DOLIROBAX 500 MG TABLETS

Introduction

Package Leaflet: Information for the User

DoliRobax 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 signs of illness are the same as yours.
• If you get 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 DoliRobax and what is it used for
2. What you need to know before you take DoliRobax
3. How to take DoliRobax
4. Possible side effects
5. Storage of DoliRobax
6. Contents of the pack and other information

1. What is DoliRobax and what is it used for

DoliRobax 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 DoliRobax

Do not take DoliRobax

• If you are allergic to metocarbamol or any of the other ingredients of this medicine (listed in section 6).
• If you have muscle weakness (a disease that causes muscle fatigue, called myasthenia gravis).
• If you have any brain disease.
• If you have had epilepsy or have had seizures.
• If you have ever suffered brain damage, coma, or pre-coma (a state of stupor before coma).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• 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, this medicine should not be used in children and adolescents under 18 years of age.

Other medicines and DoliRobax

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Metocarbamol may affect the way other medicines work.

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

• Barbiturates that can be taken to treat epilepsy or to help you sleep.
• Appetite suppressants that help you lose weight.
• Medicines for stomach discomfort or travel sickness (anticholinergics).
• Psychotropic medicines to treat 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 to treat myasthenia gravis.

Taking DoliRobax with food and alcohol

You should avoid drinking alcohol while taking this medicine. Both are central nervous system depressants and can 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 that you are pregnant during treatment, consult your doctor immediately, so that the treatment can be adapted 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 recommended that you do not drive vehicles or operate machines unless you check that your mental ability remains unchanged, especially if you are taking other medicines that can also cause drowsiness.

DoliRobax contains sodium

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

3. How to take DoliRobax

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

Method of administration

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

Take this medicine with a glass of water.

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

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), 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 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).

Patient with liver problems:

A longer interval between doses of the tablets may be necessary. If you have liver problems, consult your doctor.

Use in children and adolescents:

It is not recommended to use this medicine 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 this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more DoliRobax than you should

If you have taken more metocarbamol 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 DoliRobax

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

If you stop taking DoliRobax

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 other 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 that range 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 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 be indicative of 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 movements of the eyes);
• decrease in heart rate
• flushing of the skin (flushing).

The following side 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 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, even if it is possible side effects that are 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. Storage of DoliRobax

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

This medicine does not require any special storage conditions.

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

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

6. Contents of the pack and other information

Composition of DoliRobax

• The active ingredient is metocarbamol. Each tablet contains 500 mg of metocarbamol.
• The other ingredients are: cornstarch, magnesium stearate, anhydrous colloidal silica, povidone, and sodium carboxymethyl starch type A (potato).

Appearance of the product and packaging contents

Tablets of 12 mm in diameter and 6.6 mm in thickness, white, biconvex, round, with a score line on one face, smooth surface, free of fractures and regular edges.

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

DoliRobax is presented in PVC-Aluminum blisters in packs of 20 or 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

O

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the last revision of this leaflet: March 2024

Other sources of information

Updated information on this medicine can be found on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/