Daxas

Основна информация

  • Търговско наименование:
  • Daxas
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Daxas
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Drugs for obstructive airway diseases,
  • Терапевтична област:
  • Pulmonary Disease, Chronic Obstructive
  • Терапевтични показания:
  • Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.
  • Каталог на резюме:
  • Revision: 12

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/001179
  • Дата Оторизация:
  • 04-07-2010
  • EMEA код:
  • EMEA/H/C/001179
  • Последна актуализация:
  • 29-03-2019

Доклад обществена оценка

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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

EMA/154550/2018

EMEA/H/C/001179

Daxas (roflumilast)

An overview of Daxas and why it is authorised in the EU

What is Daxas and what is it used for?

Daxas is a medicine used to treat severe chronic obstructive pulmonary disease (COPD) in adults who

have chronic bronchitis (long-term inflammation of the airways), and whose COPD flares up frequently.

COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or

blocked, leading to difficulty breathing air in and out of the lungs.

Daxas is not used on its own but as an ‘add-on’ to treatment with bronchodilators (medicines that

widen the airways in the lungs).

Daxas contains the active substance roflumilast.

How is Daxas used?

Daxas is available as tablets (250 and 500 micrograms) and can only be obtained with a prescription.

The recommended dose of Daxas for treatment is one 500-microgram tablet once a day, but treatment

is started with one 250-microgram tablet daily to reduce side effects that might make patients stop

taking the medicine. The tablets should be taken at the same time each day. After taking

250 micrograms daily for 4 weeks, the dose is increased to 500 micrograms daily. Patients may need

to take Daxas 500 micrograms for several weeks before it starts to have an effect.

For more information about using Daxas, see the package leaflet or contact your doctor or pharmacist.

How does Daxas work?

The active substance in Daxas, roflumilast, belongs to a group of medicines called ‘phosphodiesterase

type 4 (PDE4) inhibitors’. It blocks the action of the PDE4 enzyme, which is involved in the

inflammation process that leads to COPD. By blocking the action of PDE4, roflumilast reduces the

inflammation in the lungs, helping to reduce the patient’s symptoms or to prevent them from getting

worse.

What benefit of Daxas have been shown in studies?

Daxas 500 micrograms was shown to be more effective than placebo (a dummy treatment) at treating

COPD in two main studies. These involved over 3,000 adults with severe COPD who had had at least

Daxas (roflumilast)

EMA/154550/2018

Page 2/3

one flare-up of their disease in the past year. The patients could continue to receive treatment with a

bronchodilator during the study. The main measure of effectiveness was the improvement in forced

expiratory volumes (FEV

) and the reduction in the number of moderate or severe flare-ups of their

COPD over a year of treatment. FEV

is the most air a person can breathe out in one second.

At the beginning of the studies, both groups of patients had an FEV

of around 1 litre (1,000 ml). After

a year, the patients who took Daxas had an average increase of 40 ml while those given placebo had

an average decrease of 9 ml. In addition, the patients who took Daxas had an average of 1.1 moderate

or severe flare-ups of their disease, compared with 1.4 flare-ups in the patients who took placebo.

Another 12-week study involving 1,323 patients examined the effect of starting treatment with Daxas

250 micrograms daily for 4 weeks before increasing the dose to 500 micrograms daily, compared with

starting at the higher dose. Around 18% (81 of 441 patients) of those started at 250 micrograms daily

dropped out of the study, compared with 25% (109 of 443) of those starting with 500 micrograms

daily. Patients started on the lower dose had fewer side effects. The benefits in improving FEV

were

similar in both groups at the end of the study; however, patients who could not take 500 micrograms

daily and were then just given 250 micrograms daily did not show an improvement in lung function.

What are the risks associated with Daxas?

The most common side effects with Daxas (seen in between 1 and 10 patients in 100) are decreased

weight, decreased appetite, insomnia (difficulty sleeping), headache, diarrhoea, nausea (feeling sick)

and abdominal pain (stomach ache). Because patients taking Daxas may lose weight, they are advised

to weigh themselves on a regular basis. The doctor may stop treatment with Daxas if the patient loses

too much weight. For the full list of side effects of Daxas, see the package leaflet.

Daxas must not be used in patients who have moderate or severe problems with their liver. For the full

list of restrictions, see the package leaflet.

