Country: Израел
Језик: Енглески
Извор: Ministry of Health
FLUTICASONE PROPIONATE
GLAXO SMITH KLINE (ISRAEL) LTD
R03BA05
POWDER FOR INHALATION
FLUTICASONE PROPIONATE 100 MCG
INHALATION
Required
GLAXO WELLCOME PRODUCTION, FRANCE
FLUTICASONE
Prophylactic management of all grades of asthma.
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 Прочитајте комплетан документ
Page 1 of 13 FLIXOTIDE DISKUS 100 MCG FLIXOTIDE DISKUS 250 MCG FLIXOTIDE DISKUS 500 MCG 1. NAME OF THE MEDICINAL PRODUCT Flixotide Diskus 100 mcg Flixotide Diskus 250 mcg Flixotide Diskus 500 mcg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each blister each contains , 100 micrograms fluticasone propionate. Excipients: Each blister contains 11.9mg lactose (as monohydrate) Each blister each contains ,250 micrograms fluticasone propionate. Excipients: Each blister contains 11.6mg lactose (as monohydrate) Each blister each contains , 500 micrograms fluticasone propionate. Excipients: Each blister contains 11. 4mg lactose (as monohydrate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder, pre-dispensed Fine, white to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flixotide diskus 100, 250, 500 mcg are indicated for the Prophylactic management of all grades of ASTHMA. Flixotide diskus 250 mcg and 500 mcg are 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 Diskus is for inhalation by oral inhalation only. _ _ 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 dosage of fluticasone propionate should be adjusted according to the individual response. ASTHMA 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. Page 2 of 13 If patients find that relief with short-acting bronchodilator treatment becomes less effective or they need more inhalations than usual, medical attention must be sought. Adults and children over 16 years of age:- 100 to 1000 micrograms twice daily. Patients should be given a starting dose of inhaled fluticasone propio Прочитајте комплетан документ