País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
FLUTICASONE PROPIONATE; Formoterol fumarate
IMED Healthcare Ltd.
R03AK; R03AK11
FLUTICASONE PROPIONATE; Formoterol fumarate
250/10 µg/µg
Pressurised inhalation, suspension
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and fluticasone
2020-10-02
1 PACKAGE LEAFLET: INFORMATION FOR THE USER _FLUTIFORM_ _® _ 125 MICROGRAM/5 MICROGRAM PER METERED DOSE PRESSURISED INHALATION, SUSPENSION _FLUTIFORM_ _® _ 250 MICROGRAM/10 MICROGRAM PER METERED DOSE PRESSURISED INHALATION, SUSPENSION fluticasone propionate/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, pharmacist or nurse. 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 this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What _FLUTIFORM _inhaler is and what it is used for 2. What you need to know before you use _FLUTIFORM _inhaler 3. How to use _FLUTIFORM _inhaler 4. Possible side effects 5. How to store _FLUTIFORM _inhaler 6. Contents of the pack and other information. 1. WHAT _FLUTIFORM _INHALER IS AND WHAT IT IS USED FOR Please note: - _FLUTIFORM _pressurised inhalation, suspension is the product name, however throughout this leaflet it is shortened to _FLUTIFORM _inhaler. Sometimes this may refer to a specific strength. _FLUTIFORM _is an inhaler (a pressurised inhalation suspension) which contains two active ingredients: Fluticasone propionate which belongs to a group of medicines called steroids. Steroids help to reduce swelling and inflammation in the lungs. Formoterol fumarate dihydrate which belongs to a group of medicines called long-acting beta 2 agonists. Long-acting beta 2 agonists are long-acting bronchodilators which help the airways in your lungs to stay open, making it easier for you to breathe. Together these two active ingredients help to improve your breathing. It is advised that you should use this medicine every day as directed by your Leer el documento completo
Health Products Regulatory Authority 14 December 2021 CRN00CNWL Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flutiform 250 microgram/10 microgram per metered dose pressurised inhalation, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose (ex-valve) contains: 250 micrograms of fluticasone propionate and 10 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 230 micrograms of fluticasone propionate and 9.0 micrograms of formoterol fumarate dihydrate. Excipient with known effect Each actuation contains 1 mg ethanol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pressurised inhalation, suspension _Product imported from Czech Republic_ The canister contains white to off white liquid suspension. The canister is in a white actuator with a grey integrated dose indicator and a light grey mouthpiece cover. 4 CLINICAL PARTICULARS As per PA1688/013/003 5 PHARMACOLOGICAL PROPERTIES As per PA1688/013/003 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Sodium Cromoglicate Ethanol Anhydrous Apaflurane HFA 227 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 package of the product on the market in the country of origin. In use shelf – life: 3 months after opening the foil pouch. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Health Products Regulatory Authority 14 December 2021 CRN00CNWL Page 2 of 2 Do not store above 25°C. Do not refrigerate or freeze. If the inhaler is exposed to freezing conditions then the patient must be advised to allow the inhaler to warm at room temperature for 30 minutes then re‑prime the inhaler (see section 4.2). The canister contains a pressurised liquid. Do not expose to temperatures higher than 50°C. Do not puncture, break or burn, even when apparently empty. 6.5 NATURE AND CONTENTS OF CONTAINER 120 actuations per inhaler The actuator is white with a grey integ Leer el documento completo