LIORESAL INTRATHECAL INFUSION 10MG/20ML

Active substance: BACLOFEN

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LIORESAL® Intrathecal Injection
50 micrograms/1 ml
LIORESAL® Intrathecal Infusion
10 mg/5 ml
LIORESAL® Intrathecal Infusion
10 mg/20 ml
(baclofen)
Patient Information Leaflet
The product will be called Lioresal Intrathecal in this leaflet
What you need to know about Lioresal Intrathecal
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 treatment.
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 nurse.
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 Intrathecal is and what it’s used for
2. Things to consider before you have Lioresal Intrathecal
3. Having Lioresal Intrathecal
4. Possible side effects
5. How to store Lioresal Intrathecal
6. Further information

1. What Lioresal Intrathecal is and what it’s used for

Lioresal Intrathecal contains the active ingredient, baclofen. It
is administered by intrathecal injection directly into the spinal

fluid. It is available in three different sizes and strengths
containing either 50 micrograms in 1 ml, 10 mg in 5 ml or
10 mg in 20 ml of baclofen.
Baclofen is a muscle-relaxant drug. Lioresal Intrathecal is
intended for adults and children of 4 years and above and is
used to reduce and relieve the excessive tension in your
muscles (spasms) occurring in various illnesses such as
cerebral palsy, multiple sclerosis, spinal cord diseases,
cerebrovascular accidents, and other nervous system
disorders.This injection is used in people who haven’t
responded to oral medicines or who get unacceptable side
effects when they take baclofen by mouth.

2. Things to consider before you have Lioresal
Intrathecal

Some people MUST NOT have Lioresal Intrathecal. Talk to
your doctor if:
• you think you may be allergic to baclofen or to any of the
other ingredients of the injection. (These are listed at the
end of the leaflet.)
You should also ask yourself these questions before having
Lioresal Intrathecal:
• Have you understood everything the doctor or nurse has
told you about the risks associated with Lioresal Intrathecal?
• Do you understand how to use the injection pump?
If you are at all confused about either of these points, please
ask the doctor or nurse.
• Are you having any other injections into the spine?
• Are you suffering from any infection?
• Have you had a head injury within the last year?
• Have you ever had a crisis caused by a condition called
autonomic dysreflexia? (Your doctor will be able to explain
this to you.)
• Have you had a stroke?
• Do you have epilepsy?
• Do you have a stomach ulcer or any other problem with
your digestion?
• Do you suffer from any mental illness?
• Are you being treated for high blood pressure?
• Do you have Parkinson’s disease?

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983516
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Are you taking other medicines?
Some medicines can interfere with your treatment. Remind
your doctor or nurse if you are taking any of the following:
• Other medicines for your spastic condition e.g. tizanidine or
diazepam
• Antidepressants e.g. imipramine or amitriptyline
• Medicines for high blood pressure e.g. diltiazem or
moxonidine
• Other drugs which also affect the kidney, e.g. ibuprofen
• Medicines for Parkinson’s disease e.g. levodopa or
carbidopa
• Medicines for epilepsy e.g. carbamazepine or clonazepam
• Opiates for pain relief e.g. morphine
• Medicines which slow down the nervous system,
e.g. anti-histamines such as promethazine and sedatives
such as temazepam. (Some of these can be bought
over-the-counter.)
Always tell your doctor or nurse about all the medicines you
are taking. This means medicines you have bought yourself
as well as medicines on prescription from your doctor.
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 being treated with Lioresal
Intrathecal. 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.
• Contact your doctor immediately if you think that Lioresal
Intrathecal is not working as well as usual. It is important
to make sure that there are no problems with the pump.

• Treatment with Lioresal Intrathecal must not stop suddenly
because of the risk of withdrawal effects. You must make
sure that you do not miss those hospital visits when the
pump reservoir is being refilled.
• Your doctor may want to give you a check up from time to
time while you are being treated with Lioresal Intrathecal.
• If you are going to have an operation of any kind, make
sure that the doctor knows that you are being treated with
Lioresal Intrathecal. Anaesthetics such as propofol may
increase the risk of side effects.
Children and adolescents:
Lioresal Intrathecal formulation is intended for children of
4 years and above.

