Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use
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.

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. These reports included patients with confounding risk factors, electrolyte abnormalities and concomitant treatment which may have been contributing factors (see section 4.8).

Epidemiological studies showed that domperidone was associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death (see section 4.8). 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.

Domperidone should be used at the lowest effective dose.

Domperidone is contraindicated in patients with known existing prolongation of cardiac conduction intervals, particularly QTc, in patients with significant electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia), or bradycardia, or in patients with underlying cardiac diseases such as congestive heart failure due to increased risk of ventricular arrhythmia (see section 4.3).
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 contraindicated with QT-prolonging drugs including apomorphine, unless the benefit of 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.

Precautions for use
The film-coated tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Effects on Driving

4.7 Effects on ability to drive and use machines
Dizziness and somnolence have been observed following use of domperidone (see section 4.8).
Therefore, patients should be advised not to drive or use machinery or engage in other activities requiring mental alertness and coordination until they have established how Motilium affects them.