Why is Daxas authorised in the EU?

The European Medicines Agency noted that there was a need for new COPD treatments and that the

main studies showed a modest benefit of Daxas 500 micrograms in patients with severe COPD. This

benefit was seen on top of the effects of the treatments that the patients were already receiving.

Although a dose of 250 micrograms daily does not improve lung function it was useful in preventing

patients from dropping out because of side effects when starting treatment. After considering all of the

available data on the effects of the medicine, the Agency decided that Daxas’s benefits are greater

than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of

Daxas?

The company that makes Daxas will ensure that healthcare professionals who will prescribe the

medicine in all Member States of the European Union (EU) are provided with educational materials

containing information on the medicine’s side effects and how it should be used. The company will also

provide cards for patients, telling them what information about their symptoms and past illnesses they

need to give their doctor to help the doctor determine whether Daxas is appropriate for them. The card

will include an area where patients can record their weight.

The company is also carrying out an observational study on the long-term safety of the medicine.

Daxas (roflumilast)

EMA/154550/2018

Page 3/3

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Daxas have also been included in the summary of product characteristics and the

package leaflet.

As for all medicines, data on the use of Daxas are continuously monitored. Side effects reported with

Daxas are carefully evaluated and any necessary action taken to protect patients.

Other information about Daxas:

Daxas received a marketing authorisation valid throughout the EU on 5 July 2010.

Further information on Daxas can be found on the Agency’s website: ema.europa/Find

medicine/Human medicine/European public assessment reports.

This overview was last updated in 03-2018.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Daxas 250 micrograms tablets

Roflumilast

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

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.

What is in this leaflet:

What Daxas is and what it is used for

What you need to know before you take Daxas

How to take Daxas

Possible side effects

How to store Daxas

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 an anti-inflammatory medicine called

phosphodiesterase-4 inhibitor. Roflumilast reduces the activity of phosphodiesterase-4, a protein

occurring naturally in body cells. When the activity of this protein is reduced, there is less

inflammation in the lungs. This helps to stop narrowing of airways occurring in chronic obstructive

pulmonary disease (COPD). Thus Daxas eases breathing problems.

Daxas is used for maintenance treatment of severe COPD in adults who in the past had frequent

worsening of their COPD symptoms (so-called exacerbations) and who have chronic bronchitis.

COPD is a chronic disease of the lungs that results in tightening of the airways (obstruction) and

swelling and irritation of the walls of the small air passages (inflammation). This leads to symptoms

such as coughing, wheezing, chest tightness or difficulty in breathing. Daxas is to be used in addition

to 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

if you have moderate or severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Daxas.

Sudden attack of breathlessness

Daxas is not intended for the treatment of a sudden attack of breathlessness (acute bronchospasms). In

order to relieve a sudden attack of breathlessness it is very important that your doctor provides you

with another medicine to be available to you at all times that can cope with such an attack. Daxas will

not help you in this situation.

Body weight

You should check your body weight on a regular basis. Talk to your doctor if, while taking this

medicine, you observe an unintentional loss of body weight (not related to a diet or exercise

programme).

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)

severe acute infectious diseases such as tuberculosis, or acute hepatitis

cancer (except basal-cell carcinoma, a slow-growing type of skin cancer)

or severe impairment of the heart function

There is a lack of relevant experience with Daxas under these conditions. You should talk to your

doctor, if you are diagnosed with any of these diseases.

Experience is also limited in patients with a previous diagnosis of tuberculosis, viral hepatitis, herpes

viral infection or herpes zoster. Please talk to your doctor if you have one of these diseases.

Symptoms you should be aware of

You may experience diarrhoea, nausea, abdominal pain or headache during the first weeks of

treatment with Daxas. Talk to your doctor if these side effects do not resolve within the first weeks of

treatment.

Daxas is not recommended in patients with a history of depression associated with suicidal thinking or

behaviour. You may also experience sleeplessness, anxiety, nervousness, or depressive mood. Before

starting treatment with Daxas, inform your doctor if you are suffering from any symptoms of this kind

and of any additional medicines you may take since some of those could increase the probability of

these side effects. You or your caregiver should also immediately inform your doctor of any changes

in behaviour or mood and of any suicidal thoughts you may have.

