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

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Publisher: neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Str.23, 40764, Langenfeld, Germany

Therapeutic indications

Symptomatic treatment of painful muscle tension, in particular low back pain (lumbago).

Methocarbamol is indicated in adults.

Posology and method of administration

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 film-coated tablets should be taken with sufficient water.

Overdose

Limited information is available on the acute toxicity of methocarbamol. Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures and coma.

After oral intake of 22.5 to 50 g methocarbamol with suicidal intent two patients showed drowsiness, but recovered completely within 24 hours.

In literature 3 fatal cases are mentioned when patients in addition to methocarbamol consumed large quantities of alcohol (2 cases) or took opiates (1 case) with suicidal intent.

Management of overdose includes gastric lavage, symptomatic therapy and monitoring of vital functions. The usefulness of haemodialysis in managing overdose has not been established.

Shelf life

Shelf life: 2 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

PVC/ACLAR//Al blisters.

Pack sizes:

20, 50 or 100 film-coated tablets.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

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