3. Having Lioresal Intrathecal

Lioresal Intrathecal is administered by intrathecal injection.
This means that the medicine is injected directly into the spinal
fluid. The dose needed varies from person to person depending
on their condition, and the doctor will decide what dose you
need after he/she has tested your response to the drug.
First of all the doctor will find out, by giving you single doses
of Lioresal Intrathecal, whether it is suitable for you. During
this period your heart and lung functions will be closely
monitored. If your symptoms improve, a special pump which
can deliver the drug continuously, will be implanted into your
chest or abdominal wall. The doctor will give you all of the
information you need to use the pump and to get the correct
dosage. Make sure that you understand everything.
The final dose of Lioresal Intrathecal 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 are more likely to
experience side effects.
To avoid unpleasant side effects which may be serious and
even life-threatening, it is important that your pump does not

Information for the healthcare professional
Please see the SPC for full details.
Therapeutic indications
Lioresal Intrathecal is indicated in patients with severe chronic spasticity of
spinal or cerebral origin (associated with injury, multiple sclerosis, cerebral
palsy) who are unresponsive to oral baclofen or other orally administered
antispastic agents and/or those patients who experience unacceptable
side-effects at effective oral doses.
In patients with spasticity due to head injury a delay of at least one year before
treatment with Lioresal Intrathecal is recommended, to allow the symptoms of
spasticity to stabilise.
Lioresal Intrathecal may be considered as an alternative to ablative
neurosurgical procedures.
Paediatric population
Lioresal Intrathecal is indicated in patients aged 4 to <18 years with severe
chronic spasticity of cerebral origin or of spinal origin (associated with injury,
multiple sclerosis, or other spinal cord diseases) who are unresponsive to orally
administered antispastics (including oral baclofen) and/or who experience
unacceptable side effects at effective oral doses.
Posology and method of administration
Intrathecal administration of Lioresal through an implanted delivery system
should only be undertaken by physicians with the necessary knowledge and
experience. Specific instructions for implantation, programming and/or refilling
of the implantable pump are given by the pump manufacturers, and must be
strictly adhered to.
Lioresal Intrathecal 50 micrograms/1ml is intended for administration in single
bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use,
in implantable pumps suitable for continuous administration of Lioresal
Intrathecal 10mg/20ml and 10mg/5ml into the intrathecal space (EU certified
pumps). Establishment of the optimum dose schedule requires that each
patient undergoes an initial screening phase with intrathecal bolus, followed by
a very careful individual dose titration prior to maintenance therapy.
Respiratory function should be monitored and appropriate resuscitation facilities
should be available during the introduction of treatment with Lioresal
Intrathecal. Intrathecal administration using an implanted delivery system
should only be undertaken by physicians with appropriate knowledge and
experience. Specific instructions for using the implantable pump should be
obtained from the pump manufacturers. Only pumps constructed of material
known to be compatible with the product and incorporating an in-line bacterial
retentive filter should be used.

Adult Screening Phase
Prior to initiation of a chronic infusion, the patient’s response to intrathecal
bolus doses administered via a catheter or lumbar puncture must be assessed.
Low concentration ampoules containing 50 micrograms baclofen in 1ml are
available for the purpose. Patients should be infection-free prior to screening, as
the presence of a systemic infection may prevent an accurate assessment of the
response.
The usual initial test dose in adults is 25 or 50 micrograms, increasing
step-wise by 25 microgram increments at intervals of not less than 24 hours
until a response of approximately 4 to 8 hours duration is observed. Each dose
should be given slowly (over at least one minute). In order to be considered a
responder the patient must demonstrate a significant decrease in muscle tone
and/or frequency and/or severity of muscle spasms.
The variability in sensitivity to intrathecal baclofen between patients is
emphasised. Signs of severe overdose (coma) have been observed in an adult
after a single test dose of 25 micrograms. It is recommended that the initial test
dose is administered with resuscitative equipment on hand.
Patients who do not respond to a 100 micrograms test dose should not be given
further dose increments or considered for continuous intrathecal infusion.
Monitoring of respiratory and cardiac function is essential during this phase,
especially in patients with cardiopulmonary disease and respiratory muscle
weakness or those being treated with benzodiazepine-type preparations or
opiates, who are at higher risk of respiratory depression.
Paediatric population Screening Phase
The initial lumbar puncture test dose for patients 4 to <18 years of age should
be 25-50 micrograms/day based upon age and size of the child. Patients who do
not experience a response may receive a 25 micrograms/day dose escalation
every 24 hours. The maximum screening dose should not exceed
100 micrograms/day in paediatric patients.
Dose-Titration Phase
Once the patient’s responsiveness to Lioresal Intrathecal has been established,
an intrathecal infusion may be introduced. Lioresal Intrathecal is most often
administered using an infusion pump which is implanted in the chest wall or
abdominal wall tissues. Implantation of pumps should only be performed in
experienced centres to minimise risks during the perioperative phase.
Infection may increase the risk of surgical complications and complicate
attempts to adjust the dose.
The initial total daily infused dose is determined by doubling the bolus dose
which gave a significant response in the initial screening phase and
administering it over a 24 hour period. However, if a prolonged effect (i.e. lasting

more than 12 hours) is observed during screening the starting dose should be
the unchanged screening dose delivered over 24 hours. No dose increases
should be attempted during the first 24 hours.
After the initial 24 hour period dosage should be adjusted slowly to achieve the
desired clinical effect. If a programmable pump is used the dose should be
increased only once every 24 hours; for non-programmable multi-dose reservoir
pumps intervals of 48 hours between dose adjustments are recommended. In
either case increments should be limited as follows to avoid possible overdosage:
Patients with spasticity of spinal origin: 10-30% of the previous daily dose
Patients with spasticity of cerebral origin: 5-15% of the previous daily dose.
If the dose has been significantly increased without apparent clinical effect
pump function and catheter patency should be investigated.
There is limited clinical experience using doses greater than
1000 micrograms/day.
It is important that patients are monitored closely in an appropriately equipped
and staffed environment during screening and immediately following pump
implantation. Resuscitative equipment should be available for immediate use in
case of life-threatening adverse reactions.
Adult Maintenance Therapy
The clinical goal is to maintain as normal a muscle tone as possible, and to
minimise the frequency and severity of spasms without inducing intolerable side
effects. The lowest dose producing an adequate response should be used. The
retention of some spasticity is desirable to avoid a sensation of “paralysis” on
the part of the patient. In addition, a degree of muscle tone and occasional
spasms may help support circulatory function and possibly prevent the
formation of deep vein thrombosis.
In patients with spasticity of spinal origin: maintenance dosing for long-term
continuous infusions of intrathecal baclofen has been found to range from
12 to 2003 micrograms/day, with most patients being adequately maintained on
300 to 800 micrograms/day.
In patients with spasticity of cerebral origin: maintenance dosage has been
found to range from 22 to 1400 micrograms/day, with a mean daily dosage of
276 micrograms per day at 12 months and 307 micrograms per day at
24 months.
Paediatric population Maintenance Therapy
In children aged 4 to <18 years with spasticity of cerebral and spinal origin, the
initial maintenance dosage for long-term continuous infusion of Lioresal Intrathecal
ranges from 25 to 200 micrograms/day (median dose: 100 micrograms/day). The
total daily dose tends to increase over the first year of therapy, therefore the

maintenance dose needs to be adjusted based on individual clinical response.
There is limited experience with doses greater than 1,000 micrograms/day.
The safety and efficacy of Lioresal Intrathecal for the treatment of severe
spasticity of cerebral or spinal origin in children younger than 4 years of age
have not been established.
Delivery specifications
Lioresal Intrathecal ampoules of 20ml containing 500 micrograms/ml and
5ml containing 2mg (2000micrograms)/ml are intended for use with infusion
pumps. The concentration to be used depends on the dose requirements and
size of pump reservoir. Use of the more concentrated solution obviates the need
for frequent refilling in patients with high dosage requirements.
Delivery regimen
Lioresal Intrathecal is most often administered in a continuous infusion mode
immediately following implant. After the patient has stabilised with regard to
daily dose and functional status, and provided the pump allows it, a more
complex mode of delivery may be started to optimise control of spasticity at
different times of the day. For example, patients who have increased spasm at
night may require a 20% increase in their hourly infusion rate. Changes in flow
rate should be programmed to start two hours before the desired onset of
clinical effect.
Most patients require gradual dose increases to maintain optimum response
during chronic therapy due to decreased responsiveness or disease progression.
In patients with spasticity of spinal origin the daily dose may be increased
gradually by 10-30% to maintain adequate symptom control. Where the
spasticity is of cerebral origin any increase in dose should be limited to 20%
(range: 5-20%). In both cases the daily dose may also be reduced by 10-20% if
patients suffer side effects.
A sudden requirement for substantial dose escalation is indicative of a catheter
complication (i.e. a kink or dislodgement) or pump malfunction.
In order to prevent excessive weakness the dosage of Lioresal Intrathecal should
be adjusted with caution whenever spasticity is required to maintain function.
During long-term treatment approximately 5% of patients become refractory to
increasing doses due to tolerance or drug delivery failure (see Special Warnings
and Precautions for Use “Treatment Withdrawal” section). This “tolerance” may
be treated by gradually reducing Lioresal Intrathecal dose over 2 to 4 week
period and switching to alternative methods of spasticity management
(e.g. Intrathecal preservative-free morphine sulphate). Lioresal Intrathecal
should be resumed at the initial continuous infusion dose. Caution should be
exercised when switching from Lioresal Intrathecal to morphine and vice versa.

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• 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?
If the answer to any of this second list of questions is YES,
tell your doctor or nurse because Lioresal Intrathecal may
not be the right medicine for you.

STEIN
Martin, Rosalyn
Black

Claire Flint

! P L EASE TU RN OV E R P R I NT I N G O N !
480656_0

Discontinuation
Except in overdose-related emergencies, the treatment with Lioresal Intrathecal
should always be gradually discontinued by successively reducing the dosage.
Lioresal Intrathecal should not be discontinued suddenly (see below).
Special populations
Renal impairment
Because baclofen is primarily excreted unchanged by the kidneys it should be
given with special care and caution in patients with impaired renal function.
Hepatic impairment
No dosage adjustment is recommended as the liver does not play any significant
role in the metabolism of baclofen after intrathecal administration of Lioresal.
Therefore, hepatic impairment is not expected to impact the drug systemic
exposure.
Elderly population
Several patients over the age of 65 years have been treated with Lioresal
Intrathecal during the clinical trials without increased risks compared to younger
patients. Problems specific to this age group are not expected as doses are
individually titrated.
Special warnings and precautions for use
Intrathecal baclofen therapy is valuable but hazardous. Careful pre-operative
assessment is mandatory.
The patient must be given adequate information regarding the risks of this mode
of treatment, and be physically and psychologically able to cope with the pump.
It is essential that the responsible physicians and all those involved in the care
of the patient receive adequate instruction on the signs and symptoms of
overdose, procedures to be followed in the event of an overdose and the proper
home care of the pump and insertion site.
Inflammatory mass at the tip of the implanted catheter: cases of inflammatory
mass at the tip of the implanted catheter that can result in serious neurological
impairment, including paralysis, have been reported. Although they have been
reported with Lioresal intrathecal, they have not been confirmed by contrast MRI
or histopathology. The most frequent symptoms associated with inflammatory
mass are: 1) decreased therapeutic response (worsening spasticity, return of
spasticity when previously well controlled, withdrawal symptoms, poor response
to escalating doses, or frequent or large dosage increases), 2) pain,
3) neurological deficit/dysfunction. Clinicians should monitor patients on
intraspinal therapy carefully for any new neurological signs or symptoms.
Clinicians should use their medical judgement regarding the most appropriate
monitoring specific to their patients’ medical needs to identify prodromal signs
and symptoms for inflammatory mass especially if using pharmacy
compounded drugs or admixtures that include opioids. In patients with new

neurological signs or symptoms suggestive of an inflammatory mass, consider a
neurosurgical consultation since many of the symptoms of inflammatory mass
are not unlike the symptoms experienced by patients with severe spasticity from
their disease. In some cases, performance of an imaging procedure may be
appropriate to confirm or rule-out the diagnosis of an inflammatory mass.
Pump Implantation
Patients should be infection-free prior to pump implantation because the
presence of infection may increase the risk of surgical complications. Moreover,
a systemic infection may complicate attempts to adjust the dose. A local
infection or catheter malplacement can also lead to drug delivery failure, which
may result in sudden Lioresal Intrathecal withdrawal and its related symptoms
(see “Treatment Withdrawal” section).
Reservoir refilling
Reservoir refilling must be performed by trained and qualified personnel in
accordance with the instructions provided by the pump manufacturer. Refills
should be timed to avoid excessive depletion of the reservoir, as this would
result in the return of spasticity or potentially life-threatening symptoms of
Lioresal Intrathecal withdrawal (see “Treatment Withdrawal” section).
When refilling the pump care should be taken to avoid discharging the contents
of the catheter into the intrathecal space.
Strict asepsis is required to avoid microbial contamination and infection.
Extreme caution must be taken when filling a pump equipped with an injection
port that allows direct access to the intrathecal catheter as a direct injection into
the catheter through the access port could cause a life-threatening overdose.
Precautions in paediatric patients
For patients with spasticity due to head injury, it is recommended not to proceed
to long-term Lioresal Intrathecal therapy until the symptoms of spasticity are
stable (i.e. at least one year after the injury).
Children should be of sufficient body mass to accommodate the implantable
pump for chronic infusion. Use of Lioresal Intrathecal in the paediatric population
should be only prescribed by medical specialists with the necessary knowledge
and experience. There is very limited clinical data regarding the safety and
efficacy of the use of Lioresal Intrathecal in children under the age of four years.
Precautions in special patient populations
In patients with abnormal CSF flow the circulation of drug and hence
antispastic activity may be inadequate.
Psychotic disorders, schizophrenia, confusional states or Parkinson’s
disease may be exacerbated by treatment with oral Lioresal. Patients suffering
from these conditions should therefore be treated cautiously and kept under
close surveillance.

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

Live Text:
WO:
Comp. Description:

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/
No
983516
PREA LIORESAL LIAM GB

Production Site:
CTM:
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Comp. Number Old:
Format/Dimension:
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2145564 GB
2141251 GB
594x148mm
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Technical Colours: Cutting

7.5pt
20/12/2013

Renal impairment
After oral Lioresal dosing severe neurological outcomes have been reported in
patients with renal impairment. Thus caution should be exercised while
administering Lioresal Intrathecal in patients with renal impairment.
In rare instances elevated SGOT, alkaline phosphatase and glucose levels in the
serum have been recorded when using oral Lioresal.
Treatment withdrawal
Abrupt discontinuation of Lioresal Intrathecal, regardless of cause, manifested
by increased spasticity, pruritus, paraesthesia and hypotension, has resulted in
sequelae including a hyperactive state with rapid uncontrolled spasms,
hyperthermia and symptoms consistent with neuroleptic malignant syndrome,
e.g. altered mental status and muscle rigidity. In rare cases this has advanced
to seizures/status epilepticus, rhabdomyolysis, coagulopathy, multiple organ
failure and death. All patients receiving intrathecal baclofen therapy are
potentially at risk for withdrawal.
Some clinical characteristics associated with intrathecal baclofen withdrawal
may resemble autonomic dysreflexia, infection (sepsis), malignant
hyperthermia, neuroleptic-malignant syndrome, or other conditions associated
with a hypermetabolic state or widespread rhabdomyolysis.
Patients and caregivers should be advised of the importance of keeping
scheduled refill visits and should be educated on the signs and symptoms of
baclofen withdrawal particularly those seen early in the withdrawal syndrome.
In most cases, symptoms of withdrawal appeared within hours to a few days
following interruption of baclofen therapy. Common reasons for abrupt
interruption of intrathecal baclofen therapy included malfunction of the catheter
(especially disconnection), low volume in the pump reservoir and end of pump
battery life.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful
attention to programming and monitoring of the infusion system, refill
scheduling and procedures, and pump alarms. The suggested treatment for
intrathecal Lioresal withdrawal is the restoration of intrathecal Lioresal at or
near the same dosage as before therapy was interrupted. However, if restoration
of intrathecal delivery is delayed, treatment with GABA-ergic agonist drugs such
as oral or enteral Lioresal, or oral, enteral, or intravenous benzodiazepines may
prevent potentially fatal sequelae. Oral or enteral Lioresal alone should not be
relied upon to halt the progression of intrathecal baclofen withdrawal.
Incompatibilities
If alternative baclofen concentrations are required Lioresal Intrathecal may be
diluted under aseptic conditions with sterile preservative-free sodium chloride
for injections. The ampoules should not be mixed with other solutions for
injection or infusion (dextrose has proved to be incompatible due to a chemical
reaction with baclofen).
The compatibility of Lioresal Intrathecal with the components of the infusion
pump (including the chemical stability of baclofen in the reservoir) and the
presence of an in-line bacterial retentive filter should be confirmed with the
pump manufacturer prior to use.
Shelf life
LIORESAL® Intrathecal Injection 50 micrograms/1 ml: 3 years
LIORESAL® Intrathecal Infusion 10 mg/5 ml: 3 years
LIORESAL® Intrathecal Infusion 10 mg/20 ml: 5 years
Special precautions for storage
Protect from heat (store below 30°C).
Medicines should be kept out of the reach and sight of children.
Nature and content of container
Colourless glass ampoules, glass type I, according to Ph. Eur.
Instructions for use / handling
Each ampoule is intended for single use only, and any unused solution should be
discarded. Ampoules should not be either frozen or autoclaved.
Date of revision: November 2013

run out. The pump must always be filled by a doctor or nurse,
and you must make sure that you do not miss your clinic
appointments.

