DAXAS 500 micrograms FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Daxas 500micrograms film-coated tablets

roflumilast

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

Contents of the pack and other information:

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

1. What is Daxas and what is it used for

Daxas contains the active substance roflumilast, which is a phosphodiesterase-4 inhibitor with anti-inflammatory properties. Roflumilast reduces the activity of phosphodiesterase-4, a protein that occurs naturally in the body's cells. When the activity of this protein is reduced, the inflammation in the lungs decreases. This helps to stop the narrowing of the airways that occurs in chronic obstructive pulmonary disease (COPD). Therefore, Daxas relieves breathing problems.

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

This leads to symptoms such as coughing, wheezing, chest tightness, or difficulty breathing. Daxas should be used in combination with bronchodilators.

2. What you need to know before you take Daxas

Do not take Daxas

• 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.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Daxas.

Sudden episodes of shortness of breath (dyspnea)

Daxas is not intended for the treatment of acute bronchospasm (sudden episodes of shortness of breath). To relieve a sudden episode of shortness of breath, it is essential that your doctor provides you with another medicine that you will have available at all times to overcome these episodes. Daxas will not help you in these situations.

Weight

You should check your weight regularly. Talk to your doctor if, while taking this medicine, you notice an unintentional weight loss (not due to diet or exercise).

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), systemic lupus erythematosus (SLE), or progressive multifocal leukoencephalopathy (PML)
• severe acute infectious diseases such as acute hepatitis
• cancer (except for patients with basal cell carcinoma, a type of slow-growing skin cancer)
• or severe heart disease

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

Experience with the use of Daxas in patients with a previous diagnosis of tuberculosis, viral hepatitis, viral herpes, or herpes zoster is also limited. Talk to your doctor if you have any of these diseases.

Symptoms to watch out for

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

Daxas is not recommended in 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 have any of these symptoms or if you are taking any other medication that may increase the likelihood of these side effects. You or your caregivers should immediately inform your doctor of any changes in behavior or mood and any suicidal thoughts you may have.

Children and adolescents

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

Other medicines and Daxas

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

• a medicine that contains theophylline (a medicine used to treat respiratory diseases), or
• a medicine used to treat immunological diseases, such as methotrexate, azathioprine, infliximab, etanercept, or prolonged use of oral corticosteroids.
• a medicine that contains fluvoxamine (a medicine used to treat anxiety and depression), enoxacin (a medicine used to treat bacterial infections), or cimetidine (a medicine used to treat stomach ulcers or acidity).

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 contraceptive method during treatment, as Daxas may harm the fetus.

Driving and using machines

Daxas does not affect the ability to drive or use machines.

Daxas contains lactose.

If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to take Daxas

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

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

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 before it starts to work.

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, mucous, and low blood pressure. Go to your doctor or pharmacist immediately. If possible, take the medicine and this leaflet with you.

If you forget to take Daxas

If you forget to take a tablet at the scheduled time, take it as soon as you remember on the same day. If you have forgotten to take it for the entire day, continue taking the normal dose the next day. Continue taking the medicine at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Daxas

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

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

4. Possible side effects

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

You may experience diarrhea, nausea, stomach pain, or headache during the first few weeks of treatment with Daxas. Talk to your doctor if these side effects do not resolve within the first few 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 if you have any suicidal thoughts. You may also experience insomnia (frequent), anxiety (uncommon), nervousness (rare), panic 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 can lead to difficulty breathing and/or a decrease in blood pressure and rapid heartbeat. If you experience an allergic reaction, stop taking Daxas and contact your doctor immediately or go to the emergency department of the nearest hospital. Bring all your medicines and this leaflet with you and provide all the information about your current medication.

Other side effects include:

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

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

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

• tremors, feeling of dizziness (vertigo), dizziness
• feeling of rapid or irregular heartbeat (palpitations)
• gastritis, vomiting
• acid reflux from the stomach to the throat (acid reflux), indigestion
• rash
• muscle pain, muscle weakness, or cramps
• back pain
• feeling of weakness or tiredness; general malaise

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

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

Reporting of side effects

If you experience 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Daxas

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

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 protect the environment.

6. Contents of the pack and further information

What is in Daxas

The active substance is roflumilast.

Each film-coated tablet contains 500 micrograms of roflumilast.

• The other ingredients are:

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

Appearance and packaging

Daxas 500 microgram 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.

Not all pack sizes may be marketed.

Marketing authorisation holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

Corden Pharma GmbH

Otto-Hahn-Str.

68723 Plankstadt

Germany

You can get more information about this medicine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet

Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu