Land: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Budesonide, formoterol fumarate dihydrate
Teva Pharma B.V.
R03AK07
budesonide, formoterol fumarate dihydrate
Drugs for obstructive airway diseases,
Asthma; Pulmonary Disease, Chronic Obstructive
Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only.AsthmaBudesonide/Formoterol Teva Pharma B.V. is indicated in 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.or-in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.COPDSymptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1)
Revision: 2
Authorised
2020-04-03
47 B. PACKAGE LEAFLET 48 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BUDESONIDE/FORMOTEROL TEVA PHARMA B.V. 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 Budesonide/Formoterol Teva Pharma B.V. is and what it is used for 2. What you need to know before you use Budesonide/Formoterol Teva Pharma B.V. 3. How to use Budesonide/Formoterol Teva Pharma B.V. 4. Possible side effects 5. How to store Budesonide/Formoterol Teva Pharma B.V. 6. Contents of the pack and other information 1. WHAT BUDESONIDE/FORMOTEROL TEVA PHARMA B.V. IS AND WHAT IT IS USED FOR Budesonide/Formoterol Teva Pharma B.V. 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. BUDESONIDE/FORMOTEROL TEVA PHARMA B.V. IS INDICATED FOR USE IN ADULTS 18 YEARS OF AGE AND OLDER ONLY. BUDESONIDE/FORMOTEROL TEVA PHARMA B.V. IS NOT INDICATED FOR USE IN CHILDREN 12 YEARS OF AGE AND YOUNGER OR ADOLESCENTS 13 TO 17 YEARS OF AGE. Your Lestu allt skjalið
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Budesonide/Formoterol Teva Pharma B.V. 160 micrograms / 4.5 micrograms inhalation powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece of the Spiromax) 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. White inhaler with a semi-transparent wine red mouthpiece cover. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only. Asthma _ _ Budesonide/Formoterol Teva Pharma B.V. is indicated in 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 _ _ 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. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Asthma _ _ _ Budesonide/Formoterol Teva Pharma B.V. is not intended for the initial management of asthma. Budesonide/Formoterol Teva Pharma B.V. is not an appropriate treatment for the adult patient with only mild asthma who is not adequately controlled with an inhaled corticosteroid and “as needed” inhaled short-acting β Lestu allt skjalið