MOTILIUM Film-coated tablet Ref.[6806] Active ingredients: Domperidone

Motilium should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting.

It is recommended to take oral Motilium before meals. If taken after meals, absorption of the drug is somewhat delayed.

Patients should try to take each dose at the scheduled time. If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed. The dose should not be doubled to make up for a missed dose.

Usually, the maximum treatment duration should not exceed one week.

See section 4.4. for further information.

Adults and adolescents (12 years of age and older and weighing 35 kg or more)

One 10mg tablet up to three times per day with a maximum dose of 30 mg per day.

Neonates, infants, children (less than 12 years of age) and adolescents weighing less than 35 kg

Due to the need for accurate dosing, Motilium tablets are unsuitable for use in children and adolescents weighing less than 35 kg.

Hepatic Impairment

Motilium is contraindicated in moderate or severe hepatic impairment (see section 4.3). Dose modification in mild hepatic impairment is however not needed (see section 5.2).

Renal Impairment

Since the elimination half-life of domperidone is prolonged in severe renal impairment, on repeated administration, the dosing frequency of Motilium should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced. Such patients on prolonged therapy should be reviewed regularly (see sections 4.4 and 5.2).

Symptoms

Overdose has been reported primarily in infants and children. Symptoms of overdosage may include agitation, altered consciousness, convulsions,disorientation, somnolence and extrapyramidal reactions.

Treatment

There is no specific antidote to domperidone, but in the event of overdose, standard symptomatic treatment should be given immediately. Gastric lavage as well as the administration of activated charcoal, may be useful. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Close medical supervision and supportive therapy is recommended.

Anticholinergic, anti-parkinson drugs may be helpful in controlling the extrapyramidal reactions.

3 years.

Do not store above 25°C.

Blister packs consisting of aluminium foil and PVC genotherm clear glass.

Pack sizes of 4, 10, 28, 30 and 100 tablets.

HDPE (Duma) containers

Pack size 500 tablets.

Not all pack sizes may be marketed.

No special requirements.