1. Name of the medicinal product
Domperidone 10mg Tablets
2. Qualitative and quantitative composition
Each tablet contains Domperidone maleate equivalent to 10mg domperidone base.
For a full list of excipients see section 6.1.
3. Pharmaceutical form
Domperidone 10mg Tablet is presented as a white round biconvex tablet with “Dm 10” inscription on one side.
4. Clinical particulars
4.1 Therapeutic indications
Domepridone is indicated for the relief of the symptoms of nausea and vomiting.
4.2 Posology and method of administration
Domeperidone should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting.
Domperidone 10mg Tablets are for oral administration.
It is recommended to take oral domperidone tablets before meals. If taken after meals, absorption of the drug is somewhat delayed.
Patients should try to take each dose at 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.
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 maximum dose of 30 mg per day.
The efficacy of Domperidone in children less than 12 years of age has not been established (see section 5.1).
The efficacy of Domperidone in adolescents 12 years of age and older and weighing less than 35 kg has not been established.
Domperidone 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).
Since the elimination half-life of domperidone is prolonged in severe renal impairment, on repeated administration, the dosing frequency of Domperidone tablets 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)
Domperidone is contraindicated in the following situations:
• In patients with moderate or severe hepatic impairment (see section 5.2).
• In patients who have known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure (see section 4.4)
• Co-administration with QT-prolonging drugs, at the exception of apomorphine (see section 4.4 and 4.5).
• Co-administration with potent CY3A4 inhibitors (regardless of their QT prolonging effects) (see section 4.5)
• Known hypersensitivity to domperidone or any of the excipients.
• Prolactin-releasing pituitary tumour (prolactinoma.)
• Renal impairment
Domperidone should not be used when stimulation of gastric motility could be harmful: gastro-intestinal haemorrhage, mechanical obstruction or perforation.
4.4 Special warnings and precautions for use
Precautions for use
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Use in infants
Neurological side effects are rare (see "Undesirable effects" section). Since metabolic functions and the blood-brain barrier are not fully developed in the first months of life the risk of neurological side effects is higher in young children.
Overdosing may cause extrapyramidal symptoms in children, but other causes should be taken into consideration