Baclofen Sintetica

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Baclofen Sintetica, 0.05 mg/1 ml, solution for injection

(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 nurse.
• 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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Baclofen Sintetica and what is it used for

Baclofen Sintetica belongs to a group of medicines called muscle relaxants. Baclofen Sintetica is administered by injection into the spinal canal directly into the cerebrospinal fluid (intrathecal injection) and relieves severe muscle stiffness (spasticity). Baclofen Sintetica is used to treat severe, long-term muscle tension (spasticity) that occurs in various diseases, such as:

• injuries or diseases of the brain or spinal cord
• multiple sclerosis, which is a progressive disease of the nerves in the brain and spinal cord with physical and mental symptoms

Baclofen Sintetica is used in adults and children from 4 years of age. The medicine is used when other oral medicines, including baclofen, have been ineffective or have caused unacceptable side effects.

2. Important information before using Baclofen Sintetica

When not to use Baclofen Sintetica

• if the patient is allergic to baclofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has epilepsy that is resistant to treatment;
• in case of administration by a route other than intrathecal.

Warnings and precautions

Before starting treatment with Baclofen Sintetica, discuss with your doctor

• if the patient is using other spinal injections,
• if the patient has any infection,
• if the patient has had a head injury in the last year,
• if the patient has ever had a crisis caused by a condition called autonomic dysreflexia, a nervous system reaction to excessive stimulation, causing a sudden severe increase in blood pressure (the doctor will provide additional explanations),
• if the patient has had a stroke,
• if the patient has epilepsy,
• if the patient has stomach ulcers or other digestive problems,
• if the patient has any mental illness,
• if the patient is being treated for high blood pressure,
• if the patient has Parkinson's disease,
• if the patient has liver, kidney, lung, heart disease, or breathing difficulties
• if the patient has diabetes,
• if the patient has problems with urination.

Tell your doctor if the answer to any of the above questions is yes, as Baclofen Sintetica may not be suitable for the patient.

• If the patient is scheduled for any surgery, make sure the doctor is informed about the use of Baclofen Sintetica.
• The presence of a percutaneous endoscopic gastrostomy (PEG) tube increases the frequency of infections in children.
• If the patient has reduced circulation of the fluid contained in the brain and spinal cord due to impaired flow, for example, due to inflammation or injuries.
• If the patient has slowed cerebrospinal fluid flow, the effect of Baclofen Sintetica may be reduced.
• It is essential to contact the treating doctor immediately if Baclofen Sintetica does not work as usual. It is crucial to ensure that there are no problems with the pump.
• Do not stop treatment with Baclofen Sintetica abruptly, due to the risk of withdrawal effects. Remember to attend hospital visits where the pump reservoir is refilled.
• During treatment with Baclofen Sintetica, periodic monitoring by the treating doctor may be required.

Youmustimmediately tell your doctorif the patient experiences any of the following symptoms during treatment with Baclofen Sintetica:

• If the patient experiences back painduring the procedure, arms, neck, and buttocks (a type of spinal deformity called scoliosis).
• Some patients treated with Baclofen Sintetica had thoughts of self-harm, suicidal thoughts, or attempted suicide. Most of these patients had depression, alcohol dependence, and (or) had attempted suicide in the past. You must immediately consult a doctor or hospital if the patient has had thoughts of self-harm or suicidal thoughts.The patient should ask a relative or close person to read this leaflet and pay attention to any disturbing changes in the patient's behavior.

Children and adolescents

Baclofen Sintetica is not recommended for children under 4 years of age. In children, certain requirements regarding adequate body weight, allowing for the implantation of an infusion pump, must be met. There are very limited clinical data on the safety and efficacy of Baclofen Sintetica in children under four years of age.

Baclofen Sintetica and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Some other medicines may affect the treatment with baclofen. Remind your doctor or nurse if you are taking any of the following medicines:

• other medicines used for spasticity
• antidepressants
• medicines used to treat high blood pressure
• medicines used to treat Parkinson's disease
• strong painkillers, such as morphine
• medicines with a sedating effect on the central nervous system, such as sleeping pills.

