Neteka

PACKAGE LEAFLET: INFORMATION FOR THE USER

NETEKA 10 mg/20 ml infusion solution

Baclofen
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be dangerous.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What NETEKA is and what it is used for

NETEKA belongs to a group of medicines called muscle relaxants. NETEKA is administered directly into the spinal fluid via an injection into the spinal canal (intrathecal injection) and is used to relieve severe muscle stiffness (spasticity).

NETEKA is used to treat severe and persistent muscle tightness (spasticity) occurring in various diseases such as:

• brain or spinal cord injuries or diseases
• multiple sclerosis, a progressive neurological disease affecting the brain and spinal cord, causing physical and mental symptoms

NETEKA is used in adults and children aged 4 years and older. It is used when other oral medications, including baclofen, have not been effective or have caused unacceptable side effects.

2. What you should know before using NETEKA

Do not use NETEKA

• if you are allergic to baclofen or to any of the other ingredients of this medicine (listed in section 6)
• if you have therapy-resistant epilepsy
• for routes of administration other than intrathecal injection

Warnings and precautions
Talk to your doctor or pharmacist before using NETEKA:

• if you receive other injections into your spine
• if you have infections
• if you have had a head injury within the past year
• if you have experienced an episode caused by a condition called autonomic dysreflexia, a nervous system reaction to excessive stimulation that causes a severe and sudden increase in blood pressure (your doctor can explain this condition to you)
• if you have had a stroke
• if you have epilepsy
• if you have a stomach ulcer or other digestive problems
• if you suffer from any mental illness
• if you are undergoing treatment for high blood pressure
• if you have Parkinson’s disease
• if you have liver, kidney, heart or respiratory problems
• if you have diabetes
• if you have urinary problems. If you answer YES to any of the above conditions, inform your doctor or nurse, as NETEKA may not be the appropriate medicine for you.
• If you need to undergo any type of surgical procedure, make sure your doctor is aware of your treatment with NETEKA.
• The presence of a PEG tube increases the incidence of infections in children.
• if you have reduced circulation of the fluid in the brain and spinal cord due to obstruction of the passage, for example caused by inflammation or injury.
• If you think that NETEKA is not working as usual, contact your doctor immediately. It is important to check that there are no problems with the pump.
• Treatment with NETEKA must not be stopped suddenly due to the risk of withdrawal symptoms. Make sure you do not miss your hospital appointments for refilling the pump reservoir.
• During treatment with NETEKA, your doctor may schedule regular check-ups.

Inform your doctor immediately if you experience any of the following symptoms during
treatment with NETEKA:

• If you experience pain in the back, shoulders, neck or buttocks (a type of spinal deformity called scoliosis) during treatment.
• Some patients treated with baclofen have had thoughts of self-harm or suicide, or have attempted suicide. Most of these patients also suffered from depression, alcohol abuse, or had a history of previous suicide attempts. If you are thinking about harming yourself or committing suicide, contact your doctor immediately or go to hospital. Also, ask a family member or close friend to inform you if they are concerned about any changes in your behaviour, and ask them to read this patient information leaflet.

Children and adolescents
NETEKA is not recommended for children under 4 years of age. Children must have sufficient body weight to allow implantation of the chronic infusion pump. Clinical data on the safety and efficacy of NETEKA in children under 4 years of age are very limited.
Patients aged 65 years and older
In clinical studies, elderly patients treated with NETEKA did not experience specific problems. However, experience with oral administration of baclofen shows that adverse effects are more likely to occur in this patient group. Therefore, elderly patients should be closely monitored for the occurrence of adverse effects.
Other medicines and NETEKA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interfere with the treatment. Inform your doctor or nurse if you are taking:

• other medicines for the treatment of spasticity
• medicines for the treatment of depression
• medicines for high blood pressure
• medicines for Parkinson’s disease
• strong painkillers, such as morphine
• medicines that slow down the central nervous system, such as sleeping pills
• medicines used for general anaesthesia, such as fentanyl and propofol

NETEKA and alcohol
Avoid consuming alcohol during treatment with NETEKA, as this may cause an undesirable intensification or unpredictable changes in the medicine’s effects.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Experience with intrathecal baclofen use during pregnancy is limited. Oral baclofen use during pregnancy is not recommended unless absolutely necessary, due to reports of birth defects (central nervous system malformations, bone abnormalities, omphalocele (abdominal wall defect)) in children born to mothers who received this treatment. If oral baclofen is used up to delivery, neonatal withdrawal syndrome may occur. The newborn may experience seizures and other symptoms related to sudden discontinuation of treatment immediately after birth (see If you stop using NETEKA). This syndrome may be delayed by several days after birth. If you take this medicine during pregnancy, you should be monitored and treated accordingly.
NETEKA must not be used during pregnancy unless your doctor considers it necessary and the expected benefit to the mother outweighs the potential risk to the unborn child.
Breastfeeding
NETEKA passes into breast milk, but in such small amounts that the infant is unlikely to experience any adverse effects. Consult your doctor before using NETEKA during breastfeeding.
Driving and using machines
During treatment with NETEKA, some patients may experience drowsiness and/or dizziness or visual disturbances. In this case, do not drive or operate machinery or perform any activity requiring alertness until these symptoms have resolved.
NETEKA contains sodium
This medicine contains 70 mg of sodium (the main component of table salt) per vial. This corresponds to 3.5% of the maximum daily sodium intake recommended in the diet for an adult.

3. How to use NETEKA

NETEKA is administered by intrathecal injection. This means that the medicine is injected directly into the spinal fluid. The required dose varies from person to person depending on individual conditions, and your doctor will decide the appropriate dose after evaluating your response to the medicine.

Your doctor will first determine whether the medicine is suitable for you by administering single doses of NETEKA. This test is usually performed via lumbar puncture or through an intrathecal (spinal) catheter until a response is achieved. During this time, your cardiac and pulmonary functions will be closely monitored. If your symptoms improve, a special pump for continuous delivery of the medicine will be implanted in your abdominal or chest wall. Your doctor will provide you with all necessary information on how to use the pump to ensure correct dosing. Make sure you fully understand all instructions provided.

The final dosage of NETEKA depends on each individual's response to the medicine. You will start with a low dose, which will be gradually increased over several days under medical supervision until the correct dose for you is reached. If the initial dose is too high or increased too quickly, you may experience adverse effects.

It is extremely important that you keep your scheduled appointments with your doctor for pump refills.
To avoid potentially serious and even life-threatening adverse effects, it is essential that the pump never runs completely empty. The pump must always be refilled by a doctor or nurse, and you must ensure you do not miss your scheduled appointments.

The efficacy of intrathecal baclofen has been demonstrated in clinical studies using a pump system for the delivery of baclofen directly into the spinal fluid (infusion system). The pump, certified under EU standards, is implanted under the skin, usually in the abdominal wall. The pump contains and delivers, through the catheter, the correct amount of medicine directly into the spinal fluid.

During long-term treatment, some patients may experience a decrease in the effectiveness of NETEKA. You may require occasional interruptions of therapy. Your doctor will advise you accordingly.

NETEKA is not suitable for treatment in all children. Your doctor will decide whether it is appropriate in your child’s case.

If treatment with NETEKA is interrupted
It is very important that you and those caring for you know how to recognize signs of NETEKA withdrawal. These signs may appear suddenly or gradually, for example, if the pump or delivery system is not functioning properly.

Signs of withdrawal include:

• Increased spasticity, excessive muscle tone
• Difficulty with muscle movement
• Increased heart rate or heartbeat
• Itching, tingling, burning sensation, or numbness (paresthesia) in hands or feet
• Palpitations
• Anxiety
• Elevated body temperature
• Low blood pressure
• Altered mental state, such as agitation, confusion, hallucinations, abnormal thoughts or behavior, seizures

If you experience any of these signs, inform your doctor immediately. These symptoms may progress to more serious adverse effects if you are not treated promptly.

If you use more NETEKA than you should
It is very important that you or your caregiver can recognize the signs or symptoms of overdose. These may occur if the pump is not working properly, and you must contact your doctor immediately.

Symptoms of overdose include:
Unusual muscle weakness (reduced muscle tone)
Drowsiness
Dizziness or feeling faint
Excessive salivation
Nausea or vomiting
Difficulty breathing
Seizures
Loss of consciousness
Rapid heartbeat (tachycardia)
Ringing in the ears (tinnitus)

