Country: Żvezja
Lingwa: Svediż
Sors: Läkemedelsverket (Medical Products Agency)
budesonid; formoterolfumaratdihydrat
Orion Corporation
R03AK07
budesonide; formoterol
320 mikrogram/9 mikrogram/inhalation
Inhalationspulver
budesonid 320 mikrog Aktiv substans; laktosmonohydrat Hjälpämne; formoterolfumaratdihydrat 9 mikrog Aktiv substans
Receptbelagt
Förpacknings: Inhalator, 60 doser; Inhalator, 60 doser med fodral; Inhalator, 180 (3 x 60) doser
Godkänd
2016-01-22
1 QR code to www.oeh.fi/ xxxx [to be completed nationally]. Scan this code or visit www.oeh.fi/ xxxx [to be completed nationally] to see instructions on how to use Easyhaler PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BUFOLER EASYHALER, 320 MICROGRAMS/9 MICROGRAMS/INHALATION, INHALATION POWDER Budesonide/formoterol fumarate dihydrate 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 Bufoler Easyhaler 320/9 is and what it is used for 2. What you need to know before you use Bufoler Easyhaler 320/9 3. How to use Bufoler Easyhaler 320/9 4. Possible side effects 5. How to store Bufoler Easyhaler 320/9 6. Contents of the pack and other information 1. WHAT BUFOLER EASYHALER 320/9 IS AND WHAT IT IS USED FOR Bufoler Easyhaler is an inhaler that is used to treat asthma in adults aged 18 years and older. It is also used to treat the symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults aged 18 years and older. It contains two different medicines: budesonide and formoterol fumarate dihydrate. Budesonide belongs to a group of medicines called ‘corticosteroids’. It works by reducing and preventing swelling and inflammation in your lungs. Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting beta 2 adrenoceptor agonists’ or ‘bronchodilators’. It works by relaxing the muscles in your airways. This helps you to breathe more easily. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE BUFOLER EASYHALER 320/9 DO NOT USE BUFOLER EASYHALER 320/9: 2 - if you are allergic Aqra d-dokument sħiħ
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bufoler Easyhaler, 320 micrograms/9 micrograms/inhalation, inhalation powder. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide 320 micrograms/inhalation and formoterol fumarate dihydrate 9 micrograms/inhalation. With the Easyhaler device the delivered dose (ex-actuator) contains similar quantity of active substance as the metered dose (ex-reservoir). Excipients with known effect: Lactose monohydrate 7600 micrograms per delivered dose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder in a device metered inhaler (Easyhaler). White to yellowish powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bufoler Easyhaler is indicated in adults 18 years of age and older only. ASTHMA Bufoler Easyhaler is indicated for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting β 2 -adrenoceptor agonist) is appropriate: - patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β 2 -adrenoceptor agonists. or - patients already adequately controlled on both inhaled corticosteroids and long-acting β 2 - adrenoceptor agonists. CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) Bufoler Easyhaler is indicated for the symptomatic treatment of patients with COPD with FEV 1 < 70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy (see also section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Bufoler Easyhaler is indicated in adults 18 years of age and older only. Bufoler Easyhaler is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age. ASTHMA 2 Bufoler Easyhaler is not intended for the initial management of asthma. The dosage of the components of Bufoler Easyhaler is individual and should be adjusted to the severity of the disease. This should be c Aqra d-dokument sħiħ