LIORESAL 10 mg Коированная Таблетка

Содержание инструкции

1. Lioresal 10 mg tablets, 25 mg tablets
   1. What is Lioresal and what is it used for
   2. What you need to know before taking Lioresal
   3. How to take Lioresal
   4. Possible side effects
   5. How to store Lioresal
   6. Contents of the pack and other information
2. Lioresal 10 mg/20 ml injectable solution for intrathecal use, 10 mg/5 ml injectable solution for intrathecal use, 0.05 mg/1 ml injectable solution for intrathecal use
   1. What is Lioresal and what is it used for
   2. What you need to know before you are given Lioresal
   3. How Lioresal will be administered to you
   4. Possible side effects
   5. How to store Lioresal
   6. Package Contents and Other Information

Lioresal 10 mg tablets, 25 mg tablets

baclofen

Read this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Lioresal is and what it is used for
• 2. What you need to know before you take Lioresal
• 3. How to take Lioresal
• 4. Possible side effects
• 5. How to store Lioresal
• 6. Contents of the pack and other information

1. What is Lioresal and what is it used for

Lioresal contains the active ingredient baclofen which belongs to the class of medicines known as
“centrally acting muscle relaxants”. Baclofen works by relaxing the muscles.

Adults
Lioresal is indicated for the treatment of manifestations characterized by increased muscle tone and
contraction (spastic hypertonia):

• in multiple sclerosis
• in diseases of the spinal cord of infectious, degenerative, traumatic, tumorous, unknown origin for example: spastic spinal paralysis amyotrophic lateral sclerosis syringomyelia transverse myelitis paraplegia or traumatic paraparesis states of spinal cord compression
• following damage to the brain, in particular in cases of: disease occurring in childhood (childhood encephalopathy) diseases of the brain's blood vessels (cerebrovascular disease) diseases of the brain due to tumors or degeneration.

Children and adolescents (from 0 to 18 years of age)
Lioresal is indicated for the treatment of symptoms of increased muscle tone and contraction
of the muscles (spastic hypertonia):

• following damage to the brain, in particular in cases of: cerebral palsy stroke or transient ischemic attack diseases of the brain due to tumors or degeneration
• in diseases of the spinal cord of infectious, degenerative, traumatic, tumorous, unknown origin for example: multiple sclerosis spastic spinal paralysis amyotrophic lateral sclerosis syringomyelia transverse myelitis paraplegia or traumatic paraparesis states of spinal cord compression.

2. What you need to know before taking Lioresal

Do not use Lioresal

• if you/your child are allergic to baclofen or any of the other ingredients of this medicine (listed in section 6)
• if you/your child have or have had a stomach ulcer or an ulcer in the first part of the intestine (peptic ulcer).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lioresal.
Inform your doctor, who will pay particular attention when prescribing Lioresal and will keep you/your child under
close monitoring, if you/your child:

• suffer from mood disorders (e.g. psychosis, schizophrenia, depressive or manic disorders)
• suffer from states of confusion
• have Parkinson's disease
• have epilepsy
• have disorders of the blood vessels of the brain
• have problems with breathing
• have liver problems
• have kidney problems
• have problems urinating due to an increase in the tone of the muscles that control the release of urine (vesical sphincter hypertonia)
• are pregnant: immediately after childbirth your baby may have convulsions and other symptoms related to the sudden interruption of treatment (see “If you/your child stop taking Lioresal”)
• excessively use alcohol or have a history of drug abuse or dependence.

