of the study, both groups of patients had an FEV1 of around 1 litre (1,000 ml). After a year, the patients who took Daliresp had an average increase of 40 ml while those given placebo had an average decrease of 9 ml. In addition, the patients who took Daliresp had an average of 1.1 moderate or severe flare-ups of their disease, compared with 1.4 flare-ups in the patients who took placebo.
What is the risk associated?
The most common side effects with Daliresp (seen in between 1 and 10 patients in 100) are decreased weight, decreased appetite, insomnia (difficulty sleeping), headache, diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache). Because patients taking Daliresp may lose weight, they are advised to weigh themselves on a regular basis. The doctor may stop treatment with Daliresp if the patient loses too much weight. For the full list of all side effects reported with Daliresp, see the package leaflet.
Daliresp should not be used in people who may be hypersensitive (allergic) to roflumilast or any of the other ingredients. It must not be used in patients who have moderate or severe problems with their liver. Daliresp is not recommended in patients with diseases that severely weaken the immune system (the body’s natural defences). Because there have been rare cases of patients taking Daliresp feeling suicidal, the medicine is also not recommended in patients who have had depression with suicidal thoughts.
Why has it been approved?
The CHMP noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Daliresp in patients with severe COPD. This benefit was seen on top of the effects of the treatments that the patients were already receiving. After considering all of the available data on the effects of the medicine, the Committee decided that Daliresp’s benefits are greater than its risks and recommended that it be given marketing authorisation.
How has it been studied?
The company that makes Daliresp will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine’s side effects and how it should be used. The company will also provide cards for patients, telling them what information that they need to give their doctor about their symptoms and past illnesses to help the doctor know whether Daliresp is appropriate for them. The card will include an area where patients can record their weight.
Further information
The European Commission granted a marketing authorisation valid throughout the European Union for Daliresp to Nycomed GmbH on 28 February 2011. The marketing authorisation is valid for five years, after which it can be renewed.
This authorisation was based on the authorisation granted to Daxas in 2010 (‘informed consent’). europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Daliresp, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in 01-2011.
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Name
Daliresp 500 micrograms film-coated tablets
Composition
Each tablet contains 500 micrograms of roflumilast.
Excipient: This product contains 199 mg lactose monohydrate per film-coated tablet.
For a full list of excipients, see section 6.1.
Phar
