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Domperidone is contra-indicated with QT prolonging drugs including apomorphineunless the benefit of the co-administration with apomorphine outweighs the risksand only if the recommended precautions for co-administration mentioned in the apomorphine SmPC are strictly fulfilledPlease refer to the apomorphine SmPC.

In addition to reviewing the PRAC recommendationthe TGA will be assessing new information provided by the sponsorJanssen-Cilagto evaluate the benefit-risk profile of domperidone and determine if new measures are required to ensure its safe use in AustraliaIn particularthe TGA will consider whether any changes should be made to the maximum dose and duration of use for Australian patients.

There are limited post-marketing data on the use of domperidone in pregnant womenStudies in animals have shown reproductive toxicity at maternally toxic dosessee section 5.3Motilium should only be used during pregnancy when justified by the anticipated therapeutic benefit.

Talk to a doctor straight away if you experience dizzinessfaintingchest painor a rapidflutteringor pounding heartbeat while taking domperidone.

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