Children and adolescents

Daxas should not be used by children and 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 any other

medicines, especially the following:

- a medicine containing theophylline (a medicine to treat respiratory diseases), or

- a medicine used for treatment of immunological diseases, such as methotrexate, azathioprine,

infliximab, etanercept, or oral corticosteroids to be taken long-term.

- a medicine containing fluvoxamine (a medicine to treat anxiety disorders and depression), enoxacin

(a medicine to treat bacterial infections

or cimetidine (a medicine to treat stomach ulcers or

heartburn).

The effect of Daxas may be reduced if taken together with rifampicin (an antibiotic medicine) or with

phenobarbital, carbamazepine or phenytoin (medicines usually prescribed for the treatment of

epilepsy). Ask your doctor for advice.

Daxas may be taken with other medicines used in the treatment of COPD such as inhaled or oral

corticosteroids or bronchodilators. Do not stop taking these medicines or reduce their dose unless

advised by your doctor.

Pregnancy and breast-feeding

Do not take Daxas if you are or plan to become pregnant, think you may be pregnant, or are

breast-feeding. You should not become pregnant during treatment with this medicine and should use

an effective method of contraception during therapy, because Daxas may be harmful for the unborn

baby.

Driving and using machines

Daxas has no influence on the ability to drive and 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.

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 28 days - the recommended starting dose is one 250 micrograms tablet once daily.

The starting dose is a low dose used 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 from the medicine –

therefore it is important that you move on to the full dose (called a ‘maintenance dose’) after

28 days.

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

Swallow the tablet with some water. You may take this medicine with or without food. Take the tablet

at the same time every day.

You may need to take Daxas for several weeks to achieve 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, diarrhoea, dizziness, throbbing of your heart, light-headedness, clamminess and low

blood pressure. Tell your doctor or pharmacist straight away. If possible take your medicine and this

leaflet with you.

If you forget to take Daxas

If you forget to take a tablet at the usual time, take the tablet as soon as you remember on the same

day. If on one day you have forgotten to take a tablet of Daxas, just carry on the next day with the next

tablet as usual. Continue taking your medicine at the usual times. Do not take a double dose to make

up for a forgotten dose.

If you stop taking Daxas

It is important to continue taking Daxas for as long as prescribed by your doctor, even when you have

no symptoms, in order to maintain control of your lung function.

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 diarrhoea, nausea, stomach ache or headache during the first weeks of treatment

with Daxas. Talk to your doctor if these side effects do not resolve within the first weeks of treatment.

Some side effects could be serious. In clinical studies and post-marketing experience, rare instances of

suicidal thinking and behaviour (including suicide) were reported. Please notify your doctor

immediately of any suicidal thoughts you may have. You may also experience sleeplessness

(common), anxiety (uncommon), nervousness (rare), panic attack (rare) or depressive mood (rare).

In uncommon cases allergic reactions may occur. Allergic reactions may affect the skin and in rare

cases cause swelling of the eyelids, face, lips and tongue, possibly leading to difficulties in breathing

and/or a drop in blood pressure and accelerated heartbeat. In case of an allergic reaction, stop taking

Daxas and contact your doctor immediately, or go immediately to the emergency department in the

nearest hospital. Take all your medicines and this leaflet with you and provide full information of your

current medications.

Other side effects include the following:

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

- diarrhoea, nausea, stomach ache

- weight decrease, decreased appetite

- headache

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

- trembling, sensation of spinning head (vertigo), dizziness

- sensation of rapid or irregular heartbeat (palpitations)

- gastritis, vomiting

- reflux of stomach acid to the gullet (acid regurgitations), indigestion

- rash

- muscle pain, muscle weakness or cramps

- back pain

- feeling of weakness or tiredness, feeling unwell.

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

- male breast enlargement

- decreased sense of taste

- respiratory tract infections (excluding pneumonia)

- bloody stools, constipation

- elevation of liver or muscle enzymes (seen in blood tests)

- wheals (urticaria).

Reporting of side effects

If you get 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.

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

expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Daxas contains

The active substance is roflumilast.

Each Daxas 250 micrograms tablet contains 250 micrograms roflumilast. The other ingredients are

lactose monohydrate (see section 2 under “Daxas contains lactose”), maize starch, povidone,

magnesium stearate.

