Lioresal Intrathecal 0,05 mg/1 ml

Leaflet attached to the packaging: information for the user

Lioresal Intrathecal 0.05 mg/1 ml solution for injection

For use in adult patients and children aged 4 years and older
baclofen

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Lioresal Intrathecal and what is it used for
• 2. Important information before using Lioresal Intrathecal
• 3. How to use Lioresal Intrathecal
• 4. Possible side effects
• 5. How to store Lioresal Intrathecal
• 6. Contents of the packaging and other information

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

Lioresal Intrathecal contains the active substance baclofen. Lioresal Intrathecal is a medicine used for
excessive muscle tension.
Lioresal Intrathecal is used to test the responseto intrathecal administration of baclofen in
patients with severe, chronic spasticity (increased muscle tone)that cannot be effectively treated with standard medications:

• in multiple sclerosis This is a progressive disease of the nervous system, brain, and spinal cord with physical and mental symptoms.
• after spinal cord injuries or injuries with brain damage
• in other spinal cord diseases

If there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before using Lioresal Intrathecal

When not to use Lioresal Intrathecal

• if the patient is allergic to baclofenor any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic, they should consult their doctor.
• if the patient has untreatable epilepsy.

Warnings and precautions

If any of the following points apply to the patient, they should tell their doctor or pharmacist before starting to use Lioresal Intrathecal:

• disorders of cerebrospinal fluid circulation caused by obstruction
• treatable epilepsy or other types of seizures affecting the brain
• neurological disorders caused by damage to the cranial nerves in the spinal cord (bulbar symptoms) or partial paralysis of the respiratory muscles
• acute or chronic confusion
• psychiatric or psychological disorders, such as schizophrenia
• Parkinson's disease
• autonomic dysreflexia (uncontrolled) in history
• insufficient blood flow to the brain
• breathing difficulties
• overactive bladder sphincter
• heart disease
• kidney function disorders
• stomach and intestinal ulcers
• severe liver function disorders
• increased muscle tone caused by a previous head injury Prolonged treatment of increased muscle tone should be started when the symptoms of spasticity are stable and can be reliably assessed.
• infection Before administering a test dose of Lioresal Intrathecal, it should be ensured that the patient does not have an infection, as it may interfere with the assessment of the patient's response.

If any of these symptoms occur during the use of Lioresal Intrathecal, the patient should immediately inform their doctor:

• If the patient experiences back, arm, neck, and buttock pain during treatment (a type of spinal deformity called scoliosis)
• If the patientever thinks about self-harm or suicide, they should immediately talk to their doctor or go to the hospital. They should also ask a relative or close friend to inform them if they notice changes in their behavior and read this leaflet.

Children
The following requirements should be met for children regarding appropriate body weight, allowing for the implantation of an infusion pump. Lioresal Intrathecal is intended for use in children aged 4 years and older. The safety of intrathecal use of Lioresal Intrathecal in children under 4 years of age has not been established yet.
Patient over 65 years of age
During clinical trials, Lioresal Intrathecal was administered to a few elderly patients and did not cause particular problems. However, experience with the use of Lioresal in tablet form shows that this group of patients may be more prone to side effects. Therefore, elderly patients should be closely monitored for side effects.

Lioresal Intrathecal and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
The following medicines may affect the action of Lioresal Intrathecal or Lioresal Intrathecal may interact with them. It may be necessary to adjust the dose of Lioresal Intrathecal or one of the other medicines taken at the same time:

• medicines used in Parkinson's disease
• medicines that relieve severe muscle spasms
• medicines with a sedating effect on the central nervous system
• medicines used to treat depression, such as imipramine, doxepin, amitriptyline, opipramol
• medicines that lower blood pressure, including those used to treat high blood pressure

Lioresal Intrathecal with alcohol

When using Lioresal Intrathecal, you should avoid consuming alcohol at the same time, as it may cause undesirable intensification or unpredictable changes in the action of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Due to the lack of experience in pregnant and breastfeeding women, Lioresal Intrathecal can only be used if the doctor considers it absolutely necessary.

Driving and using machines

Do not drive vehicles, operate machinesor perform other hazardous activities, as Lioresal Intrathecal may significantly affect these activities.

Lioresal Intrathecal contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml, i.e., the medicine is considered "sodium-free".
If the doctor needs to dilute Lioresal Intrathecal 0.05 mg/1 ml with a physiological saline solution, the resulting dose of sodium will be higher.

