Pharmacovigilance

Reporting of suspected adverse reactions by healthcare professionals:

Reporting suspected adverse reactions 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 suspected adverse reactions with the use of any Otsuka products.  Reporting forms and information can be found at the agency websites below. Side effects should also be reported to Otsuka by phone or email:

United Kingdom:

T: 0808 168 6726
E:
W: www.mhra.gov.uk/yellowcard

Ireland:

T: +353 (01) 695 0725
E:
W: https://www.hpra.ie/homepage/about-us/report-an-issue/human-adverse-reaction-form

Reporting of Side Effects by Members of the Public:

If you experience any side effects, even those that may not be listed on the Patient Information Leaflet, talk to your doctor, pharmacist or nurse.  Adverse events should be reported. Reporting forms and information can be found at the agency website below. You can also report your side effects to Otsuka via the email address below:

United Kingdom:

W: www.mhra.gov.uk/yellowcard
E:

Ireland:

W: https://www.hpra.ie/homepage/about-us/report-an-issue/human-adverse-reaction-form
E:

Date of preparation: August 2018

Reference OPUK/1017/GEN/1165h

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