Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
roflumilast
AstraZeneca AB
R03DX08
roflumilast
Drugs for obstructive airway diseases,
Pulmonary Disease, Chronic Obstructive
Libertek 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.
Revision: 11
Withdrawn
2011-02-28
23 B. PACKAGE LEAFLET Medicinal product no longer authorised 24 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LIBERTEK 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: 1. What Libertek is and what it is used for 2. What you need to know before you take Libertek 3. How to take Libertek 4. Possible side effects 5. How to store Libertek 6. Contents of the pack and other information 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 Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Libertek 500 micrograms film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500 micrograms of roflumilast. Excipient with known effect: Each film-coated tablet contains 188.72 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Yellow, D-shaped film-coated tablet of 9 mm, embossed with “D” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV 1 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 500 micrograms (one tablet) roflumilast once daily. Libertek may need to be taken for several weeks to achieve its effect (see section 5.1). Libertek has been studied in clinical trials for up to one year. Special populations _Elderly_ No dose adjustment is necessary. _Renal impairment _ No dose adjustment is necessary. _Hepatic impairment _ The clinical data with Libertek in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment (see section 5.2) and therefore Libertek should be used with caution in these patients. Medicinal product no longer authorised 3 Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Libertek (see section 4.3). _Paediatric population _ There is no relevant use of Libertek in the paediatric population ( Przeczytaj cały dokument