Daxas: detailed information

Package leaflet: Information for the patient

Daxas 250 micrograms tablets

roflumilast
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Daxas is and what it is used for
What you need to know before taking 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 a 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, there is less inflammation in the lungs. This helps prevent the narrowing of the airways that occurs in chronic obstructive pulmonary disease (COPD). Thus, Daxas improves breathing problems.
Daxas is indicated for the maintenance treatment of severe COPD in adults who have had frequent episodes of worsening COPD symptoms (so-called exacerbations) in the past and who have chronic bronchitis. COPD is a chronic lung disease that causes narrowing of the airways (obstruction) and swelling and irritation of the walls of the small airways (inflammation), leading to symptoms such as cough, wheezing, chest tightness, or difficulty breathing. Daxas is to be used in addition to bronchodilators.

2. What you need to know before taking Daxas

Do not take Daxas

if you are allergic to roflumilast or to 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 taking Daxas.
Sudden breathing difficulty
Daxas is not indicated for the treatment of a sudden attack of breathing difficulty (acute bronchospasm). It is very important that your doctor provides you with another medicine to carry with you at all times to treat such sudden attacks. Daxas will not help you in this situation.
Body weight
You should monitor your body weight regularly. Contact your doctor if, while taking this medicine, you experience unintentional weight loss (not related to dieting or an exercise program).
Other diseases
Daxas is not recommended if you have one or more of the following conditions:

severe immunological disorders such as HIV infection, multiple sclerosis (MS), systemic lupus erythematosus (SLE), or progressive multifocal leukoencephalopathy (PML)
severe acute infections such as acute hepatitis
cancer (except basal cell carcinoma, a slow-growing type of skin cancer)
severe reduction in cardiac function. There is a lack of relevant data with Daxas in these conditions. Inform your doctor if you have been diagnosed with any of these diseases.

Experience is also limited in patients with a previous diagnosis of tuberculosis, viral hepatitis, herpes-type viral infections, or herpes zoster. Inform 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. Inform your doctor if these side effects do not resolve within the first few weeks of treatment.
The use of Daxas is not recommended in patients with a history of depression associated with suicidal thoughts or behavior. You may also experience insomnia, anxiety, restlessness, or depressed mood. Before starting treatment with Daxas, inform your doctor if you are experiencing any symptoms of this kind and about any other medicines you have taken, as some of them could increase the likelihood of these side effects. You or your caregiver should also immediately inform your doctor of any changes in behavior or mood, or of any suicidal thoughts that may occur.
Children and adolescents
This medicine must not be given to children and 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 drug used to treat respiratory problems), or
a medicine used to treat immunological disorders, such as methotrexate, azathioprine, infliximab, etanercept, or long-term oral corticosteroids.
a medicine containing fluvoxamine (a medicine to treat anxiety and depression), enoxacin (a medicine to treat bacterial infections), or cimetidine (a medicine to treat stomach ulcers or heartburn).

The effect of Daxas may decrease if taken together with rifampicin (an antibiotic) or with phenobarbital, carbamazepine, or phenytoin (medicines commonly prescribed for the treatment of epilepsy). Ask your doctor for advice.
Daxas may be taken together 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 doses without consulting your doctor.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant, or if you are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
You must not become pregnant while being treated with this medicine and you must use an effective method of contraception during treatment, as Daxas may be harmful to the fetus.
Driving and using machines
Daxas has no effect on the ability to drive vehicles or operate machinery.
Daxas contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Daxas

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.

For the first 28 days – the recommended starting dose is one 250 microgram tablet once daily.
The starting dose is a low dose used to help your body get used to the medicine before you take the full dose. With this low dose, you will not achieve 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 a glass of water. You may take this medicine with or without food. Take the tablet at the same time each day.
It may take several weeks before you experience the beneficial 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, sensation of a pounding heartbeat, mild confusion, stickiness, 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 your tablet at the usual time, take it as soon as you remember, on the same day. If you forget to take a Daxas tablet one day, simply continue the next day by taking the next tablet as usual. Continue taking the tablet at your usual time. 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 the entire period prescribed by your doctor, even when you have no symptoms, in order to maintain control of lung function.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
During the first weeks of treatment with Daxas, diarrhoea, nausea, stomach ache or headache may occur.
Tell your doctor if these side effects do not resolve within the first weeks of treatment.
Some side effects can be serious. In clinical studies and in post-marketing experience, rare cases of suicidal thoughts and behaviour (including suicide) have been observed. Contact your doctor immediately if you have any suicidal thoughts.
Other possible side effects include insomnia (common), anxiety (uncommon), nervousness (rare), panic attacks (rare), or depressed mood (rare).
Allergic reactions may occur uncommonly. Allergic reactions may affect the skin and, in rare cases, cause swelling of the eyelids, face, lips and tongue, which may sometimes lead to breathing difficulties and/or a drop in blood pressure and rapid heartbeat. If you experience an allergic reaction, stop taking Daxas immediately and contact your doctor or go immediately to the nearest hospital emergency department. Bring all your medicines and this leaflet with you and provide all information regarding the medicines you are currently taking.
Other side effects include the following:
Common side effects (may affect up to 1 in 10 people)

diarrhoea, nausea, stomach ache
weight loss, reduced appetite
headache

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

tremor, sensation of spinning (dizziness), dizziness
sensation of rapid or irregular heartbeat (palpitations)
gastritis, vomiting
gastric acid reflux into the oesophagus (acid regurgitation), indigestion
skin rash
muscle pain, muscle weakness or cramps
back pain
feeling of weakness or fatigue, feeling unwell.

