Pharmacovigilance

Reporting of suspected adverse reactions by healthcare professionals:

Reporting suspected adverse reactions after authorization 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 of our products.
Side effects should be reported to Otsuka by email or phone:
Email address (containing your information): or via telephone – number: +46854528660.
In addition: information around Safety reporting can be found at the MPA (Läkemedelsverket), FIMEA (Lääkealan turvallisuus – ja kehittämiskeskus), DKMA (Laegemiddelstyrelsen) and NoMA (Statens legemiddelverk) websites.

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.
Please report your side effects to Otsuka via email address or phone number as of below:
e-mail address: or via phone number: +46854528660. You can also find information on Safety reporting on the websites of the Nordic Authorities: MPA (Läkemedelsverket), FIMEA (Lääkealan turvallisuus – ja kehittämiskeskus), DKMA (Laegemiddelstyrelsen) or NoMA (Statens legemiddelverk).

Date of preparation: February 2019

Reference OPSE/0219/COMS/1022

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