ROBAXISAL COMPOUND 380 mg / 300 mg TABLETS

2. What you need to know before you take Robaxisal Compound

Do not takeRobaxisal Compound:

• If you are allergic or sensitive to metocarbamol, paracetamol, or any of the other components of this medicine (listed in section 6).
• If you have any brain disease.
• If you have ever suffered brain damage or have been in a coma.
• If you suffer from epilepsy or have seizures.
• If you have muscle weakness (or a disease called myasthenia gravis).

Warnings and precautions

Do not take more than the recommended dose in section 3. How to take Robaxisal Compound. Check that you are not taking other medicines that contain paracetamol (e.g., cold medicines or other pain or fever medicines).

Consult your doctor or pharmacist before starting to take Robaxisal:

• If you regularly consume alcohol (more than three alcoholic drinks per day).
• If you have chronic alcoholism, you should be cautious not to take more than 2 g/day of paracetamol (maximum 6 tablets per day).
• If you have liver or kidney disease, your doctor may adjust the dose, increase the time between doses, and insist that it is essential not to prolong treatment longer than necessary.
• If you have anemia or any heart or lung disease.
• If you are asthmatic and sensitive to acetylsalicylic acid.
• If you are being treated with medicines for epilepsy. See below: Use of Robaxisal Compound with other medicines. When used at the same time, the efficacy is decreased, and the hepatotoxicity of paracetamol is potentiated, especially in high-dose paracetamol treatments.

During treatment with Robaxisal, inform your doctor immediately if you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Interference with laboratory tests

If you are going to have any diagnostic tests, inform your doctor that you are taking this medicine, as it may alter the results.

Paracetamol may alter the values of uric acid and glucose determinations.

Use of Robaxisal Compound with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine, including those obtained without a prescription.

Metocarbamol may interact with the following medicines:

• Barbiturates (used for epilepsy or to help you sleep)
• Appetite suppressants (used to help with weight loss)
• Anticholinergics (used for relief of spasms or contractions of the intestine and bladder or for motion sickness)
• Psychotropic medicines (used to treat anxiety, depression, or other mental illnesses)
• Anesthetics (if you are going to receive anesthesia for any reason, inform your doctor or dentist that you are taking this medicine)
• Anticholinesterases (used to treat myasthenia gravis)

Paracetamol may interact with the following medicines:

• Oral anticoagulants (used to treat thromboembolic diseases)
• Antiepileptics (used to treat epileptic seizures)
• Antibiotics (chloramphenicol, flucloxacillin)
• Contraceptives
• Diuretics (used to increase urine elimination)
• Isoniazid (used to treat tuberculosis)
• Metoclopramide and domperidone (used to treat vomiting)
• Probenecid (used to treat gout)
• Propranolol (used to treat hypertension, cardiac arrhythmias)
• Rifampicin (used to treat tuberculosis)
• Anticholinergics (used for relief of spasms or contractions of the intestine and bladder)
• Zidovudine (used to treat HIV infections)
• Colestyramine (used to decrease cholesterol levels in the blood)

Do not use with other analgesics (pain-relieving medicines) without consulting your doctor.

Inform your doctor or pharmacist if you are taking flucloxacillin (an antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis) that requires urgent treatment (see section 2).

Use of Robaxisal Compound with food, drinks, and alcohol

You should avoid drinking alcohol while taking this medicine. Alcohol can potentiate the depressor effect of metocarbamol on the central nervous system. The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day: beer, wine, liquor...) can cause liver damage.

Pregnancy and breastfeeding

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

The use of this medicine is not recommended during pregnancy. If you discover that you are pregnant during treatment, consult your doctor immediately, so that the treatment can be adjusted to your condition.

If necessary, Robaxisal can be used during pregnancy. You should use the lowest dose that reduces pain or fever and use it for the shortest possible time.

Contact your doctor if the pain or fever does not decrease or if you need to take the medicine more frequently.

Breastfeeding

Women who are breastfeeding should consult their doctor before using this medicine. Your doctor will discuss with you whether you should breastfeed your baby. Metocarbamol and/or its metabolites have been detected in milk in dogs, but it is not known if metocarbamol or its metabolites are excreted in human breast milk. Paracetamol is excreted in breast milk, but not in a clinically significant amount.

Driving and using machines

You may feel drowsy with this medicine, so it is not recommended that you drive or operate machinery until you check that this medicine does not affect you. This is especially important if you have consumed alcohol or are also using other medicines that can cause drowsiness.

