You should go to https://www.infarmed.pt/documents/15786/1983294/Boletim%2bde%2bFarmacovigil%ff%ffncia%2c%2bVolume%2b21%2c%2bn%ff%ff10%2c%2boutubro%2bde%2b2017/06e28ef9-09a0-4f04-87a2-9da68719e61e