METHOCARBAMOL

Posology Adults The recommended dose for adults is 1500 mg methocarbamol 3 times a day. At the beginning of treatment a dose of 1500 mg methocarbamol 4 times a day is recommended. In severe cases up to 7500 mg methocarbamol per day can be taken.

The duration of treatment depends on the symptoms induced by muscle tension, but should not exceed 30 days. Paediatric population The safety and efficacy of methocarbamol in children and adolescents have not been established. Elderly patients Half the maximum dose or less may be sufficient to produce a therapeutic response.

Patients with hepatic impairment In patients with chronic hepatic disease the elimination half-life may be prolonged. Therefore, consideration should be given to increasing the dose interval. Method of administration Methocarbamol is for oral use.

The tablets should be taken with sufficient water.

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.

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

Interference with laboratory tests Methocarbamol may cause colour interference in screening tests for hydroxyindolacetic acid (5-HIAA) and vanillylmandelic acid (VMA). Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1. − Comatose or pre-comatose states − Disorders of the central nervous system (CNS) − Myasthenia gravis − Epilepsy