Lioresal 10 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lioresal 10 mg tablets

Baclofen

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet

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

1. What Lioresal is and what it is used for

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

Adults

It is used to reduce and relieve excessive muscle stiffness (spasms) occurring in certain diseases such as multiple sclerosis, stroke, spinal cord disorders, and other nervous system disorders.

Use in children and adolescents

It is used in patients from 0 to 18 years of age for the symptomatic treatment of muscle stiffness (spasms), particularly when due to cerebral palsy, stroke, degenerative brain diseases, infectious diseases of the spinal cord, and other disorders of the nervous system.

2. What you need to know before taking Lioresal

Do not take Lioresal

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Lioresal:

• if you have Parkinson's disease or any mental illness associated with confusion or depression,
• if you suffer from epilepsy (seizures),
• if you have acute stomach pain (ulcer) or intestinal disorders, cerebral circulation disorders, breathing difficulties, or liver disease,
• if you have kidney disease. Your doctor will decide whether Lioresal is the appropriate treatment for you,
• if you have difficulty urinating,
• if you are diabetic,
• if you are pregnant and take Lioresal during pregnancy, the newborn may experience seizures and other symptoms related to sudden withdrawal of treatment immediately 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 manage and prevent symptoms,
• do not stop treatment without consulting your doctor,
• if maintaining posture, balance, or circulatory function is required, your doctor will adjust your dose accordingly,
• if you are elderly or have cerebrovascular disease, your doctor will monitor you closely and may need to adjust your Lioresal dosage,
• if you have a history of drug abuse or dependence.

Some patients treated with baclofen have had thoughts of self-harm or suicide, or have attempted suicide. Most of these patients also had depression, had consumed excessive alcohol, or were prone to suicidal thoughts. If at any time you have thoughts of self-harming or suicide, speak to your doctor or go to a hospital immediately. In addition, ask a close family member or friend to inform you if they notice any worrying changes in your behaviour, and ask them to read this leaflet.

If you are in any of these situations, inform your doctor before starting Lioresal.

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

If you experience any of these symptoms, inform your doctor immediately. Your doctor will decide whether treatment with baclofen should be discontinued.

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

Lioresal tablets are not recommended for children weighing less than 33 kg or for 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

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

Some medicines interfere with the action of Lioresal, potentially increasing adverse effects or reducing the effectiveness of Lioresal:

• medicines (opioids such as morphine) and substances that inhibit the central nervous system (alcohol),
• medicines used to treat mood disorders such as tricyclic antidepressants or lithium, as movement disorders may occur,
• medicines that lower blood pressure, including those used to treat high blood pressure. When taken together with Lioresal, blood pressure may decrease,
• medicines used to treat Parkinson's disease (carbidopa, levodopa), as nervous system disturbances 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 and with some liquid. You must 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not use this medicine during pregnancy unless your doctor specifically instructs you to do so. Your doctor will assess whether you can take this medicine during pregnancy and will inform you of any potential risks. If you must take Lioresal during pregnancy, your baby may have seizures and other symptoms related to sudden withdrawal of treatment immediately after birth (see “If you stop taking Lioresal” and “Warnings and precautions”).

Breastfeeding

The active substance in Lioresal passes into breast milk in very small amounts. This medicine should not be used during breastfeeding unless your doctor advises it. In such a case, your doctor will inform you about the possible effects this medicine may have on the infant.

Fertility

There are no data available on the effect of baclofen on fertility in humans.

Driving and using machines

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

Important information about some ingredients of Lioresal

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

One Lioresal 10 mg tablet contains no more than 6.1 micrograms of gluten.

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

3. How to take Lioresal

Follow exactly the instructions for use of this medicine provided 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 small amount of liquid. The tablet may be divided into equal doses.

Take Lioresal at the same time every day; this will help you remember when to take the medicine.

Make sure you take the medicine every day as directed by your doctor. This will help you achieve the best results and reduce the risk of adverse reactions.

