Patient leaflet - Methocarbamol 750 mg tablets

1. What Methocarbamol is and what it is used for

Methocarbamol contains methocarbamol, an active substance used to treat muscle tension.

Methocarbamol is used for the symptomatic treatment of painful muscular tension, especially in the lower back (lumbago).

Methocarbamol is used in adults.

2. What you need to know before you take Methocarbamol

Do not take Methocarbamol

if you are allergic to methocarbamol, or to any of the
other ingredients of this medicine (listed in section 6);
in the event of comatose or pre-comatose states; - if you suffer from disorders of the central nervous
system;
if you suffer from pathological muscle weakness
(myasthenia gravis);
if you tend to have epilepsy.

Warnings and precautions

Talk to your doctor or pharmacist before taking methocarbamol,

if you suffer from impaired kidney and / or liver
function.
if you are having any medical investigations or tests
as methocarbamol could interfere with the results. Tell your doctor that you are taking methocarbamol before you have the test.

Children

This medicine is not intended for use in children and adolescents, as safety and efficacy in this patient group have not been established.

Other medicines and Methocarbamol

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

The concomitant administration of methocarbamol and centrally acting medicines such as barbiturates, opiate derivatives and appetite suppressants may potentiate the effects of the medicines.

Methocarbamol can potentiate the effect of anticholinergic medicines such as atropine and some psychotropic medicines.

Methocarbamol may inhibit the effect of pyridostigmine bromide. Therefore methocarbamol must not be administered to patients with pathological muscle weakness (myasthenia gravis) receiving pyridostigmine.

Methocarbamol with alcohol

Using methocarbamol together with alcohol may potentiate the effect of the medicine. Do not drink alcohol while you are taking methocarbamol.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you are pregnant, you should not take methocarbamol, since the safe use of methocarbamol during pregnancy has not been established.

Breast-feeding

It is not known whether methocarbamol and/or its metabolites are excreted into human milk. Therefore, you should not take methocarbamol if you are breast-feeding.

Driving and using machines

Methocarbamol may affect your ability to drive and use machines. Methocarbamol may make you feel sleepy and may affect your ability to drive, operate machinery and carry out other hazardous activities. Before you consider driving a vehicle or using machines, you should take account of your state of health and the possible side effects of methocarbamol. You should therefore refrain from these activities until you have sufficient experience to know that you will not suffer any side effects.

Methocarbamol contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

3. How to take Methocarbamol

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Adults

Unless otherwise prescribed by your doctor, the usual dose for adults is 1500 mg methocarbamol (2 tablets of methocarbamol 750 mg tablets or one tablet of methocarbamol 1500 mg tablets) 3 times a day. At the beginning of the treatment a dose of 1500 mg methocarbamol (2 tablets of methocarbamol 750 mg tablets or one tablet of methocarbamol 1500 mg tablets) 4 times a day is recommended.

In severe cases up to 7500 mg methocarbamol (10 tablets of methocarbamol 750 mg tablets or 5 tablets of methocarbamol 1500 mg tablets) per day can be taken.

Elderly

Elderly patients may only need half the usual dose to give the same relief from the pain and muscle spasms.

Liver impairment

You may need a longer interval between taking the tablets if you have liver disease.

You should always follow your doctor's instructions carefully.

Method of administration

Methocarbamol is for oral use.

Take the tablets with sufficient water.

The score line is only there to help you break the tablet if you have difficulties in swallowing it whole and not to divide the tablet into equal doses.

The duration of treatment depends on the symptoms induced by muscle tension, but should not exceed 30 days.

If you take more Methocarbamol than you should

Inform your doctor who will decide what measures to take.

If you forget to take Methocarbamol

If you forget to take a dose, simply take the next dose when it is due. Do not take a double dose to make up for the forgotten dose.

If you stop taking Methocarbamol

Please inform your doctor if you intend to discontinue the treatment with methocarbamol. Special effects of discontinuation of the medicine are not to be expected.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

12031 12031

2085454

UK (Unit-III) Methocarbamol Leaﬂet

Version: 00

Dimension: 160 x 320 mm

Printing Colour: Black

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare (may affect up to 1 in 1,000 people) - Reddening of the eyes (conjunctivitis) with nasal

congestion

Headache, vertigo, metallic taste
Low blood pressure
Angioneurotic oedema
Itching, skin rash, urticaria, fever

Very rare (may affect up to 1 in 10,000 people) - Shock reaction

Loss of appetite
Unrest, anxiety, confusion
Fainting, involuntary eye movement, dizziness,
tremor, convulsion
Impaired vision
Slow heartbeat
Hot flushes
Nausea, vomiting

Not known (frequency cannot be estimated from the available data)

Drowsiness

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Methocarbamol

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

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Methocarbamol contains

The active substance is Methocarbamol.

Each tablet contains 750 mg methocarbamol. Each tablet contains 1500 mg methocarbamol.

The other ingredients are:

Sodium lauryl sulphate, sodium starch glycolate (Type-A), povidone K-90, macrogol (Grade 8000), magnesium stearate, silica, colloidal anhydrous (Grade 200), low substituted hydroxy propyl cellulose & stearic acid-50.

What Methocarbamol looks like and contents of the pack

Methocarbamol 750 mg tablets

White to off white, capsule shaped, tablets debossed with 'M 25' on scored side and 'H' on other unscored side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Methocarbamol 1500 mg tablets

White to off white, oval shaped, tablets debossed with 'M 26' on one side and 'H' on other side.

Methocarbamol is available in blister packs containing 20, 24, 48, 50, 96 & 100 tablets and HDPE containing for 750 mg 20's & 100's tablets and for 1500 mg 20's & 96's tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Amarox Limited

Congress House, 14 Lyon Road

Harrow, HA1 2EN

United Kingdom

This leaflet was last revised in 09/2024.