Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ROFLUMILAST, MICRONIZED
ASTRAZENECA SDN. BHD.
ROFLUMILAST, MICRONIZED
30Tablet Tablets; 90Tablet Tablets; 10Tablet Tablets
Takeda GmbH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ DAXAS ® FILM-COATED TABLETS _ _ Roflumilast (500 micrograms) 1 WHAT IS IN THIS LEAFLET 1. What Daxas is used for 2. How Daxas works 3. Before you use Daxas 4. How to use Daxas 5. While you are using it 6. Side effects 7. Storage & Disposal of Daxas 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT DAXAS IS USED FOR Daxas is used for maintenance treatment of severe chronic obstructive pulmonary disease (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 bronchodilator medicine. HOW DAXAS WORKS 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. BEFORE YOU USE DAXAS - _When you must not use it _ Do not take Daxas if: • You are allergic to roflumilast or any of the other ingredients of this medicine (listed in product description) • You have moderate or severe liver problems. - _Before you start to use it _ Before you take Daxas, tells your doctor if you: • Have severe immunological disease such as HIV infection, multiple sclerosis (MS), lupus erythematosus (LE) or progressive multifocal leukoencephalopathy (PML). • Have mild liver problems • Have severe acute infectious disease such as tuberculosis, or viral hepatitis • Hav Pročitajte cijeli dokument
1 1. NAME OF THE MEDICINAL PRODUCT Daxas 500 micrograms film -coated tablets 2. NAME AND STRENGTH OF ACTIVE SUBSTANCES Each tablet contains 500 micrograms of roflumilast. 3. PRODUCT DESCRIPTION Yellow, D -shaped film -coated tablet, embossed with “D” on one side. 4. PHARMACOLOGICAL PROPERTIES 4.1 Pharmacodynamic properties Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX07 Mechanism of action Roflumilast is a PDE4 inhi bitor, a non -steroid, anti -inflammatory agent designed to target both the systemic and pulmonary inflammation associated with COPD. The mechanism of action is the inhibition of PDE4, a major cyclic adenosine monophosphate (cAMP) -metabolizing enzyme found i n structural and inflammatory cells important to the pathogenesis of COPD. Roflumilast targets the PDE4A, 4B and 4D splicing variants with similar potency in the nanomolar range. The affinity to the PDE4C splicing variants is 5 to 10 -fold lower. This mecha nism of action and the selectivity also apply to roflumilast N -oxide, which is the major active metabolite of roflumilast. Pharmacodynamic effects Inhibition of PDE4 leads to elevated intracellular cAMP levels and mitigates COPD -related malfunctions of l eukocytes, airway and pulmonary vascular smooth muscle cells, endothelial and airway epithelial cells and fibroblasts in experimental models. Upon in vitro stimulation of human neutrophils, monocytes, macrophages or lymphocytes, roflumilast and roflumilast N-oxide suppress the release of inflammatory mediators e.g. leukotriene B4, reactive oxygen species, tumor necrosis factor α, interferon γ and granzyme B. In patients with COPD, roflumilast reduced sputum neutrophils. Furthermore, roflumilast attenuated influx of neutrophils and eosinophils into the airways of endotoxin challenged healthy volunteers. Clinical efficacy In two confirmative replicate one -year studies (M2 -124 and M2 -125) and two supplementary six - month studies (M2 -127 and M2 - Pročitajte cijeli dokument