Robaxisal Compuesto 380 mg/300 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Robaxisal compuesto 380 mg/300 mg tablets

Metocarbamol/Paracetamol

Read the entire leaflet carefully before you start taking this medicine, as 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; do not give it to others, even if they have the same symptoms as you, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Robaxisal Compound is a combination of an analgesic and antipyretic (to reduce pain and fever) and a muscle relaxant.

Robaxisal Compound provides relief from muscle pain and stiffness and is used to treat painful muscle spasms.

Treatment with methocarbamol should be as short as possible. As the painful symptoms subside, your doctor will discontinue the medication.

2. What you need to know before taking Robaxisal compound

Do not take Robaxisal compound:

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

Warnings and precautions

Do not exceed the recommended dose stated in section 3, How to take Robaxisal compound. To avoid this, ensure you are not simultaneously taking other medicines containing paracetamol (e.g., cold remedies or other pain or fever medications).

Consult your doctor or pharmacist before taking Robaxisal:

• If you regularly consume alcohol (more than three alcoholic drinks per day).
• If you suffer from chronic alcoholism, you should take care not to exceed 2 g/day of paracetamol (maximum 6 tablets per day).
• If you have liver or kidney disease, as your doctor may need to adjust your dose, increase the interval between doses, and emphasize the importance of not prolonging treatment longer than necessary.
• If you have anaemia or any heart or lung disease.
• If you are an aspirin-sensitive asthmatic.
• If you are being treated with medications for epilepsy. See below: Use of Robaxisal compound with other medicines. When used together, the efficacy of methocarbamol may be reduced and the hepatotoxicity of paracetamol may be enhanced, especially with high-dose paracetamol regimens.

During treatment with Robaxisal, inform your doctor immediately if you develop serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an imbalance in blood and body fluids) has been reported in patients in these situations when paracetamol is used regularly at standard doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Interference with diagnostic tests

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

Paracetamol may affect analytical test results for uric acid and glucose.

Use of Robaxisal compound with other medicines

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

Methocarbamol may interact with the following medicines:

• Barbiturates (used for epilepsy or to help you sleep)
• Appetite suppressants (used to help lose weight)
• Anticholinergics (used to relieve spasms or contractions in the intestine and bladder, or for travel sickness)
• Psychotropic medicines (used to treat anxiety, depression, or other mental disorders)
• Anaesthetics (if you are to receive anaesthesia for any reason, inform your doctor or dentist that you are taking this medicine)
• Anticholinesterases (used in the treatment of myasthenia gravis)

Paracetamol may interact with the following medicines:

• Oral anticoagulants (used to treat thromboembolic disorders)
• Antiepileptics (used to treat epileptic seizures)
• Antibiotics (chloramphenicol, flucloxacillin)
• Oral 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 in the intestine and bladder)
• Zidovudine (used to treat HIV infections)
• Cholestyramine (used to lower blood cholesterol levels)

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 blood and fluid imbalance (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 may enhance the central nervous system depressant effect of methocarbamol. The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic drinks per day: beer, wine, spirits, etc.) may cause liver damage.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 you are pregnant while undergoing treatment, consult your doctor immediately so that your treatment can be adjusted accordingly.

If necessary, Robaxisal may be used during pregnancy. Use the lowest dose that relieves pain or fever, and use it for the shortest possible time.

Contact your doctor if pain or fever does not improve 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. Methocarbamol and/or its metabolites have been detected in milk in dogs; however, it is unknown whether methocarbamol or its metabolites are excreted in human breast milk. Paracetamol is excreted in breast milk, but not in clinically significant amounts.

Driving and using machines

This medicine may cause drowsiness. Therefore, you are advised not to drive or operate machinery until you know how this medicine affects you. This is especially important if you have consumed alcohol or are simultaneously using other medicines that may also cause drowsiness.

3. How to take Robaxisal compuesto

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended doses are:

Adults

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

Elderly patients

Elderly patients may require a lower dose to achieve the same relief from pain and muscle spasms. It is recommended to take 1 tablet four times a day.

Patients with liver or 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 starting to take Robaxisal compuesto).

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

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

Use in children and adolescents

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

This medicine is administered orally.

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

Swallow the tablets without chewing, with sufficient liquid.

Treatment with this medicine should be as short as possible. Your doctor will determine the duration of treatment, which will depend on the presence of painful symptoms or muscle contracture. As these symptoms subside, your doctor will discontinue the medication.

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

If you think that the effect 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, contact 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. Telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Robaxisal compuesto

Do not take a double dose to make up for a missed dose. If you are sure you have missed a dose, take it as soon as possible and then continue taking the medicine as directed. Always leave an interval of at least 4 hours before taking the next tablet. If in doubt, consult your doctor or pharmacist.

If you stop treatment with Robaxisal

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 will experience them.

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

• Allergic reactions ranging 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 may cause difficulty swallowing or breathing), or serious skin reactions.
• Jaundice (yellowing of the skin and whites of the eyes), indicating a liver problem.
• If you experience an infection with symptoms such as fever and pain, contact your doctor immediately, as this may indicate a disturbance in white blood cells or blood platelets, reducing your resistance to infections.
• Seizures or fainting (syncope).

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

• Headache, dizziness or feeling dizzy;
• Conjunctivitis with nasal congestion;
• Decrease in blood pressure, metallic taste, increased liver transaminases;
• Fever, general malaise.

The following adverse 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);
• 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, dizziness, insomnia, double vision;
• Heartburn (pyrosis), dry mouth, fatigue, diarrhea;
• A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 Robaxisal compuesto

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. 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 substances are metocarbamol and paracetamol. Each tablet contains 380 mg of metocarbamol and 300 mg of paracetamol.
• The other components are: stearic acid, pregelatinized corn starch, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica, povidone, glyceryl distearate, sodium carboxymethyl potato starch, and talc.

Description of the product and pack contents

Robaxisal Compound 380 mg/300 mg tablets are white, round, biconvex tablets, 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 most recent revision of this leaflet: January 2025

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