Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Budesonide; Formoterol fumatrate dihydrate
IMED Healthcare Ltd.
R03AK; R03AK07
Budesonide; Formoterol fumatrate dihydrate
100 µg/6 µg/inhalation
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
2010-10-29
PACKAGE LEAFLET: INFORMATION FOR THE USER SYMBICORT ® TURBOHALER ® 100 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, adolescents and children aged 6 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. This medicine is not suitable for people with severe asthma. It 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 symptoms from happening. • They use their ‘reliever inhaler’ when they get asthma sy Прочитайте повний документ
Health Products Regulatory Authority 10 November 2022 CRN00D77Y Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Symbicort Turbohaler 100 micrograms/6 micrograms/inhalation inhalation powder 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose that leaves the mouthpiece) contains: budesonide 80 micrograms/inhalation and formoterol fumarate dihydrate 4.5 micrograms/inhalation. Each metered dose contains: budesonide 100 micrograms/inhalation and formoterol fumarate dihydrate 6 micrograms/inhalation. Excipient with known effect: Lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder. _Product imported from Czech Republic and France_ White powder. 4 CLINICAL PARTICULARS As per PA1019/020/001 5 PHARMACOLOGICAL PROPERTIES As per PA1019/020/001 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 is the date shown on the turbohaler 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. 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. The inhaler is made of different plastic materials. Health Products Regulatory Authority 10 November 2022 CRN00D77Y Page 2 of 2 Each inhaler contains 120 doses. There is one inhaler per carton. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER IMED Healthcare Ltd. Unit 625 Kilshane Avenue Northwest Business Park Ballycoolin Dublin 15 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1463/051/002 9 DATE OF FIRST AUTHORISATI Прочитайте повний документ