Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Budesonide; Formoterol fumarate dihydrate
AstraZeneca AB
R03AK
Budesonide; Formoterol fumarate dihydrate
100 mcg/6 microgram(s)
Inhalation powder
Product subject to prescription which may be renewed (B)
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics
Marketed
2001-02-23
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 sym Soma hati kamili
Health Products Regulatory Authority 01 February 2021 CRN009ZSV Page 1 of 11 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 810 micrograms per delivered dose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Inhalation powder White powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symbicort Turbohaler is indicated in adults, adolescents, and children aged 6 years and older. Symbicort Turbohaler is indicated in 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. NOTE: Symbicort Turbohaler (100 micrograms/6 micrograms/inhalation) is not appropriate in patients with severe asthma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: For inhalation use. Posology Symbicort Turbohaler 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 corticost Soma hati kamili