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

enlargement of the male breast
reduced sense of taste
respiratory tract infections (excluding lung infection)
blood in the stools, constipation
increased liver or muscle enzymes (seen in blood tests)
hives (urticaria).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex 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 cardboard box and on the blister
after Exp. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Daxas contains
The active substance is roflumilast.
Each Daxas 250 microgram tablet contains 250 micrograms of roflumilast. The other
ingredients are: monohydrate lactose (see section 2 “Daxas contains lactose”), maize starch,
povidone, magnesium stearate.
Description of the appearance of Daxas and contents of the pack
Daxas 250 microgram tablets are white to off-white, marked with “D” on one side and “250” on the
other side.
Each pack contains 28 tablets.
Marketing Authorization Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden
Manufacturer
Corden Pharma GmbH
Otto-Hahn-Str.
68723 Plankstadt
Germany
For further information about this medicine, contact the local representative of the Marketing
Authorization Holder:
België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550
България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V.
Тел.: +359 24455000 Tél/Tel: +32 2 370 48 11
Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500
Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf: +45 43 66 64 62 Tel: +356 2277 8000
Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900
Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00
Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 210 6871500 Tel: +43 1 711 31 0
España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00
France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00
Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41
Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600
Ísland Slovenská republika
Vistor hf. AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777
Italia Suomi/Finland
Simesa S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010
Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000
Latvija United Kingdom (Northern Ireland)
SIA AstraZeneca Latvija AstraZeneca UK Ltd
Tel: +371 67377100 Tel: +44 1582 836 836
More detailed information on this medicine is available on the website of the European Medicines Agency, http://www.ema.europa.eu.

Package leaflet: Information for the patient

Daxas 500 microgram tablets, film-coated

roflumilast
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Daxas is and what it is used for
What you need to know before taking 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 a 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, there is less inflammation in the lungs. This helps prevent the narrowing of the airways that occurs in chronic obstructive pulmonary disease (COPD). Thus, Daxas improves breathing problems.
Daxas is indicated for the maintenance treatment of severe COPD in adults who have had frequent episodes of worsening COPD symptoms (so-called exacerbations) in the past and who have chronic bronchitis. COPD is a chronic lung disease that causes narrowing (obstruction) of the airways and swelling and irritation of the walls of the small airways (inflammation), leading to symptoms such as cough, wheezing, chest tightness, or difficulty breathing. Daxas is to be used in addition to bronchodilators.

2. What you need to know before taking Daxas

Do not take Daxas

if you are allergic to roflumilast or to 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 taking Daxas.
Sudden breathing difficulty
Daxas is not indicated for the treatment of a sudden attack of breathing difficulty (acute bronchospasm). It is very important that your doctor provides you with another medicine to carry with you at all times to treat such sudden attacks. Daxas will not help you in this situation.
Body weight
You should monitor your body weight regularly. Contact your doctor if, while taking this medicine, you experience unintentional weight loss (not related to diet or exercise).
Other diseases
Daxas is not recommended if you have one or more of the following conditions:

severe immunological disorders such as HIV infection, multiple sclerosis (MS), systemic lupus erythematosus (SLE), or progressive multifocal leukoencephalopathy (PML)
severe acute infections such as acute hepatitis
cancer (except basal cell carcinoma, a slow-growing type of skin cancer)
severe reduction in cardiac function

There is a lack of relevant data with Daxas in these conditions. Inform your doctor if you have been diagnosed with any of these diseases.

Experience is also limited in patients with a previous diagnosis of tuberculosis, viral hepatitis, herpes-type viral infections, or herpes zoster. Inform your doctor if you have any of these conditions.
Symptoms you should be aware of
During the first few weeks of treatment with Daxas, you may experience diarrhea, nausea, abdominal pain, or headache. Inform your doctor if these side effects do not resolve within the first few weeks of treatment.
The use of Daxas is not recommended in patients with a history of depression associated with suicidal thoughts or behavior. You may also experience insomnia, anxiety, restlessness, or depressed mood. Before starting treatment with Daxas, inform your doctor if you are experiencing any symptoms of this kind and about any other medicines you have taken, as some of them may increase the likelihood of these side effects. You or your caregiver should also immediately inform your doctor of any changes in behavior or mood and of any suicidal thoughts that may occur.
Children and adolescents
This medicine must not be given to children and 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 drug used to treat respiratory problems), or
a medicine used to treat immunological disorders, such as methotrexate, azathioprine, infliximab, etanercept, or long-term oral corticosteroids.
a medicine containing 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 heartburn).

The effect of Daxas may decrease if taken together with rifampicin (an antibiotic) or with phenobarbital, carbamazepine, or phenytoin (medicines normally prescribed for the treatment of epilepsy). Ask your doctor for advice.
Daxas may be taken together 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 doses without consulting your doctor.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine. You must not become pregnant during treatment with this medicine and you should use an effective method of contraception during treatment, as Daxas may be harmful to the fetus.
Driving and using machines
Daxas has no influence on the ability to drive or use machines.
Daxas contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Daxas

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

For the first 28 days – the recommended starting dose is one 250 microgram tablet once daily.
The starting dose is a low dose used to help your body get used to the medicine before you take the full dose. With this low dose, you will not achieve 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 some water. You may take this medicine with or without food. Take the tablet every day at the same time.
You may need to take Daxas for several weeks to achieve the 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, sensation of a pounding heartbeat, mild confusion, stickiness (viscosity), and low blood pressure. Contact your doctor or pharmacist immediately. If possible, bring the medicine and this leaflet with you.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

During the first weeks of treatment with Daxas, diarrhoea, nausea, stomach ache or headache may occur. Inform your doctor if these side effects do not resolve within the first weeks of treatment.

Some side effects may be serious. In clinical studies and in post-marketing experience, rare cases of suicidal thoughts and behaviour (including suicide) have been observed. Inform your doctor immediately if you experience any suicidal thoughts. Other possible side effects include insomnia (common), anxiety (uncommon), nervousness (rare), panic attack (rare), or depressed mood (rare).

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

Other side effects include the following:

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

diarrhoea, nausea, stomach ache
weight loss, reduced appetite
headache

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

tremor, sensation of dizziness (vertigo), dizziness
sensation of rapid or irregular heartbeat (palpitations)
gastritis, vomiting
gastric acid reflux into the oesophagus (acid regurgitation), indigestion
skin rash
muscle pain, muscle weakness or cramps
back pain
feeling of weakness or fatigue, feeling unwell

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

enlargement of the breast in men
reduced sense of taste
respiratory tract infections (excluding lung infection)
blood in the faeces, constipation
increased liver or muscle enzymes (seen in blood tests)
hives (urticaria)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in Annex 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 cardboard box and on the 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 dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Daxas contains
The active substance is roflumilast.
Each film-coated tablet (tablet) contains 500 micrograms of roflumilast.

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).

Description of the appearance of Daxas and the contents of the pack
Daxas 500 microgram film-coated tablets are yellow, D-shaped, marked 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
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:

België/Belgique/Belgien Lietuva
AstraZeneca S.A./N.V. UAB AstraZeneca Lietuva
Tel: +32 2 370 48 11 Tel: +370 5 2660550

България Luxembourg/Luxemburg
АстраЗенека България ЕООД AstraZeneca S.A./N.V.
Тел.: +359 24455000 Tél/Tel: +32 2 370 48 11

Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500

Danmark Malta
AstraZeneca A/S Associated Drug Co. Ltd
Tlf: +45 43 66 64 62 Tel: +356 2277 8000

Deutschland Nederland
AstraZeneca GmbH AstraZeneca BV
Tel: +49 40 809034100 Tel: +31 85 808 9900

Eesti Norge
AstraZeneca AstraZeneca AS
Tel: +372 6549 600 Tlf: +47 21 00 64 00

Ελλάδα Österreich
AstraZeneca A.E. AstraZeneca Österreich GmbH
Τηλ: +30 210 6871500 Tel: +43 1 711 31 0

España Polska
AstraZeneca Farmacéutica Spain, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 301 91 00 Tel.: +48 22 245 73 00

France Portugal
AstraZeneca AstraZeneca Produtos Farmacêuticos, Lda.
Tél: +33 1 41 29 40 00 Tel: +351 21 434 61 00

Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41

Ireland Slovenija
AstraZeneca Pharmaceuticals (Ireland) DAC AstraZeneca UK Limited
Tel: +353 1609 7100 Tel: +386 1 51 35 600

Ísland Slovenská republika
Vistor hf. AstraZeneca AB, o.z.
Sími: +354 535 7000 Tel: +421 2 5737 7777

Italia Suomi/Finland
Simesa S.p.A. AstraZeneca Oy
Tel: +39 02 00704500 Puh/Tel: +358 10 23 010

Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ AstraZeneca AB
Τηλ: +357 22490305 Tel: +46 8 553 26 000

Latvija United Kingdom (Northern Ireland)
SIA AstraZeneca Latvija AstraZeneca UK Ltd
Tel: +371 67377100 Tel: +44 1582 836 836

More detailed information on this medicinal product is available on the European Medicines Agency website, http://www.ema.europa.eu.