Prospect: Patient Information

Daxas 250microgram tablets

roflumilast

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospect. See section 4.

1.What is Daxas and for what it is used

2.What you need to know before starting to take Daxas

3.How to take Daxas

4.Possible adverse effects

5.Storage of Daxas

6.Contents of the package and additional information

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, inflammation in the lungs 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 should 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.

Body 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), or progressive 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)
• 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 of using Daxas in patients with a previous diagnosis of tuberculosis, viral hepatitis, viral herpes, or herpes zoster is also limited. Consult your doctor if you have any of these diseases.

Symptoms you should be aware of

During the first weeks of treatment with Daxas, you may experience diarrhea, nausea, 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 of any change in behavior or mood and any suicidal thoughts you may have.

Children and adolescents

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

Other medications and Daxas

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, 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), 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 tells you to.

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

The influence of Daxas on the ability to drive and operate machinery is negligible or insignificant.

Daxas contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• During the first 28 days- the recommended initial dose is one 250microgram roflumilast tablet 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 important to switch to the full dose (called the "maintenance dose") after 28days.

• After 28days -the recommended maintenance dose is one 500microgram 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 produce its beneficial 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 forget 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 the use of 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 headaches during the first weeks of treatment with Daxas. If these side effects do not disappear after the first weeks of treatment, consult your doctor.

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. Immediately inform your doctor 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 breathing difficulties or decreased blood pressure and rapid heart rate. In case of an allergic reaction, stop taking Daxas and immediately contact your doctor 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 1 in 10 people)

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

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

• shakiness, 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 1 in 1,000 people)

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

Reporting side effects

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

Keep this medication out of the sight and reach of children.

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

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Daxas

The active ingredient is roflumilast.

Each Daxas 250 tablet contains 250 micrograms of roflumilast. The other components are lactose monohydrate (see section 2 "Daxas contains lactose"), maize starch, povidone, and magnesium stearate.

Appearance of the medicinal product and contents of the pack

Daxas 250 micrograms tablets are white or off-white with "D" engraved on one face and "250" on the other.

Each pack contains 28 tablets.

Marketing authorisation 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 authorisation 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 Agency:http://www.ema.europa.eu