500 micrograms film-coated tablets 
roflumilast

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
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 packaging and other information 

1. What Daxas is and what it is used for

Daxas contains the active substance roflumilast which is an anti-inflammatory agent called phosphodiesterase -4 inhibitor. 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, inflammation in the lungs decreases. This helps to stop the narrowing of the airways that occurs in chronic obstructive pulmonary disease (COPD). Daxas thus relieve breathing problems.

Daxas is used for the maintenance treatment of severe COPD in adults whose COPD symptoms have often worsened in the past (so-called exacerbations ) and who have chronic bronchitis. COPD is a chronic disease of the lungs that leads to the airways becoming narrower ( obstruction ) and to the walls of the small airways becoming swollen and irritated ( inflammation ). This causes symptoms such as coughing, wheezing and vomiting, chest tightness, and difficulty breathing. Daxas should be used as an adjunct to bronchodilators.

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 cautions

Talk to your doctor or pharmacist before taking Daxas.

Sudden attacks of shortness of breath

Daxas should not be used to relieve sudden attacks of shortness of breath (acute bronchospasm ). To relieve a sudden attack of shortness of breath, your doctor must prescribe another medicine that is designed for this and that you can always carry with you. Daxas do not help in such situations.

Bodyweight

You should weigh yourself regularly. Talk to your doctor if you inadvertently lose weight while taking this medicine (a weight loss that is not linked to any particular diet or exercise program).

Other diseases

Daxas is not recommended if you have any of the following diseases:

  • severe immunological diseases e.g. HIV infection, multiple sclerosis (MS), lupus erythematosus (LE), or progressive multifocal leukoencephalopathy (PML)
  • severe acute infectious diseases e.g. acute hepatitis
  • cancer (in addition to basal cell carcinoma, a slow-growing type of skin cancer)
  • or severe disorders of cardiac function

This is due to the lack of experience with the use of Daxas in these conditions. Tell your doctor if you have such a disease.

Experience is also limited in the treatment of patients who have previously had tuberculosis, hepatitis caused by a viral infection, herpes infection, or shingles. Talk to your doctor if you have 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. Talk to your doctor if these side effects do not go away after the first few weeks of treatment.

Daxas are not recommended for patients who have a history of depression associated with suicidal ideation or behavior. You may also experience insomnia, anxiety, nervousness, or depression. Tell your doctor if you are suffering from or taking medicines for any of these conditions. Such drugs may increase the risk of getting any of these side effects. You or your healthcare provider should immediately tell your doctor if your behavior or mood has changed and if you have any suicidal thoughts.

Children and young people

This medicine should not be given to children and adolescents under 18 years of age.

Other medicines and Daxas

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, in particular, the following:

  • a medicine containing theophylline (a medicine for respiratory diseases) or
  • a drug for any immunological disease, e.g. methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids are to be taken for a long time.
  • medicines containing fluvoxamine (a medicine for anxiety disorders and depression), enoxacin (a medicine for bacterial infections), or cimetidine (a medicine for stomach ulcers and acid reflux).

The effect of Daxas may be reduced if it is taken with rifampicin (an antibiotic ) or with phenobarbital, carbamazepine, or phenytoin (medicines commonly used for epilepsy ). Consult a doctor.

Daxas can be taken with other medicines used to treat COPD, e.g. inhaled or oral corticosteroids or bronchodilators. Do not stop using these medicines or do not reduce the dose of one of them unless your doctor has given you the go-ahead.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. You must not become pregnant during treatment with this medicine and you must use an effective method of contraception during treatment as Daxas may be harmful to the unborn baby.

Driving and using machines

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

Daxas contains lactose

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

How to take Daxas

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

  • For the first 28 days – the recommended starting dose is one 250 microgram tablet once a day.
  • The starting dose is a low dose to help your body get used to the medicine before you start taking the full dose. At this low dose, you will not get the full effect of the medicine – therefore you must switch to the full dose (maintenance dose ) after 28 days.
  • After 28 days – the recommended maintenance dose is one 500 microgram tablet once a day.

Swallow the tablet with a little water. You can take this medicine with or without food. Take the tablet at the same time each day.

You may need to take Daxas for several weeks before the intended effect is achieved.

If you take more Daxas then you should

If you take more tablets than you should, you may experience the following symptoms: headache, nausea, diarrhea, dizziness, palpitations, fainting, stickiness, and low blood pressure.

Contact a doctor or pharmacist as soon as possible. If possible, bring the remaining tablets and this leaflet.

If you forget to take Daxas

If you forget to take a tablet at the usual time, take it as soon as you remember on the same day. If you forget to take your Daxas tablet one day, take the next tablet, as usual, the next day. Continue to take the medicine at the usual times. Do not take a double dose to make up for a forgotten dose.

