Roflumilast

The 250 micrograms starting dose is intended to reduce adverse reactions and patient discontinuation when initiating therapy but is a SUB-THERAPEUTIC dose, and should be used only as a starting dose. Roflumilast 500 micrograms may need to be taken for several weeks to achieve its full effect; it has been studied in clinical trials for up to one year and is intended for maintenance treatment in COPD. Not indicated as a rescue medicinal product for the relief of acute bronchospasm. Elderly: no dose adjustment necessary. Hepatic impairment: clinical data in mild impairment (Child-Pugh A) are insufficient to recommend a dose adjustment, so use with caution; patients with moderate or severe impairment (Child-Pugh B or C) must not take it (contraindicated). Weight decrease occurs more frequently than with placebo - check body weight of underweight patients at each visit, advise regular self-weighing, and stop roflumilast if there is unexplained and clinically concerning weight loss. Do not initiate, or stop existing treatment, in patients with severe immunological disease, severe acute infectious disease, cancers (except basal cell carcinoma), or patients on immunosuppressive medicinal products; not recommended in congestive heart failure NYHA grades 3 and 4. Associated with an increased risk of psychiatric disorders including insomnia, anxiety, nervousness and depression, with rare instances of suicidal ideation and behaviour usually within the first weeks of treatment - not recommended in patients with a history of depression associated with suicidal ideation or behaviour, and discontinue if new or worsening psychiatric symptoms or suicidal ideation occur. Paediatric: there is no relevant use of this product in the paediatric population (under 18 years) for the indication of COPD; no per-kg dose is stated.