Lioresal Intrathecal 10 mg/5 ml

Leaflet attached to the packaging: information for the user

Lioresal Intrathecal 10 mg/20 ml solution for infusion

Lioresal Intrathecal 10 mg/5 ml solution for infusion

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, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any side effects occur, 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 treat severe, chronic spasticity (increased muscle tone)that cannot be effectively treated with standard medicines:

• 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

During the qualification phase for treatment and during the dose escalation phase, immediately after the pump is implanted, the patient will be closely monitored in conditions that ensure access to appropriate equipment and personnel care. The dosage, possible side effects, or signs of infection will be regularly evaluated. The functioning of the drug delivery system will also be checked.
If there is no improvement or the patient feels worse, consult a 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 a doctor.
• if the patient has untreatable epilepsy.

Warnings and precautions

Consult a doctor immediately if the patient thinks the device is not working properly or if they notice withdrawal symptoms (see withdrawal symptoms in section 3 "How to use Lioresal Intrathecal")
If any of the following points apply to the patient, they should tell their doctor before starting treatment with Lioresal Intrathecal:

• disorders of cerebrospinal fluid circulation due to obstruction
• treatable epilepsy or other seizures affecting the brain
• neurological disorders caused by damage to the cranial nerves in the spinal cord (symptoms of bulbar palsy) or partial paralysis of the respiratory muscles
• acute or chronic confusion
• psychiatric and (or) psychological disorders, such as schizophrenia
• Parkinson's disease
• autonomic reflex disorders (uncontrolled) in history
• insufficient blood flow to the brain
• breathing difficulties
• overactive bladder sphincter
• heart disease
• kidney function disorders
• stomach and intestine ulcers
• severe liver function disorders
• increased muscle tone caused by a previous head injury Long-term treatment of increased muscle tone should be started when the symptoms of spasticity are stable and can be reliably assessed.

If any of these symptoms occur during treatment with 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 a 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
Children should meet certain requirements regarding adequate 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 old
During clinical trials, Lioresal Intrathecal was administered to several 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans 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, 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before using this medicine.
Due to the lack of experience with pregnant and breastfeeding women, Lioresal Intrathecal can only be used if the doctor considers it absolutely necessary.

Driving and operating machines

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

Lioresal Intrathecal contains sodium

Lioresal Intrathecal 10 mg/20 ml: the medicine contains 70.81 mg of sodium (main component of table salt) per 20 ml. This corresponds to 3.5% of the maximum recommended daily sodium intake in the diet for adults.
Lioresal Intrathecal 10 mg/5 ml: the medicine contains less than 1 mmol (23 mg) of sodium per 5 ml, i.e., the medicine is considered "sodium-free".
If the doctor needs to dilute Lioresal Intrathecal 10 mg/5 ml with a physiological saline solution, the resulting sodium dose will be higher.

3. How to use Lioresal Intrathecal

This medicine should always be used as directed by the doctor. In case of doubts, consult a doctor or pharmacist.

Method of administration

Lioresal Intrathecal can be administered by direct injection or infusion into the spinal canalonly by a qualified specialist and with the help of appropriate equipment.
For this reason, hospitalization is necessary at the beginning of treatment.
At the beginning of treatment, the doctor will determine whether a single injection of the medicine in a smaller dose - Lioresal Intrathecal, 0.05 mg/1 ml, solution for injection - will relieve muscle spasms. If possible, a special pump will be implanted under the patient's skin, which will allow for continuous dosing tailored to the patient.
It is very important for the patient to attend scheduled appointments, during which the doctor will refill the pump.
If the patient receives too small a dose of Lioresal Intrathecal, increased muscle tone may return. Muscle spasms may also worsen.
Tell the doctor immediatelyif muscle spasms do not improve or worsen.
The doctor must regularly monitor the patient's condition and the pump's function - at least once a month.

Duration of treatment

The duration of treatment will be decided by the doctor.

Using a higher dose of Lioresal Intrathecal than recommended

Consult a doctor immediatelyif the patient or caregiver notices symptoms of overdose, which can occur suddenly or gradually:

• too little muscle tone
• drowsiness
• dizziness or a 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 treatment with Lioresal Intrathecal

If it is necessary to stop treatment, it can only be done by the attending doctor, who will gradually reduce the dose of the medicine to avoid side effects. Abrupt cessation of treatment with Lioresal Intrathecal may cause severe side effects, which in several cases have been fatal.
Consult a doctor immediatelyif the patient or caregiver notices the following withdrawal symptomsof Lioresal Intrathecal. This is especially important for further administration 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 of the penis (priapism) The above symptoms can cause more severe side effects, which can lead to death if not treated immediately.

Remember that pump malfunctions, such as battery problems or catheter defects, alarm signal defects, or device malfunctions, can lead to overdose or underdose of the medicine.
In case of any doubts related to the use of the medicine, consult a 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 initiation of 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.
Malfunction of the implanted drug delivery device or infusion system can lead to withdrawal symptoms, which can be life-threatening (see withdrawal symptoms in section 3 "How to use Lioresal Intrathecal").
The following side effects have been reported, along with their frequency:

Very common: may occur in more than 1 in 10 patients

• low muscle tone
• drowsiness

Common: may occur in no more than 1 in 10 patients

• anxiety
• decreased appetite
• shortness of breath, slow or shallow breathing
• decreased alertness
• decreased blood pressure when sitting and standing
• depression
• disorientation
• diarrhea, even incontinence of feces
• 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 occur in no more than 1 in 100 patients

• decreased amount of fluids in the body (dehydration)
• pale skin
• high blood pressure
• intestinal obstruction
• memory loss/distractibility
• 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 heart rate
• reduced sense of taste
• blockage of a blood vessel due to a clot in the deep veins
• hallucinations
• euphoria

Rare: may occur in no more than 1 in 1,000 patients

• life-threatening withdrawal symptoms due to delivery problems

Unknown: frequency cannot be determined 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 any side effects occur, including any side effects not listed in the 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, you can help gather more information on the safety of this medicine.

5. How to store Lioresal Intrathecal

Store the medicine in a place that is 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 no longer required. This will help protect the environment.
6.

Contents of the packaging and other information

• The active substance of the medicine is baclofen.

Lioresal Intrathecal 10 mg/20 ml solution for infusion:
1 ml of the solution for infusion contains 0.5 mg of baclofen.
1 ampoule with 20 ml of the solution for infusion contains 10 mg of baclofen.
Lioresal Intrathecal 10 mg/5 ml solution for infusion:
1 ml of the solution for infusion contains 2.0 mg of baclofen.
1 ampoule with 5 ml of the solution for infusion contains 10 mg of baclofen.

• 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 10 mg/20 ml solution for infusion and Lioresal Intrathecal 10 mg/5 ml solution for infusion are available in packs containing 1, 2, or 5 ampoules.
Not all pack sizes may be marketed.

Responsible entity

Novartis Poland Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
phone: +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:

Information intended for healthcare professionals only:

How to prepare and administer the medicinal product Lioresal Intrathecal?

The administration of a test dose, implantation of the infusion pump, and dose escalation of the intrathecally administered medicinal product 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 treatment with Lioresal Intrathecal, a myelographic examination of the subarachnoid space should be performed in patients with post-traumatic spasticity. If signs of arachnoiditis are found in the radiological examination, treatment with Lioresal Intrathecal should not be initiated.
Before administering Lioresal Intrathecal, check the clarity and colorlessness of the solution. If the solution is turbid or discolored, the medicinal product should not be administered.
Each ampoule is for single use only. The solution contained in it is stable, isotonic, free of pyrogens, and antioxidants, with a pH of 5.0-7.0.

Implantation of the infusion pump / dose escalation phase (in a hospital setting)

After confirming the patient's response to Lioresal Intrathecal therapy in the test phase, intrathecal infusion of the medicinal product can be started using the above-mentioned infusion pump. The antispastic effect of baclofen begins within 6 to 8 hours after the start of continuous infusion, and the maximum effect of the medicinal product is observed after 24 to 48 hours.
The initial total daily dose of Lioresal Intrathecal is calculated as follows: if the effect of the medicinal product after the test dose lasts more than 12 hours, this dose is considered the initial dose. If the effect of the medicinal product after the test dose lasts less than 12 hours, the test dose should be doubled and administered as the initial dose. The dose of the medicinal product should not be increased during the first 24 hours of treatment.
After the first day of treatment, the dose of the medicinal product can be gradually increased to achieve the desired therapeutic effect. The daily dose of the medicinal product should not be increased by more than 10% to 30% of the previous dose in patients with spinal cord spasticity and 5% to 15% in patients with cerebral spasticity. When using a programmable pump, it is recommended to modify the dose only once every 24 hours. When using non-programmable pumps equipped with a 76 cm catheter, delivering 1 ml of solution per day, it is recommended to assess the patient's response to the new dose of the medicinal product after a period of 48 hours. If a significant increase in the daily dose does not cause an increase in the clinical effect, the proper functioning of the pump and the patency of the catheter should be checked.
Essentially, the dose of Lioresal Intrathecal is increased to achieve a maintenance dose in the range of 300 µg to 800 µg per day in patients with spinal cord spasticity. Patients with cerebral spasticity usually require smaller doses (see below).

