- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6. Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
For the relief of symptoms of post-prandial stomach discomfort
Adults and children 16 years of age and older:Up to 10 mg three times daily and at night. Maximum duration of course of treatment 2 weeks.
For the relief of nausea and vomiting
Adults and children 16 years of age and older:Up to 10 mg three times daily and at night.Maximum duration of course of treatment 48 hours.
Use in children under 16 years of age:Not recommended.See section 4.4
Use during lactationThe total amount of domperidone excreted in human breast milk is expected to be less than 7 micrograms per day at the highest recommended dosing regimen. It is not known whether this is harmful to the newborn. Therefore breast-feeding is not recommended for mothers who are taking domperidone.
Use in infantsNeurological 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. Therefore, it is recommended that the dose be determined accurately and followed strictly in neonates, infants, toddlers and small children. Overdosing may cause extrapyramidal symptoms in children, but other causes should be taken into consideration.
Use in liver disordersSince domperidone is highly metabolised in the liver, domperidone should be not be used in patients with hepatic impairment
Renal insufficiencyIn patients with severe renal insufficiency (serum creatinine > 6 mg/100 mL, i.e. > 0.6 m mol/L) the elimination half-life of domperidone was increased from 7.4 to 20.8 hours, but plasma drug levels were lower than in healthy volunteers. Since very little unchanged drug is excreted via the kidneys, it is unlikely that the dose of a single administration needs to be adjusted in patients with renal insufficiency. However, on repeated administration, the dosing frequency 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.
Use with CYP3A4 inhibitorsCo-administration with oral ketoconazole, erythromycin or other potent CYP3A4 inhibitors that prolong the QTc interval should be avoided (see section 4.5 Interaction with other medicinal products and other forms of interaction).
Cardiovascular effectsSome epidemiological studies showed that domperidone may be associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death (see section 4.8.) Use is therefore contraindicated in patients with underlying cardiac disease (see sections 4.3 and 4.8) The risk may be higher in patients older than 60 years or at daily doses of more than 30 mg. Domperidone should be used at the lowest effective dose in adults (see section 4.2) and children. Domperidone is not recommended for those under 16 years of age (see section 4.2).Use of Domperidone and other drugs which prolong QTc intervals requires that caution be exercised in patients who have existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure (see section 4.3).The label will include:Do not take if you are pregnant.
|System Organ Class||Adverse Drug Reaction Frequency|
|Psychiatric disorders||Loss of libido Anxiety|
|Nervous system disorders||Somnolence Headache|
|Gastrointestinal disorders||Dry mouth||Diarrhoea|
|Skin and subcutaneous tissue disorder||Rash Pruritus|
|Reproductive system and breast disorders||Galactorrhoea Breast pain Breast tenderness|
|General disorders and administration site conditions||Asthenia|
Postmarketing experienceIn addition to the adverse effects reported during clinical studies and listed above, the following adverse drug reactions have been reported.
Immune System Disorder:Not know: anaphylactic reactions including anaphylactic shock, angioedema, allergic reaction
Psychiatric System Disorder:Not known: agitation, nervousness
Nervous system disorders:Not known; extrapyramidal disorder, convulsions, Eye disorders: Not known: Oculogyric crisis
Skin and subcutaneous tissue disorders:Not known: urticaria, angioedema
Reproductive system and breast disorders:Not known:, gynaecomastia, amenorrhoea.
Cardiac disorders:Unknown; ventricular arrhythmias QTc prolongation and sudden cardiac death (See sections 4.3 and 4.4).
Investigations:Not known: liver function test abnormal, blood prolactin increasedAs 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-endocrinological side effects such as galactorrhoea, gynaecomastia and amenorrhoea.Extrapyramidal side effects are very rare in neonates and infants, and exceptional in adults. These side effects reverse spontaneously and completely as soon as the treatment is stopped.Other central nervous system-related effects of convulsion, agitation and somnolence also are very rare and primarily reported in infants and children.
SymptomsOverdose has been reported primarily in infants and children. Symptoms of overdosage may include agitation, altered consciousness, convulsions, disorientation, somnolence and extrapyramidal reactions.
TreatmentThere is no specific antidote to domperidone, but in the event of overdose, gastric lavage as well as the administration of activated charcoal, may be useful. Close medical supervision and supportive therapy is recommended.Anticholinergic, anti-parkinson drugs may be helpful in controlling the extrapyramidal reactions.
Changes to indications, contraindications and dosage
In May 2014, the MHRA issued the following information:
Domperidone (Motilium) is associated with a small increased risk of serious cardiac side effects. Its use is now restricted to the relief of nausea and vomiting and the dosage and duration of use have been reduced. It should no longer be used for the treatment of bloating and heartburn. Domperidone is now contraindicated in those with underlying cardiac conditions and other risk factors (see below). Patients with these conditions and patients receiving long-term treatment with domperidone should be reassessed at a routine appointment, in light of the new advice
Further information is available on the MHRA website .
An Information sheet for patients has also been issued.
Aurobindo Pharma - Milpharm Ltd.
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