side effects

Reporting of side effects

PL No: 04423/0194

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:

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

Tiredness, sleepiness, nausea (feeling sick).

5. How to store Lioresal Tablets

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
Sleeplessness
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:







The expiry date for these tablets is given on the carton. Do
not use after this date.
Do not store above 25°C. Protect from heat and moisture.
Keep out of the sight and reach of children.
If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep the
tablets if your doctor tells you to. Do not throw them away
with your normal household water or waste. This will help to
protect the environment.
If the tablets become discoloured or show signs of any
deterioration, you should seek the advice of your pharmacist.

6. Further information
What Lioresal Tablets contain

Each tablet contains 10mg of baclofen.

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).

Lioresal Tablets also contain the following inactive ingredients:
silicon dioxide, microcrystalline cellulose, magnesium stearate,
povidone and wheat starch.

Very rarely (less than 1 in 10,000) people have
experienced:

Lioresal Tablets are available as blister packs of 60 tablets.

What Lioresal Tablets look like and contents of the
pack
The tablets are white or faintly yellow, round, flat with bevelled
edges and are coded 'CG' on one side and 'KJ' and a breakline on
the reverse.

Hypothermia (low body temperature).

Page 2 of 2

POM

LIORESAL® is a registered trademark of Novartis AG.
Leaflet revision and issue date (Ref): 03.07.15
To request a copy of this leaflet in Braille, large print or audio
please call 01302 552940 and ask for the Regulatory Department.

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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.

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