Baclofen sintetica

Package leaflet: Information for the patient

Baclofen Sintetica, 2 mg/ml (10 mg/5 ml; 40 mg/20 ml), solution for infusion
(Baclofenum)
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Baclofen Sintetica is and what it is 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 pack and other information

1. What Baclofen Sintetica is and what it is 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, chronic muscle spasm (spasticity) occurring
in various diseases, such as:

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

Baclofen Sintetica is used in adults and children aged 4 years and older. The medicine is used when other orally administered medicines, including baclofen, have proven ineffective or 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 treatment-resistant epilepsy;
• if administered by any route other than intrathecal (into the spinal canal).

Warnings and precautions
Before starting treatment with Baclofen Sintetica, discuss with your doctor:

• if the patient is receiving other spinal injections,
• if the patient has any infection,
• if the patient suffered a head injury within the past year,
• if the patient has ever experienced a crisis due to a condition called autonomic dysreflexia, a nervous system reaction to excessive stimulation causing sudden, severe increase in blood pressure (your doctor will provide further explanation),
• 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 psychiatric disorder,
• if the patient is being treated for high blood pressure,
• if the patient has Parkinson's disease,
• if the patient has liver, kidney, lung, or heart disease, or breathing difficulties,
• if the patient has diabetes,
• if the patient has problems with urination.

Inform your doctor if you answer yes to any of the above questions, as Baclofen Sintetica may not be the appropriate medicine for the patient.

• If the patient has any planned surgery, ensure that 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 in the brain and spinal cord due to obstructed flow, for example caused by inflammation or trauma.
• If the patient has slowed cerebrospinal fluid flow, the effect of Baclofen Sintetica may be reduced.
• Contact your treating doctor immediately if Baclofen Sintetica does not work as usual. It is important to ensure there are no problems with the pump.
• Do not suddenly stop treatment with Baclofen Sintetica due to the risk of withdrawal effects. Remember to attend hospital visits for pump refills.
• Periodic monitoring by the treating physician may be required during treatment with Baclofen Sintetica.

Immediately inform your doctor if any of the following symptoms occur during treatment with Baclofen Sintetica:

• If the patient experiences back, shoulder, neck, or buttock pain during the procedure (a type of spinal deformity called scoliosis).
• Some patients treated with Baclofen Sintetica have had thoughts of self-harm, suicidal thoughts, or attempted suicide. Most of these patients had a history of depression, alcohol dependence, and/or previous suicide attempts. Seek immediate medical help or go to a hospital if the patient has thoughts of self-harm or suicidal thoughts. The patient should ask a relative or close person to read this leaflet and to monitor for any worrying changes in the patient's behavior.

Children and adolescents
Baclofen Sintetica is not recommended for children under 4 years of age. In children, certain body weight requirements must be met to allow implantation of the infusion pump. Clinical data on the safety and efficacy of Baclofen Sintetica in children under four years of age are very limited.

Baclofen Sintetica with 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.
Some other medicines may affect treatment with baclofen. Remind your doctor or nurse if the patient is taking any of the following medicines:

• other medicines used for spastic conditions,
• antidepressants,
• medicines used to treat high blood pressure,
• medicines used in Parkinson’s disease,
• strong painkillers such as morphine,
• medicines with a depressant effect on the central nervous system, such as sedatives.

Baclofen Sintetica and alcohol
Avoid drinking alcohol during treatment with Baclofen Sintetica, as this may lead to undesirable intensification or unpredictable changes in the medicine’s effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her 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 considered necessary by the doctor and the expected benefits to the mother outweigh the potential risks to the fetus.

Breastfeeding
Baclofen Sintetica passes into breast milk, but in such small amounts that the infant is unlikely to experience any adverse effects. Consult your doctor before using Baclofen Sintetica while breastfeeding.

Driving and operating machinery
Some patients may experience drowsiness and/or dizziness or vision problems while taking Baclofen Sintetica. In such cases, the patient should not drive or perform any activities requiring mental alertness (e.g. operating equipment or machinery) until these symptoms resolve.

Baclofen Sintetica contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose unit, i.e. it is essentially "sodium-free".

3. How to use Baclofen Sintetica

Baclofen Sintetica is administered via intrathecal injection. This means that Baclofen Sintetica is injected directly into the cerebrospinal fluid. The required dose varies for each patient depending on their condition. The dose is determined by the physician based on the patient's response to the medication.

At the beginning of treatment, the physician will determine whether single injections of Baclofen Sintetica alleviate muscle spasms. Usually, a test dose is administered via lumbar puncture or through an intrathecal catheter (into the spine) to elicit a response to the drug. During this period, cardiac and pulmonary functions are monitored. If muscle spasms are reduced, further treatment is continued using a special pump that allows continuous administration of the drug. The pump is implanted in the chest or abdominal wall. All necessary information regarding the use of the pump and determination of the correct dose should be provided to the patient by the physician. The patient should ensure they fully understand everything.

The final dose of Baclofen Sintetica depends on the individual patient's response to the drug. Treatment begins with a small dose, which is gradually increased over several days under medical supervision until the patient receives the appropriate dose for them. If the initial dose is too high or increased too quickly, the risk of adverse reactions increases.

It is extremely important that the patient contacts their physician to have the pump refilled.

To avoid unpleasant adverse effects, which may be severe and even life-threatening, it is essential that the pump functions continuously. The pump must always be refilled by a physician or nurse, and the patient must ensure regular attendance at medical appointments.

The efficacy of intrathecally administered baclofen has been demonstrated in clinical trials using pump systems for delivering baclofen directly into the cerebrospinal fluid (infusion systems). The pump system with CE marking is implanted under the skin, primarily in the abdominal wall. The pump stores and releases the appropriate amount of medication through a catheter directly into the cerebrospinal fluid.

