• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Daxas is and what it is used for
2. What you need to know before you take Daxas
3. How to take Daxas
4. Possible side effects
5. How to store Daxas
6. Contents of the pack and other information

• if you are allergic to roflumilast or any of the other ingredients of this medicine (listed in section 6)
• if you have moderate or severe liver problems.

Talk to your doctor or pharmacist before taking Daxas.

Sudden attack of breathlessness

Daxas 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. Daxas will not help you in this situation.

Body weight

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).

Other diseases

Daxas is not recommended if you have one or more of the following diseases:

• severe immunological diseases such as HIV infection, multiple sclerosis (MS), lupus erythematosus (LE) or progressive multifocal leukoencephalopathy (PML)
• severe acute infectious diseases such as acute hepatitis
• cancer (except basal-cell carcinoma, a slow-growing type of skin cancer)
• or severe impairment of the heart function

There is a lack of relevant experience with Daxas 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. Please talk to your doctor if you have one of these diseases.

Symptoms you should be aware of

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

Daxas is not recommended in patients with a history of depression associated with suicidal thinking or behaviour.You may also experience sleeplessness, anxiety, nervousness, or depressive mood. Before starting treatment with Daxas, inform your doctor if you are suffering from any symptoms of this kind and of any additional medicines you may take since some of those could increase the probability of these side effects. You or your caregiver should also immediately inform your doctor of any changes in behaviour or mood and of any suicidal thoughts you may have.

Do not give this medicine to children and adolescents under 18 years of age.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially the following:

• a medicine containing theophylline (a medicine to treat respiratory diseases), or
• a medicine used for treatment of immunological diseases, such as methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term.
• a medicine containing fluvoxamine (a medicine to treat anxiety disorders and depression), enoxacin (a medicine to treat bacterial infections) or cimetidine (a medicine to treat stomach ulcers or heartburn).

The effect of Daxas may be reduced if taken together with rifampicin (an antibiotic medicine) or with phenobarbital, carbamazepine or phenytoin (medicines usually prescribed for the treatment of epilepsy). Ask your doctor for advice.

Daxas 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.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not become pregnant during treatment with this medicine and should use an effective method of contraception during therapy, because Daxas may be harmful for the unborn baby.

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

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you have taken more tablets than you should, you may experience the following symptoms: headache, nausea, diarrhoea, dizziness, throbbing of your heart, light-headedness, clamminess and low blood pressure. Tell your doctor or pharmacist straight away. If possible take your medicine and this leaflet with you.

If you forget to take a tablet at the usual time, take the tablet as soon as you remember on the same day. If on one day you have forgotten to take a tablet of Daxas, just carry on the next day with the next tablet as usual. Continue taking your medicine at the usual times. Do not take a double dose to make up for a forgotten dose.

It is important to continue taking Daxas for as long as prescribed by your doctor, even when you have no symptoms, in order to maintain control of your lung function.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is roflumilast.

Each film-coated tablet (tablet) contains 500 micrograms roflumilast.

The other ingredients are:

Core: lactose monohydrate (see section 2 under “Daxas contains lactose”), maize starch, povidone, magnesium stearate.

Coating: hypromellose, macrogol (4000), titanium dioxide (E171), and iron oxide yellow (E172).

Daxas 500 micrograms film-coated tablets are yellow, D-shaped film-coated tablets, embossed with 'D' on one side.

Each pack contains 10, 14, 28, 30, 84 , 90 or 98 film-coated tablets.

Not all pack sizes may be marketed.