MOLITREM 750 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Molitrem 750 mg film-coated tablets EFG

Metocarbamol

Read the entire package leaflet carefully before starting to take this medication because it contains important information for you.

-Keep this package leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Molitrem and what is it used for
   1. What you need to know before taking Molitrem
   2. How to take Molitrem
   3. Possible side effects
   4. Storage of Molitrem
   5. Package Contents and Additional Information

1. What is Molitrem and what is it used for

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

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

2. What you need to know before taking Molitrem

Do not take Molitrem

• If you are allergic to metocarbamol, soy, or peanuts, or to any of the other components of this medication (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

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

• 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 undergo any diagnostic test (including blood or urine tests), 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, metocarbamol should not be used in children and adolescents under 18 years of age.

Other Medications and Molitrem

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

Metocarbamol may affect how other medications work. Other medications may also affect metocarbamol. If you are taking any of the following medications, you should 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 upset or motion sickness (anticholinergics).
• Psychotropic medications 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 medication.
• Piridostigmine bromide used to treat myasthenia gravis.

Taking Molitrem with Food and Alcohol

You should avoid drinking alcohol while taking this medication. Both are central nervous system depressants and may potentiate 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 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 to adjust your treatment.

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 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 medication, so it is not recommended that you drive vehicles or operate machines unless you verify that your mental ability remains unchanged, especially if you are taking other medications that may also cause drowsiness.

Molitrem contains Lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Molitrem

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

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

The recommended doses are:

Adults:

The recommended dose in adults is 2 tablets (1500 mg), 3 to 4 times a day (daily dose of 4 grams to 6 grams), and the dose may be increased up to a maximum of 8 g per day for the first 48-72 hours, depending on the severity of the case.

Elderly Patients:

For elderly patients, half the dose may be sufficient to achieve a therapeutic response.

Patients with Liver Problems:

A longer interval between tablet intakes may be necessary. Follow your doctor's recommendations strictly.

Use in Children and Adolescents:

Its use is not recommended 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 medication. Do not exceed the recommended dose.

If you think the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

Take this medication with a glass of water.

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

If you take more Molitrem 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 medication and the amount ingested.

If you forget to take Molitrem

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 interrupt treatment with Molitrem

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 discontinue the medication.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

• A severe allergic reaction called angioedema (rash, itching, swelling of the extremities, face, lips, mouth, or throat that may cause difficulty swallowing or breathing).
• 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.

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;
• decreased 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);
• decreased 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;
• heartburn (stomach burn).

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaRAM.es/. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Molitrem

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

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

PVC/Aluminum Blister: Store below 30°C.

Aclar/Aluminum Blister: No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

The active ingredient is metocarbamol. Each tablet contains 750 mg of metocarbamol.

The other ingredients are: lactose monohydrate, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate, anhydrous colloidal silica, povidone, Opadry II 85G18490 white (polyvinyl alcohol, macrogol, titanium dioxide (E171), talc, and soy lecithin).

Appearance of the Product and Package Contents

Molitrem 750 mg are film-coated, biconvex, oblong tablets with a score line on one side. This medication is presented in packages of 20 and 50 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the Last Revision of this Package Leaflet: March 2022

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/