Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
Budesonide, formoterol fumarate dihydrate
Teva Pharma B.V.
R03AK07
budesonide, formoterol
Drugs for obstructive airway diseases,
Pulmonary Disease, Chronic Obstructive; Asthma
Asthma DuoResp Spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β₂ adrenoceptor agonist) is appropriate:in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β₂ adrenoceptor agonists.orin patients already adequately controlled on both inhaled corticosteroids and long-acting β₂ adrenoceptor agonists.COPDDuoResp Spiromax is indicated in adults, aged 18 years and older for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV₁)
Revision: 12
Authorised
2014-04-28
44 B. PACKAGE LEAFLET 45 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DUORESP SPIROMAX 160 MICROGRAMS/4.5 MICROGRAMS, INHALATION POWDER budesonide/formoterol fumarate dihydrate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What DuoResp Spiromax is and what it is used for 2. What you need to know before you use DuoResp Spiromax 3. How to use DuoResp Spiromax 4. Possible side effects 5. How to store DuoResp Spiromax 6. Contents of the pack and other information 1. WHAT DUORESP SPIROMAX IS AND WHAT IT IS USED FOR DuoResp Spiromax contains two different active substances: budesonide and formoterol fumarate dihydrate. • Budesonide belongs to a group of medicines called ‘corticosteroids’ also known as ‘steroids’. It works by reducing and preventing swelling and inflammation in your lungs and helps you to breathe more easily. • Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting β 2 adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This will help to open the airways and help you to breathe more easily. DUORESP SPIROMAX IS INDICATED FOR USE IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER ONLY. Your doctor has prescribed this medicine to treat asthma or chronic obstructive pulmonary disease (COPD). ASTHMA DuoResp Spiromax can be prescribed for asthma in two different ways. A) YOU MAY BE PRESCRIBED TWO ASTHMA INHALERS: DUORESP SPIROMAX TOGETHER WITH A SEPARATE ‘RELIEVER INHALER’ SUCH AS SALBUT Přečtěte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT DuoResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece) contains 160 micrograms of budesonide and 4.5 micrograms of formoterol fumarate dihydrate. This is equivalent to a metered dose of 200 micrograms budesonide and 6 micrograms of formoterol fumarate dihydrate. Excipient(s) with known effect: Each dose contains approximately 5 milligrams of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder. White powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Asthma _ _ DuoResp Spiromax is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β 2 adrenoceptor agonist) is appropriate: -in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β 2 adrenoceptor agonists. or -in patients already adequately controlled on both inhaled corticosteroids and long-acting β 2 adrenoceptor agonists. COPD _ _ DuoResp Spiromax is indicated in adults, aged 18 years and older for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV 1 ) < 70% predicted normal (post bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long- acting bronchodilators. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Asthma _ _ _ DuoResp Spiromax is not intended for the initial management of asthma. 3 DuoResp Spiromax is not an appropriate treatment for the adult or adolescent patient with only mild asthma. The dosage of DuoResp Spiromax is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination medicinal products is initiated but also when the maintenance dose Přečtěte si celý dokument