In clinical studies, some instances of suicidal thinking and behavior (including suicide) were reported. Please notify your doctor immediately of any suicidal thoughts you may have.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?
Keep out of the reach and sight of children.

Do not use Daliresp after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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For doctors
What is it?
Daliresp is a medicine that contains the active substance roflumilast. It is available as yellow, D-shaped tablets (500 micrograms).

This medicine is the same as Daxas, which is already authorised in the European Union (EU). The company that makes Daxas has agreed that its scientific data can be used for Daliresp (‘informed consent’).

What is it used for?
Daliresp is used to treat severe chronic obstructive pulmonary disease (COPD) in adults who have chronic bronchitis (long-term inflammation of their airways), and whose COPD flares up frequently. COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing air in and out of the lungs.

Daliresp is not used on its own but as an ‘add-on’ to treatment with bronchodilators (medicines that widen the airways in the lungs).

The medicine can only be obtained with a prescription.

How is it used?
The recommended dose of Daliresp is one tablet once a day. The tablets should be swallowed with water at the same time each day. Patients may need to take Daliresp for several weeks before it starts to have an effect.

How does it work?
The active substance in Daliresp, roflumilast, belongs to a group of medicines called ‘phosphodiesterase type 4 (PDE4) inhibitors’. It blocks the action of the PDE4 enzyme, which is involved in the inflammation process that leads to COPD. By blocking the action of PDE4, roflumilast reduces the inflammation in the lungs, helping to reduce the patient’s symptoms or to prevent them from getting worse.

How has it been studied?
The effects of Daliresp were first tested in experimental models before being studied in humans.

Daliresp has been compared with placebo (a dummy treatment) in two main studies involving over 3,000 adults with severe COPD who had had at least one flare-up of their disease in the past year. The patients could continue to receive treatment with a bronchodilator during the study. The main measure of effectiveness was the improvement in forced expiratory volumes (FEV1) and the reduction in the number of moderate or severe flare-ups of their COPD over a year of treatment. FEV1 is the most air a person can breathe out in one second.

What benefits has it shown during the studies?
Daliresp was shown to be more effective than placebo at treating COPD. At the beginning