What Daxas looks like and contents of the pack

Daxas 250 micrograms tablets are white to off-white, embossed with ‘D’ on one side and ‘250’ on the

other side.

Each pack contains 28 tablets.

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Manufacturer

Takeda GmbH

Production site Oranienburg

Lehnitzstraße 70-98

16515 Oranienburg

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

AstraZeneca S.A./N.V.

Tel: +32 2 370 48 11

Lietuva

UAB AstraZeneca Lietuva

Tel: +370 5 2660550

България

АстраЗенека България ЕООД

Тел.: +359 24455000

Luxembourg/Luxemburg

AstraZeneca S.A./N.V.

Tél/Tel: +32 2 370 48 11

Česká republika

AstraZeneca Czech Republic s.r.o.

Tel: +420 222 807 111

Magyarország

AstraZeneca Kft.

Tel.: +36 1 883 6500

Danmark

AstraZeneca A/S

Tlf: +45 43 66 64 62

Malta

Associated Drug Co. Ltd

Tel: +356 2277 8000

Deutschland

AstraZeneca GmbH

Tel: +49 41 03 7080

Nederland

AstraZeneca BV

Tel: +31 79 363 2222

Eesti

AstraZeneca

Tel: +372 6549 600

Norge

AstraZeneca AS

Tlf: +47 21 00 64 00

Ελλάδα

AstraZeneca A.E.

Τηλ: +30 210 6871500

Österreich

AstraZeneca Österreich GmbH

Tel: +43 1 711 31 0

España

AstraZeneca Farmacéutica Spain, S.A.

Tel: +34 91 301 91 00

Polska

AstraZeneca Pharma Poland Sp. z o.o.

Tel.: +48 22 245 73 00

France

AstraZeneca

Tél: +33 1 41 29 40 00

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Tel: +351 21 434 61 00

Hrvatska

AstraZeneca d.o.o.

Tel: +385 1 4628 000

România

AstraZeneca Pharma SRL

Tel: +40 21 317 60 41

Ireland

AstraZeneca Pharmaceuticals (Ireland) DAC

Tel: +353 1609 7100

Slovenija

AstraZeneca UK Limited

Tel: +386 1 51 35 600

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

AstraZeneca AB, o.z.

Tel: +421 2 5737 7777

Italia

Simesa S.p.A.

Tel: +39 02 9801 1

Suomi/Finland

AstraZeneca Oy

Puh/Tel: +358 10 23 010

Κύπρος

Αλέκτωρ Φαρµακευτική Λτδ

Τηλ: +357 22490305

Sverige

AstraZeneca AB

Tel: +46 8 553 26 000

Latvija

SIA AstraZeneca Latvija

Tel: +371 67377100

United Kingdom

AstraZeneca UK Ltd

Tel: +44 1582 836 836

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu

Package leaflet: Information for the patient

Daxas 500 micrograms film-coated tablets

Roflumilast

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

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.

What is in this leaflet:

What Daxas is and what it is used for

What you need to know before you take Daxas

How to take Daxas

Possible side effects

How to store Daxas

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 an anti-inflammatory medicine called

phosphodiesterase-4 inhibitor. Roflumilast reduces the activity of phosphodiesterase-4, a protein

occurring naturally in body cells. When the activity of this protein is reduced, there is less

inflammation in the lungs. This helps to stop narrowing of airways occurring in chronic obstructive

pulmonary disease (COPD). Thus Daxas eases breathing problems.

Daxas is used for maintenance treatment of severe COPD in adults who in the past had frequent

worsening of their COPD symptoms (so-called exacerbations) and who have chronic bronchitis.

COPD is a chronic disease of the lungs that results in tightening of the airways (obstruction) and

swelling and irritation of the walls of the small air passages (inflammation). This leads to symptoms

such as coughing, wheezing, chest tightness or difficulty in breathing. Daxas is to be used in addition

to 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

if you have moderate or severe liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Daxas.

Sudden attack of breathlessness

Daxas is not intended for the treatment of a sudden attack of breathlessness (acute bronchospasms). In

order to relieve a sudden attack of breathlessness it is very important that your doctor provides you

with another medicine to be available to you at all times that can cope with such an attack. Daxas will

not help you in this situation.