Some people treated with baclofen have developed thoughts of self-harm or suicide or
have attempted suicide. Almost all of these people were also suffering from depression, excessively
used alcohol or were prone to suicidal thoughts. If at any time you should develop thoughts of
self-harm or suicide, tell your doctor immediately or go to hospital. Also, ask a
relative or close friend to warn you if they should notice any change in your
behavior and invite them to read this leaflet.
If during treatment with Lioresal you undergo some laboratory tests to evaluate the function
of the liver (aspartate aminotransferase and alkaline phosphatase levels) or the blood sugar level,
be aware that these values may be altered. The doctor will subject you or your child to
periodic checks, especially if you have liver problems or suffer from diabetes.
Cases of reduced brain function (encephalopathy) have been reported in some patients in
treatment with Lioresal at the prescribed doses, which resolved after discontinuation of the medicine. The
symptoms include increased or onset of drowsiness, confusion, muscle contractions or coma.
If any of these symptoms occur, consult your doctor immediately. The doctor will decide
whether to stop taking baclofen.

Children
Clinical data on the use of Lioresal in children under one year of age are limited, therefore the doctor
will carefully assess the use of this medicine in these patients.

Other medicines and Lioresal
Tell your doctor or pharmacist if you/your child are taking, have recently taken or might take
any other medicines.
Tell your doctor if you/your child are taking:

• medicines for Parkinson's disease (e.g. levodopa, carbidopa)
• medicines that cause a reduction in the activity of the Central Nervous System, for example: other medicines to relax muscles, for example tizanidine, synthetic opioids
• morphine
• medicines against depression of the tricyclic class
• lithium (medicine against mood disorders)
• medicines that lower blood pressure including antihypertensives (medicines against high blood pressure)
• medicines that reduce kidney function.

The doctor will keep you/your child under close monitoring and will assess whether to modify the dose of Lioresal or the other
medicine.

Lioresal with alcohol
The use of Lioresal with alcohol can increase the sedative effect and the risk of difficulty breathing.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are no adequate studies in pregnant women. Baclofen crosses the placenta, therefore if you are pregnant
the medicine will be prescribed to you only in cases of actual necessity and under the direct control of the doctor.
If you have to take Lioresal during pregnancy, immediately after childbirth your baby may have
convulsions and other symptoms related to the sudden interruption of treatment (see “If you/your child
stop taking Lioresal” and “Warnings and precautions”).
Breastfeeding
Baclofen passes into breast milk in small amounts, therefore no adverse effects are expected for
the infant.
Fertility
No data are available regarding the activity of baclofen on male fertility, nor data that
support particular recommendations for women of childbearing age.

Driving and using machines
Lioresal can cause dizziness, sedation, drowsiness and impaired vision. Therefore patients
who have experienced these symptoms should not drive vehicles (including bicycles) and use
machinery.

Lioresal contains wheat starch
This medicine contains only a very small amount of gluten (from wheat starch) and is
very unlikely to cause you problems if you are coeliac.
One Lioresal 10 mg tablet contains no more than 6.1 micrograms of gluten and one
Lioresal 25 mg tablet contains no more than 8.3 micrograms of gluten.
If you are allergic to wheat (a condition different from coeliac disease) do not take this medicine.

3. How to take Lioresal

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
The doctor will initially prescribe you/your child the lowest possible dose of Lioresal effective for
treating your condition, which may then be gradually increased.
If 6-8 weeks after reaching the maximum dose, no therapeutic benefit is evident, the doctor will
decide whether to continue or discontinue therapy with Lioresal.
Lioresal tablets should be taken during meals with some liquid.

Use in adults
The daily dose should be divided preferably into three administrations.
Keep in mind that the doctor:

• will start treatment with an initial dose of 5 mg, to be taken 3 times a day
• will increase, every 3 days and up to reaching the effective dose, the daily dose of 15 mg divided into 3 administrations. The optimal dose is generally between 30 and 80 mg per day, up to 100 - 120 mg in hospitalized patients under close supervision.

If you are a patient particularly sensitive to medicines, the doctor may prescribe you a lower initial daily
dose (5 or 10 mg) and reach the optimal dose more gradually.