If you stop taking Daxas

For the best possible lung function, you must continue to take Daxas for the time prescribed by your doctor, even if you have no symptoms.

If you have any further questions on the use of this product, 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, abdominal pain, or headache during the first few weeks of treatment with Daxas. Talk to your doctor if these side effects do not subside during the first weeks of treatment.

Some side effects can be serious. In clinical trials and post-marketing experience, rare cases of suicidal ideation and suicidal behavior (including suicide) have been reported. Tell your doctor immediately if you have any suicidal thoughts. You may also experience side effects such as insomnia (common), anxiety (uncommon), nervousness (rare), panic attack (rare), or depression (rare).

In less common cases, allergic reactions occur. Allergic reactions can affect the skin and in rare cases cause swelling of the eyelids, face, lips, and tongue, which can cause difficulty breathing and/or a drop in blood pressure and increased heart rate. If you experience an allergic reaction, stop taking Daxas immediately and contact a doctor or go to the emergency department of the nearest hospital. Bring the remaining tablets and this leaflet and provide full details of your current treatments.

Other side effects:

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

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

Less common side effects are (may affect up to 1 in 100)

  • tremors, feeling of tingling in the head (dizziness), dizziness
  • the feeling of irregular heartbeat or increased number of heartbeats (palpitations)
  • gastritis, vomiting
  • leakage of stomach acid to the esophagus (acid reflux), indigestion
  • rash
  • muscle pain, muscle weakness, or cramps
  • back pain
  • feeling weak or tired, feeling sick.

Rare side effects are (may affect up to 1 in 1000)

  • enlarged breasts in men
  • impaired sense of taste
  • respiratory tract infections (other than pneumonia )
  • blood in the stool, constipation
  • elevated liver or muscle enzymes (examined using blood tests)
  • swelling of the skin ( hives ).

5. How to store 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 expiration date is the last day of the specified month.

No special storage instructions.

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.

6. Contents of the packaging and other information

Content declaration

The active substance is roflumilast.

One film-coated tablet (tablet) contains 500 micrograms of roflumilast.

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

What the medicine looks like and the contents of the pack

Daxa’s 500 microgram film-coated tablets are yellow, D-shaped film-coated tablets marked with “D” on one side.

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

Not all pack sizes may be marketed.

Manufacturer

Takeda GmbH

Production site Oranienburg

Lehnitzstraße 70‑98

16515 Oranienburg

Germany

Corden Pharma GmbH

Otto-Hahn-Str.

68723 Plankstadt

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine

Belgium / Belgique / BelgienAstraZeneca SA / NVTel: +32 2 370 48 11 LithuaniaUAB AstraZeneca LietuvaTel: +370 5 2660550
BulgariaAstrology Bulgaria BODYTel: +359 24455000 Luxembourg / LuxemburgAstraZeneca SA / NVTel: +32 2 370 48 11
Czech RepublicAstraZeneca Czech Republic sroTel: +420 222 807 111 HungaryAstraZeneca Kft.Tel .: +36 1 883 6500
DenmarkAstraZeneca A / STel: +45 43 66 64 62 MaltaAssociated Drug Co. Ltd.Tel: +356 2277 8000
GermanyAstraZeneca GmbHTel: +49 41 03 7080 The NetherlandsAstraZeneca BVTel: +31 79 363 2222
EestiAstraZenecaTel: +372 6549 600 NorwayAstraZeneca ASTel: +47 21 00 64 00
GreeceAstraZeneca AE:Ηλ: +30 210 6871500 AustriaAstraZeneca Österreich GmbHTel: +43 1 711 31 0
SpainAstraZeneca Pharmacéutica Spain, SATel: +34 91 301 91 00 PolandAstraZeneca Pharma Poland Sp. z ooTel .: +48 22 245 73 00
FranceAstraZenecaTel: +33 1 41 29 40 00 PortugalAstraZeneca Pharmaceutical Products, Lda.Tel: +351 21 434 61 00
CroatiaAstraZeneca dooTel: +385 1 4628 000 RomaniaAstraZeneca Pharma SRLTel: +40 21 317 60 41
IrelandAstraZeneca Pharmaceuticals (Ireland) DACTel: +353 1609 7100 SloveniaAstraZeneca UK LimitedTel: +386 1 51 35 600
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicAstraZeneca AB, ozTel: +421 2 5737 7777
ItalySimesa SpATel: +39 02 9801 1 Finland / FinlandAstraZeneca OyPuh / Tel: +358 10 23 010
LatviaSIA AstraZeneca LatvijaTel: +371 67377100 United KingdomAstraZeneca UK LtdTel: +44 1582 836 836

Muhammad Nadeem

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