The recommended dose is:

Adults:

Treatment is usually started at 15 mg per day, preferably in divided doses of 2 to 3 times daily. The dose will be gradually increased until the desired effect is achieved; this may be at doses between 30 and 80 mg per day, divided into 2 to 4 doses. Your doctor may decide to prescribe even higher doses.

Use in children and adolescents

Treatment in children should be adjusted according to body weight. The recommended starting dose for children is usually very low (approximately 0.3 mg/kg per day), given in two divided doses. The dose should then be cautiously increased at weekly intervals until the dose sufficient to meet the individual child's needs is reached, which is typically between 0.75 and 2 mg/kg body weight. The total daily dose must 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 must not exceed 60 mg/day.

Lioresal tablets are not suitable for use in children weighing less than 33 kg or in children under 6 years of age.

Patients with renal problems

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

Patients with hepatic problems

The dose recommended by your doctor may be lower.

Elderly patients

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

The dose prescribed by your doctor may differ from that stated in this leaflet. If this is the case, follow your doctor's instructions.

Your doctor will inform you how many tablets to take. Depending on your response to treatment, your doctor may recommend increasing or reducing the dose.

Follow exactly the instructions for use of the medicine contained in this leaflet or those provided by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

How long should you take Lioresal?

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

Continue taking Lioresal until your doctor tells you otherwise.

If you have any 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the name of the medicine and the amount ingested.

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

Other symptoms may include: confusion, hallucinations, agitation, seizures, blurred vision, unusual muscle weakness, sudden muscle contractions, reduced 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 make up for missed doses. Simply return to your regular dosing schedule. If you have missed 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 advise you when and how you can stop taking this medicine. Stopping treatment suddenly may cause serious adverse 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: restlessness, confusion, hallucinations, abnormal thoughts or behavior, seizures, uncontrollable tics, jerking movements or twisting spasms, abnormally increased muscle tone, tachycardia, and increased body temperature. Excessive muscle tension (spasms) may even worsen.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

Some adverse effects can be serious

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

• breathing difficulties,
• severe impairment in motor coordination and speech,
• skin rash, hives, and signs of hypersensitivity to the medicine,
• rapid breathing at rest or during activity, swelling of the legs, and fatigue (signs of reduced cardiac output).

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

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

• drowsiness,
• sopor,
• nausea.

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

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

• tiredness,
• fatigue,
• dizziness,
• headache,
• difficulty sleeping,
• breathing problems,
• confusion,
• euphoria,
• sadness (depression),
• loss of coordination, affecting balance, gait, 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 disturbances,
• retching,
• vomiting,
• constipation,
• diarrhea,
• increased sweating,
• increased urine volume,
• nocturnal incontinence.

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

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

• tingling or numbness in hands and/or feet,
• difficulty speaking,
• taste disturbances,
• abdominal pain,
• sudden decrease in urine output,
• inability to achieve or maintain an erection (impotence),
• abdominal pain, yellowing of the skin or eyes (signs of liver disorder).

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

• low body temperature.

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

• increased blood sugar levels,
• slow heart rate,
• itching,
• withdrawal syndrome,
• skin rash and hives,
• symptoms occurring after abrupt discontinuation of treatment (withdrawal syndrome*) are described in section 3,
• difficulty breathing during sleep (sleep apnoea syndrome),
• swelling of ankles, feet, or lower legs,
• facial swelling,
• allergic reaction (hypersensitivity),
• hair loss,
• sexual problems,
• decreased brain function (encephalopathy).

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

If you experience any of the above-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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lioresal

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

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

No special storage conditions are required.

"Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment."

6. Contents of the package and other information

Composition of Lioresal 10 mg tablets

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

Appearance of the medicine and contents of the pack

White, round, flat tablets with slightly beveled edges, marked on one side with the inscription “CG” and on the other side with the letters “K” and “J” on either side of the score. The tablet can be divided into equal doses.

Each pack 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 most recent revision of this leaflet: September 2024

Other sources of information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es.