Use in children and adolescents (from 0 to 18 years of age)
The maximum total daily dose in children under 8 years of age is 40 mg per day and in
children over 8 years of age is 60 mg per day.
Do not use Lioresal tablets in children with a body weight of less than 33 Kg.
Keep in mind that the doctor:

• will start treatment with a very low dose (approximately 0.3 mg/Kg of body weight per day) divided into 2-4 doses (preferably in 4 doses)
• will increase the dose cautiously, at intervals of about 1 week, until reaching the effective dose. The usual daily dose for maintenance therapy is between 0.75 and 2 mg/Kg of body weight.

Use in patients with kidney problems
If you/your child have kidney problems, the doctor will prescribe a lower dose of Lioresal.
If you/your child are undergoing chronic hemodialysis, the doctor will identify the optimal dose, generally
about 5 mg per day.
If you/your child have end-stage renal failure, the doctor will prescribe Lioresal only in
cases of actual need and will keep you/your child under close control to identify early signs
and symptoms of toxicity (e.g. drowsiness, lethargy).

Use in patients with liver problems
The doctor will pay particular attention when prescribing you Lioresal.

Use in elderly patients (age ≥ 65 years)
The doctor will pay particular attention when prescribing you Lioresal and will keep you under control to monitor
any unwanted effects.

Use in patients with spasticity due to brain damage
The doctor will pay particular attention when prescribing Lioresal and will keep you/your child under control to
monitor any unwanted effects.

If you take more Lioresal than you should
In case of accidental ingestion of an excessive dose of Lioresal, immediately inform your doctor or
go to the nearest hospital.
If you/your child take more Lioresal than you should, the following may occur:

• drowsiness
• decreased level of consciousness
• reduced respiratory activity
• coma
• confusion
• hallucinations
• agitation
• convulsions
• electroencephalogram (EEG) abnormalities
• visual disturbances
• general reduction of muscle tone
• brief and sudden contractions of one or more muscles (myoclonus)
• decreased or absent reflexes
• dilation of veins and arteries in the limbs
• increase or decrease in blood pressure
• slowing or acceleration of the heartbeat
• heart rhythm alterations
• decreased body temperature
• nausea, vomiting, diarrhea
• increased saliva secretion
• increased levels of certain liver enzymes in the blood
• ringing in the ears.

If you/your child have kidney problems, the effects described above may occur even at low doses.
The simultaneous intake of substances or medicines active on the Central Nervous System (e.g.
alcohol, diazepam, tricyclic antidepressants) may worsen the syndrome associated
with the ingestion of an excessive dose of Lioresal.

If you/your child forget to take Lioresal
Do not take a double dose to make up for a missed dose.

If you/your child stop taking Lioresal
You/your child should not abruptly stop treatment with Lioresal, unless you have
manifested serious unwanted effects or in case of ingestion of an excessive dose of Lioresal.
Treatment with Lioresal must always be discontinued gradually, reducing the dose progressively
over about 1-2 weeks.
If you abruptly stop treatment with Lioresal, you may experience anxiety, confusion,
delirium, hallucinations, psychotic, manic or paranoid disorders, convulsions, involuntary movements of
tongue, mouth, trunk and limbs, accelerated heartbeat, increased body temperature,
excessive muscle tone and a temporary worsening of spasticity known as
"rebound phenomenon".
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects occur especially at the beginning of therapy (e.g. sedation, drowsiness),
when the dose is increased too rapidly, when high doses are used or if the patient is
elderly.
These effects are however often temporary and can be eliminated or reduced by reducing the dose.
Rarely have they been so severe as to require discontinuation of treatment.
Side effects may be more serious in patients with a history of psychiatric illness or with
blood vessel disorders of the brain (e.g. stroke) and in elderly patients.
Patients suffering from epilepsy may be more likely to have seizures.
Some patients have shown increased muscle spasticity as a reaction to treatment.
Many of the reported side effects are attributable to the underlying disease being treated.

