Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)
Formoterol fumarate dihydrate; Fluticasone propionate
Napp Pharmaceuticals Ltd
R03AK11
Formoterol fumarate dihydrate; Fluticasone propionate
5microgram/1dose ; 125microgram/1dose
Pressurised inhalation
Inhalation
No Controlled Drug Status
Valid as a prescribable product
BNF: 03020000; GTIN: 5012854075122
1 PACKAGE LEAFLET: INFORMATION FOR THE USER _FLUTIFORM_ _®_ _ _50 MICROGRAM /5 MICROGRAM, 125 MICROGRAM /5 MICROGRAM AND 250 MICROGRAM /10 MICROGRAM PER ACTUATION 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 asthma nurse. This medicine has been prescribed for you. 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 asthma 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 doctor or asthma nu Lesen Sie das vollständige Dokument
OBJECT 1 FLUTIFORM 50 MICROGRAM/5 MICROGRAM PER ACTUATION PRESSURISED INHALATION, SUSPENSION Summary of Product Characteristics Updated 05-Aug-2015 | Napp Pharmaceuticals Limited 1. Name of the medicinal product _FLUTIFORM_ ® 50 microgram/5 microgram, 125 microgram/5 microgram and 250 microgram/10 microgram per actuation pressurised inhalation, suspension. 2. Qualitative and quantitative composition Each metered dose (ex-valve) contains: • 50 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 46 micrograms of fluticasone propionate and 4.5 micrograms of formoterol fumarate dihydrate. • 125 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 115 micrograms of fluticasone propionate and 4.5 micrograms of formoterol fumarate dihydrate. • 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. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Pressurised inhalation, suspension 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 4.1 Therapeutic indications This fixed-dose combination of fluticasone propionate and formoterol fumarate (_FLUTIFORM_ inhaler) is indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β 2 agonist) is appropriate: • For patients not adequately controlled with inhaled corticosteroids and 'as required' inhaled short-acting β 2 agonist. Or • For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β 2 ago Lesen Sie das vollständige Dokument