The side effects listed below have been reported:
More than 1 in 10 people have experienced:
Feeling tired, drowsy or weak.

You should not stop treatment suddenly. If the doctor decides
to stop your treatment, 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). On rare
occasions these symptoms could be life-threatening. If you or
your carers notice any of these symptoms, contact your doctor
immediately just in case something has gone wrong with the
pump or delivery system.

Up to 1 in 10 people have experienced:
Feeling lethargic (having no energy)
Headache, dizziness or light-headedness
Pain, fever or chills
Seizures
Tingling hands or feet
Problems with eyesight
Slurred speech
Insomnia
Breathing difficulties, pneumonia
Feeling confused, anxious, agitated or depressed
Low blood pressure (fainting)
Feeling or being sick, constipation and diarrhoea
Loss of appetite, dry mouth or excessive saliva
Rash and itching, swelling of the face or hands and feet
Urinary incontinence, or problems when urinating
Cramps
Sexual problems in men, e.g. impotence.

During long-term treatment some patients find that Lioresal
becomes less effective. You may require occasional breaks in
treatment. Your doctor will advise you what to do.
Lioresal Intrathecal is not suitable for all children. The doctor
will decide.
Overdose
It is very important that you, and anyone caring for you, can
recognise the signs of overdose. These may appear if the
pump is not working properly, and you must tell the doctor
straight away.
Signs of overdose are:
Unusual muscle weakness (too little muscle tone)
Sleepiness
Dizziness or light-headedness
Excessive salivation
Nausea or vomiting
Difficulty in breathing
Convulsions
Loss of consciousness
Abnormally low body temperature

4. Possible side effects

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

Up to 1 in 100 people have experienced:
Feeling abnormally cold
Memory loss
Mood swings and hallucinations, feeling suicidal
Stomach ache, difficulty in swallowing, loss of taste,
dehydration
Loss of muscle control
Raised blood pressure
Slow heart beat
Deep vein thrombosis
Flushed or pale skin, excessive sweating
Hair loss.

lining around the brain and spinal cord (meningitis) or a
collection of immune cells at the tip of the delivery tube.
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.

5. How to store Lioresal Intrathecal

Keep all medicines out of the reach and sight of children.
Lioresal Intrathecal should be stored below 30ºC.
It should not be used after the expiry date which is printed on
the outside of the pack.

6. Further information

Lioresal Intrathecal is available in three different sizes and
strengths containing either 50 micrograms in 1 ml,
10 mg in 5 ml or 10 mg in 20 ml of the active ingredient,
baclofen. The ampoules also contain sodium chloride and
water for injections.
The product licence holder is Novartis Pharmaceuticals UK
Limited, Frimley Business Park, Frimley, Camberley, Surrey,
GU16 7SR, England.
Lioresal Intrathecal is manufactured by Novartis
Pharmaceuticals UK Limited, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR.
This leaflet was revised in November 2013.
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

Other side effects (how often they happen is not known)
Restlessness
Abnormally slow breathing rate.
There have been rare reports of problems associated with the
pump and delivery system e.g. infections, inflammation of the

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Special attention should be given to patients known to suffer from epilepsy as
seizures have occasionally been reported during overdose with, and withdrawal
from, Lioresal Intrathecal as well as in patients maintained on therapeutic doses.
Lioresal Intrathecal should be used with caution in patients with a history of
autonomic dysreflexia. The presence of nociceptive stimuli or abrupt withdrawal
of Lioresal Intrathecal may precipitate an autonomic dysreflexic episode.
Lioresal should be used with caution in patients with cerebrovascular or
respiratory insufficiency.
An effect of Lioresal Intrathecal on underlying, non‑CNS related diseases is
unlikely because its systemic availability is substantially lower than after oral
administration. Observations after oral baclofen therapy suggest that caution
should be exercised in patients with a history of peptic ulcers and pre‑existing
sphincter hypertonia.

STEIN
Martin, Rosalyn
Black

Claire Flint

! P L EASE TU RN OV E R P R I NT I N G O N !
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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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