البلد: السويد
اللغة: السويدية
المصدر: Läkemedelsverket (Medical Products Agency)
budesonid; formoterolfumaratdihydrat
AstraZeneca AB
R03AK07
budesonide; formoterol
80 mikrogram/2,25 mikrogram/puff
Inhalationsspray, suspension
formoterolfumaratdihydrat 2,25 mikrog Aktiv substans; budesonid 80 mikrog Aktiv substans
Receptbelagt
Förpacknings: Inhalator, 60 doser; Inhalator, 120 doser
Godkänd
2020-07-20
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER SYMBICORT 80 MICROGRAMS/2.25 MICROGRAMS/ACTUATION PRESSURISED INHALATION, SUSPENSION 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 Symbicort is and what it is used for 2. What you need to know before you use Symbicort 3. How to use Symbicort 4. Possible side effects 5. How to store Symbicort 6. Contents of the pack and other information 1. WHAT SYMBICORT IS AND WHAT IT IS USED FOR WHAT SYMBICORT IS Symbicort is an inhaler that is used to treat asthma in adults and adolescents aged 12-17 years. It contains two different medicines: budesonide and formoterol fumarate dihydrate. Budesonide belongs to a group of medicines called ‘corticosteroids’. Formoterol fumarate dihydrate belongs to a group of medicines called ‘long-acting beta 2 adrenoceptor agonists’ or ‘bronchodilators’. WHAT SYMBICORT IS USED TO TREAT Symbicort is used to treat asthma, and can be prescribed alone or with a separate reliever inhaler: Some people are prescribed two asthma inhalers: Symbicort inhaler and a separate ‘reliever inhaler’ They use Symbicort every day. This helps to prevent signs of asthma. They use their ‘reliever inhaler’ when they get signs of asthma, to make it easier to breathe again. Some people are prescribed Symbicort as their only asthma inhaler They use Symbicort every day. This helps to prevent signs of asthma. They also use Symbicort when they need ex اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1 . NAME OF THE MEDICINAL PRODUCT Symbicort, 80 micrograms/2.25 micrograms/actuation pressurised inhalation, suspension. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each actuation delivers: budesonide 80 micrograms and formoterol fumarate dihydrate 2.25 micrograms (delivered, ex-actuator). This is equivalent to budesonide 100 micrograms and formoterol fumarate dihydrate 3 micrograms (metered). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pressurised inhalation, suspension. White suspension in an aluminium canister fitted into a red actuator with a grey dust cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ASTHMA Symbicort 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Inhalation use Posology ASTHMA Symbicort is not intended for the initial management of asthma. The dosage of the components of Symbicort 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 in the combination inhaler, appropriate doses of β 2 adrenoceptor agonists and/or corticosteroids by individual inhalers should be prescribed. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Patients should be regularly reassessed by their prescriber/healthcare provider so that the dosage of Symbicort remains optimal. اقرأ الوثيقة كاملة