3. How to use Lioresal Intrathecal

This medicine should always be used exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

Method of administration

Lioresal Intrathecal can be administered by direct injection or infusion into the spinal canal
onlyby a qualified specialist and with the help of appropriate equipment.
Therefore, hospitalization is necessary at the beginning of treatment.
At the beginning of treatment, the doctor will determine whether a single injection of undiluted Lioresal Intrathecal solution for injection relieves muscle spasms. The recommended dose is ½ to 1 ampoule. The dose may be increased by ½ ampoule every 24 hours, up to a maximum dose of 2 ampoules.
After each injection, the patient must be monitored for 4 to 8 hours.
If significant relief of muscle spasms is possible, a special pump will be implanted under the patient's skin. This will allow for the continuous administration of larger doses of Lioresal Intrathecal solution for infusion. The dose will be adjusted individually for the patient.
Determining the optimal dose may take several days. After determining the optimal treatment, the doctor will regularly check the progress of treatment and the functioning of the pump.
Tell your doctor immediatelyif muscle spasms do not improve or worsen.

Duration of treatment

The duration of treatment will be decided by your doctor.

Using a higher dose of Lioresal Intrathecal than recommended

Contact your doctor immediatelyif you or your caregiver notice symptoms of overdose, which may occur suddenly or gradually:

• too little muscle tone
• drowsiness
• dizziness or feeling of emptiness in the head
• excessive salivation
• nausea or vomiting
• breathing difficulties or even respiratory arrest
• seizures
• reduced consciousness or even coma
• low body temperature
• rapid heartbeat (tachycardia)
• ringing in the ears (tinnitus)

Stopping the use of Lioresal Intrathecal

If it is necessary to stop the administration of the medicine, it can only be done by the attending physician, who will gradually reduce the dose of the medicine to avoid side effects. Abrupt cessation of Lioresal Intrathecal may cause severe side effects, which in some cases have been fatal.
Contact your doctor immediatelyif you or your caregivers notice the following symptoms of stoppingLioresal Intrathecal. This is especially important for further administration of the medicine through the pump.

• increased spasticity, too much muscle tone
• difficulty moving muscles
• rapid heartbeat (tachycardia)
• itching
• tingling, burning, or numbness of hands and feet
• palpitations
• anxiety
• fever
• low blood pressure
• changes in the patient's mental state, such as agitation, disorientation, hallucinations, abnormal thinking, and behavior
• seizures
• prolonged painful erection (priapism) These symptoms can lead to more severe side effects if treatment is not started immediately.

If you have any doubts about the use of the medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are more common during the initial treatment in the hospital, but they can also occur later. Many of the listed side effects may also be related to the underlying disease being treated.
The following side effects have been reported, along with their frequency:

Very common: may affect more than 1 in 10 people

• low muscle tone
• drowsiness

Common: may affect up to 1 in 10 people

• anxiety
• decreased appetite
• shortness of breath, slow or shallow breathing
• decreased alertness
• decreased blood pressure when sitting and standing
• depression
• disorientation
• diarrhea, even incontinence
• increased muscle tone
• fever
• increased restlessness
• urinary retention*
• itchy skin swelling, similar to an insect bite
• itching
• headache*, pain
• seizures*
• pneumonia
• strange skin sensations with tingling of hands and feet
• dry mouth
• muscle weakness
• coma
• chills
• swelling of the face, hands, and feet
• dizziness
• sexual disorders
• vision disturbances with blurred or double vision
• apathy
• involuntary urination
• nausea or vomiting*
• excessive salivation
• constipation
• slurred speech
• confusion
• respiratory depression

Uncommon: may affect up to 1 in 100 people

• decreased fluid in the body (dehydration)
• pale skin
• high blood pressure
• intestinal obstruction
• memory loss/confusion
• mood disorders
• hair loss
• false sensory perceptions not caused by an external stimulus
• skin redness
• low body temperature
• difficulty swallowing
• coordination problems
• suicidal thoughts and attempts
• excessive sweating
• nystagmus
• slow heartbeat
• reduced sense of taste
• blockage of a blood vessel due to a clot in the deep veins
• hallucinations
• euphoria

Rare: may affect up to 1 in 1,000 people

• life-threatening withdrawal symptoms due to administration problems

Unknown: frequency cannot be estimated from available data

• increase in lateral curvature of the spine (scoliosis)
• inability to achieve or maintain an erection (erectile dysfunction)
• allergic reaction (hypersensitivity)

