ROBAXIN 500 mg TABLETS

Introduction

Package Leaflet: Information for the User

Robaxin 500 mg Tablets

Metocarbamol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this leaflet, you may need to read it again.-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Robaxin and what is it used for

Robaxin contains metocarbamol, a muscle relaxant that provides relief from pain caused by muscle stiffness. It is used to treat painful muscle spasms.

Treatment with metocarbamol should be as short as possible. As the painful symptoms disappear, your doctor will stop the administration of metocarbamol.

2. What you need to know before you take Robaxin

Do not take Robaxin

• If you are allergic to metocarbamol or any of the other ingredients of this medicine (listed in section 6).
• If you have muscle weakness (or a disease called myasthenia gravis).
• If you have any brain disease.
• If you suffer from epilepsy or have seizures.
• If you have ever suffered 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 the dose, increase the time between doses, and insist that it is essential not to prolong treatment longer than necessary.
• If you are going to have any diagnostic tests (including blood or urine tests), inform your doctor that you are taking this medicine, as it may alter the results.

Children and adolescents

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

Using Robaxin with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Metocarbamol may affect how other medicines work. Other medicines may also affect metocarbamol. If you are taking any of the following medicines, you should tell your doctor or pharmacist:

• Barbiturates that may be taken for epilepsy or to help you sleep.
• Appetite suppressants that help you lose weight.
• Medicines for stomach upset or travel sickness (anticholinergics).
• Psychotropic medicines for treating 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.
• Piridostigmine bromide used for the treatment of myasthenia gravis.

Taking Robaxin with food and alcohol

You should avoid drinking alcohol while taking Robaxin. Both are central nervous system depressors and may enhance their effects.

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

Do not take this medicine if you are pregnant unless you have discussed this with your doctor. If you discover you are pregnant during treatment, consult your doctor immediately so that your treatment can be adjusted to your condition.

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; however, it is unknown whether metocarbamol or its metabolites are excreted in human breast milk.

Driving and using machines

You may feel drowsy with this medicine, so it is not recommended that you drive vehicles or operate machines unless you have checked that your mental ability remains unaltered, especially if you are taking other medicines that may also cause drowsiness.

Robaxin contains sodium

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

3. How to take Robaxin

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

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

The recommended doses are:

Adults:

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

Elderly patients:

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

Patient 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:

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

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

If you think the action of Robaxin is too strong or too weak, tell your doctor or pharmacist.

Take this medicine with a glass of water.

The score line is only to help you break 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 to inform the doctor. Metocarbamol, along with alcohol and other central nervous system depressants, can cause nausea, dizziness, blurred vision, low blood pressure, seizures, and coma.

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 Robaxin

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 medication normally. Always leave a 4-hour period before taking another tablet. In case of doubt, consult your doctor or pharmacist.

If you stop taking Robaxin

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.

If you have any further 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 ranging from a simple skin rash or urticaria 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), indicative of a liver problem.

• If you experience an infection with symptoms such as fever and pain, you should see your doctor immediately, as it may indicate a decrease in white blood cells, reducing 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;
• decrease in blood pressure, metallic taste;
• fever.

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

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 a decrease in the number of white blood cells in the blood.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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. Storing Robaxin

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

Do not use Robaxin after the expiry date stated on the pack after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and further information

Composition of Robaxin 500 mg tablets

• The active ingredient is metocarbamol. Each tablet contains 500 mg of metocarbamol.
• The other ingredients are: cornstarch, magnesium stearate, microcrystalline cellulose, povidone, and sodium carboxymethyl starch.

Appearance and pack contents

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 last revision of this leaflet:November 2022

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