This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use MOLITREM 1500 mg FILM-COATED TABLETS

Introduction

P

Molitrem 1500 mg film-coated tablets

metocarbamol

L

-Keep this leaflet, as 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.

C

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. Contents of the pack and further 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 stop 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 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

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, metocarbamol should not be used in children and adolescents under 18 years of age.

Other medicines and Molitrem

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, 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 to treat myasthenia gravis.

Taking Molitrem with food and alcohol

You should avoid drinking alcohol while taking this medicine. Both are central nervous system depressants 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 to adjust your treatment.

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 check that your mental ability remains unaltered, especially if you are taking other medicines that may also cause drowsiness.

Molitrem contains lactose

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

3. How to take Molitrem

Follow exactly the administration instructions of this medicine indicated 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 dose in adults is 1 tablet (1500 mg), three to four 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:

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 effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

Take this medicine with a glass of water.

The score line is only for breaking the tablet if you find it difficult to swallow 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 medicine and the amount taken.

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 stop taking 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 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 you experience any of the following reactions, stop treatment and inform your doctor immediately:

A severe allergic reaction called angioedema (rash, itching, swelling of the limbs, 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, go to 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;
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;
heartburn (stomach burning).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaRAM.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Molitrem

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

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry 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.

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 further information

Composition of Molitrem 1500 mg tablets

The active substance is metocarbamol. Each tablet contains 1500 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 pack contents

Molitrem 1500 mg are film-coated, biconvex, oblong tablets with a score line on one side. This medicine is presented in packs of 20 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.