METHOCARBAMOL

For oral use. Posology Adults The usual dose is 1500 mg/ml four times daily, but therapeutic response has been achieved with doses as low as 750 mg/ml three times daily. Elderly Half the maximum dose or less may be sufficient to produce a therapeutic response.

Paediatric population The safety and efficacy of Methocarbamol in children and adolescent has not yet been established, therefore no data are available. Methocarbamol should not be used in children. Hepatically impaired In patients with chronic hepatic disease the elimination half-life may be prolonged.

Therefore, consideration should be given to increasing the dose interval.

Duration of Treatment:

The duration of administration depends on the symptoms induced by increased muscle tone, but should not exceed 30 days. Method of Administration For oral use. Shake well before use. Take Methocarbamol oral suspension with a glass of water.

The following undesirable effects are listed by MedDRA system organ class and frequency: 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 available data).

The most frequent undesirable effect of the drug is headache. General disorders Rare: headache, fever, angioneurotic oedema Gastrointestinal disorders Very rare: nausea and vomiting Nervous system disorders Rare: dizziness Very rare: blurred vision, drowsiness, tremor, convulsion Psychiatric disorders Very rare: restlessness, anxiety, confusion, anorexia Skin and subcutaneous tissue disorders Rare: hypersensitive reactions (pruritus, skin rash, urticaria) Eye disorders Rare: conjunctivitis with nasal congestion The following side effects have also been reported.

Blood and Lymphatic system Leucopenia. Cardiovascular system disorders Flushing, Bradycardia, hypotension and syncope. General Disorders Anaphylactic reaction Gastrointestinal disorders Dyspepsia, Jaundice (including cholestatic jaundice) Nervous system disorders Vertigo, mild muscular in coordination, amnesia, diplopia, nystagmus, insomnia, seizures (including grand mal) Skin, subcutaneous tissue disorders, and special senses Metallic taste 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. uk/yellowcard.

Methocarbamol 750mg/5ml oral suspension should be used with caution in patients with renal and hepatic insufficiency. Since methocarbamol may possess a general CNS depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.

Excipients warnings:

Sodium benzoate (E211) - This medicine contains 5 mg sodium benzoate (E211) in each ml. 62% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

1. - Coma or pre-coma states. - Known brain damage or epilepsy. - Myasthenia gravis.