Body weight

You should check your body weight on a regular basis. Talk to your doctor if, while taking this

medicine, you observe an unintentional loss of body weight (not related to a diet or exercise

programme).

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)

severe acute infectious diseases such as tuberculosis, or acute hepatitis

cancer (except basal-cell carcinoma, a slow-growing type of skin cancer)

or severe impairment of the heart function

There is a lack of relevant experience with Daxas under these conditions. You should talk to your

doctor, if you are diagnosed with any of these diseases.

Experience is also limited in patients with a previous diagnosis of tuberculosis, viral hepatitis, herpes

viral infection or herpes zoster. Please talk to your doctor if you have one of these diseases.

Symptoms you should be aware of

You may experience diarrhoea, nausea, abdominal pain or headache during the first weeks of

treatment with Daxas. Talk to your doctor if these side effects do not resolve within the first weeks of

treatment.

Daxas is not recommended in patients with a history of depression associated with suicidal thinking or

behaviour. You may also experience sleeplessness, anxiety, nervousness, or depressive mood. Before

starting treatment with Daxas, inform your doctor if you are suffering from any symptoms of this kind

and of any additional medicines you may take since some of those could increase the probability of

these side effects. You or your caregiver should also immediately inform your doctor of any changes

in behaviour or mood and of any suicidal thoughts you may have.

Children and adolescents

Daxas should not be used by children and 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 any other

medicines, especially the following:

- a medicine containing theophylline (a medicine to treat respiratory diseases), or

- a medicine used for treatment of immunological diseases, such as methotrexate, azathioprine,

infliximab, etanercept, or oral corticosteroids to be taken long-term.

- a medicine containing fluvoxamine (a medicine to treat anxiety disorders and depression), enoxacin

(a medicine to treat bacterial infections

or cimetidine (a medicine to treat stomach ulcers or

heartburn).

The effect of Daxas may be reduced if taken together with rifampicin (an antibiotic medicine) or with

phenobarbital, carbamazepine or phenytoin (medicines usually prescribed for the treatment of

epilepsy). Ask your doctor for advice.

Daxas may be taken with other medicines used in the treatment of COPD such as inhaled or oral

corticosteroids or bronchodilators. Do not stop taking these medicines or reduce their dose unless

advised by your doctor.

Pregnancy and breast-feeding

Do not take Daxas if you are or plan to become pregnant, think you may be pregnant, or are

breast-feeding. You should not become pregnant during treatment with this medicine and should use

an effective method of contraception during therapy, because Daxas may be harmful for the unborn

baby.

Driving and using machines

Daxas has no influence on the ability to drive and 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.

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 28 days - the recommended starting dose is one 250 micrograms tablet once daily.

The starting dose is a low dose used 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 from the medicine –

therefore it is important that you move on to the full dose (called a ‘maintenance dose’) after

28 days.

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

Swallow the tablet with some water. You may take this medicine with or without food. Take the tablet

at the same time every day.

You may need to take Daxas for several weeks to achieve 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, diarrhoea, dizziness, throbbing of your heart, light-headedness, clamminess and low

blood pressure. Tell your doctor or pharmacist straight away. If possible take your medicine and this

leaflet with you.

If you forget to take Daxas

If you forget to take a tablet at the usual time, take the tablet as soon as you remember on the same

day. If on one day you have forgotten to take a tablet of Daxas, just carry on the next day with the next

tablet as usual. Continue taking your medicine at the usual times. Do not take a double dose to make

up for a forgotten dose.

If you stop taking Daxas

It is important to continue taking Daxas for as long as prescribed by your doctor, even when you have

no symptoms, in order to maintain control of your lung function.

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 diarrhoea, nausea, stomach ache or headache during the first weeks of treatment

with Daxas. Talk to your doctor if these side effects do not resolve within the first weeks of treatment.

Some side effects could be serious. In clinical studies and post-marketing experience, rare instances of

suicidal thinking and behaviour (including suicide) were reported. Please notify your doctor

immediately of any suicidal thoughts you may have. You may also experience sleeplessness

(common), anxiety (uncommon), nervousness (rare), panic attack (rare) or depressive mood (rare).

