Robaxin 500 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Robaxin 500 mg tablets

Metocarbamol

Read this 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, 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Robaxin is and what it is used for

Robaxin contains methocarbamol, a muscle relaxant that relieves pain caused by muscle stiffness. It 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 your methocarbamol treatment.

2. What you need to know before taking Robaxin

Do not take Robaxin

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Robaxin.

• If you are a patient with liver or kidney disease, your doctor may adjust your dose, increase the time between doses, and emphasize the importance of not prolonging treatment beyond what is necessary.
• If you are scheduled for any diagnostic tests (including blood or urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Children and adolescents

Due to lack of safety and efficacy data, Robaxin must not be used in children and adolescents under 18 years of age.

Taking Robaxin with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Methocarbamol may affect how other medicines work. Likewise, other medicines may affect methocarbamol. If you are taking any of the following medicines, you must inform your doctor or pharmacist:

• Barbiturates, which may be taken for epilepsy or to help you sleep.
• Appetite suppressants that help you lose weight.
• Medicines for stomach discomfort or travel sickness (anticholinergics).
• Psychotropic medicines used to treat anxiety, depression, or other mental illnesses.
• Anesthetics. If you are to receive anesthesia for any reason, inform your doctor or dentist that you are taking this medicine.
• Pyridostigmine bromide used for the treatment of myasthenia gravis.

Taking Robaxin with food and alcohol

You should avoid drinking alcohol while taking Robaxin. Both substances are central nervous system depressants and may enhance each other's effects.

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

Do not take this medicine if you are pregnant unless you have discussed it with your doctor. If you find out you are pregnant during treatment, consult your doctor immediately so that your treatment can be adjusted accordingly.

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. 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.

Driving and using machines

This medicine may cause drowsiness; therefore, driving vehicles or operating machinery is not recommended unless you are certain that your mental capacity remains unaffected, especially if other medicines that may also cause drowsiness are taken concomitantly.

Robaxin contains sodium

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

3. How to take Robaxin

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

This medicine is administered orally. Treatment with this medicine should be as short as possible.

Recommended doses are:

Adults:

The recommended daily dose in adults is between 4 grams and 6 grams, divided into three or four doses (from 8 to 12 tablets per day, divided into three or four doses), with the dose possibly increased up to a maximum of 7.5 g per day during the first 48–72 hours (15 tablets per day), depending on the severity of the case.

Elderly patients:

Elderly patients may require a lower dose to achieve the same relief from pain and muscle spasms. The recommended daily dose is 2 to 3 grams, divided into three or four doses (from 4 to 6 tablets per day, divided into three or four doses).

Patients with liver problems:

A longer interval between tablet doses may be necessary. Strictly follow the recommendations given by your doctor.

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.

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

If you feel that the effect of Robaxin is too strong or too weak, inform your doctor or pharmacist.

Take this medicine with a glass of water.

The score line is intended solely for dividing the tablet if you have difficulty swallowing it whole.

If you take more Robaxin than you should

If you have taken more Robaxin than you should, consult your doctor or pharmacist immediately or go to the nearest hospital, taking the remaining tablets with you so the doctor can be informed. Metocarbamol, together with alcohol and other central nervous system depressants, may cause nausea, dizziness, blurred vision, low blood pressure, seizures, and coma.

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 Robaxin

Do not take a double dose to make up for missed doses. If you are sure you have forgotten a dose, take it as soon as possible and then continue taking the medicine as usual. Always leave a 4-hour interval before taking another tablet. If in doubt, consult your doctor or pharmacist.

If you stop taking Robaxin

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.

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.

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 develop an infection with symptoms such as fever and pain, you should contact your doctor immediately, as this may indicate a decrease in white blood cells, 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 of dizziness;
• conjunctivitis with nasal congestion;
• decrease in blood pressure, metallic taste;
• fever.

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);
• decrease in heart rate, skin redness (flushing).

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

• mild muscle incoordination, memory loss, vertigo, insomnia, double vision;
• dry mouth, fatigue, diarrhea, dyspepsia or indigestion, and decreased number of white blood cells in the blood.

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 Robaxin

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

Do not use Robaxin 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 any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, 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 Robaxin 500 mg tablets

• The active substance is metocarbamol. Each tablet contains 500 mg of metocarbamol.
• The other components are: maize starch, magnesium stearate, microcrystalline silica, povidone, and sodium carboxymethylstarch from potato.

Appearance of the product and contents of the pack

Robaxin 500 mg are white, biconvex, round tablets, with a score line on one side.

Robaxin is available in packs of 20 and 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: November 2022

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