For further information on the use of this product, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, NETEKA can cause side effects, although not everybody gets them.
The following side effects have been reported:
Very common: may affect more than 1 person in 10
Tiredness, drowsiness or weakness
Decreased muscle tone (muscular hypotonia).
Common: may affect up to 1 person in 10
Lethargy (lack of energy)
Headache, dizziness or fainting sensation
Pain, fever or chills
Seizures
Tremor in hands or feet
Vision problems
Difficulty speaking, insomnia
Breathing difficulties, pneumonia
Confusion, anxiety, agitation or depression
Low blood pressure (fainting)
Nausea/vomiting, constipation and diarrhoea
Loss or decrease of appetite, dry mouth or excessive salivation
Rash and itching, swelling of the face, hands and feet
Urinary incontinence or urinary problems
Cramps
Sexual dysfunction in men
Sedation.
Uncommon: may affect up to 1 person in 100
Abnormal sensation of cold
Memory loss
Euphoric mood and hallucinations, suicidal ideation
Difficulty swallowing, loss of taste, dehydration
Lack of muscle control or coordination of voluntary movements (ataxia)
Increase in blood pressure
Slowing of heart rate
Deep vein thrombosis
Hot flushes, pallor, excessive sweating
Hair loss
Suicide attempt
Paranoia
Rapid involuntary eye movement (nystagmus)
Intestinal obstruction (ileus).
Rare: may affect up to 1 person in 1000
Potentially life-threatening withdrawal symptoms.
Other side effects (frequency not known)
Generalized discomfort or dissatisfaction (dysphoria)
Unusually decreased respiratory rate
Increased lateral curvature of the spine (scoliosis)
Impotence
Allergic reaction (hypersensitivity).
Problems with the pump and delivery system have been reported, such as infections,
inflammation of the membranes covering the brain and spinal cord (meningitis),
inflammation near the tip of the administration catheter.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 NETEKA

Keep NETEKA out of the sight and reach of children.
Do not use NETEKA after the expiry date stated on the outer carton and on the vial. The expiry date refers to the last day of the month indicated.
Do not refrigerate or freeze.
Store the product in its original packaging, protected from light.
From a microbiological standpoint, unless the method of opening and dilution excludes the risk of microbial contamination, the product should be used immediately after opening. If not used immediately, the times and conditions of storage prior to use are the sole responsibility of the user.
Do not use NETEKA if the solution is not clear and free from particles.
Since the use of this medicinal product is restricted to hospital settings, its disposal is carried out directly by the healthcare facility. These measures help protect the environment.

6. Package contents and other information

What NETEKA contains

• The active substance is Baclofen

NETEKA 10 mg/20ml
1 vial containing 20 ml of solution contains 10 mg of baclofen
1 ml of infusion solution contains 0.5 mg of baclofen

• The other components are sodium chloride (3.5 mg/ml of sodium) and water for injections.

Description of the appearance of NETEKA and contents of the pack
Infusion solution
Clear, colourless solution in vials
NETEKA 10 mg/20 ml
20 ml vial made of colourless glass (Type I glass) with a red circular marking and a score-break opening system. Pack containing 1 vial with 20 ml of solution.
NETEKA 10 mg/20 ml
20 ml vial made of colourless glass (Type I glass) with a red circular marking and a score-break opening system, packaged in sterile plastic blisters. Pack containing 1 vial with 20 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Nordic Group BV
Siriusdreef 41, 2132 WT Hoofddorp,
The Netherlands

Manufacturers:
Sirton Pharmaceuticals SpA
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

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

PACKAGE LEAFLET: INFORMATION FOR THE USER

NETEKA 0.05 mg/1 ml injectable solution

Baclofen
Generic medicinal product
Please read this entire leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What NETEKA is and what it is used for

NETEKA belongs to a group of medicines called muscle relaxants. NETEKA is administered directly into the spinal fluid by injection into the spinal canal (intrathecal injection) and is used to relieve severe muscle stiffness (spasticity).
NETEKA is used to treat severe and persistent muscle tightness (spasticity) occurring in various conditions such as:

• brain or spinal cord injuries or diseases
• multiple sclerosis, a progressive neurological disease affecting the brain and spinal cord, causing physical and mental symptoms

NETEKA is used in adults and children aged 4 years and older. It is used when other oral medications, including baclofen, have not worked or have caused unacceptable side effects.

2. What you should know before using NETEKA

Do not use NETEKA

• if you are allergic to baclofen or to any of the other ingredients of this medicine (listed in section 6)
• in case of therapy-resistant epilepsy
• by routes of administration other than intrathecal injection

Warnings and precautions
Talk to your doctor or pharmacist before using NETEKA:

