Package Insert: Information for the Patient

Daxas 500Film-Coated Tablets

roflumilast

Read this package insert carefully before starting to take this medication, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you and should not be given to others, even if they have the same symptomsas you, as it may harm them.
• Ifyou experienceadverse effects,consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Daxas contains the active ingredient roflumilast, which is a phosphodiesterase inhibitor‑4. Roflumilast reduces the activity of phosphodiesterase‑4, a naturally occurring protein in the body's cells. When the activity of this protein is reduced, lung inflammation decreases. This helps to stop the narrowing of the airways that occurs inchronic obstructive pulmonary disease (COPD). Therefore, Daxas alleviates respiratory problems.

Daxas is used for the maintenance treatment of severe COPD in adults who in the past had frequent exacerbations of their COPD symptoms and who have chronic bronchitis. COPD is a chronic lung disease that results in the narrowing of the airways (obstruction) and inflammation and irritation of the small airway walls in the lungs.

This leads to symptoms, such as cough, wheezing, chest tightness, or difficulty breathing. Daxas must be used in conjunction with bronchodilators.

Do not take Daxas

• if you are allergic to roflumilast or any of the other ingredients of this medication (listed in section6)
• if you have severe or moderate liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Daxas.

Sudden episodes of dyspnea (difficulty breathing)

Daxas is not indicated for the treatment of episodes of dyspnea (acute bronchospasms). To alleviate a sudden episode of dyspnea, it is very important that your doctor provides you with another medication, which you will have available at all times to overcome these episodes. Daxas will not help in these situations.

Weight

You should check your weight periodically. Consult your doctor if, while taking this medication, you observe an involuntary weight loss (not attributable to a diet or exercise program).

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), orprogressive multifocal leukoencephalopathy (PML)
• acute and severe infectious diseases such as acute hepatitis
• cancer (except for patients with basal cell carcinoma,a type of slow-evolving skin cancer)
• or severe heart disease

There is limited relevant experience with Daxas in these diseases. If you are diagnosed with any of these diseases, consult your doctor.

The experience with the use of Daxas in patients with a previous diagnosis of tuberculosis, viral hepatitis, viral herpes, or herpes zoster is also limited. Consult your doctor if you suffer from any of these diseases.

Symptoms you should be aware of

During the first weeks of treatment with Daxas, you may experience diarrhea, nausea, and abdominal or headache pain. If these adverse effects do not disappear after the first weeks of treatment, consult your doctor.

Daxas is not recommended for patients with a history of depression associated with suicidal ideation or behavior. You may also experience difficulty sleeping, anxiety, nervousness, or depression. Before starting treatment with Daxas, inform your doctor if you suffer from any of these symptoms or if you are taking any additional medication that may increase the likelihood of these adverse effects. You or your caregivers should immediately inform your doctor about any change in behavior or mood and about any suicidal thoughts you may have.

Children and adolescents

Do not administer this medication to children or adolescents under 18years.

Other medications and Daxas

Inform your doctor or pharmacist if you are using, have used recently, or may use other medications, especially the following:

• a medication containing theophylline (a medication used to treat respiratory diseases), or
• a medication used to treat immunological diseases, such as methotrexate, azathioprine, infliximab, etanercept, or prolonged oral corticosteroids.
• a medication containing fluvoxamine (a medication for anxiety and depression disorders), enoxacin (a medication for bacterial infections), or cimetidine (a medication for stomach ulcers or acid reflux).

The effect of Daxas may be reduced if combined with rifampicin (a type of antibiotic) or with phenobarbital, carbamazepine, or phenytoin (medications used to treat epilepsy). Consult your doctor.

Daxas can be combined with other medications for the treatment of COPD, such as bronchodilators and inhaled or oral corticosteroids. Do not stop taking these medications or reduce their doses unless your doctor instructs you to do so.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

You should not become pregnant during treatment with this medication and should use an effective contraceptive method during treatment, as Daxas may be harmful to the fetus.

Driving and operating machinery

Daxas does not affect your ability to drive or operate machinery.

Daxas contains lactose.

If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

• During the first 28 days days - the initial recommended dose is one 250 microgram tablet of roflumilast once a day.
• • The initial dose is a low dose used to help your body get used to the medication before starting the full dose. With this low dose, you will not get the full effect of the medication, so it is essential to switch to the full dose (called the "maintenance dose") after 28 days.

• After 28 days days - the recommended maintenance dose is one 500 microgram tablet once a day.

Take the tablet with water. You can take it with or without food. Take it every day at the same time.

You may need to take Daxas for several weeks for it to take effect.

If you take more Daxas than you should

If you have taken more tablets than you should, you may experience the following symptoms: headache, nausea, diarrhea, dizziness, palpitations, confusion, mucus, and low blood pressure. Go to your doctor or pharmacist immediately. If possible, bring the medication and this leaflet with you.

If you forget to take Daxas

If you forget to take a tablet at your usual time, take it as soon as you remember on the same day. If you have forgotten to take it all day, continue taking the usual dose the next day. Keep taking the medication at your usual time. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Daxas

It is essential to continue taking Daxas for the period indicated by your doctor to control lung function, even when you no longer have symptoms.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

You may experience diarrhea, nausea, stomach pain or headache during the first weeks of treatment with Daxas. Consult your doctor if these side effects do not resolve in the first weeks of treatment.

Some side effects can be serious. In clinical studies and post-marketing experience, rare cases of suicidal thoughts and behaviors (including suicide) have been reported. Inform your doctor immediately of any suicidal thoughts you may have. You may also experience insomnia (frequent), anxiety (infrequent), nervousness (rare), anxiety attacks (rare) or depressive mood (rare).

In rare cases, allergic reactions may occur. Allergic reactions can affect the skin and, in rare cases, cause swelling of the eyelids, face, lips, and tongue, which may lead to difficulty breathing and/or decreased blood pressure and rapid heart rate. In case of an allergic reaction, stop taking Daxas and contact your doctor immediately or go to the nearest hospital emergency department. Bring all your medications and this leaflet with you and provide all information about your current medication.

Other side effects include the following:

Frequent side effects(may affect up to 1in 10people)

• diarrhea, nausea, stomach pain
• weight loss, decreased appetite
• headache.

Infrequent side effects(may affect up to 1in 100people)

• shaking, sensation of spinning (vertigo), dizziness
• sensation of rapid or irregular heartbeats (palpitations)
• gastritis, vomiting
• acid reflux from the stomach to the throat (acid regurgitation), indigestion
• eruption
• muscle pain, muscle weakness or cramps
• back pain
• sensation of weakness or fatigue; general discomfort.

Rare side effects(may affect up to 1in 1,000people)

• gynecomastia (enlargement of breast tissue in men);
• loss of taste
• respiratory tract infections (except pneumonia)
• bloody stools, constipation
• elevation of liver and muscle enzymes (observed in blood tests)
• hives (urticaria).

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly throughthe national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keepthis medication out of the sight and reachof children.

Do not use this medication after the expiration date that appears on the packaging and blister, after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Daxas

The active ingredient is roflumilast.

Each film-coated tablet contains 500 micrograms of roflumilast.

• The other components are:

• Core: lactose monohydrate (see section 2, “Daxas contains lactose”), maize starch, povidone, magnesium stearate.
• Coating: hypromellose, macrogol (4000), titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the product and contents of the pack

The Daxas 500 micrograms film-coated tablets are yellow, D-shaped, and engraved with the letter D on one side.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Responsible for manufacturing

Corden Pharma GmbH

Otto-Hahn-Str.

68723 Plankstadt

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of the summary of product characteristics

The detailed information on this medicinal product is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu