Patient leaflet - Methocarbamol 1500 mg film-coated tablets
1. What Methocarbamol tablets are and what they are used for
The name of your medicine is Methocarbamol 1500 mg film-coated tablets, referred to as Methocarbamol tablets throughout this leaflet.
Methocarbamol tablets contain the active substance methocarbamol. Methocarbamol belongs to the group of medicinal products known as muscle relaxants. Methocarbamol is used for the symptomatic treatment of painful muscular tension, especially in the lower back (lumbago).
Methocarbamol tablets are used in adults.
2. What you need to know before you take Methocarbamol tablets
Do not take Methocarbamol tablets
- if you are allergic to methocarbamol or 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 nervous system (CNS) disorders
- if you suffer from pathological muscle weakness (myasthenia gravis)
- if you suffer from epilepsy
Warnings and precautions
Talk to your doctor or pharmacist before taking methocarbamol:
- if you suffer from impaired kidney function and/or impaired 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 and adolescents
This medicinal product is not intended for use in children and adolescents as safety and efficacy in these patient groups have not been established.
Other medicines and Methocarbamol tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The concomitant administration of methocarbamol and centrally acting medicinal products such as barbiturates, opiate derivates and appetite suppressants may potentiate the effect of these 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 taken by patients with pathological muscle weakness (myasthenia gravis), who are being treated with pyridostigmine.
Methocarbamol tablets with alcohol
Consumption of alcohol during methocarbamol treatment may potentiate the effect of the medicine. Do not drink alcohol while you are taking Methocarbamol tablets.
Pregnancy, breast-feeding and fertility
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
There is no experience available concerning the use of methocarbamol during pregnancy. The potential risk to humans is not known. You should not take methocarbamol during pregnancy.
Breast-feeding
It is not known whether methocarbamol and/or its metabolites pass into human milk. As a precautionary measure, you should not take Methocarbamol tablets if you are breast-feeding.
Fertility
No data are available concerning the influence of methocarbamol on human fertility.
Driving and using machines
Methocarbamol may affect your ability to drive and use machines. It may make you feel dizzy and drowsy. Before you consider driving a vehicle or operating machinery, you should consider your state of health and the possible side effects of methocarbamol. Therefore, you should not perform these activities until you have sufficient experience to know that you have no such side effects.
Information about some of the ingredients of this medicine
Methocarbamol tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Methocarbamol tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Unless otherwise prescribed by the doctor, the recommended dose for adults is 1500 mg 3 times a day (corresponding to 1 tablet 3 times daily).
At the beginning of treatment, the recommended dose is 1500 mg 4 times a day (corresponding to 1 tablet 4 times a day).
Package Leaflet: Information for the patient
Methocarbamol 1500 mgmg film-coated tablets
methocarbamol
In very serious cases, a dose up to 7500 mg methocarbamol can be taken each day.
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.
Route of administration
Methocarbamol tablets are for oral use.
Take the tablets with sufficient water.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
The duration of treatment depends on the symptoms caused by muscle tension, but should not exceed 30 days.
If you take more Methocarbamol tablets than you should
If you have taken too many Methocarbamol tablets, call your doctor straight away. The doctor will decide about the necessary actions.
If you forget to take Methocarbamol tablets
If you forget to take a dose, take the next dose when it is due. Do not take a double dose to make up for a forgotten dose.
If you stop taking Methocarbamol tablets
Inform your doctor if you intend to discontinue treatment with Methocarbamol tablets. Discontinuation is not expected to lead to any special effect.
If you have any further questions on 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.
Rare (may affect up to 1 in 1,000 people):
Conjunctivitis, headache, dizziness, metallic taste, decreased blood pressure, nasal congestion, angioedema (acute-onset swelling of parts of the tissue and skin), rash, itching, nettle rash (urticaria), fever
Very rare (may affect up to 1 in 10,000 people): Anaphylactic reactions (allergic hypersensitivity reactions), loss of appetite, restlessness, anxiety, confusion, fainting, involuntary eye movement, giddiness, trembling, seizures, impaired vision, slow heart beat, hot flushes, retching (nausea) and vomiting
Not known (frequency cannot be estimated from the available data):
Drowsiness, disturbance of coordination
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the 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 tablets
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 carton and the blister after “EXP”. The expiry date refers to the last day of that month.
Do not store above 30ºC.
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 tablets contain
- The active substance is methocarbamol. Each film-coated tablet contains 1500 mg methocarbamol.
The other ingredients are:
Tablet core: lactose monohydrate, croscarmellose sodium, sodium laurilsulfate, povidone, anhydrous colloidal silica, magnesium stearate.
Film-coating: poly(vinylalcohol), titanium dioxide (E171), talc, macrogol 3350.
What Methocarbamol tablets look like and contents of the pack
Methocarbamol 1500 mg film-coated tablets are white, oblong, biconvex, film-coated tablets, 23 mm x 10 mm, with a score line on one side.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Methocarbamol 1500 mg film-coated tablets are available in packs containing 50 or 100 or 100 (2 packs of
- 50) film-coated tablets.
Not all pack sizes may be marketed.
The tablets in this pack are enclosed in PVC/aluminium blister strips.
Marketing Authorisation Holder
Neuraxpharm UK Limited
First Floor, Building 1410,
Arlington Business Park
Theale, Reading,
Berkshire RG7 4SA
United Kingdom
Manufacturer
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona - Spain