• if you receive other injections into the spinal column
• if you have infections
• if you have had a head injury within the past year
• if you have experienced an episode caused by a condition called autonomic dysreflexia, a nervous system reaction to excessive stimulation that causes a severe and sudden increase in blood pressure (your doctor can explain what this is)
• if you have had a stroke
• if you suffer from epilepsy
• if you have a stomach ulcer or other digestive problems
• if you suffer from any mental illness
• if you are undergoing treatment for high blood pressure
• if you have Parkinson’s disease
• if you have liver, kidney, heart or respiratory problems
• if you have diabetes
• if you have urinary problems. If your answer to any of the above conditions is YES, inform your doctor or nurse, as NETEKA may not be the appropriate medicine for you.
• If you need to undergo any type of surgical procedure, make sure your doctor is aware of your treatment with NETEKA.
• The presence of a PEG tube increases the incidence of infections in children.
• If you have impaired circulation of the fluid surrounding the brain and spinal cord due to an obstruction, for example caused by inflammation or injury.
• If you think that NETEKA is not working as usual, contact your doctor immediately. It is important to check that there are no problems with the pump.
• Treatment with NETEKA must not be stopped suddenly due to the risk of withdrawal symptoms. Make sure you do not miss hospital appointments for refilling the pump reservoir.
• During treatment with NETEKA, your doctor may schedule regular check-ups.

Inform your doctor immediately if you experience any of the following symptoms during treatment with NETEKA:

• If you experience pain in the back, shoulders, neck, or buttocks (a type of spinal deformity called scoliosis) during treatment.
• Some patients treated with Baclofen have had thoughts of harming themselves or of suicide, or have attempted suicide. Most of these patients also suffered from depression, alcohol abuse, and/or had a history of previous suicide attempts. If you are thinking about harming yourself or committing suicide, contact your doctor immediately or go to the hospital. Additionally, ask a relative or close friend to inform you if they are concerned about any changes in your behaviour, and ask them to read this leaflet.

Children and adolescents
NETEKA is not recommended for children under 4 years of age. Children must have sufficient body weight to allow implantation of the chronic infusion pump. Clinical data on the safety and efficacy of NETEKA in children under 4 years of age are very limited.
Patients aged 65 years and older
In clinical studies, elderly patients treated with NETEKA did not experience specific problems. However, experience with oral administration of NETEKA shows that adverse effects are more likely to occur in this patient group. Elderly patients should therefore be closely monitored for the occurrence of adverse effects.
Other medicines and NETEKA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interfere with treatment. Inform your doctor or nurse if you are taking:

• other medicines for the treatment of spasticity
• medicines for depression
• medicines for high blood pressure
• medicines for Parkinson’s disease
• strong painkillers, such as morphine
• medicines that slow down the central nervous system, such as sleeping pills
• Medicines used for general anaesthesia, such as fentanyl and propofol

NETEKA and alcohol
Avoid consuming alcohol during treatment with NETEKA, as this may cause an undesirable intensification or unpredictable changes in the medicine’s effects.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There is limited experience regarding the use of intrathecal baclofen during pregnancy. Oral baclofen use during pregnancy is not recommended unless absolutely necessary, due to reported cases of malformations (of the central nervous system, bone abnormalities, omphalocele (abdominal wall malformation)) in children born to mothers who received this treatment. If oral baclofen is used up to delivery, neonatal withdrawal syndrome may occur. The newborn may experience seizures and other symptoms associated with sudden discontinuation of treatment immediately after birth (see If you stop using NETEKA). This syndrome may be delayed by several days after birth. If you take this medicine during pregnancy, you must be monitored and treated accordingly.
NETEKA must not be used during pregnancy unless your doctor considers it necessary and the expected benefit to the mother outweighs the potential risk to the child.
Breastfeeding
NETEKA passes into breast milk, but in such small amounts that the infant is unlikely to experience any adverse effects. Consult your doctor before using NETEKA while breastfeeding.
Driving and using machines
During treatment with NETEKA, some patients may experience drowsiness and/or dizziness or visual disturbances. In such cases, do not drive or perform any activity requiring alertness (such as operating tools or machinery) until these symptoms have resolved.
NETEKA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially ‘sodium-free’.

3. How to use NETEKA

NETEKA is administered by intrathecal injection. This means that the medicine is injected directly into the spinal fluid. The required dose varies from person to person depending on individual conditions, and your doctor will determine the appropriate dose after evaluating your response to the medicine.

Your doctor will first assess whether the medicine is suitable for you by administering single doses of NETEKA. This test is usually performed via lumbar puncture or through an intrathecal (spinal) catheter until a response is achieved. During this period, your cardiac and pulmonary functions will be closely monitored. If your symptoms improve, a special pump for continuous drug delivery will be implanted under the skin of your abdominal or chest wall. Your doctor will provide you with all necessary information on how to use the pump to ensure correct dosing. Make sure you fully understand all instructions provided.

The final dosage of NETEKA depends on each individual’s response to the medicine. You will start with a low dose, which will be gradually increased over several days under your doctor’s supervision until the correct dose for you is reached. If the initial dose is too high or increased too rapidly, you may experience unwanted side effects.

It is extremely important that you keep all scheduled medical appointments for pump refills.

To avoid potentially unpleasant, serious, and even life-threatening side effects, it is essential that the pump never runs completely empty. The pump must always be refilled by a doctor or nurse, and you must ensure you do not miss your scheduled appointments.

The efficacy of intrathecal baclofen has been demonstrated in clinical studies using a pump system for delivering baclofen directly into the spinal fluid (infusion system). The pump, certified under EU standards, is implanted under the skin, typically in the abdominal wall. The pump stores and delivers, via a catheter, the appropriate amount of medicine directly into the spinal fluid.

During long-term treatment, some patients may notice a decrease in the effectiveness of NETEKA. You may require occasional interruptions of therapy. Your doctor will advise you accordingly.

To open the NETEKA package, hold the package in both hands and twist the ends in opposite directions until it opens.

If treatment with NETEKA is interrupted

It is very important that you and those caring for you know how to recognize signs of NETEKA withdrawal. These signs may appear suddenly or gradually, for example if the pump or delivery system is not functioning properly.

Signs of withdrawal include:

• Increased spasticity, excessive muscle tone
• Difficulty with muscle movement
• Increased heart rate or heartbeat
• Itching, tingling, burning sensation, or numbness (paresthesia) in hands or feet
• Palpitations
• Anxiety
• Elevated body temperature
• Low blood pressure
• Altered mental status, such as agitation, confusion, hallucinations, abnormal thoughts and behaviors, seizures

If you experience any of these signs, inform your doctor immediately. If left untreated, these signs may progress to more serious adverse effects.

If you use more NETEKA than you should

It is very important that you or your caregiver can recognize the signs or symptoms of overdose. These may occur if the pump is not working properly, and you must contact your doctor immediately.

Symptoms of overdose include:

• Unusual muscle weakness (reduced muscle tone)
• Drowsiness
• Dizziness or fainting sensation
• Excessive salivation
• Nausea or vomiting
• Breathing difficulties
• Seizures
• Loss of consciousness
• Rapid heartbeat (tachycardia)
• Ringing in the ears (tinnitus)

For further information on the use of this product, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, NETEKA can cause side effects, although not everyone experiences them.
The following adverse reactions have been reported:
Very common: may affect more than 1 in 10 people
Tiredness, drowsiness or weakness
Decreased muscle tone (muscle hypotonia).
Common: may affect up to 1 in 10 people
Lethargy (lack of energy)
Headache, dizziness or fainting sensation
Pain, fever or chills
Seizures
Tremor in hands or feet
Vision problems
Difficulty speaking, insomnia
Breathing difficulties, pneumonia
Confusion, anxiety, agitation or depression
Low blood pressure (fainting)
Nausea/vomiting, constipation and diarrhoea
Loss or decrease in appetite, dry mouth or excessive salivation
Rash and itching, swelling of the face, hands and feet
Urinary incontinence or urinary problems
Cramps
Sexual dysfunction in men
Sedation.
Uncommon: may affect up to 1 in 100 people
Abnormal sensation of cold
Memory loss
Euphoric mood and hallucinations, suicidal ideation
Difficulty swallowing, loss of taste, dehydration
Lack of muscle control or coordination of voluntary movements (ataxia)
Increased blood pressure
Slowed heart rate
Deep vein thrombosis
Hot flushes, pallor, excessive sweating
Hair loss
Suicide attempt
Paranoia
Involuntary rapid eye movement (nystagmus)
Intestinal obstruction (ileus).
Rare: may affect up to 1 in 1,000 people
Potentially life-threatening withdrawal symptoms.
Other side effects (frequency not known)
Generalized discomfort or dissatisfaction (dysphoria)
Abnormally decreased respiratory rate
Increased lateral curvature of the spine (scoliosis)
Impotence
Allergic reaction (hypersensitivity).
Problems with the pump and delivery system have been reported, such as infections,
inflammation of the membranes covering the brain and spinal cord (meningitis),
inflammation near the tip of the administration catheter.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You can also report side effects directly via 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 NETEKA

Keep NETEKA out of the sight and reach of children.
Do not use NETEKA after the expiry date stated on the outer carton and on the vial. The expiry date refers to the last day of the month indicated.
Do not refrigerate or freeze.
Store the product in its original packaging, protected from light.
From a microbiological standpoint, unless the method of opening and dilution excludes the risk of microbial contamination, the product should be used immediately after opening. If not used immediately, the duration and conditions of storage prior to use are the sole responsibility of the user.
Do not use NETEKA if the solution is not clear and free from particles.
Since the use of this medicinal product is restricted to hospital settings, its disposal is carried out directly by the healthcare facility. These measures help protect the environment.

