Maa: Ruotsi
Kieli: ruotsi
Lähde: Läkemedelsverket (Medical Products Agency)
budesonid; formoterolfumaratdihydrat
Orion Corporation
R03AK07
budesonide; formoterol
160 mikrogram/4,5 mikrogram/inhalation
Inhalationspulver
formoterolfumaratdihydrat 4,5 mikrog Aktiv substans; laktosmonohydrat Hjälpämne; budesonid 160 mikrog Aktiv substans
Receptbelagt
Förpacknings: Inhalator, 60 doser; Inhalator, 60 doser med fodral; Inhalator, 120 doser med fodral; Inhalator, 120 doser; Inhalator, 360 (3 x 120) doser; Inhalator, 180 (3 x 60) doser
Godkänd
2016-02-04
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ORBUFOX EASYHALER, 160 MICROGRAMS/4.5 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 Orbufox Easyhaler 160/4.5 is and what it is used for 2. What you need to know before you use Orbufox Easyhaler 160/4.5 3. How to use Orbufox Easyhaler 160/4.5 4. Possible side effects 5. How to store Orbufox Easyhaler 160/4.5 6. Contents of the pack and other information 1. WHAT ORBUFOX EASYHALER 160/4.5 IS AND WHAT IT IS USED FOR Orbufox 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 ORBUFOX EASYHALER 160/4.5 DO NOT USE ORBUFOX EASYHALER 160/4.5: - if you are allergic to budesonide, formoterol or to the other ingredient of this medicine (listed in section 6) which is lactose (which contains small amounts of milk protein). Lue koko asiakirja
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Orbufox Easyhaler, 160 micrograms/4.5 micrograms/inhalation, inhalation powder. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide 160 micrograms/inhalation and formoterol fumarate dihydrate 4.5 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 3800 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 Orbufox Easyhaler is indicated in adults 18 years of age and older only. ASTHMA Orbufox 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) Orbufox 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 Orbufox Easyhaler is indicated in adults 18 years of age and older only. Orbufox Easyhaler is not indicated for use in children, 12 years of age and younger or adolescents, 13 to 17 years of age. 2 ASTHMA Orbufox Easyhaler is not intended for the initial management of asthma. The dosage of the components of Orbufox Easyhaler is individual and should be adjusted to the severity of the disease. This should b Lue koko asiakirja