Risk Materials

Educational Risk Minimisation Materials to help reduce the risk associated with using this medicine.

Domperidone (Cardiac Effects) Adverse Drug Reaction Follow Up Form For Healthcare Professionals

Healthcare professionals As a result of the aforementioned procedure, Marketing Authorisation Holders (MAHs) in the EU for domperidone products have made a commitment to enhanced surveillance, by rigorous follow up of all reports of suspected adverse drug reactions (ADRs) involving domperidone. If you wish to report a suspected ADR concerning any type of cardiac effect, or any other kind of adverse effect, with Wockhardt UK Limited’s Domperidone 1mg/ml Oral Suspension, please complete the questionnaire entitled: ‘Domperidone (Cardiac Effects) Adverse Drug Reaction Follow Up Form For Healthcare Professionals' and return to the Drug Safety and Information Department by email ([email protected]) or fax (+44 1978 669 430).

For Healthcare Professionals

Domperidone (Heart Associated Effects) Follow Up Form For Non-Healthcare Professionals

Patients As a result of the aforementioned procedure, Marketing Authorisation Holders (MAHs) in the EU for domperidone products have made a commitment to enhanced surveillance, by rigorous follow up of all reports of suspected adverse drug reactions (ADRs) involving domperidone. Patients must consult their doctor straight away if they suspect they have experienced an ADR whilst taking domperidone. If you wish to report a suspected ADR concerning any type of cardiac effect, or any other kind of adverse effect, with Wockhardt UK Limited’s Domperidone 1mg/ml Oral Suspension, please complete the questionnaire entitled: ‘Domperidone (Heart Associated Effects) Follow up Form For Non-Healthcare Professionals' and return to the Drug Safety and Information Department by email ([email protected]) or fax (+44 1978 669 430).

Domperidone Risk Minimisation Measures

Risk Minimisation Measures (RMMs) have been implemented for domperidone-containing products licensed in the European Union (EU), following the outcome of a review under Article 31 of Directive 2001/83/EC, of serious effects on the heart with domperidone, including prolongation of the QT interval (an alteration of the electrical activity of the heart) and arrhythmias (unstable heartbeats).

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