Baclofen Sintetica with alcohol

Avoid consuming alcohol during treatment with Baclofen Sintetica, as it may lead to undesirable intensification or unpredictable changes in the effect 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 or pharmacist before using this medicine.

Pregnancy

Experience with the use of baclofen administered intrathecally during pregnancy is limited. Baclofen Sintetica should not be used during pregnancy unless the doctor considers it necessary and the expected benefits to the mother outweigh the potential risk to the child.

Breastfeeding

Baclofen Sintetica passes into breast milk in small amounts, which are unlikely to cause any undesirable effects in the infant. Before using Baclofen Sintetica during breastfeeding, consult your doctor.

Driving and using machines

Some patients may feel drowsy and (or) dizzy, have problems with their eyes during treatment with Baclofen Sintetica. In such cases, do not drive vehicles or perform any activities that affect psychophysical fitness (e.g., operating devices or machines) until the symptoms have resolved.

Baclofen Sintetica contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per unit of volume, which means it is essentially "sodium-free".

3. How to use Baclofen Sintetica

Baclofen Sintetica is administered by intrathecal injection. This means that Baclofen Sintetica is injected directly into the cerebrospinal fluid. The required dose is different for each patient, depending on their condition. The dose is determined by the doctor based on the patient's response to the medicine. At the beginning of treatment, the doctor will determine whether single injections of Baclofen Sintetica relieve muscle spasms. Usually, a test dose is administered via a lumbar puncture or through a spinal catheter (into the spine) to induce a response to the medicine. During this period, heart and lung function are monitored. If muscle spasms are relieved, further treatment is carried out using a special pump that allows for continuous administration of the medicine. The pump is implanted in the chest or abdominal wall. The doctor will provide all necessary information about using the pump and determining the correct dose. The patient should make sure they understand everything. The final dose of Baclofen Sintetica depends on the individual patient's response to the medicine. Treatment starts with a small dose, which is gradually increased over several days, under the doctor's supervision, until the patient receives their correct dose. If the initial dose is too high or is increased too quickly, the likelihood of side effects in the patient increases.

It is extremely important for the patient to contact their doctor to refill the pump.

To avoid unpleasant and potentially life-threatening side effects, it is essential that the pump functions continuously. The pump must always be refilled by a doctor or nurse, and the patient must ensure they attend their scheduled hospital visits. The effectiveness of intrathecally administered baclofen has been demonstrated in clinical trials using pump systems to deliver baclofen directly into the cerebrospinal fluid (infusion systems). The pump system with a EU certificate is implanted under the skin, mainly in the abdominal wall. The pump stores and releases the appropriate amount of medicine through a catheter directly into the cerebrospinal fluid. During long-term treatment, some patients may experience a decrease in the effectiveness of Baclofen Sintetica. In such cases, breaks in treatment may be necessary. The doctor will inform the patient about how to proceed in such a situation. To open the Baclofen Sintetica packaging, hold the packaging with both hands and twist the edges in the opposite direction until it opens.

If treatment with Baclofen Sintetica is interrupted

It is crucial that the patient and their caregiver can recognize the symptoms of baclofen withdrawal. These symptoms may appear suddenly or gradually, for example, due to the pump or delivery system not working correctly. Withdrawal symptoms:

• increased spasticity, excessive muscle tension
• difficulty moving
• increased heart rate or pulse
• tingling, numbness, burning, or prickling sensations (paresthesia) in the hands or feet
• palpitations
• anxiety
• high body temperature
• low blood pressure
• altered mental states, such as agitation, confusion, hallucinations, abnormal thinking and behavior, seizures

If the patient experiences any of the above symptoms, they must immediately tell their doctor.

These symptoms may lead to more severe side effects unless the patient receives immediate treatment.

Using a higher dose of Baclofen Sintetica than recommended

It is essential that the patient or their caregiver can recognize the symptoms of overdose, which may occur if the pump is not working correctly. Inform your doctor immediately if you experience any of the following symptoms: Overdose symptoms:

• muscle weakness (too little muscle tension),
• drowsiness,
• dizziness or a feeling of emptiness in the head,
• excessive salivation,
• nausea or vomiting,
• breathing difficulties,
• seizures,
• reduced consciousness,
• abnormally low body temperature.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Baclofen Sintetica can cause side effects, although not everybody gets them. The following side effects have been reported:

Very common: occurs in more than 1 in 10 treated patients

Feeling tired, drowsy, or weak
Decreased muscle tone (hypotonia)

Common: occurs in less than 1 in 10 patients

Feeling lethargic (lack of energy)
Headache, dizziness, or feeling of emptiness in the head
Pain, fever, or chills
Seizures
Numbness or tingling in the hands or feet
Vision problems
Slurred speech
Insomnia
Breathing difficulties, pneumonia
Feeling disoriented, anxious, agitated, or depressed
Low blood pressure (fainting)
Nausea or vomiting, constipation, and diarrhea
Loss of appetite, dry mouth, or excessive salivation
Rash and itching, swelling of the face, hands, and feet
Urinary incontinence or problems with urination
Spasms
Sexual problems in men, such as impotence
Sedation.

Uncommon: occurs in less than 1 in 100 patients

Feeling excessively cold
Memory loss
Euphoric mood and hallucinations, suicidal thoughts
Difficulty swallowing, loss of taste, dehydration
Lack of muscle control or coordination (ataxia)
High blood pressure
Slow heart rate
Deep vein thrombosis
Redness or paleness of the skin, excessive sweating
Hair loss
Suicide attempts
Paranoia
Involuntary rapid eye movements (nystagmus)
Bowel obstruction.

Rare: occurs in less than 1 in 1000 patients

Potentially life-threatening withdrawal symptoms

Frequency not known: cannot be estimated from the available data

State of anxiety or generalized dissatisfaction (dysphoria)
Slowed breathing
Increased lateral curvature of the spine (scoliosis).
Problems related to the pump and the method of administering the medicine, such as infections, inflammation of the lining around the brain and spinal cord (meningitis) or inflammation at the site where the catheter tip is located, have been reported.
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
phone: 22 4921301
fax: 22 4921309
https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Baclofen Sintetica

Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and ampoule. The expiry date refers to the last day of the month stated.
Do not store in the refrigerator or freeze.
Store in the original packaging to protect from light.
From a microbiological point of view, the product should be used immediately, unless the opening and dilution method excludes the risk of microbiological contamination. If the medicine is not used immediately, the user is responsible for the storage time and conditions.
Do not use Baclofen Sintetica if you notice any turbidity or discoloration.
Since the medicine is used in a hospital, the disposal of leftover medicine is carried out directly by the hospital. This will help protect the environment.

6. Contents of the packaging and other information

What Baclofen Sintetica contains

The active substance of the medicine is baclofen.
Baclofen Sintetica 0.05 mg/1 ml solution for injection
1 ampoule with 1 ml of solution contains 0.05 mg of baclofen.
1 ml of solution for injection contains 0.05 mg of baclofen.
The other ingredients are: sodium chloride (3.5 mg/ml of sodium), water for injections,

What Baclofen Sintetica looks like and what the packaging contains

Solution for injection
Clear and colorless solution in ampoules.
Baclofen Sintetica 0.05 mg/1 ml
Colorless ampoules, made of type I glass, with a capacity of 2 ml and a blue marker on the ring.
Box of 5 or 10 ampoules containing 1 ml of solution.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Sintetica GmbH
Albersloher Weg 11
48155 Münster
Germany

Manufacturer/Importer:

Sirton Pharmaceuticals S.p.A
Piazza XX Settembre, 2
22079 Villa Guardia (CO)
Italy
Laboratoire AGUETTANT
1 rue Alexander Fleming
69007 Lyon
France
Sintetica GmbH
Albersloher Weg 11
48155 Münster
Germany
To obtain more detailed information, consult your doctor or the representative of the marketing authorization holder:
Poland
IMED Poland Sp. z o.o.
ul. Puławska 314
02-819 Warsaw

Date of last revision of the leaflet: December 2022