Very common side effects (may affect more than 1 in 10 people)

• drowsiness
• sedation
• nausea

Common side effects (may affect up to 1 in 10 people)

• reduction of respiratory activity
• fatigue
• confusional state
• dizziness
• headache
• insomnia
• euphoria
• depression
• muscle weakness
• loss of coordination of movements (ataxia)
• tremor
• hallucinations
• nightmares
• muscle pain (myalgia)
• nystagmus (rhythmic, involuntary, oscillating eye movements)
• dry mouth
• visual disturbances
• decreased blood volume
• low blood pressure
• feeling of discomfort in the stomach and intestines
• retching, vomiting
• constipation
• diarrhea
• excessive sweating
• skin rash
• frequent emission of small amounts of urine (pollakiuria)
• involuntary and complete loss of urine (enuresis)
• difficulty urinating (dysuria)

Rare side effects (may affect up to 1 in 1,000 people)

• tingling (paresthesia)
• speech disorders in which words are pronounced slowly and defectively (dysarthria)
• altered taste (dysgeusia)
• abdominal pain
• impaired liver function
• urinary retention
• erectile dysfunction

Very rare side effects (may affect up to 1 in 10,000 people)

• decrease in body temperature

Side effects of unknown frequency (frequency cannot be estimated based on available data)

• slowing of the heartbeat
• urticaria
• withdrawal syndrome, due to discontinuation of treatment
• increased blood sugar levels
• difficulty breathing during sleep (sleep apnea syndrome)
• swelling of the ankles, feet or lower legs
• facial swelling
• allergic reaction (hypersensitivity)
• hair loss
• sexual difficulties
• reduced brain function (encephalopathy)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Lioresal

Protect the medicine from humidity and heat.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging after “Scad. /Scade”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lioresal contains
Lioresal 10 mg tablets

• The active ingredient is baclofen. Each tablet contains 10 mg of baclofen.
• The other ingredients are wheat starch, magnesium stearate, povidone, microcrystalline cellulose, anhydrous colloidal silica.

Lioresal 25 mg tablets

• The active ingredient is baclofen. Each tablet contains 25 mg of baclofen.
• The other ingredients are wheat starch, magnesium stearate, povidone, microcrystalline cellulose, anhydrous colloidal silica.

Description of the appearance of Lioresal and contents of the pack
Each pack of Lioresal 10 mg tablets contains 50 tablets.
Each pack of Lioresal 25 mg tablets contains 50 tablets.

Marketing Authorisation Holder
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milano MI
Italy

Manufacturer
Lioresal 10 mg tablets
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata NA
Italy
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milano MI
Italy

Lioresal 25 mg tablets
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata NA
Italy
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milano MI
Italy
Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany

Lioresal 10 mg/20 ml injectable solution for intrathecal use, 10 mg/5 ml injectable solution for intrathecal use, 0.05 mg/1 ml injectable solution for intrathecal use

baclofen

Read this leaflet carefully before this medicine is administered to you because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What Lioresal is and what it is used for
• 2. What you need to know before Lioresal is administered to you
• 3. How Lioresal will be administered to you
• 4. Possible side effects
• 5. How to store Lioresal
• 6. Contents of the pack and other information

1. What is Lioresal and what is it used for

Lioresal contains the active ingredient baclofen which belongs to the class of drugs known as
“centrally acting muscle relaxants”. Baclofen works by relaxing the muscles.

Adults
Lioresal is indicated for the treatment of severe and persistent manifestations characterized by
increased muscle tone and contraction (severe chronic spasticity) in cases of:

• multiple sclerosis
• lesions and diseases of the spinal cord in patients who do not respond to orally administered therapies and who experience unacceptable adverse effects with therapeutic doses of orally administered medicines.

Lioresal is also indicated for the treatment of:

• manifestations characterized by increased muscle tone and contraction due to brain damage (cerebral spasticity), for example in cases of: cerebral palsy traumatic brain injury stroke
• patients with tetanus to reduce increased responsiveness to stimuli (hyperreflexia), involuntary muscle jerks (clonus) and jaw contracture due to spasms (trismus).

