Hypersensitivity to the active substance, soya or to any of the excipients listed in Description.
Pregnancy (see Use in Pregnancy & Lactation).
Women of childbearing potential who are not using reliable contraception (see Precautions and Use in Pregnancy & Lactation).
Breastfeeding (see Use in Pregnancy & Lactation).
Patients with severe hepatic impairment (with or without cirrhosis) (see Dosage & Administration).
Baseline values of hepatic aminotransferases (aspartate aminotransferases (AST) and/or alanine aminotransferases (ALT) > 3 × ULN) (see Dosage & Administration and Precautions).