6. Package contents and other information

What NETEKA contains

• The active substance is Baclofen

NETEKA 0.05 mg/1 ml
1 vial with 1 ml of solution contains 0.05 mg of baclofen
1 ml of injectable solution contains 0.05 mg of baclofen

• The other components are sodium chloride (3.5 mg/ml of sodium) and water for injections.

Description of the appearance of NETEKA and contents of the pack
Injectable solution
Clear, colourless solution in vials
NETEKA 0.05 mg/1 ml
2 ml vials made of colourless glass (Type I glass) with a blue circular marking and a score-break opening system. Packs of 5 and 10 vials containing 1 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Nordic Group BV
Siriusdreef 41, 2132 WT Hoofddorp,
The Netherlands

Manufacturers:
Sirton Pharmaceuticals SpA
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

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

PACKAGE LEAFLET: INFORMATION FOR THE USER

NETEKA 10 mg/5 ml infusion solution, 40 mg/20 ml infusion solution

Baclofen
Generic medicinal product
Please read this leaflet carefully before using this medicine as 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What NETEKA is and what it is used for

NETEKA belongs to a group of medicines called muscle relaxants. NETEKA is administered directly into the spinal fluid by injection into the spinal canal (intrathecal injection) and is used to relieve severe muscle stiffness (spasticity).
NETEKA is used to treat severe and persistent muscle tightness (spasticity) that occurs in various conditions, such as:

• brain or spinal cord injuries or diseases
• multiple sclerosis, a progressive nervous system disease affecting the brain and spinal cord, causing physical and mental symptoms

NETEKA is used in adults and children aged 4 years and older. It is used when other medicines taken by mouth, including baclofen, have not worked or have caused unacceptable side effects.

2. What you should know before using NETEKA

Do not use NETEKA

• if you are allergic to baclofen or to any of the other ingredients of this medicine (listed in section 6)
• in case of therapy-resistant epilepsy
• by routes of administration other than intrathecal injection

Warnings and precautions
Talk to your doctor or pharmacist before using NETEKA:

• if you receive other injections into the spinal column
• if you have infections
• if you have had a head injury within the past year
• if you have experienced an episode caused by a condition called autonomic dysreflexia, a nervous system reaction to excessive stimulation that causes a severe and sudden increase in blood pressure (your doctor can explain what this is)
• if you have had a stroke
• if you suffer from epilepsy
• if you have a stomach ulcer or other digestive problems
• if you suffer from any mental illness
• if you are undergoing treatment for high blood pressure
• if you have Parkinson’s disease
• if you have liver, kidney, heart or respiratory problems
• if you have diabetes
• if you have problems with urination. If you answer YES to any of the above conditions, inform your doctor or nurse, as NETEKA may not be the appropriate medicine for you.
• If you need to undergo any type of surgical procedure, make sure your doctor is aware of your treatment with NETEKA.
• The presence of a PEG tube increases the incidence of infections in children.
• If you have reduced circulation of the fluid in the brain and spinal cord caused by an obstruction in the passage, for example due to inflammation or injury.
• If you think that NETEKA is not working as usual, contact your doctor immediately. It is important to check that there are no problems with the pump.
• Treatment with NETEKA must not be stopped suddenly due to the risk of withdrawal symptoms. Make sure you do not miss hospital appointments for refilling the pump reservoir.
• During treatment with NETEKA, your doctor may schedule regular check-ups.

Inform your doctor immediately if you experience any of the following symptoms during treatment with NETEKA:

• If you have pain in your back, shoulders, neck, or buttocks (a type of spinal deformity called scoliosis) during treatment.
• Some patients treated with Baclofen have had thoughts of harming themselves or of suicide, or have attempted suicide. Most of these patients also suffered from depression, alcohol abuse, and/or had a history of previous suicide attempts. If you are thinking about harming yourself or committing suicide, contact your doctor immediately or go to hospital. In addition, ask a family member or close friend to inform you if they are concerned about any changes in your behaviour, and ask them to read this leaflet.

