Reporting Side Effects

Reporting of Adverse Events by healthcare professionals:

Reporting suspected adverse events after authorisation of a medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any adverse events with the use of any Otsuka products.

United Kingdom:

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/. Adverse events should also be reported to Otsuka Pharmaceuticals (U.K.) Ltd. using the below details:
T:+44 (0) 808 168 6726
E: opuksafety@otsuka.co.uk

Ireland:

Healthcare professionals are asked to report any suspected adverse reactions to Health Products Regulatory Authority (HPRA) Pharmacovigilance through their website: https://www.hpra.ie/homepage/about-us/report-an-issue/human-adverse-reaction-form. Adverse events should also be reported to Otsuka Pharmaceuticals (U.K.) Ltd. using the below details:
T: +353 (0) 1695 0725
E: opuksafety@otsuka.co.uk

Reporting of Side Effects by Members of the Public:

United Kingdom:

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the MHRA Yellow Card Scheme at https://yellowcard.mhra.gov.uk/.
• By reporting side effects, you can help provide more information on the safety of the medicine.

For medicines with black triangle: ▼ means the medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See https://yellowcard.mhra.gov.uk/ for how to report side effects.

Ireland:

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet.
• You can also report side effects directly to HPRA Pharmacovigilance through their website: https://www.hpra.ie/homepage/about-us/report-an-issue/human-adverse-reaction-form.
• Side effects can also be reported to Otsuka Pharmaceuticals (U.K.) Ltd. using the below details:

T: +353 (0) 1695 0725
E: opuksafety@otsuka.co.uk