Long-term treatment phase

The goal of treatment is to use the smallest dose that provides good control of spasticity without unacceptable side effects. Since the therapeutic effect may decrease during treatment, and the severity of spasticity may change, it is usually necessary to adjust the dose in a hospital setting during the long-term treatment phase.
Also, in this case, the daily dose of the medicinal product can be increased by 10% to 30% in patients with spinal cord spasticity and 5% to 20% (upper limit) in patients with cerebral spasticity by changing the infusion rate or changing the concentration of baclofen in the pump reservoir. And vice versa, if side effects occur, the daily dose of the medicinal product can be decreased by 10% to 20%.
The need for a rapid increase in the dose to achieve the desired therapeutic effect suggests the possibility of a pump malfunction or catheter kinking, cracking (abrasion), or displacement.
The maintenance dose of Lioresal Intrathecal in long-term treatment of patients with spinal cord spasticity is usually 300 µg to 800 µg of baclofen per day. The smallest and largest registered daily doses administered to individual patients during the saturation phase were 12 µg and 2003 µg, respectively (studies conducted in the United States). Experience with doses exceeding 1000 µg per day is limited. During the first few months of treatment, the dose of the medicinal product should be verified and modified, especially frequently.
In the case of patients with cerebral spasticity, the maintenance doses used during long-term treatment with continuous infusion of Lioresal Intrathecal are in the range of 22 µg to 1400 µg of baclofen per day, and the average daily doses of the medicinal product are 276 µg after 1 year of observation and 307 µg after 2 years. Children under 12 years of age usually require smaller doses (range: 24 µg to 1199 µg per day; average: 274 µg per day).
If the technical parameters of the pump allow, after determining the daily dose of the medicinal product and stabilizing the antispastic effect, it is possible to try to adjust the administration of the medicinal product to the daily rhythm of spasticity. For example, if spasms occur more frequently at night, this may require a 20% increase in the infusion rate for one hour. Changes in the infusion rate should be programmed to occur 2 hours before the desired clinical effect.
Throughout the treatment period, regular, at least monthly, monitoring of the patient's tolerance to Lioresal Intrathecal and possible signs of infection is necessary in the treatment center. The proper functioning of the infusion system should be regularly checked. The development of local infection or catheter malfunction can lead to a break in intrathecal administration of Lioresal Intrathecal with life-threatening consequences for the patient.
The concentration of baclofen required during pump filling depends on the total daily dose of the medicinal product and the infusion rate of the pump. If it is necessary to administer baclofen in concentrations other than 0.05 mg/ml, 0.5 mg/ml, or 2 mg/ml, Lioresal Intrathecal should be diluted under aseptic conditions using a sterile, preservative-free sodium chloride solution for injection. In this case, follow the instructions provided by the pump manufacturer.
About 5% of patients may require a higher dose of the medicinal product due to decreased efficacy of treatment ("development of tolerance") during long-term treatment. As described in the literature, the development of tolerance is prevented by maintaining a 10- to 14-day break in baclofen administration, during which preservative-free morphine sulfate is administered. After this period, the patient may respond to treatment with Lioresal Intrathecal again. Treatment should be resumed by administering the initial dose used in continuous infusion, and then the dose should be gradually increased again to avoid side effects due to overdose. This procedure should be performed in a hospital setting.

Incompatibilities

Lioresal Intrathecal 10 mg/20 ml and 10 mg/5 ml solutions for infusion should not be mixed with other solutions for injection or infusion, except for a sterile, preservative-free sodium chloride solution, diluted under aseptic conditions.
A chemical incompatibility has been demonstrated between dextrose and baclofen.
Do not freeze. Do not sterilize with high temperature