BECORIDONE Tablet

Adults: The relief of nausea and vomiting, epigastric sense of fullness, upper abdominal discomfort and regurgitation of gastric contents.

Children: The relief of symptoms of nausea and vomiting.

Dosage and administration

Oral use

For oral administration. Before meals. If taken after meals, absorption of the drug is somewhat delayed.

The initial duration of treatment is 4 weeks. Patients should be re-evaluated after 4 weeks and the need for continued treatment re-assessed.

Adults and adolescents (over 12 years and weighing 35kg or more)

1-2 tablets 3-4 times per day with a maximum daily dose of 80mg.

Children: 0.25-0.5mg/kg 3-4 times per day with a maximum daily dose of 2.4mg/kg (but do not exceed 80mg/day).

Known hypersensitivity to domperidone or any of the excipients.

Prolactin-releasing pituitary tumour (prolactinoma).

Domperidone should not be used when stimulation of gastric motility could be harmful: gastro-intestinal haemorrhage, mechanical obstruction or perforation.

Immune System Disorder: Very rare: Allergic reaction

Endocrine disorder: Rare: increased prolactin levels

Nervous system disorders: Very rare: extrapyramidal side effects

Gastro-intestinal disorders: Very rare: transient intestinal cramps

Skin and subcutaneous tissue disorders: Very rare: urticaria

Reproductive system and breast disorders: Rare: galactorrhoea, gynaecomastia, amenorrhoea

* As the hypophysis is outside the blood brain barrier, domperidone may cause an increase in prolactin levels. In rare cases this hyperprolactinaemia may lead to neuro-endrocrinological side effects such as galactorrhoea, gynaecomastia and amenorrhoea.

* Extrapyramidal side effects are exceptional in adults. These side effects reverse spontaneously and completely as soon as treatment is stopped.

The concomitant administration of anticholinergic drugs may compromise the beneficial effects of domperidone.

Since domperidone enhanced gastric and small intestinal motility, it may accelerate absorption of drugs from the small bowel while slowing absorption of drugs taken up from the stomach, particularly those with sustained-release or enteric-coated formulations.

The concomitant administration of domperidone maleate with antacids or H2-receptor blockers does not decrease the absorption of domperidone.

(See the package insert about the details.)

Pregnancy

Domperidone should not be used in pregnant women unless the benefit outweighs the potential hazard.

Lactation

Nursing is not recommended for mothers taking domperidone unless the expected benefits outweigh any potential risk.

In the event that the patient develops galactorrhoea and/or gynecomastia, withdrawal of the drug will result in alleviation of these symptoms.

Hepatic impairment: Since domperidone is highly metabolized in the liver, it should be used with caution in patients with hepatic impairment.