Package Insert: Information for the User

Lioresal 25 mg Tablets

Baclofen

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Lioresal and for what it is used

2. What you need to know before starting to take Lioresal

3. How to take Lioresal

4. Possible adverse effects

5. Storage of Lioresal

6. Contents of the package and additional information

Lioresal belongs to a group of medications known as muscle relaxants.

Adults

It is used to reduce and alleviate excessive muscle stiffness (spasms) that occur in muscles with some diseases such as multiple sclerosis, stroke, spinal cord diseases, and certain nervous system disorders.

Use in childrenand adolescents

It is used in patients from 0 to 18 years old for symptomatic treatment of muscle stiffness (spasms), especially when this is due to infantile cerebral paralysis, after stroke, degenerative brain diseases, spinal cord infectious diseases, and other nervous system disorders.

Do not take Lioresal

• if you are allergic to baclofen or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lioresal:

• if you have Parkinson's disease or any mental illness accompanied by confusion or depression,
• if you suffer from epilepsy (seizures),
• if you have acute stomach pain (ulcer) or intestinal pain, circulatory disorders, breathing problems, or liver disease,
• if you have kidney disease. Your doctor will decide if Lioresal is the appropriate treatment for you,
• if you have difficulty urinating,
• if you are diabetic,
• if you are pregnant and taking Lioresal during pregnancy, the newborn may experience seizures and other symptoms related to the sudden interruption of treatment just after birth (see "if you interrupt treatment with Lioresal" and "pregnancy, breastfeeding, and fertility"). Your doctor may need to administer small doses of Lioresal to the newborn and gradually reduce them to control and prevent symptoms,
• do not stop treatment without consulting your doctor,
• if you need to maintain posture, balance, or circulatory function, your doctor will adjust the dose,
• if you are an elderly patient or have cerebrovascular disease, your doctor will closely monitor you and may need to adapt your Lioresal dose,
• if you have a history of drug abuse or dependence.

Some people treated with baclofen have thought about self-harm or suicide or have attempted suicide. Most of these people also had depression, excessive alcohol consumption, or a history of suicidal thoughts. If you ever think about self-harm or suicide, talk to your doctor or go to the hospital immediately. Also, ask a close family member or friend to inform you if they notice any concerning changes in your behavior and ask them to read this leaflet.

If you are in any of these circumstances, inform your doctor before starting to take Lioresal.

Cases of decreased brain function (encephalopathy) have been reported in some patients taking Lioresal at prescribed doses, which resolved after treatment was discontinued. Symptoms include increased sleep, drowsiness, confusion, sudden muscle movements, or coma.

If you experience any of these symptoms, inform your doctor immediately. Your doctor will decide if you should discontinue baclofen treatment.

Other safety measures

Before undergoing any surgical intervention (including dental procedures) or emergency treatment, inform your doctor that you are taking Lioresal.

Children and adolescents

Lioresal tablets are not recommended for children weighing less than 33 kg or under 6 years old.

The experience with the use of Lioresal in children under 1 year is very limited.

Taking Lioresal with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Some medicines can interfere with the action of Lioresal, increasing the risk of adverse effects or reducing its efficacy:

• opioid medicines (such as morphine) and substances that inhibit the central nervous system (alcohol).
• medicines for mood disorders, such as tricyclic antidepressants or lithium, which may cause movement disorders.
• medicines that lower blood pressure, including medicines for high blood pressure. When taken with Lioresal, it may lower blood pressure.
• medicines for Parkinson's disease (carbidopa, levodopa), which may cause nervous system disorders and worsen Parkinsonian symptoms.
• medicines that reduce renal function.
• medicines for arthritis or pain.

Taking Lioresal with food, drinks, and alcohol

Take Lioresal with meals and a small amount of liquid. Do not consume alcohol during Lioresal treatment.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not use this medicine during pregnancy unless your doctor tells you to. Your doctor will assess whether you can take this medicine during pregnancy and inform you about the possible risks. If you need to take Lioresal during pregnancy, your baby may experience seizures and other symptoms related to the sudden interruption of treatment just after birth (see "if you interrupt treatment with Lioresal" and "warnings and precautions").