*Side effects marked with an asterisk occur more frequently in patients with cerebral palsy.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Lioresal Intrathecal

Keep the medicine out of sight and reach of children.
Do not store above 30°C.
Do not freeze. Do not sterilize with high temperature.
The medicine should be used immediately after opening. Unused solution should be discarded.
The solution must be clear and colorless. Do not use this medicine if you notice turbidity or discoloration.
Do not use this medicine after the expiration date stated on the ampoule and carton. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

• The active substance of the medicine is baclofen. 1 ampoule with 1 ml solution for injection contains 0.05 mg of baclofen.
• The other ingredients are: sodium chloride, water for injections.

What Lioresal Intrathecal looks like and what the pack contains

Lioresal Intrathecal is a clear, colorless solution in a transparent, colorless ampoule.
Lioresal Intrathecal 0.05 mg/1 ml solution for injection is available in packs containing 5 ampoules.

Marketing authorization holder

Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
tel.: +48 22 37 54 888

Manufacturer/Importer

Novartis Pharma GmbH
Roonstrasse 25
D-90429 Nürnberg
Germany
Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nuremberg
Germany
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:

Germany:
Lioresal Intrathecal 0.05 mg/1 ml Injektionslösung
Poland:
Lioresal Intrathecal 0.05 mg/1 ml, solution for injection

Date of last revision of the leaflet: 10/2024 _________________________________________________________________

Information intended for healthcare professionals only:

How to prepare and administer the medicinal product Lioresal Intrathecal?

Administration of the test dose, implantation of the infusion pump, and increase of the medicinal product dose administered intrathecally should be performed in a hospital setting, in centers with appropriate experience and under the close supervision of suitably qualified physicians. Immediate access to an intensive care unit should be ensured due to the possibility of severe or life-threatening side effects of the medicinal product.
Before starting the administration of the medicinal product Lioresal Intrathecal, check the clarity and colorlessness of the solution. In case of turbidity or discoloration of the solution, do not administer the medicinal product.
Each ampoule is intended for single use only. The solution contained in it is stable, isotonic, free from pyrogens and antioxidants, with a pH of 5.0-7.0.
Test dose(in a hospital setting).
Before starting long-term infusion of the medicinal product Lioresal Intrathecal, the patient's response to baclofen should be evaluated in a trial phase. For this purpose, the medicinal product Lioresal Intrathecal 0.05 mg/1 ml is used. The test dose is usually administered undiluted through an intrathecal catheter or lumbar puncture. The usual test dose is 25 micrograms to 50 micrograms of baclofen, which corresponds to the contents of ½ to 1 ampoule of the medicinal product Lioresal Intrathecal 0.05 mg/1 ml. In children, the recommended test dose is 25 micrograms. The dose should be administered by mixing with cerebrospinal fluid (CSF) (barbotage) for 1 minute (or longer). At intervals of at least 24 hours, the dose may be increased by 25 micrograms to achieve a maximum test dose of 100 micrograms in the following manner:

After each injection (bolus), the patient should be monitored for 4 to 8 hours.
The action of a single dose of the medicine administered intrathecally usually starts within ½ to 1 hour after administration. The maximum spasmolytic effect is usually seen after 4 hours after administration of the medicinal product and lasts for about 4 to 8 hours. The onset of action, maximum effect, and duration of action vary between patients and depend on the dose, severity of symptoms, and method and rate of administration of the solution. It is necessary to note a clinically significant reduction in muscle tone and (or) reduction in frequency or severity of spasms to consider that the patient responds to treatment. If the administration of a test dose equivalent to the contents of 2 ampoules of the medicinal product Lioresal Intrathecal 0.05 mg/1 ml (corresponding to 100 micrograms of baclofen) is insufficient, the dose should not be increased further, and the phase of continuous intrathecal infusion should not be started.
Tolerance to the test dose may vary between patients. In the past, symptoms of overdose (coma) occurred in one patient after administration of a single test dose of 25 micrograms of baclofen, therefore, treatment should only be started in a hospital setting, ensuring immediate access to an intensive care unit.

Incompatibilities

The medicinal product Lioresal Intrathecal 0.05 mg/1 ml solution for injection is administered undiluted.
A chemical incompatibility has been demonstrated between dextrose and baclofen.
Do not freeze. Do not sterilize with high temperature.