Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Budesonide; Formoterol fumatrate dihydrate
Imbat Limited
R03AK; R03AK07
Budesonide; Formoterol fumatrate dihydrate
400mcg/12mcg Mcg/Dose
Powder for Inhalation
Product subject to prescription which may be renewed (B)
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide
Authorised
2011-06-03
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER SYMBICORT ® TURBOHALER ® 400 MICROGRAMS / 12 MICROGRAMS / INHALATION, INHALATION POWDER (budesonide / formoterol fumarate dihydrate) Your medicine is available using the name Symbicort Turbohaler 400 micrograms / 12 micrograms / inhalation, inhalation powder but will be referred to as Symbicort Turbohaler throughout this leaflet. 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 TURBOHALER IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SYMBICORT TURBOHALER 3. HOW TO USE SYMBICORT TURBOHALER 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SYMBICORT TURBOHALER 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT SYMBICORT TURBOHALER IS AND WHAT IT IS USED FOR Symbicort Turbohaler is an inhaler that is used to treat asthma in adults and adolescents aged 12 to 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 For asthma, your doctor will prescribe two asthma inhaler Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Symbicort Turbohaler, 400 micrograms/12 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. Each metered dose contains: budesonide 400 micrograms/inhalation and formoterol fumarate dihydrate 12 micrograms/inhalation. Excipient: Lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder _Product imported from France, Poland and UK._ White powder 4 CLINICAL PARTICULARS As per PA0970/028/003 5 PHARMACOLOGICAL PROPERTIES As per PA0970/028/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose monohydrate (which contains milk proteins). 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product shall be the date shown on the container and outer package of the product as marketed in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 30° C. Keep the container tightly closed, in order to protect from moisture. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _6_ _/_ _0_ _7_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _2_ _0_ _8_ _0_ _9_ _1_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 6.5 NATURE AND CONTENTS OF CONTAINER Symbicort Turbohaler is an inspiratory flow driven, multidose powder inhaler. Th Läs hela dokumentet