Package Insert: Information for the User

Robaxisal Compound 380 mg/300 mg Tablets

Metocarbamol/Paracetamol

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 only for you, 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.

1.What is Robaxisal Compound and what is it used for

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

3. How to take Robaxisal Compound

4. Possible adverse effects

5. Storage of Robaxisal Compound

6. Contents of the package and additional information

Robaxisal compound is an associationofan analgesic and antipyretic (to reduce pain and fever) and a muscle relaxant.

Robaxisal compound provides relief from pain and muscle stiffness and serves as a treatment for painful muscle spasms.

The treatment with metocarbamol should be as short as possible. As painful symptoms disappear, your doctor will discontinue administration of the medication.

Do not takeRobaxisal compound:

• If you are allergic or sensitive to metocarbamol, paracetamol, or any of the other components of this medication (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 medications that contain paracetamol at the same time (for example, cold medications or other pain or fever medications).

Consult your doctor or pharmacist before starting to take Robaxisal:

• If you consume alcohol regularly (more than three alcoholic beverages per day).
• If you have chronic alcoholism, you should be careful not to take more than 2 g/day of paracetamol (maximum 6 tablets per day).
• If you have liver or kidney disease, as your doctor may need to adjust the dose, increase the time between doses, and remind you to not prolong treatment more 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 epilepsy medications. See below:Use of Robaxisal compound with other medications. When used together, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially in high-dose paracetamol treatments.

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 damage to organs), or if you have chronic malnutrition, alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Interference with diagnostic tests

Inform your doctor if you are to undergo any diagnostic tests, as this medication may alter the results.

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

Use of Robaxisal compound with other medications

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

Metocarbamol may interact with the following medications:

• Barbiturates (used for epilepsy or to help you sleep)
• Appetite suppressants (used to help you lose weight)
• Anticholinergics (used to relieve spasms or contractions of the intestines and bladder or for motion sickness)
• Psychotropic medications (used to treat anxiety, depression, or other mental disorders)
• Anesthetics (if you are to receive anesthesia for any reason, inform your doctor or dentist that you are taking this medication)
• Cholinesterase inhibitors (used to treat myasthenia gravis)

Paracetamol may interact with the following medications:

• Oral anticoagulants (used to treat thromboembolic diseases)
• Antiepileptic medications (used to treat seizures)
• Antibiotics (cloranfenicol, 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 to relieve spasms or contractions of the intestines and bladder)
• Zidovudine (used to treat HIV infections)
• Colestiramine (used to reduce blood cholesterol levels)

Do not use with other analgesics (pain medications) without consulting your doctor.

Inform your doctor or pharmacist if you are taking flucloxacillin (antibiotic), as there is a serious risk of blood and fluid alteration (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 medication. Alcohol may potentiate the depressant effect of metocarbamol on the central nervous system. The use of paracetamol in patients who consume alcohol regularly (three or more alcoholic beverages per day: beer, wine, liquor...) may cause liver damage.

Pregnancy and breastfeeding

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

Pregnancy

This medication is not recommended during pregnancy. If you discover you are pregnant during treatment, consult your doctor immediately, so they can adapt the treatment 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 time possible.

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

Breastfeeding

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

Driving and operating machinery

You may feel drowsiness with this medication, so do not drive or operate machinery until you check that this medication does not affect you, especially if you have consumed alcohol or are also taking other medications that may cause drowsiness.

Follow exactly the administration instructions of this medication as 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, four to six times a day, according to the severity of symptoms. Do not take more than 12 tablets in 24 hours and the interval between doses will not be less than 4 hours.

Older patients

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

Patients with liver and kidney problems

A longer interval between tablet doses may be necessary.

Follow strictly the recommendations given by your doctor (see section 2. What you need to know before starting to take Robaxisal compuesto).

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

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

Use in children and adolescents

It is not recommended for use in children or adolescents under 18 years old, due to the lack of safety and efficacy data in this population.

This medication is administered orally.

The groove is only for breaking the tablet if it is difficult to swallow it whole.

Swallow the tablets without chewing, with a sufficient amount of liquid.

The treatment with this medication 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 contractures. As these symptoms disappear, your doctor will discontinue the medication.

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

If you estimate that the action of Robaxisal compuesto is too strong or too weak, inform your doctor or pharmacist.

If you take more Robaxisal compuesto than you should

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

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

If you forget to take Robaxisal compuesto

Do not take a double dose to compensate for the missed doses. If you are sure you have forgotten to take a tablet, try to take it as soon as possible and continue taking the medication normally. Always leave a 4-hour interval before taking another tablet. In case of doubt, consult your doctor or pharmacist.

If you interrupt treatment with Robaxisal

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.

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

• Allergic reactions ranging from a simple skin rash or urticaria to more severe reactions such as anaphylactic reaction or angioedema (rash, itching, swelling of the extremities, face, lips, mouth, or throat, which may cause difficulty swallowing or breathing) or severe skin reactions.
• Jaundice (yellow discoloration of the skin and the white of the eyes), indicating a liver problem.
• If you experience an infection with symptoms such as fever and pain, call your doctor immediately, as it may indicate a change in white blood cells or platelets in the blood that reduces your 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;
• Decreased blood pressure, metallic taste, increased liver transaminases;
• Fever, general discomfort.

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, skin redness (flushing);
• Renal toxicity (dark urine);
• Difficulty breathing.

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

• Mild muscle incoordination, memory loss, vertigo, insomnia, double vision;
• Pyrosis (heartburn), dry mouth, fatigue, diarrhea.
• A severe disease that may make the blood more acidic (designated metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting side 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.

This medication does not require special storage conditions. Store in the original packaging.

Medications should not be disposed of through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Robaxisal compound 380 mg/300 mg tablets

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

Appearance of the product and content of the packaging

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

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

O

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Last review date of this leaflet: January 2025

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