METHOCARBAMOL NEURAXPHARM Film-coated tablet Ref.[7674] Active ingredients: Methocarbamol

Methocarbamol should be used with caution in patients with impaired renal and/or hepatic function.

Patients should beadvised that the intake of alcohol during the treatment with methocarbamol or a combination with other centrally acting agents can lead to an increase in effects.

Methocarbamol contains lactose

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Methocarbamol contains soya lecithin

Patients who are allergic to peanut or soya, should not take this medicinal product.

Interference with laboratory tests

Methocarbamol may cause colour interference in screening tests for hydroxyindolacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

The concomitant administration of methocarbamol and centrally acting medicinal products such as barbiturates, opioids and appetite suppressants may mutually potentiate the effects of the medicinal products.

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

Using methocarbamol together with alcohol may potentiate the effect of the medicinal product.

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

Pregnancy

There is no experience in the use of methocarbamol during pregnancy. Animal studies have not established safe use of methocarbamol with regard to effects upon pregnancy, embryonic/foetal development, parturition and postnatal development (see section 5.3). The potential risk for humans is not known. Therefore, methocarbamol should not be used during pregnancy.

Breast-feeding

It is not known whether methocarbamol and/or its metabolites pass into human milk. Methocarbamol and/or its metabolites are excreted into the milk of lactating dogs. Therefore methocarbamol should not be used by breast-feeding women.

Fertility

Animal reproductive studies have not been conducted with methocarbamol.

Methocarbamol has moderate influence on the ability to drive and use machines as methocarbamol may cause dizziness or drowsiness, especially if other medications capable of causing drowsiness are also being taken. Possible undesirable effects of methocarbamol may affect the patient’s ability to drive and use machines.

The following undesirable effects were reported in connection with the use of methocarbamol. The frequency of possible undesirable effects – if relevant data are given in literature – is defined using the following conventions:

Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (≥1/10,000)
Not known (frequency cannot be estimated from the available data)

Infections and infestations

Rare: Conjunctivitis

Immune system disorders

Very rare: Anaphylactic reaction

Metabolic and nutrition disorders

Very rare: Anorexia

Psychiatric disorders

Very rare: Unrest, anxiety, confusion

Nervous system disorders

Rare: Headache, vertigo, metallic taste

Very rare: Syncope, nystagmus, dizziness, tremor, convulsion

Not known: Drowsiness

Eye disorders

Very rare: Impaired vision

Cardiac disorders

Very rare: Bradycardia

Vascular disorders

Rare: Hypotension

Very rare: Hot flushes

Respiratory, thoracic and mediastinal disorders

Rare: Nasal congestion

Gastrointestinal disorders

Very rare: Nausea, vomiting

Skin and subcutaneous tissue disorders

Rare: Angioneurotic oedema, itching, skin rash, urticaria

General disorders and administration site conditions

Rare: Fever

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Not applicable.