Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Beclometasone dipropionate; Formoterol Fumarate Dihydrate
Orient Europharma (M) Sdn Bhd
Beclometasone dipropionate; Formoterol Fumarate Dihydrate
1Units Units
CHIESI FARMACEUTICI SPA
_Consumer Medication Information Leaflet (RiMUP) _ ______________________________________________________________________________ 1 FOSTER PRESSURISED INHALATION SOLUTION Beclometasone dipropionate / Formoterol Fumarate Dihydrate (100/6 mcg/dose) ________________________________________________________________________________________________________ WHAT IS IN THIS LEAFLET 1. What Foster is used for 2. How Foster works 3. Before you use Foster 4. How to use Foster 5. While you are using Foster 6. Side effects 7. Storage and disposal of Foster 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT FOSTER IS USED FOR Foster is indicated in the regular treatment of: Asthma _ _ - asthma not adequately controlled with inhaled corticosteroids and “as needed” rapid-acting β 2 -agonists or - asthma already controlled on both inhaled corticosteroids and long- acting β 2 -agonists. COPD -Foster can also be used to treat the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults. COPD is a long term disease of the airways in the lungs which is primarily caused by cigarette smoking. HOW FOSTER WORKS Foster is a pressurised inhalation solution containing beclometasone diproprionate, a glucocorticoid with anti-inflammatory action reducing the swelling and irritation in the walls of the small air passage in the lungs, and formoterol fumarate, a selective β 2 -adrenergic agonist that produces relaxation of bronchial smooth muscle in reversible airway obstruction. The combination of these active substances make breathing easier, by providing relief from symptoms such as shortness of breath, wheezing and cough in asthma and also help to prevent asthma worsening. BEFORE YOU USE FOSTER - _When you must not use it:_ -If you are allergic or think you are allergic to one or other of the active ingredients of Foster, or if you are allergic to other medicines or inhalers used to treat asthma or to any of the other ingredients of Foster, contact your doctor for advice. PR Lestu allt skjalið
Foster Summary of Product Characteristics Pag e 1 of 21 1. FOSTER 100/6 MCG/DOSE PRESSURISED INHALATION SOLUTION NAME OF THE MEDICINA L PRODUCT Foster 100/6 micrograms per actuation pressurised inhalation solution . 2. QUALITATIVE AND QUAN TITATIVE COMPOSITION Each metered dose (ex -valve) contains: 100 micrograms of beclometasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex -actuator) of 84.6 micrograms of beclometasone dipropionate and 5.0 micrograms of formoter ol fumarate dihydrate. For a full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Pressurised inhalation solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Asthma Foster is indicated in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long -acting beta 2-agonist) is appropriate: - patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled rapid -acting beta 2-agonist or - patients already adequate ly controlled on both inhaled corticosteroids and long -acting beta 2- agonists. COPD Symptomatic treatment of patients with severe COPD (FEV 1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long -acting bronchodilators. 4.2 POSOLOGY AND METHOD OF A DMINISTRATION FOSTER is for inhalation use. Lestu allt skjalið