Baclofen Combix 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Baclofen Combix 10 mg tablets EFG

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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Baclofeno Combix is and what it is used for

Baclofeno Combix belongs to a group of medicines called 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 conditions.

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 starting to take Baclofeno Combix

Do not take Baclofeno Combix

• if you are allergic to baclofen or to any of the other ingredients of this medicine (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 disorders, cerebral circulation disorders, breathing difficulties, or liver disease,
• if you have kidney disease. Your doctor will decide whether baclofen is the appropriate treatment for you,
• if you have difficulty urinating,
• if you are diabetic,
• if you are pregnant and take baclofen during pregnancy, the newborn may experience seizures and other symptoms related to sudden withdrawal of treatment immediately after birth (see “If you stop taking Baclofeno 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 maintaining posture, balance, or circulatory function is necessary, 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 baclofen dose,
• 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, excessive alcohol consumption, 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. Also, 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 Baclofeno Combix.

Cases of impaired brain function (encephalopathy) have been reported in some patients taking baclofen 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 stopped.

Other safety measures

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

Children and adolescents

The use of baclofen tablets is not recommended in children weighing less than 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 medicines and Baclofeno Combix

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

Some medicines may interfere with the action of baclofen, potentially increasing adverse effects or reducing the effectiveness of this medicine:

• 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 used to treat high blood pressure. When taken together with baclofen, 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 Baclofeno Combix with food, drinks and alcohol

Take this medicine during meals and 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 medicine.

Pregnancy

You should 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 baclofen during pregnancy, your baby may have seizures and other symptoms related to sudden withdrawal of treatment immediately after birth (see “If you stop taking Baclofeno Combix” and “Warnings and precautions”).

Breastfeeding

Baclofen passes into breast milk in very small amounts. This medicine should not be used during breastfeeding unless your doctor advises it. In such 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

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

Baclofeno Combix contains sodium

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

3. How to take Baclofeno Combix

Follow exactly the instructions for use of this medicine as given by your doctor. If in 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 may be divided into equal doses.

Take this medicine at the same time every day, which will help you remember when to take it.

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.

Recommended dose

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 dose for children usually starts at a very low dose (approximately 0.3 mg/kg per day), divided into 2 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 between 0.75 and 2 mg/kg. 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.

Baclofeno Combix tablets are not suitable for use in children weighing less than 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 whether baclofen is the appropriate treatment for you.

Patients with liver 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 you should 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 provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

How long to take Baclofeno Combix

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 baclofen.

Continue taking baclofen for as long as your doctor instructs.

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

The main symptoms of overdose are drowsiness, breathing difficulties, disturbances in 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 Baclofeno Combix

If you miss 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 must contact your doctor.

If you stop taking Baclofeno Combix

Do not stop treatment with baclofen abruptly without first consulting your doctor. Your doctor will tell you when and how you can stop taking this medicine. Stopping treatment abruptly 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 baclofen treatment suddenly, you may experience: nervousness, confusion, hallucinations, abnormal thoughts or behavior, seizures, uncontrollable tics, jerky movements or spasms, tachycardia, increased body temperature. Muscle stiffness (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:

• difficulty breathing,
• severe impairment in coordination of movements 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 above 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 during urination, or sudden decrease in urine volume,
• seizures,
• weakness in arms and legs,
• muscle pain,
• uncontrolled eye movements,
• dry mouth,
• gastrointestinal disorders,
• retching,
• vomiting,
• constipation,
• diarrhea,
• increased sweating,
• increased urine volume,
• nocturnal incontinence.

If you experience any of the above 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 volume,
• 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),
• decreased brain function (encephalopathy).

*Postnatal seizures following intrauterine exposure to oral baclofen have been reported as part of withdrawal syndrome.

If you experience any of the above 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Baclofen Combix

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 refers to 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 empty containers and unused medicines at the SIGRE Point located at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Baclofeno Combix

• The active substance 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 contents of the pack

Round, biconvex tablet with bevelled edges, white or almost white in colour, scored on one side and marked with "10" on the other. The tablet diameter 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 Authorisation 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 most recent revision of this leaflet: September 2024

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