Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
FLUTICASONE PROPIONATE
GLAXO SMITH KLINE (ISRAEL) LTD
R03BA05
POWDER FOR INHALATION
FLUTICASONE PROPIONATE 500 MCG
INHALATION
Required
GLAXO WELLCOME PRODUCTION, FRANCE
FLUTICASONE
FLUTICASONE
Prophylactic management of all grades of asthma.Fluticasone propionate is indicated for the management of COPD when used in combination with long-acting bronchodilators (e.g. long-acting beta agonists (LABAs)).
2021-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) − 1986 The medicine is dispensed according to a physician’s prescription only Flixotide Diskus 100 mcg, Powder for Inhalation Each dose contains 100 microgram fluticasone propionate, Flixotide Diskus 250 mcg, Powder for Inhalation Each dose contains 250 microgram fluticasone propionate, Flixotide Diskus 500 mcg, Powder for Inhalation Each dose contains 500 microgram fluticasone propionate For the list of the inactive and allergenic ingredients in the medicine, see section 6 –"Additional information”. Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Flixotide Diskus is used as a preventive treatment for asthma and for treatment and reduction of symptoms in chronic obstructive pulmonary disease (COPD) when used in combination with long acting bronchodilators. Only the 250 mcg or 500 mcg strength Flixotide Diskus is suitable for the treatment of COPD. Therapeutic group: Corticosteroids Flixotide Diskus contains fluticasone propionate, which belongs to a group of medicines called corticosteroids (a group of synthetic hormones, often called steroids). Flixotide Diskus works by reducing swelling and irritation in the lungs. It has an anti-inflammatory action. 2. BEFORE USING THE MEDICINE Do not use the medicine if: • you are sensitive (allergic) to the active ingredient (fluticasone propionate), lactose (which contains milk protein) or to any of the additional ingredients contained in this medicine (as listed in section 6). Special warnings regarding use of the medicine Before the treatment with Flixotide Diskus, tell the physician if: • you have ever been treated for tuberculosis (T Perskaitykite visą dokumentą
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS Flixotide Inhaler CFC Free 50 mcg Flixotide Inhaler CFC Free 125 mcg Flixotide Inhaler CFC Free 250 mcg 1. NAME OF THE MEDICINAL PRODUCT Flixotide Inhaler CFC Free 50 mcg Flixotide Inhaler CFC Free 125 mcg Flixotide Inhaler CFC Free 250 mcg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Flixotide Inhaler CFC Free 50 mcg: Each metered dose contains 50 micrograms of fluticasone propionate. Flixotide Inhaler CFC Free 125 mcg: Each metered dose contains 125 micrograms of fluticasone propionate. Flixotide Inhaler CFC Free 250 mcg: Each metered dose contains 250 micrograms of fluticasone propionate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for inhalation Pressurised inhalation suspension supplied in an aluminium can with metering valve and actuator. 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications Flixotide inhaler 50, 125, 250 mcg are indicated for the prophylactic management of all grades of asthma. Flixotide inhaler 50 mcg is of benefit to young children aged 1 to 4 years in the control of persistent asthma symptoms. Flixotide inhaler 250 mcg is also indicated for the management of chronic obstructive pulmonary disease (COPD) when used in combination with long-acting bronchodilators (e.g. long-acting beta agonists (LABAs)). 4.2 Posology and Method of Administration Flixotide Inhaler is for inhalation by oral inhalation only. Page 2 of 13 Patients should be made aware of the prophylactic nature of therapy with inhaled fluticasone propionate and that it should be taken regularly even when they are asymptomatic. The onset of therapeutic effect is 4 to 7 days, although some benefit may be apparent as soon as 24 hours for patients who have not previously received inhaled steroids. The dosage of fluticasone propionate should be adjusted according to the individual response. If patients find that relief with short-acting bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must b Perskaitykite visą dokumentą