Daxas 500 micrograms film-coated tablets

Daxas 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 Daxas eases breathing problems.

Daxas 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. Daxas is to be used in addition to bronchodilators.

Do not take Daxas

• if you are allergic (hypersensitive) to roflumilast or any of the other ingredients of Daxas (listed in section 6 ?What Daxas contains?)
• if you have moderate or severe liver disease.

Take special care with Daxas

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.

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).

Daxas 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 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.

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.

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 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

Daxas 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.

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.

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

• 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, enoxacin or cimetidine.

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.

Taking Daxas with food and drink
You may take this medicine with or without food.

Pregnancy and breast-feeding

Do not take Daxas if you are or plan to become pregnant, think you may be pregnant, or are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.

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

Important information about some of the ingredients of Daxas

Daxas tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take Daxas exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is one 500 micrograms tablet once daily. Do not take more tablets than your doctor has recommended.

Swallow the tablet with some water. You may take this medicine with or without food. Take the tablet at the same time every day.

You may need to take Daxas for several weeks to achieve its beneficial effect.

If you take more Daxas than you should
Tell your doctor or pharmacist straight away. If possible take your medicine and this leaflet with you.

If you forget to take Daxas
If you forget to take a tablet at the usual time, take the tablet as soon as you remember. 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.

If you stop taking Daxas
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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Daxas can cause side effects, although not everybody gets them.

Side effects may occur with certain frequencies, which are defined as follows very common affects more than 1 user in 10 common affects 1 to 10 users in 100 uncommon affects 1 to 10 users in 1,000 rare affects 1 to 10 users in 10,000 very rare affects less than 1 user in 10,000 not known frequency cannot be estimated from the available data.

Common side effects

Weight decrease, decreased appetite; sleeplessness; headache; diarrhoea, nausea, stomach ache.

Uncommon side effects

Hypersensitivity (a generalised allergic reaction that may affect the skin, mouth and tongue, possibly leading to difficulties in breathing and/or a drop in blood pressure and accelerated heartbeat); feeling anxious; trembling, sensation of spinning head (vertigo), dizziness; sensation of rapid or irregular heartbeat (palpitations); gastritis, vomiting, reflux of stomach acid to the gullet (acid regurgitations), indigestion; rash; muscle pain or cramps; back pain; feeling of weakness or tiredness; feeling unwell.

Rare side effects
Male breast enlargement; feeling nervous or depressed; decreased sense of taste; respiratory tract infections (excluding pneumonia); bloody stools, constipation; elevation of liver or muscle enzymes (seen in blood tests); wheals (urticaria).

In the rare case of a severe allergic reaction, stop taking Daxas and contact your doctor immediately, or go immediately to the emergency department in the nearest hospital. Take your medicine and this leaflet with you to provide full information of your proper treatment. Typical symptoms of a severe allergic reaction are: swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty in swallowing or breathing, hives (nettle rash), severe dizziness with very fast heartbeat and heavy sweating.

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.

Keep out of the reach and sight of children.

Do not use Daxas 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.

What Daxas contains

• The active substance is roflumilast. Each film-coated tablet (tablet) contains 500 micrograms roflumilast.
• The other ingredients are:
• Core: lactose monohydrate, maize starch, povidone (K90), magnesium stearate,
• Coating: hypromellose 2910, Macrogol 4000, titanium dioxide (E171), and iron oxide yellow (E172).

What Daxas looks like and contents of the pack

Daxas 500 micrograms film-coated tablets are yellow, D-shaped film-coated tablets, embossed with 'D' on one side.
Each PVC/PVDC aluminium blister pack contains 10, 30, or 90 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Nycomed GmbH
Byk-Gulden-Straße 2
78467 Konstanz
Germany

Manufacturer

Nycomed GmbH
Production site Oranienburg
Lehnitzstraße 70-98
16515 Oranienburg
Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

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