Țară: Suedia
Limbă: suedeză
Sursă: Läkemedelsverket (Medical Products Agency)
budesonid; formoterolfumaratdihydrat
Orifarm AB
R03AK07
budesonide; formoterol
160 mikrogram/4,5 mikrogram/inhalation
Inhalationspulver
laktosmonohydrat Hjälpämne; budesonid 160 mikrog Aktiv substans; formoterolfumaratdihydrat 4,5 mikrog Aktiv substans
Receptbelagt
Formoterol och budesonid
Avregistrerad
2009-12-09
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER GARDETTE 160 MICROGRAMS/4.5 MICROGRAMS/INHALATION, 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 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 Gardette is and what it is used for 2. What you need to know before you use Gardette 3. How to use Gardette 4. Possible side effects 5. How to store Gardette 6. Contents of the pack and other information 1. WHAT GARDETTE IS AND WHAT IT IS USED FOR Gardette is an inhaler that is used to treat asthma in adults and adolescents aged 12-17 years. 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. ASTHMA Gardette can be prescribed for asthma in two different ways. A) SOME PEOPLE ARE PRESCRIBED TWO ASTHMA INHALERS: GARDETTE AND A SEPARATE ‘RELIEVER INHALER’. They use Gardette every day. This helps to prevent asthma symptoms from happening. They use their ‘reliever inhaler’ when they get asthma symptoms, to make it easier to breathe Citiți documentul complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1 . NAME OF THE MEDICINAL PRODUCT Gardette, 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. Each metered dose contains: budesonide 200 micrograms/inhalation and formoterol fumarate dihydrate 6 micrograms/inhalation. Excipient with known effect Lactose monohydrate 730 micrograms per delivered dose. 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 Gardette 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: - 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) Gardette 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 an exacerbation history despite regular bronchodilator therapy (see also section 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: For inhalation use Posology ASTHMA Gardette is not intended for the initial management of asthma. The dosage of the components of Gardette is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the maintenance dose is adjusted. If an individual patient should require a combination of doses other than those available Citiți documentul complet