Not indicated as rescue medicinal product for the relief of acute bronchospasms. A decrease in body weight has been reported. Treatment with roflumilast should not be initiated or existing treatment should be stopped in patients with severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy), severe acute infectious diseases, cancers (except basal cell carcinoma), or patients being treated with immunosuppressive medicinal products (e.g. methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term; except short-term systemic corticosteroids). Not recommended in patients with congestive heart failure (NYHA grades 3 and 4). Associated with an increased risk of psychiatric disorders such as insomnia, anxiety, nervousness and depression. Rare instances of suicidal ideation and behavior, including completed suicide, have been observed. While adverse reactions like diarrhea, nausea, abdominal pain and headache mainly occur within the first weeks of therapy and mostly resolve on continued treatment, treatment should be reassessed in case of persistent intolerability, particularly in special populations that may have higher exposure, such as in black, non-smoking females or in patients concomitantly treated with the CYP1A2 inhibitor fluvoxamine or the dual CYP3A4/1A2 inhibitors enoxacin and cimetidine. Concomitant treatment with theophylline is not recommended. Tablets contain lactose (patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product).