Package Insert: Information for the Patient

Baclofen Combix10 mg Tablets

Read this 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 who 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.

Baclofeno Combix 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 children and 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 Baclofeno Combix

• if you are allergic to baclofeno or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Baclofeno Combix:

• 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 baclofeno is the appropriate treatment for you,
• if you have difficulty urinating,
• if you are diabetic,
• if you are pregnant and taking baclofeno during pregnancy, the newborn may experience seizures and other symptoms related to the sudden interruption of treatment just after birth (see "If you stop taking Baclofeno Combix" and "Pregnancy, breastfeeding, and fertility"). Your doctor may need to administer small doses of baclofeno 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 baclofeno dose,
• if you have a history of drug abuse or dependence.

Some people treated with baclofeno 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 Baclofeno Combix.

Cases of decreased brain function (encephalopathy) have been reported in some patients taking baclofeno 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 baclofeno treatment.

Other safety measures

Inform your doctor before undergoing any surgical intervention (including dental procedures) or emergency treatment that you are taking baclofeno.

Children and adolescents

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

The experience with the use of baclofeno in children under one year is very limited.

Other medications and Baclofeno Combix

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

There are some medications that interfere with the action of baclofeno, potentially increasing adverse effects or reducing the efficacy of this medication:

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

Taking Baclofeno Combix with food, drinks, and alcohol

Take this medication with meals and a little liquid. Do not take alcohol during baclofeno 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 medication.

Pregnancy

Do not use this medication during pregnancy unless your doctor tells you otherwise. Your doctor will assess whether you can take this medication during pregnancy and inform you about the possible risks. If you need to take baclofeno during pregnancy, your baby may experience seizures and other symptoms related to the sudden interruption of treatment just after birth (see "If you stop taking Baclofeno Combix" and "Warnings and precautions").

Breastfeeding

Baclofeno passes in very small amounts to breast milk. This medication should not be used during breastfeeding unless your doctor tells you otherwise. In this case, your doctor will inform you about the possible effects this medication may have on the child.

Fertility

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

Driving and operating machinery

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

Baclofeno Combix contains sodium

This medication contains less than 23 mg (1 mmol) of sodium per tablet; it is essentially "sodium-free".

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

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

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

Make sure you take the medication every day as your doctor has indicated. 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 increased progressively to achieve the desired results; this can be at doses between 30 and 80 mg per day, divided between 2 to 4 times. Your doctor may decide to administer even higher doses.

Use in children and 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. Then the dose should be increased cautiously at intervals of one week to reach the sufficient dose to cover individual needs of the child, 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 Baclofeno Combix 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 baclofen 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 reducing the dose.

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

For how long should you take Baclofeno Combix

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 baclofen.

Continue taking baclofen until your doctor tells you to.

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

If you take more Baclofeno Combix 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 contractions, 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 Baclofeno Combix

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 Baclofeno Combix

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

If you stop treatment with baclofen suddenly, you may experience: nervousness, confusion, hallucinations, abnormal thoughts or behaviors, convulsions, uncontrollable tics, sudden movements or twitching, tachycardia, increased body temperature. Excessive muscle tension 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 severe.

Some side effects can be serious

Inform your doctor immediately if you experience any of the following side effects:

• 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).

Inform your doctor immediately if any of these symptoms affect you.

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

• drowsiness,
• drowsiness,
• nausea.

Inform your doctor if you experience any of the mentioned side effects severely.

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,
• digestive tract problems,
• hiccups,
• vomiting,
• constipation,
• diarrhea,
• increased sweating,
• increased urine volume,
• nocturnal incontinence.

Inform your doctor if you experience any of the mentioned side effects severely.

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

• tingling or numbness in hands and/or feet,
• difficulty speaking,
• disturbances in taste,
• 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(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)
• decreased brain function (encephalopathy).

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

Inform your doctor if you experience any of the mentioned side effects severely.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines 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.

Medications 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. By doing so, you will help protect the environment.

Composition of Baclofeno Combix

• The active ingredient is baclofen. Each tablet contains 10 mg of baclofen.
• The other components are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, pregelatinized starch, sodium carboxymethyl starch type A (from potato), povidone, and magnesium stearate.

Appearance of the product and content of the container

Round, biconvex tablet with beveled edges, white or almost white in color, scored on one face and engraved with a "10" on the other. The diameter of the tablet is approximately 7 mm. The tablet can be divided into equal doses.

The tablets are presented in blisters, available in containers of 30 tablets.

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

O

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

O

Netpharmalab Consulting Services, S.L.

Carretera de Fuencarral 22

28108 Alcobendas, Madrid

Spain

O

Pharmex Advanced Laboratories S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

O

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

O

Misom Labs Ltd.

Malta Life Sciences Park

LS2.01.06

Industrial Estate

San Gwann, SGN 3000

Malta

Last review date of this leaflet:September 2024

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