Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
FLUTICASONE PROPIONATE
B & S Healthcare
R03BA05
FLUTICASONE PROPIONATE
125 Microgram
Pressurised Inhalation Suspension
Product subject to prescription which may be renewed (B)
Glucocorticoids
Authorised
2010-01-15
PACKAGE LEAFLET: INFORMATION FOR THE USER FLIXOTIDE™ EVOHALER™ 125 MICROGRAMS PER METERED DOSE, PRESSURISED INHALATION SUSPENSION (FLUTICASONE PROPIONATE) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, nurse 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, pharmacist or nurse. This includes any possible side-effects not listed in the leaflet. See section 4. The name of your medicine is Flixotide Evohaler 125 micrograms per metered dose, pressurised inhalation suspension but it will referred to as Flixotide or Evohaler throughout this leaflet. Please note that this leaflet also contains information about the other strength: Flixotide Evohaler 250 micrograms per metered dose, pressurised inhalation suspension. WHAT IS IN THIS LEAFLET: 1. What Flixotide is and what it is used for 2. What you need to know before you use Flixotide 3. How to use Flixotide 4. Possible side effects 5. How to store Flixotide 6. Contents of the pack and other information 1. WHAT FLIXOTIDE IS AND WHAT IT IS USED FOR Flixotide contains fluticasone propionate which belongs to a group of medicines called corticosteroids (often just called steroids). Flixotide works by reducing swelling and irritation in the lungs. It has an anti-inflammatory action. Only a very small dose is needed as it is inhaled straight to the lungs. Flixotide helps to prevent asthma attacks in people who need regular treatm Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flixotide Evohaler 125 micrograms per metered dose, pressurised inhalation suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose contains 125micrograms of fluticasone propionate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation, suspension _Product imported from _Greece: Pressurised metered dose inhaler with an orange body and a brown removable dust cap. 4 CLINICAL PARTICULARS As per PA1077/044/014 5 PHARMACOLOGICAL PROPERTIES As per PA1077/044/014 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Norflurane (Hydrofluroalkane (HFA) 134a) 6.2 INCOMPATIBILITIES Not applicable 6.3 SHELF LIFE The shelf-life expiry date of this product is the date shown on the canister 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 Do not refrigerate or freeze The canister contains a pressurised liquid Do not expose to temperatures higher than 50 ° C Do not pierce the container even when apparently empty HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 30/01/2015_ _CRN 2155391_ _page number: 1_ 6.5 NATURE AND CONTENTS OF CONTAINER The suspension is contained in an aluminium alloy can sealed with a metering valve. The canisters are fitted into plastic actuators incorporating an atomising orifice and fitted with dustcaps. Flixotide Evohaler 125 micrograms per metered dose, pressurised inhalation suspension is available in an over labeled pack size of 120 metered doses 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLI Læs hele dokumentet