Children and adolescents (from 4 to 18 years of age)
Lioresal is indicated for the treatment of severe and persistent manifestations characterized by
increased muscle tone and contraction (severe chronic spasticity) in cases of:

• brain damage or disease
• trauma or diseases of the spinal cord
• multiple sclerosis in patients who do not respond to orally administered therapies and who experience unacceptable adverse effects with therapeutic doses of orally administered medicines.

2. What you need to know before you are given Lioresal

You will not be given Lioresal

• if you/your child is allergic to baclofen or any of the other ingredients of this medicine (listed in section 6)
• intravenously, intramuscularly, subcutaneously or epidurally
• if you/your child suffers from drug-resistant epilepsy
• during pregnancy, unless under strict medical supervision (see section 'Pregnancy, breastfeeding and fertility').

Warnings and precautions
Consult your doctor or nurse before you are given Lioresal if you/your child:

• has an ongoing infection
• has heart problems
• has lung problems (respiratory failure)
• has weak lung muscles
• has abnormalities in the distribution of fluid in the central nervous system (cerebrospinal fluid)
• suffers from mood disorders (e.g. psychosis, schizophrenia)
• suffers from states of confusion
• has Parkinson's disease
• has epilepsy
• suffers from a disorder of the autonomic nervous system called autonomic dysreflexia, which manifests, for example, with increased blood pressure accompanied by a slowed heart rate, sweating, headache
• has severe problems with the blood vessels of the brain associated with a reduction in oxygen to the brain (cerebrovascular insufficiency), has or has had a stomach or duodenal ulcer (peptic ulcer)
• suffers from a condition that persists over time characterized by an excessive increase in the tone of the muscles of the sphincters called sphincteric hypertonia
• has kidney failure.

The doctor will closely monitor you/your child during treatment with Lioresal, in particular
will assess the functioning of the lungs, blood vessels and heart.
You/your child should see your doctor or nurse immediately if you develop the following symptoms during treatment with
Lioresal because there may be problems at the injection site or with the
release of the medicine:

• increased tone and contraction of the muscles (spasticity)
• poor response to increasing doses of Lioresal
• pain at the intrathecal puncture site
• itching
• tingling
• decreased blood pressure
• a state of hyperactivity with rapid, uncontrolled spasms
• increased body temperature
• altered mental state and muscle rigidity, increased body temperature, heart rate, blood pressure (neuroleptic malignant syndrome)
• muscle tissue destruction (rhabdomyolysis)
• epileptic seizures
• convulsions
• impaired blood coagulation
• multi-organ failure
• increased blood pressure accompanied by a slowed heart rate, sweating, headache (symptoms of autonomic dysreflexia)
• severe infection (sepsis).

Contact your doctor immediately if you experience any of the following
symptoms during treatment with Lioresal:

• back, shoulder, neck and buttock pain (symptoms of a particular type of spinal deformity known as scoliosis).
• if at any time you have thoughts of self-harm or suicide, tell your doctor immediately or go to hospital. Also, ask a relative or close friend to warn you if they notice any changes in your behaviour and invite them to read this leaflet.

Children and adolescents
In children with increased tone and contraction of the muscles (spasticity) due to a head injury, the doctor will not administer long-term intrathecal Lioresal therapy until the
symptoms of spasticity have stabilized (at least one year after the injury).
Lioresal should not be used in children under 4 years of age.

Other medicines and Lioresal
Tell your doctor or nurse if you/your child is taking, has recently taken or might take
any other medicine.
Tell your doctor if you/your child is taking or will be taking:

• levodopa or other medicines for Parkinson's disease
• anaesthetics (e.g. fentanyl, propofol)
• morphine (used for pain relief)
• medicines that act on the Central Nervous System such as: medicines for the treatment of pain (analgesics) neuroleptics (psychotropic drugs) medicines for epilepsy, insomnia and mood disorders (barbiturates, benzodiazepines, anxiolytics) opioid medicines (can increase the risk of you/your child having breathing problems)
• medicines against depression of the tricyclic class (tricyclic antidepressants)
• medicines that lower blood pressure including medicines against high blood pressure (antihypertensives).

