LIORESAL 10 mg TABLETS

2. What you need to know before you take Lioresal

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 intestine, cerebral circulation disorders, breathing problems, or liver disease,
• if you have kidney disease. Your doctor will decide if Lioresal is the right treatment for you,
• if you have difficulty urinating,
• if you are diabetic,
• if you are pregnant and taking Lioresal during pregnancy, the newborn may suffer from seizures and other symptoms related to the abrupt interruption of treatment just after birth (see "if you stop taking 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 it is necessary 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 the dose of Lioresal,
• 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, had consumed excessive alcohol, or were prone to having suicidal thoughts. If at any time you think about self-harm or suicide, talk to your doctor or go to a hospital immediately. Also, ask a family member or close friend to inform you if they notice any worrying change 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.

There have been reports of decreased brain function (encephalopathy) in some patients taking Lioresal at the prescribed doses, which resolved after treatment was discontinued. The symptoms include increased sleepiness, 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 treatment with baclofen.

Other safety measures

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

Children and adolescents

It is not recommended to use Lioresal tablets in children with a weight below 33 kg or in children under 6 years of age.

Experience with the use of Lioresal in children under one year of age is very limited.

Taking Lioresal with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

There are some medicines that interfere with the action of Lioresal, which may increase side effects or decrease the effectiveness of Lioresal:

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

Taking Lioresal with food, drinks, and alcohol

Take Lioresal during meals with a little liquid. You should not drink alcohol during treatment with Lioresal.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 will inform you of the possible risks. If you need to take Lioresal during pregnancy, your baby may have seizures and other symptoms related to the abrupt interruption of treatment just after birth (see "if you stop taking Lioresal" and "Warnings and precautions").

Breastfeeding

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

Fertility

No data are available on the effect of baclofen on human fertility.

Driving and using machines

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

Important information about some of the ingredients of Lioresal

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

One Lioresal 10 mg tablet does not contain more than 6.1 micrograms of gluten.

If you have a wheat allergy (different from celiac disease), you should not take this medicine.

3. How to take Lioresal

Follow exactly the instructions of administration of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again. Do not exceed the recommended dose.

Lioresal should be taken during meals with a little liquid. The tablet can be divided into equal doses.

Take Lioresal always at the same time every day and it will help you remember when you should take the medicine.

Make sure you take the medicine every day as indicated by your doctor. This will help you get 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 gradually increased until the desired results are achieved; this can be at doses between 30 and 80 mg per day, divided into 2 to 4 times. Your doctor may decide to administer higher doses.

Use in children and adolescents

Treatment in children should be adjusted 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. Then the dose should be increased with caution at intervals of one week until the sufficient dose is reached to cover the individual needs of the child, which occurs between 0.75 and 2 mg/kg body weight. The total daily dose should not exceed a maximum of 40 mg/day in children under 8 years of age. In children over 8 years of age, the maximum daily dose should not exceed 60 mg/day.

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

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 right treatment for you.

Patients with liver problems

The recommended dose by your doctor may be lower.

Elderly patients

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

The dose prescribed by your doctor may be different from the one indicated in this leaflet. If that is the 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 reducing the dose.

Follow exactly the instructions of administration of the medicine contained in this leaflet or indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

How long to take Lioresal

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

Continue taking Lioresal until your doctor tells you to stop.

If you have any doubts about how long to 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

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

Other symptoms may appear, such as: feeling confused, hallucinations, agitation, seizures, blurred vision, unusual muscle weakness, sudden muscle contraction, few or no 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 make up for forgotten doses. Simply return to your regular administration schedule. If you forget to take several doses, you should contact your doctor.

If you stop taking Lioresal

Do not stop treatment with Lioresal abruptly without first consulting your doctor. Your doctor will tell you when and how you can stop taking this medicine; stopping treatment abruptly can cause important side effects. If your doctor decides to discontinue treatment, it will be done gradually by progressively reducing the dose.

If you stop taking Lioresal suddenly, you may experience: nervousness, confusion, hallucinations, abnormal thoughts or behaviors, seizures, uncontrolled tics, sudden muscle movements or spasms, abnormal increase in muscle tone, rapid heartbeat, increased body temperature. Excessive muscle tension (spasms) may even worsen.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

Some side effects can be serious

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

• breathing problems,
• severe changes in coordination and speech,
• skin rash, hives, and signs of hypersensitivity to the medicine,
• resting or exertional dyspnea, leg swelling, 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 side effects in a severe way, inform your doctor.

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

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

If you experience any of the mentioned side effects in a severe way, inform your doctor.

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

• tingling or numbness of hands and/or feet,
• difficulty speaking,
• taste disorders,
• abdominal pain,
• sudden decrease in urine output,
• impotence,
• abdominal pain, yellowing of the skin and eyes (signs of liver disorder).

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

• low body temperature.

Side effects of unknown frequency(cannot be estimated from the available data):

• increased blood sugar levels,
• slow heart rate,
• itching,
• withdrawal syndrome,
• skin rash and hives,
• 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 the ankles, feet, or lower legs,
• swelling of the face,
• allergic reaction (hypersensitivity),
• hair loss,
• sexual problems,
• decreased brain function (encephalopathy).

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

If you experience any of the mentioned side effects in a severe way, inform your doctor.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Lioresal

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

"Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.”

6. Packaging Content and Additional Information

Lioresal 10 mg Tablet Composition

• The active ingredient is baclofen. Each tablet contains 10 mg of baclofen.
• The other components (excipients) are: anhydrous colloidal silica, microcrystalline cellulose, magnesium stearate, povidone, wheat starch.

Product Appearance and Packaging Content

White, round, flat tablets with slightly beveled edges, featuring the inscription "CG" on one side and the letters "K" and "J" on either side of the score line on the other. The tablet can be divided 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

Manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes 764

08013 Barcelona

Spain

Novartis Farma S.p.A

Via Provinciale Schito, 131

Torre Annunziata, Naples

Italy

Date of the Last Revision of this Leaflet:September 2024

Other Sources of Information

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.