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LIORESAL LIQUID

Active substance(s): BACLOFEN / BACLOFEN / BACLOFEN

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Ciba
LIORESAL® Liquid

accidents, spinal cord diseases and other
nervous system disorders.

1

2. Things to consider before you start to take
Lioresal Liquid
Some
people MUST NOT take Lioresal
Patient Information Leaflet
Liquid. Talk to your doctor if:
What you need to know about Lioresal
• you think you may be allergic to baclofen
Liquid
or to any of the other ingredients of the
Your doctor has decided that you or your
liquid, (these are listed at the end of the
child needs this medicine to help treat your
leaflet.)
condition.
• you have ever had a stomach ulcer.
Please read this leaflet carefully before you
You should also ask yourself these
start to take your medicine. It contains
important information. Keep the leaflet in a questions before taking Lioresal Liquid:
safe place because you may want to read it • Have you had a stroke?
• Do you have epilepsy?
again.
• Do you suffer from any mental illness?
If you have any other questions, or if there is
• Are you being treated for high blood
something you don’t understand, please ask
pressure?
your doctor or pharmacist.
• Do you have Parkinson’s disease?
This medicine has been prescribed for you.
• Do you suffer from any liver, kidney or lung
Never give it to someone else. It may not be
disease?
the right medicine for them even if their
• Do you have diabetes?
symptoms seem to be the same as yours.
• Do you have difficulties in urinating?
• Are you pregnant or breast-feeding?
If any of the side effects gets serious, or if
(See section "Pregnancy and
you notice any side effects not listed in this
breast-feeding").
leaflet, please tell your doctor or pharmacist.
• Do you have an intolerance to some
In this leaflet:
sugars? (The liquid contains sorbitol.)
1.What Lioresal Liquid is and what it’s
If the answer to any of these questions is
used for
YES, tell your doctor or pharmacist because
2.Things to consider before you start to take Lioresal Liquid might not be the right
Lioresal Liquid
medicine for you.
3.How to take Lioresal Liquid
4.Possible side effects
Are you taking other medicines?
5.How to store Lioresal Liquid
Some medicines can interfere with your
6.Further information
treatment. Tell your doctor or pharmacist if
you are taking any of the following:
1. What Lioresal Liquid is and what it’s
• Other medicines to relax muscles e.g.
used for
tizanidine
Lioresal Liquid is a syrup containing 5 mg • Medicines to treat mood disorders such as
of the active ingredient, baclofen, in each
lithium or tricyclic antidepressants such as
5 ml.
amitriptyline
• Medicines for high blood pressure e.g.
Baclofen is a muscle-relaxant drug. Lioresal
diltiazem
Liquid is used to reduce and relieve the
• Other drugs which also affect the kidney,
excessive tension in your muscles (spasms)
e.g. ibuprofen
occurring in various illnesses such as cerebral
Continued on next page
palsy, multiple sclerosis, cerebrovascular
(baclofen)

The Maltings

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

x Yes
Live Text:
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WO:
1609603
Comp. Description: LFT_LIORESAL SYR 0.1%300ML 1X1 GB
Comp. Number New: 1609603 GB
Comp. Number Old: N/A
Format/Dimension: 160 x 210 mm
Tech. Drawing No.: NOTF004

Both

Production Site:
ACC:
Printing Colours:

France, TPO, Famar, Orleans la Source
Goodchild, Keith
Black

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26/05/2017

Ryan Wardell

! P LE ASE TU R N OVE R P R I N T I N G O N !
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2

If you have to take Lioresal during pregnancy,
your unborn baby will also be exposed to
Lioresal. After birth your baby may develop
withdrawal symptoms such as convulsions
(symptoms of withdrawal are described in
the section “If you stop taking Lioresal”).

Liquid to take and when to take it. 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.

ZONE DE COLLAGE

reactions which might appear some time
after first taking the medicine.
2.Sodium 1.6mg/mL. Take this into
consideration if you are on a controlled
sodium diet.
3.Sorbitol. This can have a mild laxative
effect and you might be affected if you
take more than 25 ml of Lioresal Liquid
per day. Calorific value 2.6 kcal/g
Always tell your doctor or pharmacist about all
sorbitol.
the medicines you are taking. This means
• Be careful when drinking alcohol - it may
medicines you have bought yourself as well as
affect you more than usual.
medicines on prescription from your doctor.
• Your doctor may want to give you a check
up from time to time while you are taking
Pregnancy and breast-feeding
Lioresal Liquid.
Ask your doctor or pharmacist for advice
• If you are going to have an operation of any
before taking any medicine.
kind, make sure that the doctor knows that
You should not use Lioresal during pregnancy
you are taking Lioresal Liquid.
unless your doctor advises you to do so. Tell
your doctor if you are pregnant, or planning
3. How to take Lioresal Liquid
to become pregnant.
The doctor will tell you how much Lioresal
• 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).

The doctor will tell you the best time to take
Only a very small amount of Lioresal passes the medicine. Some people take it only at
into breast milk. Your doctor will discuss with
night or before doing a task such as washing,
you whether you should breast-feed whilst
dressing, shaving, etc.
taking Lioresal.
The final dose of Lioresal depends on how
Will there be any problems with driving or
each person responds to the drug. You will
using machinery?
be started on a low dose, and this will be
Some people may feel drowsy and/or dizzy
increased gradually over a few days, under
or have problems with their eyes while they the supervision of the doctor, until you are
are taking Lioresal Liquid. If this happens,
having the dose which is right for you. If
you should not drive or do anything that
the starting dose is too high, or if the dose
requires you to be alert (such as operate
is increased too quickly, you may
tools or machinery) until these effects have experience side effects, particularly if you
worn off.
are elderly, have kidney problems or have
had a stroke.
Other special warnings
If you feel sick after taking Lioresal Liquid,
• Lioresal Liquid contains
you may find it helps to take it with food or a
1.Small amounts of the preservatives
milk drink.
methyl and propyl hydroxybenzoate.
Continued on next page
These can sometimes cause allergic

The Maltings

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

x Yes
Live Text:
/
No
/
WO:
1609603
Comp. Description: LFT_LIORESAL SYR 0.1%300ML 1X1 GB
Comp. Number New: 1609603 GB
Comp. Number Old: N/A
Format/Dimension: 160 x 210 mm
Tech. Drawing No.: NOTF004

Both

Production Site:
ACC:
Printing Colours:

France, TPO, Famar, Orleans la Source
Goodchild, Keith
Black

Technical Colours: Cutting
TextFree

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

26/05/2017

Ryan Wardell

! P LE ASE TU R N OVE R P R I N T I N G O N !
5134351_1

3

ZONE DE COLLAGE

Adults
• The usual dose is 20 mg (20 ml) three
times a day.
• The maximum daily dose is 100 mg
(100 ml) except if you are in hospital
when a higher dose may be used.

The side effects listed below have been
reported:
More than 1 in 10 people have experienced:
Tiredness, sleepiness, nausea (feeling sick).

If you stop taking Lioresal
You should not stop taking Lioresal Liquid
suddenly. If the doctor decides to stop your
treatment with Lioresal Liquid, 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).

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

Up to 1 in 10 people have experienced:
Excessively weak limbs or feeling tired and
Children (0 to < 18 years)
exhausted, aching muscles
Headache, dizziness or light-headedness
Children’s treatment is adjusted to their body
weight. Children’s treatment usually starts with Breathing difficulties
a very low dose (approximately 0.3 mg/kg/day), Sleeplessness
Mood changes, confusion, hallucinations or
in 2-4 divided doses (preferably in 4 doses).
nightmares
The dosage is then gradually increased until it
Dry mouth
becomes sufficient for the child’s individual
Problems with their eyes
requirements, this may be between 0.75 and
Unsteadiness, trembling or other problems
2 mg/kg body weight. The total daily dose
should not exceed a maximum of 40 mg/day in with muscle control
children below 8 years of age. In children over Low blood pressure (fainting)
Stomach problems including retching,
8 years of age a maximum daily dose of
vomiting, constipation and diarrhoea
60 mg/day may be given.
Excessive sweating, rash
Patients with kidney problems
Increased need to pass urine or pain on
You will probably be given a much lower dose. passing urine.
The doctor will decide what the dose should be.
Up to 1 in 1,000 people have experienced:
What if you forget to take a dose?
Numbness or tingling in hands or feet
If you forget to take a dose, take the next dose Increased muscle spasm
at the usual time. DO NOT take a double dose. Disturbed sense of taste
Slurred or slow speech
What if you take too much?
Stomach ache
If you accidentally take too much Lioresal
Liver problems
Liquid, tell your doctor at once or contact
Difficulty in passing urine
your nearest hospital casualty department.
Sexual problems in men, e.g. impotence
Take your medicine with you.
Convulsions (particularly in epileptics)

4. Possible side effects
Lioresal Liquid is suitable for most people,
but, like all medicines, it can sometimes
cause side effects.

The Maltings

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
Continued on next page

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

x Yes
Live Text:
/
No
/
WO:
1609603
Comp. Description: LFT_LIORESAL SYR 0.1%300ML 1X1 GB
Comp. Number New: 1609603 GB
Comp. Number Old: N/A
Format/Dimension: 160 x 210 mm
Tech. Drawing No.: NOTF004

Both

Production Site:
ACC:
Printing Colours:

France, TPO, Famar, Orleans la Source
Goodchild, Keith
Black

Technical Colours: Cutting
TextFree

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

26/05/2017

Ryan Wardell

! P LE ASE TU R N OVE R P R I N T I N G O N !
5134351_1

not mentioned here, please go and see your
doctor. He/she may want to adjust the dose
or give you a different medicine.

This leaflet was revised in May 2017.
If you would like any more information, or
would like the leaflet in a different format,
please contact Medical Information at
Reporting of side effects
Novartis Pharmaceuticals UK Ltd,
If you get any side effects, talk to your doctor or
telephone number 01276 698370.
pharmacist. This includes any possible side
LIORESAL is a registered trade mark
effects not listed in this leaflet. You can also
Copyright Novartis Pharmaceuticals UK
report side effects directly via the Yellow Card
Limited
Scheme (www.mhra.gov.uk/yellowcard). By
reporting side effects you can help provide more
information on the safety of this medicine.

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, Frimley Business
Park, Frimley, Camberley, Surrey, GU16 7SR.

The Maltings

1609603 GB

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

x Yes
Live Text:
/
No
/
WO:
1609603
Comp. Description: LFT_LIORESAL SYR 0.1%300ML 1X1 GB
Comp. Number New: 1609603 GB
Comp. Number Old: N/A
Format/Dimension: 160 x 210 mm
Tech. Drawing No.: NOTF004

Technical approval Box in case ArtBase is not used.
If a manual signature is given the approver hand-sign
with the name and the date in readable letters.
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ACC:
Printing Colours:

France, TPO, Famar, Orleans la Source
Goodchild, Keith
Black

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Ryan Wardell

! P LE ASE TU R N OVE R P R I N T I N G O N !
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Expand Transcript

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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