In uncommon cases allergic reactions may occur. Allergic reactions may affect the skin and in rare

cases cause swelling of the eyelids, face, lips and tongue, possibly leading to difficulties in breathing

and/or a drop in blood pressure and accelerated heartbeat. In case of an allergic reaction, stop taking

Daxas and contact your doctor immediately, or go immediately to the emergency department in the

nearest hospital. Take all your medicines and this leaflet with you and provide full information of your

current medications.

Other side effects include the following:

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

- diarrhoea, nausea, stomach ache

- weight decrease, decreased appetite

- headache

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

- trembling, sensation of spinning head (vertigo), dizziness

- sensation of rapid or irregular heartbeat (palpitations)

- gastritis, vomiting

- reflux of stomach acid to the gullet (acid regurgitations), indigestion

- rash

- muscle pain, muscle weakness or cramps

- back pain

- feeling of weakness or tiredness, feeling unwell.

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

- male breast enlargement

- decreased sense of taste

- respiratory tract infections (excluding pneumonia)

- bloody stools, constipation

- elevation of liver or muscle enzymes (seen in blood tests)

- wheals (urticaria).

Reporting of side effects

If you get 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.

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

expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Daxas contains

The active substance is roflumilast.

Each film-coated tablet (tablet) contains 500 micrograms roflumilast.

The other ingredients are:

Core: lactose monohydrate (see section 2 under “Daxas contains lactose”), maize starch,

povidone, magnesium stearate,

Coating: hypromellose, Macrogol 4000, titanium dioxide (E171), and iron oxide yellow

(E172).

What Daxas looks like and contents of the pack

Daxas 500 micrograms film-coated tablets are yellow, D-shaped film-coated tablets, embossed with '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

Takeda GmbH

Production site Oranienburg

Lehnitzstraße 70-98

16515 Oranienburg

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

AstraZeneca S.A./N.V.

Tel: +32 2 370 48 11

Lietuva

UAB AstraZeneca Lietuva

Tel: +370 5 2660550

България

АстраЗенека България ЕООД

Тел.: +359 24455000

Luxembourg/Luxemburg

AstraZeneca S.A./N.V.

Tél/Tel: +32 2 370 48 11

Česká republika

AstraZeneca Czech Republic s.r.o.

Tel: +420 222 807 111

Magyarország

AstraZeneca Kft.

Tel.: +36 1 883 6500

Danmark

AstraZeneca A/S

Tlf: +45 43 66 64 62

Malta

Associated Drug Co. Ltd

Tel: +356 2277 8000

Deutschland

AstraZeneca GmbH

Tel: +49 41 03 7080

Nederland

AstraZeneca BV

Tel: +31 79 363 2222

Eesti

AstraZeneca

Tel: +372 6549 600

Norge

AstraZeneca AS

Tlf: +47 21 00 64 00

Ελλάδα

AstraZeneca A.E.

Τηλ: +30 210 6871500

Österreich

AstraZeneca Österreich GmbH

Tel: +43 1 711 31 0

España

AstraZeneca Farmacéutica Spain, S.A.

Tel: +34 91 301 91 00

Polska

AstraZeneca Pharma Poland Sp. z o.o.

Tel.: +48 22 245 73 00

France

AstraZeneca

Tél: +33 1 41 29 40 00

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Tel: +351 21 434 61 00

Hrvatska

AstraZeneca d.o.o.

Tel: +385 1 4628 000

România

AstraZeneca Pharma SRL

Tel: +40 21 317 60 41

Ireland

AstraZeneca Pharmaceuticals (Ireland) DAC

Tel: +353 1609 7100

Slovenija

AstraZeneca UK Limited

Tel: +386 1 51 35 600

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

AstraZeneca AB, o.z.

Tel: +421 2 5737 7777

Italia

Simesa S.p.A.

Tel: +39 02 9801 1

Suomi/Finland

AstraZeneca Oy

Puh/Tel: +358 10 23 010

Κύπρος

Αλέκτωρ Φαρµακευτική Λτδ

Τηλ: +357 22490305

Sverige

AstraZeneca AB

Tel: +46 8 553 26 000

Latvija

SIA AstraZeneca Latvija

Tel: +371 67377100

United Kingdom

AstraZeneca UK Ltd

Tel: +44 1582 836 836

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu