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LIORESAL LIQUID

Active substance(s): BACLOFEN

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Ciba
LIORESAL® Liquid

1

accidents, spinal cord diseases and other
nervous system disorders.

(baclofen)
Patient Information Leaflet
What you need to know about Lioresal
Liquid
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 Liquid is and what it’s
used for
2. Things to consider before you start to take
Lioresal Liquid
3. How to take Lioresal Liquid
4. Possible side effects
5. How to store Lioresal Liquid
6. Further information

2. Things to consider before you start to take
Lioresal Liquid
Some people MUST NOT take Lioresal
Liquid. Talk to your doctor if:
• you think you may be allergic to baclofen
or to any of the other ingredients of the
liquid, (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 Liquid:
• 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 some
sugars? (The liquid contains sorbitol.)
If the answer to any of these questions is
YES, tell your doctor or pharmacist because
Lioresal Liquid 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
1. What Lioresal Liquid is and what it’s
• Medicines to treat mood disorders such as
used for
lithium or tricyclic antidepressants such as
Lioresal Liquid is a syrup containing 5 mg
amitriptyline
of the active ingredient, baclofen, in each
• Medicines for high blood pressure e.g.
5 ml.
diltiazem
• Other drugs which also affect the kidney,
Baclofen is a muscle-relaxant drug. Lioresal
e.g. ibuprofen
Liquid is used to reduce and relieve the
• Medicines for Parkinson’s disease e.g.
excessive tension in your muscles (spasms)
levodopa or carbidopa
occurring in various illnesses such as cerebral
Continued on next page
palsy, multiple sclerosis, cerebrovascular

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Comp. Description: Leaflet_LIORESAL_SYR_0.1% 300ML_GB

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Comp. Number New: F310411 GB
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Format/Dimension: 160 x 210 mm
Tech. Drawing No.: F310411 - Leaflet LIORESAL 0 1 300ML UKv2.0

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France, TPO, Famar, Orleans
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• 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.

2

• 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 Liquid.
• If you are going to have an operation of any
kind, make sure that the doctor knows that
you are taking Lioresal Liquid.

3. How to take Lioresal Liquid
The doctor will tell you how much Lioresal
Liquid to take and when to take it. Always
follow his/her instructions carefully. The dose
Pregnancy and breast-feeding
will be on the pharmacist’s label. Check the
Ask your doctor or pharmacist for advice
label carefully. If you are not sure, ask your
before taking any medicine.
You should not use Lioresal during pregnancy doctor or pharmacist.
unless your doctor advises you to do so. Tell The doctor will tell you the best time to take
the medicine. Some people take it only at
your doctor if you are pregnant, or planning
night or before doing a task such as washing,
to become pregnant.
Only a very small amount of Lioresal passes dressing, shaving, etc.

F310411_GB_p1_LFT.indd 2

ZONE DE COLLAGE

into breast milk. Your doctor will discuss with The final dose of Lioresal depends on how
you whether you should breast-feed whilst
each person responds to the drug. You will
taking Lioresal.
be started on a low dose, and this will be
increased gradually over a few days, under
Will there be any problems with driving or
the supervision of the doctor, until you are
using machinery?
having the dose which is right for you. If
Some people may feel drowsy and/or dizzy
the starting dose is too high, or if the dose
or have problems with their eyes while they is increased too quickly, you may
are taking Lioresal Liquid. If this happens,
experience side effects, particularly if you
you should not drive or do anything that
are elderly, have kidney problems or have
requires you to be alert (such as operate
had a stroke.
tools or machinery) until these effects have
You should not stop taking Lioresal Liquid
worn off.
suddenly. If the doctor decides to stop your
treatment with Lioresal Liquid, the dose will
Other special warnings
be reduced gradually to prevent withdrawal
• Lioresal Liquid contains
symptoms such as muscle spasms and
1. Small amounts of the preservatives
increased muscle rigidity, fast heart rate,
methyl and propyl hydroxybenzoate.
fever, confusion, hallucinations, changes in
These can sometimes cause allergic
reactions which might appear some time mood and emotion, mental disorders, feeling
persecuted or convulsions (fits).
after first taking the medicine.
2. Sodium 1.6mg/mL. Take this into
If you feel sick after taking Lioresal Liquid,
consideration if you are on a controlled
you may find it helps to take it with food or a
sodium diet.
milk drink.
3. Sorbitol. This can have a mild laxative
Adults
effect and you might be affected if you
take more than 25 ml of Lioresal Liquid • The usual dose is 20 mg (20 ml) three
times a day.
per day. Calorific value 2.6 kcal/g
Continued on next page
sorbitol.

07/05/2015 13:28

The Maltings

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

x Yes
Live Text:
/
No
/
WO:
1393548
Comp. Description: Leaflet_LIORESAL_SYR_0.1% 300ML_GB

Both

Comp. Number New: F310411 GB
Comp. Number Old: F308733 GB
Format/Dimension: 160 x 210 mm
Tech. Drawing No.: F310411 - Leaflet LIORESAL 0 1 300ML UKv2.0

Production Site:
CTM:
Printing Colours:

France, TPO, Famar, Orleans
Andersen, Claire
Black

Technical Colours: Cutting
TextFree

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• The maximum daily dose is 100 mg
(100 ml) except if you are in hospital
when a higher dose may be used.

Dry mouth
Problems with their eyes
Unsteadiness, trembling or other problems
with muscle control
Children (0 to < 18 years)
Low blood pressure (fainting)
Children’s treatment is adjusted to their body
Stomach problems including retching,
weight. Children’s treatment usually starts with
a very low dose (approximately 0.3 mg/kg/day), vomiting, constipation and diarrhoea
Excessive sweating, rash
in 2-4 divided doses (preferably in 4 doses).
Increased need to pass urine or pain on
The dosage is then gradually increased until it
passing urine.
becomes sufficient for the child’s individual
requirements, this may be between 0.75 and
Up to 1 in 1,000 people have experienced:
2 mg/kg body weight. The total daily dose
Numbness or tingling in hands or feet
should not exceed a maximum of 40 mg/day in
Increased muscle spasm
children below 8 years of age. In children over
Disturbed sense of taste
8 years of age a maximum daily dose of
Slurred or slow speech
60 mg/day may be given.
Stomach ache
Liver problems
Patients with kidney problems
Difficulty in passing urine
You will probably be given a much lower
Sexual problems in men, e.g. impotence
dose. The doctor will decide what the dose
Convulsions (particularly in epileptics)
should be.
ZONE DE COLLAGE

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 much Lioresal
Liquid, tell your doctor at once or contact
your nearest hospital casualty department.
Take your medicine with you.
4. Possible side effects
Lioresal Liquid is suitable for most people,
but, like all medicines, it can sometimes
cause side effects.

3

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

The side effects listed below have been
reported:
More than 1 in 10 people have experienced:
Reporting of side effects
Tiredness, sleepiness, nausea (feeling sick).
If you get any side effects, talk to your doctor
or pharmacist. This includes any possible
Up to 1 in 10 people have experienced:
side effects not listed in this leaflet. You can
Excessively weak limbs or feeling tired and
also report side effects directly via the Yellow
exhausted, aching muscles
Card Scheme (www.mhra.gov.uk/yellowcard).
Headache, dizziness or light-headedness
By reporting side effects you can help provide
Breathing difficulties
more information on the safety of this
Sleeplessness
medicine.
Mood changes, confusion, hallucinations or
Continued on next page
nightmares

F310411_GB_p1_LFT.indd 3

07/05/2015 13:28

The Maltings

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

x Yes
Live Text:
/
No
/
WO:
1393548
Comp. Description: Leaflet_LIORESAL_SYR_0.1% 300ML_GB

Both

Comp. Number New: F310411 GB
Comp. Number Old: F308733 GB
Format/Dimension: 160 x 210 mm
Tech. Drawing No.: F310411 - Leaflet LIORESAL 0 1 300ML UKv2.0

Production Site:
CTM:
Printing Colours:

France, TPO, Famar, Orleans
Andersen, Claire
Black

Technical Colours: Cutting
TextFree

Minimum Font Size: 9.0pt
Font Type: News Gothic MT Pro, Helvetica Neue LT Std, News Gothic
Proof Number: 1
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4

5. How to store Lioresal Liquid
Keep all medicines out of the reach and sight
of children.
Store the elixir below 25ºC. Protect from
light. Do not refrigerate. Any syrup which has
been diluted with water can be stored at
room temperature for up to 14 days.
Do not take the elixir after the expiry date
which is printed on the outside of the pack.
If your doctor tells you to stop taking Lioresal
Liquid, please take any which is left back to
your pharmacist to be destroyed. Only keep it
if the doctor tells you to. Do not throw it
away with your normal household water or
waste. This will help to protect the
environment.
6. Further information
Lioresal Liquid is clear, slightly yellow syrup
with a raspberry flavour containing 5 mg of
the active ingredient, baclofen, in each 5 ml.
The liquid also contains the inactive
ingredients sorbitol, methyl and propyl
hydroxybenzoate, carmellose sodium,
raspberry flavour and water.
The liquid comes in 300 ml bottles with
child-proof closures.
The product licence holder is Novartis
Pharmaceuticals UK Limited, Frimley
Business Park, Frimley, Camberley, Surrey,
GU16 7SR, England.
Lioresal Liquid is manufactured by Novartis
Pharmaceuticals UK Limited, Wimblehurst
Road, Horsham, West Sussex, RH12 5AB
and Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR.
This leaflet was revised in May 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

F310411 GB

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The Maltings

Approval Box and Ready for Print Box only to be used
in case ArtBase is not used.

Brewery House,
The Maltings,
Silvester Street
Kingston-Upon-Hull
HU1 3HA
Tel: +44 (0) 1482 973000

x Yes
Live Text:
/
No
/
WO:
1393548
Comp. Description: Leaflet_LIORESAL_SYR_0.1% 300ML_GB

Both

Comp. Number New: F310411 GB
Comp. Number Old: F308733 GB
Format/Dimension: 160 x 210 mm
Tech. Drawing No.: F310411 - Leaflet LIORESAL 0 1 300ML UKv2.0

Production Site:
CTM:
Printing Colours:

Checking against manuscript according to
SOP-0022667. To be signed by AwOps.

France, TPO, Famar, Orleans
Andersen, Claire
Black

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Minimum Font Size: 9.0pt
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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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