3. How to take Robaxisal Compound

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended doses are:

Adults

The recommended dose is 2 tablets, 4 to 6 times a day, depending on the severity of the symptoms. Do not take more than 12 tablets in 24 hours, and the interval between doses should not be less than 4 hours.

Elderly patients

Older patients may need a lower dose to obtain the same pain relief and muscle spasm relief. It is recommended to take 1 tablet, 4 times a day.

Patient with liver and kidney problems

A longer interval between tablet doses may be necessary.

Strictly follow the recommendations given by your doctor (see section 2. What you need to know before you take Robaxisal Compound).

Depending on the severity of your kidney problem, your doctor will indicate whether you should take 1 tablet every 6 or 8 hours.

If you have severe liver disease, do not take more than 6 tablets in 24 hours.

Use in children and adolescents

Its use is not recommended in children or adolescents under 18 years of age due to the lack of safety and efficacy data in this population.

This medicine is administered orally.

The score line is only for breaking the tablet if you find it difficult to swallow it whole.

Swallow the tablets without chewing, with enough liquid.

Treatment with this medicine should be as short as possible. Your doctor will determine the duration of treatment, which will be conditioned by the appearance of painful symptoms or muscle contracture. As these disappear, your doctor will stop the medication.

Remember to take your medicine. Do not exceed the recommended dose.

If you think the effect of Robaxisal Compound is too strong or too weak, tell your doctor or pharmacist.

If you take more Robaxisal Compound than you should

If you have taken more Robaxisal Compound than you should, consult your doctor or pharmacist immediately or go to the nearest hospital, taking the remaining tablets with you to inform the doctor.

In case of overdose or accidental ingestion, call the Toxicology Information Service. Phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Robaxisal Compound

Do not take a double dose to make up for forgotten doses. If you are sure you have forgotten to take a tablet, try to take it as soon as possible and continue taking the medicine normally. Always leave a period of 4 hours before taking another tablet. In case of doubt, consult your doctor or pharmacist.

If you stop taking Robaxisal Compound

If you have any other questions 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.

If any of the following reactions occur, stop treatment and inform your doctor immediately:

• Allergic reactions that range from a simple skin rash or hives to more severe reactions such as anaphylactic reaction or angioedema (rash, itching, swelling of the limbs, face, lips, mouth, or throat, which can cause difficulty swallowing or breathing) or severe skin reactions.
• Jaundice (yellowing of the skin and the whites of the eyes), which indicates a liver problem.
• If you experience an infection with symptoms such as fever and pain, call your doctor immediately, as it may be indicative of an alteration of white blood cells or blood platelets that reduces resistance to infections.
• Seizures or fainting (syncope).

The following side effects may occur rarely (may affect up to 1 in 1,000 people):

• headache, dizziness, or feeling of dizziness;
• conjunctivitis with nasal congestion;
• decrease in blood pressure, metallic taste, increase in liver transaminases;
• fever, general malaise.

The following side effects may occur very rarely (may affect up to 1 in 10,000 people):

• nausea, vomiting;
• nervousness, anxiety, confusion, tremor, drowsiness, blurred vision, nystagmus (rapid, involuntary eye movements);
• low blood sugar levels, decreased heart rate, flushing of the skin (redness);
• kidney toxicity (dark urine);
• difficulty breathing.

The following effects have been reported, but their frequency cannot be estimated from the available data (frequency not known):

• mild muscle incoordination, memory loss, vertigo, insomnia, double vision;
• heartburn (heartburn), dry mouth, fatigue, diarrhea.
• a severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect 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. Storage of Robaxisal Compound

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.

This medicine does not require special storage conditions. Store in the original package.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Robaxisal Compound 380 mg/300 mg Tablets

• The active ingredients are metocarbamol and paracetamol. Each tablet contains 380 mg of metocarbamol and 300 mg of paracetamol.
• The other ingredients are: stearic acid, pregelatinized corn starch, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica, povidone, glycerol distearate, sodium carboxymethyl potato starch, and talc.

Appearance of the product and pack contents

Robaxisal Compound 380 mg/300 mg Tablets are white, round, biconvex, and scored on one side. They are packaged in PVC-Aluminum blisters, in packs of 50 tablets.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Or

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the last revision of this leaflet:January 2025

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