Lioresal with alcohol
Do not drink alcohol during treatment with Lioresal as alcohol can enhance its effect.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or nurse for advice before you are given this medicine.
Pregnancy
There are no adequate studies in pregnant women. It is possible that small amounts of baclofen
may reach the maternal blood. Data from animal studies have shown that baclofen crosses the
placenta, therefore if you are pregnant the medicine will only be prescribed in cases of actual necessity and under the
direct control of the doctor.
Breastfeeding
Small amounts of baclofen have been identified in the blood after intrathecal administration; baclofen is not
believed to reach breast milk and therefore no adverse effects on the infant are expected.
Fertility
There are no special recommendations for women of childbearing potential.

Driving and operating machinery
Take particular care if you/your child needs to drive vehicles (including bicycles) or operate
machinery.
During treatment with Lioresal you/your child may experience symptoms that reduce attention
and may therefore affect the ability to drive vehicles and operate machinery, such as:

• sleepiness
• sedation
• loss of coordination of movements (ataxia)
• hallucinations
• double vision (diplopia)
• withdrawal symptoms (see section “If you/your child stops taking Lioresal”).

Important information about some excipients

Lioresal 0.05 mg/1 ml solution for intrathecal injection

Lioresal 10 mg/5 ml solution for intrathecal injection
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially “sodium-free”.
If your doctor needs to dilute Lioresal intrathecal 0.05 mg/1 ml or Lioresal intrathecal 10
mg/5 ml with a common sodium solution, the amount of sodium taken would be higher.

Lioresal 10 mg/20 ml solution for intrathecal injection
This medicine contains 70.81 mg of sodium (the main component of table salt) per dose.
This is equivalent to 3.5% of the recommended daily intake of sodium with the diet of an adult.

3. How Lioresal will be administered to you

The administration of Lioresal will only be carried out by duly trained medical personnel in an adequately equipped environment, equipped with resuscitation devices.
Lioresal is used with a dedicated infusion device that can be programmed. This device will be implanted under your skin, generally in the abdomen and is equipped with reservoirs for the release of the medicine that can be refilled.

• To establish the most suitable dose of Lioresal, you/your child will be subjected to: first a single test dose to see if you/your child respond to treatment (selection phase)
• then a careful increase in the dose (individualized titration phase)
• and then to maintenance therapy.

In the selection phase, the doctor will inject a single dose of Lioresal to evaluate your/your child’s response.
To determine the initial total daily dose of Lioresal to be used, the doctor will then double the dose used in the selection phase and administer it over a period of 24 hours.
In the event that the effectiveness of the dose used in the selection phase lasts more than 12 hours, the doctor will administer to you/your child a dose equal to that administered in the selection phase but slowly over 24 hours.
After the first 24 hours, the doctor will slowly increase the dose, with small daily variations, in order to reach the maintenance dose most suitable for you/your child.
To maintain an optimal response during maintenance therapy, the doctor may further increase the dose over time.
If you/your child use Lioresal for long periods of time, it is possible that Lioresal is no longer effective.
The doctor will assess how to intervene in this situation.
If you/your child experience undesirable effects, the doctor may reduce the dose of Lioresal.

Use in adults
The dose used in the selection phase is generally 25 or 50 micrograms, which can be increased by 25 micrograms at intervals of 24 hours, until a clinical response of a duration between 4 and 8 hours is observed.
The maximum selection dose should not exceed 100 micrograms per day.
The maintenance dose of Lioresal can vary from 10 to 1,200 micrograms per day, most patients respond well to doses between 300-800 micrograms per day.

