Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
fluticasone propionate, Quantity: 20 mg; formoterol fumarate dihydrate, Quantity: 0.8 mg
Mundipharma Pty Ltd
fluticasone propionate,formoterol (eformoterol) fumarate dihydrate
Inhalation, pressurised
Excipient Ingredients: sodium cromoglycate; ethanol absolute; apaflurane
Inhalation
120 actuations per inhaler
(S4) Prescription Only Medicine
FLUTIFORM inhaler is indicated for the regular maintenance treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting beta2-agonist) is appropriate. This includes patients not adequately controlled with inhaled corticosteroids and inhaled short-acting beta2-agonist on an ?as required? basis.
Visual Identification: white slurry residue after propellant evaporation, free of agglomerates; Container Type: Aerosol Can - Metered Dose; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-06-14
FLUTIFORM ® INHALER _Fluticasone propionate/formoterol (eformoterol) fumarate dihydrate_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about FLUTIFORM pressurised inhalation ("inhaler"). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using FLUTIFORM inhaler against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT FLUTIFORM INHALER IS USED FOR FLUTIFORM inhaler is used to help with asthma in people who need regular treatment. Asthma is a disease where the lining of the lungs become inflamed (red and swollen), making it difficult to breathe. This may be due to an allergy to house dust mites, smoke, air-borne pollution or other irritants. Symptoms of asthma include shortness of breath, wheezing, chest tightness and cough. FLUTIFORM inhaler contains two different medicines called fluticasone propionate and formoterol (eformoterol) fumarate dihydrate. Fluticasone propionate belongs to a group of medicines known as corticosteroids, frequently called 'steroids'. They are not 'anabolic steroids' which are sometimes misused by athletes. Corticosteroids help to reduce swelling and inflammation in the lungs. Formoterol (Eformoterol) fumarate dihydrate belongs to a group of medicines known as long-acting beta-2-agonists. Beta-2-agonists help the airways in your lungs to stay open, making it easier for you to breathe. When used together regularly, fluticasone propionate and formoterol (eformoterol) fumarate dihydrate help to control your asthma symptoms and prevent asthma attacks. FLUTIFORM inhaler is known as a 'preventer'. It does not work if you are already having an asthma attack, i.e. you are already wheezing and breathless. You will need to use a fast acting 'reliever' Read the complete document
FLUTIFORM ® PRESSURISED METERED DOSE INHALER Page 1 of 27 AUSTRALIAN PRODUCT INFORMATION – FLUTIFORM ® [FLUTICASONE PROPIONATE/FORMOTEROL (EFORMOTEROL) FUMARATE DIHYDRATE] PRESSURISED METERED DOSE INHALER 1 NAME OF THE MEDICINE Fluticasone propionate and eformoterol fumarate dihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Fluticasone propionate_: It is a white to almost white powder, practically insoluble in water, slightly soluble in alcohol and sparingly soluble in dichloromethane. _Eformoterol fumarate dihydrate_: It is a white to almost white or yellowish powder. It is slightly soluble in water, sparingly soluble in isopropyl alcohol, soluble in methanol and practically insoluble in acetonitrile. _FLUTIFORM_ _inhaler_: FLUTIFORM pressurised inhalation (‘inhaler’) is a white to off-white liquid suspension inside a pressurised metal canister. The inactive ingredients are sodium cromoglycate, absolute ethanol and apaflurane (HFA 227). The active ingredients delivered by each metered dose from the canister valve are given in the table below: STRENGTHS (MICROGRAMS) ACTIVE INGREDIENTS DELIVERED PER ACTUATION FLUTIFORM 50/5 50 micrograms of fluticasone propionate and 5 micrograms of eformoterol fumarate dihydrate (equivalent to an ex-actuator delivered dose of approximately 46 micrograms of fluticasone propionate and 4.5 micrograms of eformoterol fumarate dihydrate). FLUTIFORM 125/5 125 micrograms of fluticasone propionate and 5 micrograms of eformoterol fumarate dihydrate (equivalent to an ex-actuator delivered dose of approximately 115 micrograms of fluticasone propionate and 4.5 micrograms of eformoterol fumarate dihydrate). FLUTIFORM 250/10 250 micrograms of fluticasone propionate and 10 micrograms of eformoterol fumarate dihydrate (equivalent to an ex-actuator delivered dose of approximately 230 micrograms of fluticasone propionate and 9 micrograms of eformoterol fumarate dihydrate). 3 PHARMACEUTICAL FORM FLUTIFORM pressurised inhalation is contained in an aluminium pressurised canister crimped wi Read the complete document