LIORESAL INTRATHECAL INFUSION 10MG/20ML

Active substance: BACLOFEN

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Ciba
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.  hat Lioresal Intrathecal is and what it’s used for
W
2.  hings to consider before you start Lioresal
T
Intrathecal
H
3.  aving Lioresal Intrathecal
4.  ossible side effects
P
5.  ow to store Lioresal Intrathecal
H
6. Further information

1.  hat Lioresal Intrathecal is and what it’s
W
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.  hings to consider before you have a Lioresal
T
Intrathecal injection
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?
▯▯ 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.
▯▯
▯▯

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.  aving a Lioresal Intrathecal injection
H

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

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 stepwise 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 multidose 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.
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
2141251  GB
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.

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.
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, 3 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.

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 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.
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.
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.  ossible side effects
P

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

The side effects listed below have been reported:
More than 1 in 10 people have experienced:
Feeling tired, drowsy or weak.
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.
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.
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 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.  ow to store Lioresal Intrathecal
H

Keep all medicines out of the reach and sight of children.
Lioresal Intrathecal should be stored below 30°C.
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 September 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

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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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