Use in children and adolescents (from 4 to 18 years of age)
The dose used in the selection phase is generally 25 or 50 micrograms per day based on age and body weight.
The dose can be increased by 25 micrograms per day every 24 hours.
The maximum selection dose should not exceed 100 micrograms per day.
The maintenance dose is between 25 and 200 micrograms per day.

Use in children under 4 years of age
Lioresal will not be administered to children under 4 years of age.

Use in patients with kidney or liver problems
The doctor will pay particular attention before prescribing Lioresal and will keep you/your child under control.

If you/your child use more Lioresal than you should
In case of accidental administration of an excessive dose of Lioresal, immediately inform the doctor or go to the nearest hospital.
It is important that you/your child and those providing care are able to recognize the symptoms related to the administration of an excessive dose of Lioresal. The medical staff will tell you how to recognize the signs and symptoms.
If you/your child have been given an excessive dose of Lioresal, the following may occur:

• excessive reduction of muscle tone
• drowsiness
• feeling of emptiness in the head
• feelings of dizziness
• seizures
• loss of consciousness
• reduction of body temperature
• excessive production of saliva
• nausea
• vomiting
• decreased respiratory activity
• apnea
• coma
• fast heartbeat (tachycardia)
• ringing/buzzing/whistling in the ears (tinnitus).

If you/your child stop treatment with Lioresal
Except for emergency situations due to the use of an excessive dose or the appearance of particularly serious side effects, treatment with intrathecal Lioresal must always be discontinued gradually, progressively decreasing the dose.
Intrathecal Lioresal should not be stopped abruptly.
Sudden discontinuation of treatment with intrathecal Lioresal may cause:

• increased tone and contraction of muscles (spasticity)
• itching
• tingling
• reduction of blood pressure
• hyperactive state with rapid uncontrolled spasms
• increased body temperature potentially fatal
• altered mental state and muscle rigidity, increased body temperature, blood pressure (malignant neuroleptic syndrome)
• fast heartbeat (tachycardia)
• destruction of muscle tissue (rhabdomyolysis)
• epileptic seizures
• convulsions
• increased blood pressure accompanied by slowed heartbeat, sweating, headache (autonomic dysreflexia symptoms)
• severe infection (sepsis)
• alteration of blood coagulation
• prolonged and painful erection of the penis (priapism)
• multi-organ failure
• death. In most cases, symptoms due to discontinuation have appeared from a few hours to a few days after discontinuation of Lioresal therapy.

Discontinuation of treatment with Lioresal may be caused by malfunction of the catheter, poor reservoir volume of the pump, battery discharge, malfunction of the release device.
It is very important to schedule visits with the doctor for battery recharging and to check the pump’s operation. It is equally important that you/your child and those providing care are able to recognize the symptoms related to the interruption of therapy with Lioresal.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects (may affect more than 1 in 10 people)

• drowsiness
• feeling of instability
• reduced muscle tone (hypotonia)

Common side effects (may affect up to 1 in 10 people)

• depression
• anxiety
• agitation
• convulsions
• confusional state
• sedation
• dizziness/feeling of emptiness in the head
• headache
• tingling (paresthesia)
• speech disorders in which words are pronounced slowly and defectively (dysarthria)
• continuous sleepiness (lethargy)
• decreased coordination
• insomnia
• disorientation
• visual disturbances
• low blood pressure (hypotension)
• reduced respiratory rate
• pneumonia
• difficulty breathing (dyspnea)
• nausea
• vomiting
• constipation
• dry mouth
• diarrhea
• decreased appetite
• increased saliva production
• urticaria
• itching
• swelling of the face, arms or legs (facial and/or peripheral edema)
• increased muscle tone (hypertonia)
• urinary incontinence
• urinary retention
• bladder disorders
• sexual dysfunction
• weakness (asthenia)
• fever
• pain
• chills

Uncommon side effects (may affect up to 1 in 100 people)

