Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

All patients should be informed about the risks of Daliresp and the precautions for safe use before starting treatment.

Rescue medicinal products
Daliresp is not indicated as rescue medicinal product for the relief of acute bronchospasms.

Weight decrease
In 1-year studies (M2-124, M2-125), a decrease of body weight occurred more frequently in patients treated with roflumilast compared to placebo-treated patients. After discontinuation of roflumilast, the majority of patients had regained body weight after 3 months.
Body weight of underweight patients should be checked at each visit. Patients should be advised to check their body weight on a regular basis. In the event of an unexplained and clinically concerning weight decrease, the intake of roflumilast should be stopped and body weight should be further followed-up.

Special clinical conditions
Due to lack of relevant experience, treatment with roflumilast should not be initiated or existing treatment with roflumilast 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 (i.e.: methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term; except short-term systemic corticosteroids). Experience in patients with latent infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster is limited.
Patients with congestive heart failure (NYHA grades 3 and 4) have not been studied and therefore treatment of these patients is not recommended.

Psychiatric disorders
Roflumilast is associated with an increased risk of psychiatric disorders such as insomnia, anxiety, nervousness and depression. Rare instances of suicidal ideation and behaviour, including suicide, have been observed in patients with or without history of depression, usually within the first weeks of treatment (see section 4.8). The risks and benefits of starting or continuing treatment with roflumilast should be carefully assessed if patients report previous or existing psychiatric symptoms or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended. Roflumilast is not recommended in patients with a history of depression associated with suicidal ideation or behaviour.
Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation. If patients suffered from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt is identified, it is recommended to discontinue treatment with roflumilast.

Persistent intolerability
While adverse reactions like diarrhoea, nausea, abdominal pain and headache mainly occur within the first weeks of therapy and mostly resolve on continued treatment, roflumilast treatment should be reassessed in case of persistent intolerability. This might be the case in special populations that may have higher exposure, such as in black, non-smoking females (see section 5.2) or in patients concomitantly treated with CYP1A2/ 2C19/3A4 inhibitors (such as fluvoxamine and cimetidine) or the CYP1A2/3A4 inhibitor enoxacin (see section 4.5).

Body weight <60 kg
Treatment with roflumilast may lead to a higher risk of sleep disorders (mainly insomnia) in patients with a baseline body weight of <60 kg, due to a higher total PDE4 inhibitory activity found in these patients (see section 4.8).

Theophylline
There are no clinical data to support the concomitant treatment with theophylline for maintenance therapy. Therefore, the concomitant treatment with theophylline is not recommended.

Lactose
Daliresp tablets contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Effects on Driving

4.7   Effects on ability to drive and use machines

Daliresp has no influence on the ability to drive and use machines.