Patient leaflet - Libertek
1 What Libertek is and what it is used for
Libertek 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 Libertek eases breathing problems.
Libertek 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. Libertek is to be used in addition to bronchodilators.
2 What you need to know before you take Libertek
Do not take Libertek
- 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 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:
- 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 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 •/v«'
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.
h a history of depression associated with suicidal thinking or ssness, anxiety, nervousness, or depressive mood. Before r doctor if you are suffering from any symptoms of this kind ke since some of those could increase the probability of these
Libertek is not recommended in patients wit behaviour. You may also experience sleeple starting treatment with Libertek, inform you and of any additional medicines you side effects. You or your caregiver s behaviour or mood and of any suicid ould also immediately inform your doctor of any changes in l 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:
- 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 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.
3 How to take Libertek
pharmacist if
Always take this medicine exactly as your doctor has told you. Check with your do you are not sure.
The recommended dose is one 500 micrograms tablet once daily.
ithout food. Take the tablet
Swallow the tablet with some water. You may take this medicine wi at the same time every day.
You may need to take Libertek for several weeks to achieve its beneficial effect.
If you take more Libertek than you should
If you have taken more tablets than you should, yo 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.
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 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 100people)
- 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).
* //2r
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 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.
6. Contents of the pack and other information
What Libertek contains
- The active substance is roflumilast. Each film-coated tablet (tablet) contains 500 micrograms roflumilast.
- The other ingredients are:
- Core: lactose monohydrate, maize starch, povidone (K90), magnesium stearate,
- Coating: hypromellose, Macrogol 4000, titanium dioxide (E171), and iron oxide yellow (E172).
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
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
Etnrapufl
AcTpa3eHeKa Etnrap:
Ten.: +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
Deutschland
AstraZeneca GmbH
Tel: +49 41 03 7080
Eesti
AstraZeneca
Tel: +372 6549 600
Malta
Associated Drug Co. Ltd
Tel: +356 2277 8000
Nederland
AstraZeneca BV
Tel: +31 79 363 2222
Norge
AstraZeneca AS
Tlf: +47 21 00 64 00
EXXâôa
AstraZeneca A.E.
Tql: +30 210 6871500
Österreich
AstraZeneca Österreich GmbH
Tel: +43 1 711 31 0
Espana
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
island
Vistor hf.
Simi: +354 535 7000
AstraZeneca AB, o.z.
Tel: +421 2 5737 7777
Italia
Simesa S.p.A.
Tel: +39 02 9801 1
Suomi/Fi nd
neca Oy el: +358 10 23 010
Knnpoç
AXéKTœp Oap^aKsuTiKrç At5
Tql: +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 la
roved in
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
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