Company: Takeda Products Ireland Ltd.
Legal category: Prescription. Sport pending.
Active ingredient: Roflumilast 500mcg.
Description: Yellow, D-shaped film-coated tablet marked D on one side.
Presentation: 30, price available on request.
Indication: Maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adults with history of frequent exacerbations as add on to bronchodilator treatment.
Pharmacology: Roflumilast is a PDE-4 inhibitor, a non-steroid, anti-inflammatory agent designed to target both the systemic and pulmonary inflammation associated with COPD.
Dosage: Adult: One tablet daily at same time each day. Elderly: As per adults. Children: Under 18 years, no relevant use.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Moderate or severe hepatic impairment (Child-Pugh B or C). Pregnancy, lactation.
Special precautions: Do not use as rescue product for acute bronchospasms. Not recommended: Severe immunological diseases (e.g. HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy), severe acute infectious diseases, cancers (except basal cell carcinoma), congestive heart failure (NYHA grades 3 and 4), history of depression associated with suicidal ideation or behaviour. Caution: Mild hepatic impairment (Child-Pugh A). Stop treatment if unexplained and clinically concerning weight decrease occurs. Associated with increased risk of psychiatric disorders such as insomnia, anxiety, nervousness and depression; rarely, suicidal ideation and behaviour, including completed suicide, observed in patients with or without history of depression, usually within first weeks of treatment; discontinue if new or worsening psychiatric symptoms develop. Limited experience in latent infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster. Reassess treatment if intolerability persists beyond first weeks (e.g. diarrhoea, nausea, abdominal pain, headache); higher exposure in black, non-smoking females. Contains lactose.
Drug interactions: Not recommended: Immunosuppressives (e.g. methotrexate, azathioprine, infliximab, etanercept, long-term oral corticosteroids), theophylline, strong cytochrome P450 enzyme inducers (e.g. phenobarbital, carbamazepine, phenytoin). CYP1A2/ 2C19/3A4 inhibitors (e.g. fluvoxamine, cimetidine), CYP1A2/3A4 inhibitor enoxacin.
Adverse drug reactions: Decreased weight, decreased appetite, insomnia, headache, GI upset.
Full prescribing information and references available from Takeda Products Ireland Ltd. Telephone: +44 (1628) 537900 or 1800 937 970. Email: DSO-UK@takeda.com