Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - daxas

Document Subject

Generated Narrative: MedicinalProductDefinition mp1f1abc0830f94db591b845bd71b79232

identifier: http://ema.europa.eu/identifier/EU/1/10/636/008

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Daxas 250 micrograms tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-1f1abc0830f94db591b845bd71b79232

identifier: http://ema.europa.eu/identifier/EU/1/10/636/008

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - daxas

Attesters

What is in this leaflet:

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

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.

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 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 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 Do not give this medicine to 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 If you are pregnant or breast-feeding, 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 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 medicinal product.

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.

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.

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.

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 S dert lje Sweden Manufacturer Takeda GmbH Production site Oranienburg Lehnitzstra e 70-16515 Oranienburg Germany Corden Pharma GmbH Otto-Hahn-Str. 68723 Plankstadt Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660

.: +359 24455Luxembourg/Luxemburg AstraZeneca S.A./N.V. T l/Tel: +32 2 370 48 esk republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 Magyarorsz g AstraZeneca Kft. Tel.: +36 1 883 6Danmark AstraZeneca A/S Tlf: +45 43 66 64 Malta Associated Drug Co. Ltd Tel: +356 2277 8Deutschland AstraZeneca GmbH Tel: +49 40 809034Nederland AstraZeneca BV Tel: +31 85 808 9Eesti AstraZeneca Tel: +372 6549 Norge AstraZeneca AS Tlf: +47 21 00 64
AstraZeneca A.E. : +30 210 6871 sterreich AstraZeneca sterreich GmbH Tel: +43 1 711 31 0 Espa a AstraZeneca Farmac utica Spain, S.A. Tel: +34 91 301 91 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 France AstraZeneca T l: +33 1 41 29 40 Portugal AstraZeneca Produtos Farmac uticos, Lda. Tel: +351 21 434 61 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 sland Vistor hf. S mi: +354 535 7Slovensk republika AstraZeneca AB, o.z. Tel: +421 2 5737 7Italia Simesa S.p.A. Tel: +39 02 00704Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23

: +357 22490Sverige AstraZeneca AB Tel: +46 8 553 26 Latvija SIA AstraZeneca Latvija Tel: +371 67377United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 This leaflet was last approved in Detailed information on this medicine is available on the European Medicines Agency web site: