Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Fluticasone propionate; Formoterol fumarate dihydrate
Mundipharma Pharmaceuticals Limited
R03AK; R03AK11
Fluticasone propionate; Formoterol fumarate dihydrate
125 µg/5 µg/actuation
Pressurised inhalation, suspension
Product subject to prescription which may be renewed (B)
Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and fluticasone
Marketed
2018-01-26
1 PACKAGE LEAFLET: INFORMATION FOR THE USER _FLUTIFORM_ _®_ _ K-HALER_ _®_ _ _50 MICROGRAM /5 MICROGRAM PER ACTUATION PRESSURISED INHALATION, SUSPENSION, AND _FLUTIFORM_ _®_ _ K-HALER_ _®_ _ _125 MICROGRAM /5 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 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 K-HALER _ is and what it is used for 2. What you need to know before you use _FLUTIFORM K-HALER _ 3. How to use _FLUTIFORM K-HALER _ 4. Possible side effects 5. How to store _FLUTIFORM K-HALER _ 6. Contents of the pack and other information 1. WHAT _FLUTIFORM K-HALER _IS AND WHAT IT IS USED FOR Please note:- _FLUTIFORM K-HALER_ pressurised inhalation, suspension is the full name of the product, however throughout this leaflet it is referred to as _FLUTIFORM K-HALER _ or simply as an inhaler, sometimes together with a reference to a specific strength. _FLUTIFORM K-HALER _ 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 Aqra d-dokument sħiħ
Health Products Regulatory Authority 25 June 2021 CRN009ZSG Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flutiform K-haler 125 microgram/5 microgram per actuation pressurised inhalation, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each metered dose (ex-valve) contains: · 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. 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 The canister contains white to off-white liquid suspension. The canister is sealed inside a pale grey breath-triggered actuator with an integrated dose indicator and an orange mouthpiece cover. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This fixed-dose combination of fluticasone propionate and formoterol fumarate (Flutiform K-haler) 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 agonist. Flutiform K-haler is indicated in adults and adolescents aged 12 years and above. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Patients will need to be trained on the use of the inhaler and their asthma should be regularly reassessed by a doctor, so that the strength of Flutiform K-haler they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Once control of asthma is achieved with the lowest strength of Flutiform K-haler admin Aqra d-dokument sħiħ