Breastfeeding

The active ingredient in Lioresal passes in very small amounts into breast milk. This medicine should not be used during breastfeeding unless your doctor tells you to. In this case, your doctor will inform you about the possible effects of this medicine on the child.

Fertility

There is no data on the effect of baclofen on human fertility.

Driving and operating machinery

Lioresal may cause drowsiness, dizziness, vision problems, or clumsiness in some people. If this happens, do not drive or use hazardous tools or machinery.

Information about some of the components of Lioresal

This medicine contains very low levels of gluten (from wheat starch) and is unlikely to cause problems if you have celiac disease.

A Lioresal 25 mg tablet contains no more than 8.3 micrograms of gluten.

If you are allergic to wheat (other than celiac disease), do not take this medicine.

Followexactlythe administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. Do not exceed the recommended dose.

Lioresal should be taken during meals with a little liquid.The notch is only for breaking the tablet if it is difficult to swallow it whole.

Take Lioresal at the same time every day and it will help you remember when to take the medication.

Make sure to take the medication every day as your doctor has instructed. This will help you achieve the best results and reduce the risk of adverse reactions.

The recommended dose is:

Adults:

Normally, you will start treatment with 15 mg per day, preferably in divided doses of 2 to 3 times. The dose will be increased gradually to achieve the desired results; this may be at doses between 30 and 80 mg per day, divided into 2 to 4 doses. Your doctor may decide to administer even higher doses.

Use in childrenand adolescents

Treatment in children should be adjusted according to their body weight. The recommended dose for treatment in children usually starts at very low doses (approximately 0.3 mg/kg per day), in divided doses of 2 times. After that, the dose should be increased cautiously at intervals of one week to achieve the sufficient dose for individual child needs, which occurs between 0.75 and 2 mg/kg weight. The total daily dose should not exceed a maximum of 40 mg/day in children under 8 years old. In children over 8 years old, the maximum daily dose should not exceed 60 mg/day.

The Lioresal tablets are not suitable for use in children with a weight below 33 kg or in children under 6 years old.

Patients with kidney problems

If you have kidney disease or are receiving hemodialysis, your dose may be lower and your doctor will decide if Lioresal is the appropriate treatment for you.

Patients with liver problems

Your doctor's recommended dose may be lower.

Older patients

Your doctor may recommend a lower dose that will be increased gradually.

The dose prescribed by your doctor may be different from the one indicated in this leaflet. If that is your case, follow your doctor's instructions.

Your doctor will inform you of how many tablets you should take. Depending on how you respond to treatment, your doctor may recommend increasing or decreasing the dose.

Follow exactly the administration instructions for the medication contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

For how long should you take Lioresal

If after 6-8 weeks of treatment you do not notice improvement, inform your doctor. Your doctor will decide if you should or not continue treatment with Lioresal.

Continue taking Lioresal until your doctor tells you to.

If you have doubts about how long you should take Lioresal, consult your doctor or pharmacist.

If you take more Lioresal than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The main symptoms of overdose are drowsiness, breathing difficulties, altered consciousness, and coma.

Other symptoms may appear such as: feeling confused, hallucinations, agitation, convulsions, blurred vision, unusual muscle weakness, sudden muscle contraction, few or absent reflexes, high or low blood pressure, slow, fast, or irregular heartbeat, low body temperature, nausea, vomiting, diarrhea, excessive salivation, or ringing in the ears.

If you forget to take Lioresal

If you forget to take a dose, take it as soon as possible.

Do not take a double dose to compensate for the missed doses. Simply return to your regular administration schedule. If you forget to take several doses, you should contact your doctor.

If you interrupt treatment with Lioresal

Do not stop treatment with Lioresal abruptly without first consulting your doctor. Your doctor will indicate when and how you can stop taking this medication; stopping treatment abruptly can produce significant adverse effects. If your doctor decides to stop your treatment, he will do it gradually by reducing the dose progressively.

If you stop treatment with Lioresal suddenly, you may experience: nervousness, confusion, hallucinations, abnormal thoughts or behaviors, convulsions, uncontrollable tics, sudden movements or muscle spasms, abnormal muscle tone increase, tachycardia, increased body temperature. Excessive muscle tension (spasms) can even worsen.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

They are usually mild and often appear at the beginning of treatment and usually disappear within a few days.

In elderly patients, these adverse reactions may be more serious.

Some side effects can be serious

If you experience any of the following side effects, inform your doctor immediately:

• breathing problems,
• intense alteration in movement coordination and speech,
• skin eruptions, urticaria, and signs of hypersensitivity to the medication,
• agitated breathing at rest or during activity, leg inflammation, and fatigue (signs of decreased cardiac output).

If any of these symptoms affect you, inform your doctor immediately.

Some side effects are very common(may affect more than 1 in 10 patients):

• drowsiness,
• lethargy,
• nausea.

If you experience any of the mentioned effects severely, inform your doctor.

Some side effects are common(may affect up to 1 in 10 patients):

• fatigue,
• fatigue,
• dizziness,
• headache,
• difficulty sleeping,
• breathing problems,
• confusion,
• euphoria,
• depression (sadness),
• loss of coordination, affecting balance and walking, eye and limb movements, and/or speech (ataxia signs),
• tremors,
• hallucinations,
• nightmares,
• blurred vision/vision disturbances,
• heart problems,
• low blood pressure (hypotension),
• difficulty urinating, painful urination, or sudden decrease in urine output,
• seizures,
• weakness in arms and legs,
• muscle pain,
• uncontrollable eye movement,
• dry mouth,
• gastrointestinal problems,
• hiccups,
• vomiting.
• constipation,
• diarrhea,
• increased sweating,
• increased urine volume,
• nocturnal incontinence.

If you experience any of the previously mentioned effects severely, inform your doctor.

Some side effects are rare(may affect up to 1 in 1,000 patients):

• tingling or numbness in hands and/or feet,
• difficulty speaking,
• gustatory disturbances,
• abdominal pain,
• sudden decrease in urine output,
• impossibility of achieving or maintaining an erection (impotence),
• abdominal, skin, or eye yellowing (liver disorder signs).

Some side effects are very rare(may affect fewer than 1 in 10,000 patients):

• low body temperature.

Adverse effects of unknown frequency have been reported(cannot be estimated from available data):

• increased blood sugar levels,
• slow heart rate,
• itching,
• withdrawal syndrome,
• skin eruptions and urticaria,
• the symptoms that occur after abrupt discontinuation of treatment (withdrawal syndrome*) have been described in section 3,
• difficulty breathing during sleep (sleep apnea syndrome),
• swelling of ankles, feet, or lower legs,
• swelling of the face,
• allergic reaction (hypersensitivity),
• hair loss,
• sexual problems,
• cerebral function decrease (encephalopathy).

*Postnatal convulsions have been reported after intrauterine exposure to oral Lioresal as a withdrawal syndrome

If you experience any of the previously mentioned effects severely, inform your doctor.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

“Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.”

Composition of Lioresal 25 mg tablets

• The active ingredient is baclofen. Each tablet contains 25 mg of baclofen.
• The other components (excipients) are: anhydrous colloidal silica, microcrystalline cellulose, magnesium stearate, povidone, wheat starch.

Appearance of the product and contents of the packaging

White, round, flat tablets with slightly beveled edges, which have the inscription “CG” on one face and the letters “U” and “R” on either side of the groove on the other face. The groove is only for splitting and facilitating swallowing, but not for dividing into equal doses.

Each package contains 30 tablets.

Marketing authorization holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes 764

08013 Barcelona

Spain

Responsible for manufacturing

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Novartis Farmacéutica, S.A.

Gran Vía de les Corts Catalanes, 764

08013 Barcelona

Spain

Last review date of this leaflet:September 2024

Other sources of information

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.