Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
roflumilast
AstraZeneca AB
R03DX07
roflumilast
Drugs for obstructive airway diseases,
Pulmonary Disease, Chronic Obstructive
Daxas 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: 19
Authorised
2010-07-05
39 B. PACKAGE LEAFLET 40 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DAXAS 250 MICROGRAMS TABLETS roflumilast 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 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 1. WHAT DAXAS IS AND WHAT IT IS USED FOR 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DAXAS DO NOT TAKE DAXAS - if you are allergic to roflumilast or any of the other ingredients of this medicine (listed in s Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Daxas 250 micrograms tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 micrograms of roflumilast. Excipient with known effect: Each tablet contains 49.7 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White to off-white, round tablet, 5 mm in diameter, embossed with “D” on one side and “250” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Daxas 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 _Starting dose_ The recommended starting dose is one tablet of 250 micrograms roflumilast to be taken once daily, for 28 days. This starting dose is intended to reduce adverse reactions and patient discontinuation when initiating therapy, but it is a sub-therapeutic dose. Therefore, the 250 micrograms dose should be used only as a starting dose (see sections 5.1 and 5.2). _Maintenance dose_ After 28 days of treatment with the 250 micrograms starting dose, patients must be up-titrated to one tablet of 500 micrograms roflumilast, to be taken once daily. Roflumilast 500 micrograms may need to be taken for several weeks to achieve its full effect (see sections 5.1 and 5.2). Roflumilast 500 micrograms has been studied in clinical trials for up to one year, and is intended for maintenance treatment. Special populations _Elderly_ No dose adjustment is necessary. 3 _Renal impairment_ No dose adjustment is necessary. _Hepatic impairment_ The clinical data with roflumilast in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment (see section 5.2) and therefore Daxas should be used with caution in these patient Przeczytaj cały dokument