During long-term treatment, some patients may experience reduced effectiveness of Baclofen Sintetica. In such cases, treatment interruptions may become necessary. The physician should inform the patient about how to proceed in such a situation.

Baclofen Sintetica 10 mg/5 ml:
To open the Baclofen Sintetica packaging, hold the package in both hands and twist the edges in opposite directions until it opens.

If treatment with Baclofen Sintetica is interrupted

It is very important that the patient and the patient's caregiver are able to recognize symptoms of baclofen withdrawal. These symptoms may appear suddenly or gradually, for example due to malfunction of the pump or delivery system.

Withdrawal symptoms:

• increased spasticity, excessive muscle tone
• difficulty with muscle movement
• increased heart rate or pulse
• itching, tingling, burning, or numbness (paresthesia) in the hands or feet
• palpitations
• restlessness
• high body temperature
• low blood pressure
• altered mental status, such as agitation, confusion, hallucinations, abnormal thinking and behavior, seizures

If any of the above symptoms occur, the patient must immediately inform their physician. These symptoms may lead to more serious adverse effects unless the patient receives immediate treatment.

Use of a higher than recommended dose of Baclofen Sintetica

It is important that the patient or caregiver is able to recognize symptoms of overdose, which may occur due to malfunction of the pump. This should be reported to the physician immediately.

Symptoms of overdose:

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

If you have any doubts about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like any medicine, Baclofen Sintetica may cause adverse reactions, although not everyone will experience them.

The following adverse reactions have been reported:

Very common: occurs in more than 1 in 10 treated patients
Feeling of fatigue, drowsiness or weakness
Reduced muscle tone (muscle hypotonia)

Common: occurs in less than 1 in 10 patients
Feeling of lethargy (lack of energy)
Headache, dizziness or feeling of emptiness in the head
Pain, fever or chills
Seizures
Tingling in hands or feet
Vision problems
Slurred speech
Insomnia
Breathing difficulties, pneumonia
Feeling of disorientation, anxiety, agitation or depression
Low blood pressure (fainting)
Nausea or vomiting, constipation and diarrhoea
Loss of appetite, dry mouth or excessive salivation
Rash and itching, swelling of the face, hands and feet
Urinary incontinence or problems with urination
Cramps
Sexual problems in men, e.g. impotence
Sedation

Uncommon: occurs in less than 1 in 100 patients
Feeling of excessive cold
Memory loss
Euphoric mood and hallucinations, suicidal thoughts
Difficulty swallowing, loss of taste, dehydration
Lack of muscle control or lack of coordination of voluntary movements (ataxia)
Increased blood pressure
Slowed heart rate
Deep vein thrombosis
Skin redness or pallor, excessive sweating
Hair loss
Suicide attempts
Paranoia
Involuntary rapid eye movements (nystagmus)
Intestinal obstruction

Rare: occurs in less than 1 in 1000 patients
Potentially life-threatening withdrawal symptoms

Frequency unknown: cannot be estimated from the available data
Anxiety state or generalized dissatisfaction (dysphoria)
Slowed breathing
Increase in lateral curvature of the spine (scoliosis)

Problems related to the pump and method of drug delivery have been reported, such as infections, inflammation of the membranes surrounding the brain and spinal cord (meningitis), or inflammation at the site where the pump catheter is located.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: 22 4921301
Fax: 22 4921309
https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Baclofen Sintetica

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the ampoule. The expiry date refers to the last day of the stated month.
Do not store in a 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 method of opening and dilution excludes the risk of microbiological contamination. If the medicine is not used immediately, the user is responsible for the storage duration and conditions.
Do not use Baclofen Sintetica if cloudiness or discoloration is observed.
Since this medicine is used in a hospital setting, disposal of any unused medicine is carried out directly by the hospital. This helps protect the environment.

6. Contents of the package and other information

What Baclofen Sintetica contains
The active substance is baclofen.
Baclofen Sintetica 2 mg/ml (10 mg/5 ml) solution for infusion
One 5 ml vial contains 10 mg of baclofen.
1 ml of infusion solution contains 2 mg of baclofen.
Baclofen Sintetica 2 mg/ml (40 mg/20 ml) solution for infusion
One 20 ml vial contains 40 mg of baclofen.
1 ml of infusion solution contains 2 mg of baclofen.
The other ingredients are: sodium chloride (3.5 mg/ml of sodium), water for injections.

What Baclofen Sintetica looks like and contents of the pack
Solution for infusion
A clear, colourless solution in vials.
Baclofen Sintetica 2 mg/ml (10 mg/5 ml)
Colourless vials made of Type I glass, with a capacity of 5 ml, graduated scale and a violet ring mark.
Carton containing 1, 5 or 10 vials with 5 ml of solution.
Baclofen Sintetica 2 mg/ml (10 mg/5 ml)
Colourless vials made of Type I glass, with a capacity of 5 ml, graduated scale and a violet ring mark, packed in a sterile plastic blister.
Carton containing 5 or 10 vials with 5 ml of solution.
Baclofen Sintetica 2 mg/ml (40 mg/20 ml)
Colourless vials made of Type I glass, with a capacity of 20 ml, graduated scale and a green ring mark.
Carton containing 1 vial with 20 ml of solution.
Baclofen Sintetica 2 mg/ml (40 mg/20 ml)
Colourless vials made of Type I glass, with a capacity of 20 ml, graduated scale and a green ring mark, packed in a sterile plastic blister.
Carton containing 1 vial with 20 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation 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

For further information, please contact the Marketing Authorisation Holder or its representative:
Poland
IMED Poland Sp. z o.o.
ul. Puławska 314
02-819 Warszawa