Package Insert: Information for the User

Robaxin 500 mg Tablets

Metocarbamol

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 read 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, even if they 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 Robaxin and how is it used

2. What you need to know before starting to take Robaxin

3. How to take Robaxin

4. Possible adverse effects

5. Storage of Robaxin

6. Contents of the package and additional information

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

Metocarbamol treatment should be as short as possible. As painful symptoms subside, your doctor will discontinue metocarbamol administration.

Do not take Robaxin

• If you are allergic to metocarbamol, or to any of the other components of this medication (listed in section 6).
• If you have muscle weakness (or a condition 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

Consult your doctor or pharmacist before starting to take Robaxin.

• If you are a patient with liver or kidney disease, your doctor may adjust the dose, increase the time between doses, and remind you that it is essential not to prolong treatment any longer than necessary.
• If you are to undergo any diagnostic tests (including blood or urine analysis) inform your doctor that you are taking this medication, 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 old.

Use of Robaxin with other medications

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

Metocarbamol may affect the way other medications work. Other medications may also affect metocarbamol. If you are taking any of the following medications, inform your doctor or pharmacist:

• Barbiturates that may be taken for epilepsy or to help you sleep.
• Appetite suppressants that help you lose weight.
• Medications for stomach discomfort or motion sickness (anticholinergics).
• Psychotropic medications 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.
• Piridostigmine bromide used to treat myasthenia gravis.

Taking Robaxin with food and alcohol

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

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

Do not take this medication 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 they can adapt the treatment to your condition.

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

Driving and operating machines

You may feel drowsiness with this medication, so it is not recommended that you drive vehicles or operate machines unless you check that your mental capacity remains unchanged, especially if you are taking other medications that may also cause drowsiness.

Robaxin contains sodium

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

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

This medication is administered orally. The treatment with this medication 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 per day, divided into three or four doses), which may be increased to a maximum of 7.5 g per day for the first 48-72 hours (15 tablets per day), according to the severity of the case.

Senior patients:

Senior patients may need a lower dose to obtain the same relief from pain and muscle spasms.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).

Patients with liver problems:

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

Use in children and adolescents:

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

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

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

Take this medication with a glass of water.

The groove is only for breaking the tablet if it is difficult to swallow 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, bringing the remaining tablets with you to inform the doctor. Metocarbamol along with alcohol and other central nervous system depressants may produce nausea, dizziness, blurred vision, low blood pressure, seizures, and coma.

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 forgot to take Robaxin

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 the treatment with Robaxin

Your doctor will determine the duration of treatment, which will be conditioned by the appearance of painful symptoms or contracture. As these symptoms disappear, your doctor will suspend the medication.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse 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 (yellowing of the skin and white of the eyes), indicative of a liver problem.

• If you experience an infection with symptoms such as fever and pain, seek medical attention immediately, as it may be indicative of 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 sensation of dizziness;

- Conjunctivitis with nasal congestion;

- Decreased 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);

- Decreased heart rate, flushing of the skin (rubor).

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

- Mild muscular incoordination, memory loss, vertigo, insomnia, double vision;

- Dry mouth, fatigue, diarrhea, dyspepsia or indigestion, and decrease in white blood cell count in the blood.

Reporting 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 prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use Robaxin 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.

Medications should not be disposed of through drains or in the trash. Dispose of 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 Robaxin 500 mg tablets

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

Appearance of the product and content of the packaging

Robaxin 500 mg are white, biconvex, round, tablets with a notch on one of their faces.

Robaxin is presented in packaging of 20 and 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

Or

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Last review date of this leaflet:November 2022

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/