• dehydration
• thoughts of suicide
• suicide attempt
• hallucinations
• paranoia
• euphoric state
• loss of coordination of movements (ataxia)
• impaired memory
• nystagmus (rhythmic, undulating and involuntary eye movements)
• slowed heartbeat
• high blood pressure
• formation of blood clots in blood vessels (deep vein thrombosis)
• redness of the skin
• pale skin
• intestinal obstruction
• difficulty swallowing (dysphagia)
• decreased taste (hypogeusia)
• hair loss
• excessive sweating
• reduced body temperature

Rare side effects (may affect up to 1 in 1,000 people)

• withdrawal symptoms with life-threatening danger due to failure to release the drug (see section “If you stop treatment with Lioresal”)

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• mood alteration (dysphoria)
• decreased respiratory rate (bradypnea)
• increased lateral curvature of the spine (scoliosis)
• inability to achieve or maintain an erection (erectile dysfunction)
• allergic reaction (hypersensitivity).

Some side effects associated with the drug delivery system have been reported:

• formation of an inflammatory mass at the catheter tip
• displacement of the catheter with possible complications
• infection of the subcutaneous pocket
• meningitis
• overdose due to incorrect handling of the device
• death

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Lioresal

Store at a temperature below 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Lioresal contains
Lioresal 0.05 mg/1 ml injectable solution for intrathecal use

• The active ingredient is baclofen. Each vial contains 0.05 mg of baclofen.
• The other ingredients are sodium chloride, water for injections, nitrogen gas.

Lioresal 10 mg/5 ml injectable solution for intrathecal use

• The active ingredient is baclofen. Each vial contains 10 mg of baclofen.
• The other ingredients are sodium chloride, water for injections, nitrogen gas.

Lioresal 10 mg/20 ml injectable solution for intrathecal use

• The active ingredient is baclofen. Each vial contains 10 mg of baclofen.
• The other ingredients are sodium chloride, water for injections, nitrogen gas.

Description of the appearance of Lioresal and contents of the pack
Each pack of Lioresal 0.05 mg/1 ml injectable solution for intrathecal use contains 1 vial of
0.05 mg/1 ml.
Each pack of Lioresal 10 mg/5 ml injectable solution for intrathecal use contains 1 vial of 10
mg/5 ml.
Each pack of Lioresal 10 mg/20 ml injectable solution for intrathecal use contains 1 vial of 10
mg/20 ml.

Marketing Authorisation Holder
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milan MI
Italy

Manufacturer
Novartis Farma S.p.A.
Via Provinciale Schito 131
80058 Torre Annunziata NA
Italy
Novartis Farma S.p.A.
Viale Luigi Sturzo 43
20154 Milan MI
Italy
Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany

Information for healthcare professionals
Lioresal intrathecal is administered using a dedicated programmable infusion system.
This device is an implantable system equipped with rechargeable reservoirs for drug delivery;
it is implanted in a subcutaneous pocket generally in the abdominal wall. The device is
connected to an intrathecal catheter which reaches via the subcutaneous space the subarachnoid space.

Intrathecal administration of Lioresal using an implantable system must be
performed only by physicians with appropriate knowledge and experience. Specific information for
implantation, programming and/or refilling of the implantable pump is
provided by the pump manufacturers and must be carefully followed.
Before intrathecal administration of Lioresal, it is recommended to read carefully the
section 4.2 'Dosage and Administration' of the summary of product characteristics
where detailed information on dosage and route of administration of the medicinal product is provided.
It is also necessary to pay particular attention to the early recognition of symptoms of
possible overdose, especially during the initial phase of "Selection" and "Dosage Titration"; the same
caution must be exercised when restarting therapy previously interrupted with Lioresal intrathecal. For
further details on symptoms and treatment in case of overdose, please refer to section “4.9
'Overdose' of the summary of product characteristics.
As with other drugs, vials of Lioresal for intrathecal administration should not be mixed
with other infusion or injection solutions. Glucose has been shown to be chemically incompatible with baclofen
from a chemical point of view.