For doctors
What is it and how is it used?
Daliresp contains the active substance roflumilast, which is an anti-inflammatory medicine called phosphodiesterase 4 inhibitor. Roflumilast reduces the activity of phosphodiesterase 4, a protein occurring naturally in body cells. When the activity of this protein is reduced, there is less inflammation in the lungs. This helps to stop narrowing of airways occurring in chronic obstructive pulmonary disease (COPD). Thus Daliresp eases breathing problems.

Daliresp is used to treat severe COPD in adults. COPD is a chronic disease of the lungs that results in tightening of the airways (obstruction) and swelling and irritation of the walls of the small air passages (inflammation) leading to symptoms such as coughing, wheezing, chest tightness or difficulty in breathing. Daliresp is to be used in addition to bronchodilators.

What do you have to consider before using it?
Do not take Daliresp

Take special care with Daliresp
Daliresp is not intended for the treatment of a sudden attack of breathlessness (acute bronchospasms). In order to relieve a sudden attack of breathlessness it is very important that your doctor provides you with another medicine to be available to you at all times that can cope with such an attack. Daliresp will not help you in this situation.

You should check your body weight on a regular basis. Talk to your doctor if, while taking this medicine, you observe an unintentional loss of body weight (not related to a diet or exercise programme).

Daliresp is not recommended for patients having severe immunological diseases (such as HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy, and others), severe acute infectious diseases (such as tuberculosis, or acute hepatitis), cancer (except basal-cell carcinoma, a slow-growing type of skin cancer), or severe impairment of the heart function, due to lack of relevant experience with Daliresp under these conditions. You should talk to your doctor, if you are diagnosed with any of these diseases.

Experience is also limited in patients with a previous diagnosis of tuberculosis, viral hepatitis, herpes viral infection or herpes zoster.

You may experience diarrhoea, nausea, abdominal pain or headache during the first weeks of treatment with Daliresp. Talk to your doctor if these side effects do not resolve within the first weeks of treatment.

You may also experience sleeplessness, anxiety, nervousness, or depressive mood. Before starting treatment with Daliresp, inform your doctor if you are suffering from any symptoms of this kind and of any additional medicinal products you may take since some of those could increase the probability of these side effects. You should also immediately inform your doctor of any suicidal thoughts you may have.

Children
Daliresp should not be used by children and adolescents under 18 years of age.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Daliresp may be taken with other medicines used in the treatment of COPD such as inhaled or oral corticosteroids or bronchodilators. Do not stop taking these medicines or reduce their dose unless advised by your doctor.

Please let your doctor know before you start to take Daliresp, if you already take:

The effect of Daliresp may be reduced if taken together wit