Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Formoterol fumatrate dihydrate; Budesonide
PCO Manufacturing Ltd.
R03AK; R03AK07
Formoterol fumatrate dihydrate; Budesonide
400/12 microgram(s)/dose
Inhalation powder
Product subject to prescription which may be renewed (B)
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide
Authorised
2009-08-07
_ _ _ _ _ _ _ _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER SYMBICORT ® TURBOHALER ® 200 MICROGRAMS/6 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 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 Symbicort Turbohaler can be prescribed for asthma in two different ways. A) SOME PEOPLE ARE PRESCRIBED TWO ASTHMA INHALERS: SYMBICORT TURBOHALER AND A SEPARATE ‘RELIEVER INHALER’. They use Symbicort Turbohaler every day. This helps to prevent asthma Đọc toàn bộ tài liệu
Health Products Regulatory Authority 22 September 2022 CRN00D5P1 Page 1 of 2 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. Excipients with known effect: Lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder _ _ _Product imported from France, Romania, Slovakia, Netherlands and Belgium_ White powder 4 CLINICAL PARTICULARS As per PA1019/020/003 5 PHARMACOLOGICAL PROPERTIES As per PA1019/020/003 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 carton 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. Health Products Regulatory Authority 22 September 2022 CRN00D5P1 Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER Symbicort Turbohaler is an inspiratory flow-driven, multidose powder inhaler. The inhaler is white with a red turning grip. In each secondary package there is 1 inhaler containing 60 doses. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/225/002 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 7th August 2009 Last updated: April 2011 Last updated: November 2014 Last updated: M Đọc toàn bộ tài liệu