Daxas 500 micrograms film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Daxas 500 micrograms film-coated tablets

roflumilast

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Daxas is and what it is used for

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

Daxas is used for the maintenance treatment of severe COPD in adults who have had frequent episodes of worsening COPD symptoms in the past (known as exacerbations) and who have chronic bronchitis. COPD is a chronic lung disease that results in 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 cough, wheezing, chest tightness, or difficulty breathing. Daxas should be used in combination with bronchodilators.

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

Sudden episodes of dyspnea (difficulty breathing)

Daxas is not indicated for the treatment of acute episodes of dyspnea (acute bronchospasm). To relieve a sudden episode of dyspnea, it is very important that your doctor provides you with another medicine, which you should always have available to manage such episodes. Daxas will not help you in these situations.

Weight

You should check your weight periodically. Consult your doctor if, while taking this medicine, you experience unintentional weight loss (not due to diet or an exercise program).

Other diseases

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

• severe immunological diseases such as HIV infection, multiple sclerosis (MS), systemic lupus erythematosus (SLE), or progressive multifocal leukoencephalopathy (PML)
• acute and severe infectious diseases such as acute hepatitis
• cancer (except patients with basal cell carcinoma, a type of slow-progressing skin cancer)
• or severe heart disease

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

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

Symptoms you should be aware of

During the first weeks of treatment with Daxas, you may experience diarrhea, nausea, abdominal pain, or headache. If these adverse effects do not resolve after the first few weeks of treatment, consult 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 symptoms of this kind or if you are taking any additional medicines that may increase the likelihood of these adverse effects. You or your caregivers should immediately report to your doctor any changes in behavior or mood, or 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

Inform 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 used to treat respiratory diseases), or
• a medicine used to treat immunological diseases, such as methotrexate, azathioprine, infliximab, etanercept, or long-term oral corticosteroids.
• a medicine containing fluvoxamine (a medicine to treat anxiety and depression disorders), enoxacin (a medicine to treat bacterial infections), or cimetidine (a medicine to treat stomach ulcer or acid reflux).

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

Daxas may be used together 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 doses unless instructed by your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

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

Daxas contains lactose

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

3. How to take Daxas

Follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist.

• During the first 28 days – the recommended initial dose is one 250 microgram roflumilast tablet once daily.

  • The initial dose is a low dose used to help your body get used to the medicine before starting the full dose. This low dose will not provide the full effect of the medicine; therefore, it is important that you switch to the full dose (called the “maintenance dose”) after 28 days.

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

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

It may take several weeks before you notice the full effect of Daxas.

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, diarrhoea, dizziness, palpitations, confusion, mucus production, and low blood pressure. Contact your doctor or pharmacist immediately. If possible, bring the medicine 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 for the entire day, continue taking your next dose as usual the following day. Continue taking the medicine at your regular time. Do not take a double dose to make up for a missed dose.

If you stop taking Daxas

It is important that you continue taking Daxas for the period indicated by your doctor in order to maintain lung function, even if your symptoms improve.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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 adverse effects do not resolve within the first weeks of treatment.

Some adverse effects may be serious. In clinical studies and post-marketing experience, rare cases of suicidal thoughts and behaviour (including suicide) have been reported. Immediately inform your doctor of any suicidal thoughts you may have. You may also experience insomnia (common), anxiety (uncommon), restlessness (rare), panic attacks (rare), or depressed mood (rare).

Allergic reactions may occur in uncommon cases. Allergic reactions may affect the skin and, in rare instances, cause swelling of the eyelids, face, lips, or tongue, which may lead to breathing difficulties and/or a drop in blood pressure and rapid heart rate. If you experience an allergic reaction, stop taking Daxas immediately and contact your doctor right away or go immediately to the nearest hospital emergency department. Bring all your medicines and this leaflet with you, and provide all information regarding your current medication.

Other adverse effects include the following:

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

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

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

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

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Daxas

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

Do not use this medicine after the expiry date stated on the packaging and blister, following CAD/EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Daxas

The active substance is roflumilast.

Each film-coated tablet (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

Daxas 500 microgram film-coated tablets are yellow, D-shaped, and marked with the letter D on one side.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

Corden Pharma GmbH

Otto-Hahn-Strasse 1

68723 Plankstadt

Germany

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet

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