Children and adolescents
NETEKA is not recommended for children under 4 years of age. Children must have sufficient body weight to allow implantation of a chronic infusion pump. Clinical data on the safety and efficacy of NETEKA use in children under 4 years of age are very limited.
Patients aged 65 years and older
In studies, elderly patients treated with NETEKA did not experience specific problems. However, experience with oral administration of NETEKA shows that adverse effects are more likely to occur in this patient group. Elderly patients should therefore be closely monitored for the occurrence of adverse effects.
Other medicines and NETEKA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interfere with treatment. Inform your doctor or nurse if you are taking:

• other medicines for the treatment of spasticity
• medicines for the treatment of depression
• medicines for high blood pressure
• medicines for Parkinson’s disease
• strong painkillers, such as morphine
• medicines that slow down the central nervous system, such as sleeping pills
• medicines used for general anaesthesia, such as fentanyl and propofol

NETEKA and alcohol
Avoid consuming alcohol during treatment with NETEKA, as this may cause an unwanted intensification or unpredictable changes in the medicine’s effects.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There is limited experience regarding the use of intrathecal baclofen during pregnancy.
Oral baclofen use during pregnancy is not recommended unless absolutely necessary, due to reports of malformations (of the central nervous system, bone abnormalities, omphalocele (abdominal wall malformation)) in children born to mothers who received this treatment. If oral baclofen is used up to delivery, neonatal withdrawal syndrome may occur. The newborn may experience seizures and other symptoms associated with sudden discontinuation of treatment immediately after birth (see If you stop using NETEKA). This syndrome may appear several days after birth. If you take this medicine during pregnancy, you must be monitored and treated accordingly.
NETEKA must not be used during pregnancy unless your doctor considers it necessary and the expected benefit to the mother outweighs the potential risk to the unborn child.
Breastfeeding
NETEKA passes into breast milk, but in such small amounts that the infant is unlikely to experience any adverse effects. Consult your doctor before using NETEKA while breastfeeding.
Driving and using machines
During treatment with NETEKA, some patients may experience drowsiness and/or dizziness or visual disturbances. In such cases, do not drive or perform any activity requiring alertness (such as operating tools or machinery) until these symptoms have resolved.
NETEKA contains sodium
NETEKA 10 mg/5 ml
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially ‘sodium-free’.
NETEKA 40 mg/20 ml
This medicine contains 70 mg of sodium (the main component of table salt) per vial. This corresponds to 3.5% of the maximum daily sodium intake recommended in the adult diet.

3. How to use NETEKA

NETEKA is administered by intrathecal injection. This means that the medicine is injected directly into the spinal fluid. The required dose varies from person to person depending on individual conditions, and your doctor will determine the appropriate dose after evaluating your response to the medicine.

Your doctor will first assess whether this medicine is suitable for you by administering single doses of NETEKA. This test is usually performed via lumbar puncture or through an intrathecal (spinal) catheter until a response is achieved. During this time, your cardiac and respiratory functions will be closely monitored. If your symptoms improve, a special pump for continuous drug delivery will be implanted under your abdominal or chest wall. Your doctor will provide you with all necessary information on how to use the pump to ensure correct dosing. Make sure you fully understand all instructions given.

The final dosage of NETEKA depends on each individual's response to the medicine. You will start with a low dose, which will be gradually increased over several days under your doctor’s supervision until the correct dose for you is reached. If the initial dose is too high or increased too quickly, you may experience adverse effects.

It is extremely important that you keep your scheduled appointments with your doctor for pump refills.

To avoid unpleasant adverse effects, which may even be serious and life-threatening, it is essential that the pump never runs completely empty. The pump must always be refilled by a doctor or nurse, and you must ensure you do not miss your scheduled appointments.

The efficacy of intrathecal baclofen has been demonstrated in clinical studies using a pump system for the delivery of baclofen directly into the spinal fluid (infusion system). The pump, certified to EU standards, is implanted under the skin, usually in the abdominal wall. The pump contains and delivers, through the catheter, the correct amount of medicine directly into the spinal fluid.

During long-term treatment, some patients may notice a decrease in the effectiveness of NETEKA. You may require occasional interruptions of therapy. Your doctor will advise you accordingly.

NETEKA 10 ml/5 mg:
To open the NETEKA package, hold the package in both hands and twist the ends in opposite directions until it opens.

If treatment with NETEKA is interrupted

It is very important that you and those caring for you know how to recognize signs of NETEKA withdrawal. These signs may appear suddenly or gradually, for example, if the pump or delivery system is not working properly.

Signs of withdrawal include:

• Increased spasticity, increased muscle tone
• Difficulty with muscle movement
• Increased heart rate or palpitations
• Itching, tingling, burning sensation, or numbness (paresthesia) in hands or feet
• Palpitations
• Anxiety
• Elevated body temperature
• Low blood pressure
• Altered mental status, such as agitation, confusion, hallucinations, abnormal thoughts or behaviors, seizures

If you experience any of these signs, inform your doctor immediately. These signs may progress to more serious adverse effects if you are not treated promptly.

If you use more NETEKA than you should

It is very important that you or your caregiver can recognize the signs or symptoms of overdose. These may occur if the pump is not functioning properly, and you must contact your doctor immediately.

Symptoms of overdose include:

• Unusual muscle weakness (reduced muscle tone)
• Drowsiness
• Dizziness or feeling faint
• Excessive salivation
• Nausea or vomiting
• Difficulty breathing
• Seizures
• Loss of consciousness
• Rapid heartbeat (tachycardia)
• Ringing in the ears (tinnitus)

For further information on the use of this product, please consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, NETEKA may cause side effects, although not everyone experiences them.
The following adverse reactions have been reported.

Very common: may affect more than 1 in 10 people
Tiredness, drowsiness or weakness
Decreased muscle tone (muscular hypotonia)

Common: may affect up to 1 in 10 people
Lethargy (lack of energy)
Headache, dizziness or fainting sensation
Pain, fever or chills
Seizures
Tremor in hands or feet
Vision problems
Difficulty speaking, insomnia
Breathing difficulties, pneumonia
Confusion, anxiety, agitation or depression
Low blood pressure (fainting)
Nausea/vomiting, constipation and diarrhoea
Loss or decrease of appetite, dry mouth or excessive salivation
Rash and itching, swelling of the face, hands and feet
Urinary incontinence or urinary problems
Cramps
Sexual dysfunction in men
Sedation

Uncommon: may affect up to 1 in 100 people
Abnormal sensation of cold
Memory loss
Euphoric mood and hallucinations, suicidal ideation
Difficulty swallowing, loss of taste, dehydration
Lack of muscle control or coordination of voluntary movements (ataxia)
Increased blood pressure
Slowed heart rate
Deep vein thrombosis
Hot flushes, pallor, excessive sweating
Hair loss
Suicide attempt
Paranoia
Involuntary rapid eye movement (nystagmus)
Intestinal obstruction (ileus)

Rare: may affect up to 1 in 1000 people
Potentially life-threatening withdrawal symptoms

Other side effects (frequency not known)
General discomfort or generalized dissatisfaction (dysphoria)
Unusually decreased respiratory rate
Increased lateral curvature of the back (scoliosis)
Impotence
Allergic reaction (hypersensitivity)

Problems with the pump and delivery system have been reported, such as infections, inflammation of the membranes covering the brain and spinal cord (meningitis), or inflammation near the tip of the administration catheter.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist.
You may also report side effects directly via 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 NETEKA

Keep NETEKA out of the sight and reach of children.
Do not use NETEKA after the expiry date stated on the outer carton and on the vial. The expiry date refers to the last day of the month indicated.
Do not refrigerate or freeze.
Store the product in its original packaging, protected from light.
From a microbiological standpoint, unless the method of opening and dilution excludes the risk of microbial contamination, the product should be used immediately after opening. If not used immediately, the storage times and conditions prior to use are the sole responsibility of the user.
Do not use NETEKA if the solution is not clear and free from particles.
Since the use of this medicinal product is restricted to hospital settings, its disposal is carried out directly by the healthcare facility. These measures help protect the environment.

6. Package contents and other information

What NETEKA contains

• The active substance is Baclofen

NETEKA 10 mg/5 ml
1 vial containing 5 ml of solution contains 10 mg of baclofen
1 ml of infusion solution contains 2.0 mg of baclofen

NETEKA 40 mg/20 ml
1 vial containing 20 ml of solution contains 40 mg of baclofen
1 ml of infusion solution contains 2.0 mg of baclofen.

• The other components are sodium chloride (3.5 mg/ml of sodium) and water for injectable preparations.

Description of the appearance of NETEKA and contents of the pack
Infusion solution
Clear, colourless solution in vials
NETEKA 10 mg/5 ml
5 ml colourless glass vial (Type I glass) with a circular purple mark and score-break opening system. Pack containing 1, 5 or 10 vials with 5 ml of solution.
NETEKA 10 mg/5 ml
5 ml colourless glass vial (Type I glass) with a circular purple mark and score-break opening system, packed in sterile plastic blisters. Pack containing 5 or 10 vials with 5 ml of solution.
NETEKA 40 mg/20 ml
20 ml colourless glass vial (Type I glass) with a circular green mark and score-break opening system. Pack containing 1 vial with 20 ml of solution.
NETEKA 40 mg/20 ml
20 ml colourless glass vial (Type I glass) with a circular green mark and score-break opening system, packed in sterile plastic blisters. Pack containing 1 single vial with 20 ml of solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Nordic Group BV
Siriusdreef 41, 2132 WT Hoofddorp,
The Netherlands

Manufacturers:
Sirton Pharmaceuticals SpA
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

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: