DOMPERIDONE

Domeperidone should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting. It is recommended to take oral domperidone 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. 4).

Adults and adolescents (over12 years and weighing 35kg or more):

One 10 mg tablet up to three times per day with a maximum dose of 30 mg per day. 3). 2). Renal Impairment Since the elimination half-life of domperidone is prolonged in severe renal impairment, on repeated administration, the dosing frequency of domperidone should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced.

1). The efficacy of Domperidone in adolescents 12 years of age and older and weighing less than 35 kg has not been established.

The safety of Domperidone was evaluated in clinical trials and in post marketing experience. The clinical trials included 1275 patients with dyspepsia, gastro-oesophageal reflux disorder (GORD), Irritable Bowel Syndrome (IBS), nausea and vomiting or other related conditions in 31 double-blind, placebo-controlled studies.

All patients were at least 15 years old and received at least one dose of Domperidone (domperidone base). The median total daily dose was 30 mg (range 10 to 80 mg), and median duration of exposure was 28 days (range 1 to 28 days). Studies in diabetic gastroparesis or symptoms secondary to chemotherapy or Parkinsonism were excluded.

The following frequencies are used for the description of the occurrence of adverse reactions: 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 (cannot be estimated from the available data).

4) Gastrointestinal disorders: Dry mouth Diarrhoea transient intestinal Cramps. Skin and subcutaneous tissue disorders: pruritus, rash urticaria, angioedema Renal and urinary disorders Urinary retention Reproductive system and breast disorders: galactorrhoea, Breast Pain Breast tenderness gynaecomastia amenorrhoea General disorders and administration site conditions Asthenia Investigations: liver function test abnormal increased prolactin levels In 45 studies where domperidone was used at higher dosages, for longer duration and for additional indications including diabetic gastroparesis, the frequency of adverse events (apart from dry mouth) was considerably higher.

This was particularly evident for pharmacologically predictable events related to increased prolactin. In addition to the reactions listed above, akathisia, breast discharge, breast enlargement, breast swelling, depression, hypersensitivity, lactation disorder, and irregular menstruation were also noted.

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

Cardiovascular effects Domperidone has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been very rare cases of QT prolongation and torsades de pointes in patients taking domperidone.

8). 8). A higher risk was observed in patients older than 60 years, patients taking daily doses greater than 30 mg, and patients concurrently taking QT-prolonging drugs or CYP3A4 inhibitors. ). Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) or bradycardia are known to be conditions increasing the proarrythmic risk.

Treatment with domperidone should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patients should consult their physician. Patients should be advised to promptly report any cardiac symptoms.

Use with apomorphine:

Domperidone is contra-indicated with QT prolonging drugs including apomorphine, unless the benefit of the co-administration with apomorphine outweighs the risks, and only if the recommended precautions for co-administration mentioned in the apomorphine SmPC are strictly fulfilled.

Please refer to the apomorphine SmPC. Renal impairment The elimination half-life of domperidone is prolonged in severe renal impairment. For repeated administration, the dosing frequency of domperidone should be reduced to once or twice daily depending on the severity of the impairment.

The dose may also need to be reduced. Excipients Domperidone tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine

Domperidone is contraindicated in the following situations: • Known hypersensitivity to domperidone or any of the excipients. ) • Domperidone should not be used when stimulation of gastric motility could be harmful: gastro- intestinal haemorrhage, mechanical obstruction or perforation.

2). 4). 5) • Confirmed or suspected pheochromocytoma due to the risk of severe hypertension episodes.