Not indicated as rescue medicinal product for the relief of acute bronchospasms. Decrease in body wt; check body wt regularly. Patients w/ severe immunological diseases (eg, HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy), severe acute infectious diseases, cancers (except basal cell carcinoma) or patients treated w/ immunosuppressive medicinal products (ie, methotrexate, azathioprine, infliximab, etanercept or oral corticosteroids to be taken long-term; except short-term systemic corticosteroids); patients w/ latent infections eg, TB, viral hepatitis, herpes viral infection & herpes zoster; CHF (NYHA grades 3 & 4). Increased risk of psychiatric disorders eg, insomnia, anxiety, nervousness & depression. Reassess treatment in case of persistent intolerability especially in special populations that may have higher exposure eg, black patients, non-smoking females or in patients concomitantly treated w/ CYP1A2/ 2C19/3A4 inhibitors (eg, fluvoxamine & cimetidine) or the CYP1A2/3A4 inhibitor enoxacin. Higher risk of sleep disorders (mainly insomnia) in patients w/ a baseline body wt of <60 kg. Concomitant treatment w/ theophylline is not recommended. Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Mild hepatic impairment (Child-Pugh A). Women of childbearing potential should use effective method of contraception during treatment. Pregnancy & lactation. Childn <18 yr.
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