Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Formoterol fumarate dihydrate; Budesonide
IMED Healthcare Ltd.
R03AK; R03AK07
Formoterol fumarate dihydrate; Budesonide
400 µg /12 µg/inhalation
Inhalation powder
For inhalation use
1 inhaler containing 60 dose
Product subject to prescription which may be renewed (B)
AstraZeneca AB
Adrenergics and other drugs for obstructive airway diseases.
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and budesonide
It is indicated: in adults and adolescents aged 12 to 17 years for the regular treatment of asthma where use of a combination is appropriate; in adults, aged 18 years and older, for the symptomatic treatment of patients with severe COPD and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators
Authorised
2015-05-15
PACKAGE LEAFLET: INFORMATION FOR THE USER SYMBICORT® TURBOHALER® 400 MICROGRAMS/12 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 beta2 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 inhalers: Symbicort Turbohaler and a separate ‘reliever inhaler’. • Use Symbicort Turbohaler every day. This helps to prevent asthma symptoms from happening. • Use your ‘reliever inhaler’ when you get asthma symptoms, Soma hati kamili
Health Products Regulatory Authority 30 March 2023 CRN00DHHS 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. Excipient with known effect Lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder _Product imported from the Czech Republic_ 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 is the date shown on the inhaler and outer carton of the product on the market 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 30 March 2023 CRN00DHHS Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER Symbicort Turbohaler is an inspiratory flow-driven, multi-dose powder inhaler. The inhaler is white with a red turning grip. In each secondary package there are 1 inhaler containing 60 doses. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL 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 PPA1463/051/003 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 th May 2015 10 DATE OF REVISION OF THE TEXT March 2023 Soma hati kamili