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AstraZeneca

Libertek
roflumilast

Package leaflet: Information for the patient


Libertek 500 micrograms film-coated tablets

Roflumilast


image

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.


Warnings and precautions

Talk to your doctor or pharmacist before taking Libertek

Sudden attack of breathlessness

Libertek 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. Libertek 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

Libertek is not recommended if you have one or more of the following diseases:

There is a lack of relevant experience with Libertek 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

Medicinal product no longer authorised

You may experience diarrhoea, nausea, abdominal pain or headache during the first weeks of treatment with Libertek. Talk to your doctor if these side effects do not resolve within the first weeks of treatment.


Libertek 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 Libertek, 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

Libertek should not be used by children and adolescents under 18 years of age.


Other medicines and Libertek

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


The effect of Libertek 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.


Libertek 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 Libertek 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 Libertek may be harmful for the unborn baby.


Driving and using machines

Libertek has no influence on the ability to drive and use machines.


Libertek 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.


  1. How to take Libertek


Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.


The recommended 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 Libertek for several weeks to achieve its beneficial effect.


Medicinal product no longer authorised

If you take more Libertek 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 Libertek

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 Libertek, 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 Libertek

It is important to continue taking Libertek 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.


  1. 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 Libertek. 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 Libertek 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.


      Medicinal product no longer authorised

      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.


  2. How to store Libertek


    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.

  3. Contents of the pack and other information


What Libertek contains


What Libertek looks like and contents of the pack

Libertek 500 micrograms film-coated tablets are yellow, D-shaped film-coated tablets, embossed with 'D' on one side.

Each pack contains 10, 30, or 90 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

Medicinal product no longer authorised

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

Laboratorio Beta, 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) Ltd 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.

Medicinal product no longer authorised

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