BACLOFEN COMBIX 10 mg TABLETS

2. What you need to know before taking Baclofen Combix

Do not take Baclofen Combix

• if you are allergic to baclofen 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 Baclofen 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 intestine, cerebral circulation disorders, breathing problems, or liver disease,
• if you have kidney disease. Your doctor will decide if baclofen is the appropriate treatment for you,
• if you have difficulty urinating,
• if you are diabetic,
• if you are pregnant and taking baclofen during pregnancy, the newborn may experience seizures and other symptoms related to the sudden interruption of treatment after birth (see "If you stop taking Baclofen Combix" and "Pregnancy, Breastfeeding, and Fertility"). Your doctor may need to administer small doses of baclofen 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 baclofen,
• 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 observe any worrying changes in your behavior and ask them to read this package leaflet.

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

There have been reports of decreased brain function (encephalopathy) in some patients taking baclofen 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 baclofen.

Children and Adolescents

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

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

Other Medications and Baclofen Combix

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

There are some medications that interfere with the action of baclofen, which may increase side effects or decrease the effectiveness of this medication:

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

Taking Baclofen Combix with Food, Drinks, and Alcohol

Take this medication during meals with a little liquid. You should not drink alcohol during treatment with baclofen.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should not use this medication during pregnancy unless your doctor advises you to do so. Your doctor will assess whether you can take this medication during pregnancy and inform you about the possible risks. If you need to take baclofen during pregnancy, your baby may experience seizures and other symptoms related to the sudden interruption of treatment after birth (see "If you stop taking Baclofen Combix" and "Warnings and Precautions").

Breastfeeding

Baclofen passes into breast milk in very small amounts. This medication should not be used during breastfeeding unless your doctor advises you to do so. In this case, your doctor will inform you about the possible effects on the baby.

Fertility

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

Driving and Using Machines

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

Baclofen Combix contains Sodium

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

3. How to take Baclofen Combix

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

Baclofen 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 each day, and it will help you remember when you should take it.

Make sure you take the medication 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 may 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 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 until the sufficient dose is reached to cover the individual needs of the child, which is 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.

The tablets of Baclofen Combix 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 undergoing hemodialysis, your dose may be lower, and your doctor will decide if baclofen is the appropriate 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 package leaflet. If that is the case, follow your doctor's instructions.

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

Follow the instructions for administration of the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

How long should you take Baclofen Combix

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

Continue taking baclofen until your doctor tells you to stop.

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

If you take more Baclofen 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, changes in consciousness, and coma.

Other symptoms may appear, such as: feeling confused, hallucinations, agitation, seizures, 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 Baclofen Combix

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 Baclofen 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; sudden discontinuation of treatment may 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 baclofen suddenly, you may experience: nervousness, confusion, hallucinations, abnormal thoughts or behaviors, seizures, uncontrolled tics, sudden muscle movements or cramps, tachycardia, increased body temperature. Excessive muscle tension (spasms) may even worsen.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience 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 experience any of the following side effects, inform your doctor immediately:

• breathing problems,
• severe coordination and speech disorders,
• skin rashes, hives, and signs of hypersensitivity to the medication,
• agitated breathing at rest or during activity, swelling of the legs, 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,
• sleepiness,
• 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,
• tiredness,
• 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, painful urination, 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 effects severely, 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 with unknown frequency(cannot be estimated from available data):

• increased blood sugar levels,
• slow heart rate,
• itching,
• withdrawal syndrome,
• skin rash and hives,
• the symptoms that occur after sudden discontinuation of treatment (withdrawal syndrome*) have been described in section 3,
• difficulty breathing during sleep (sleep apnea syndrome)
• decreased brain function (encephalopathy).

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

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

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Baclofen Combix

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

Do not use this medication after the expiration date stated 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 wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

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 (potato), povidone, and magnesium stearate.

Appearance of the Product and Packaging Content

Round, biconvex tablet, with beveled edges, white or almost white in color, scored on one side 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 packs of 30 tablets.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

Or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

Or

Netpharmalab Consulting Services, S.L.

Carretera de Fuencarral 22

28108 Alcobendas, Madrid

Spain

Or

Pharmex Advanced Laboratories S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

Or

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

Or

Misom Labs Ltd.

Malta Life Sciences Park

LS2.01.06

Industrial Estate

San Gwann, SGN 3000

Malta

Date of the Last Revision of this Prospectus:September 2024

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/)