Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLUTICASONE PROPIONATE; Salmeterol Xinafoate
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
FLUTICASONE PROPIONATE; Salmeterol Xinafoate
1 mcg/mL
GLAXO WELLCOME S.A.
_ _ _ _ _Consumer Medication Information Leaflet (RiMUP) _ SERETIDE EVOHALER DOSE COUNTER _ _ Salmeterol xinafoate/ Fluticasone propionate (25/50 mcg, 25/125 mcg, 25/250 mcg) 1 WHAT IS IN THIS LEAFLET 1. What SERETIDE is used for 2. How SERETIDE works 3. Before you use SERETIDE 4. How to use SERETIDE 5. While you are using it 6. Side Effects 7. Storage and Disposal of SERETIDE 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT SERETIDE IS USED FOR Your doctor has chosen this medicine to suit you and your condition. SERETIDE is used to help with breathing problems in people who need regular treatment. Asthma is a long-term condition affecting the lungs. Symptoms of asthma include shortness of breath, wheezing, chest tightness and cough. Two main causes of asthma symptoms are bronchoconstriction (tightening of the muscle surrounding the airways) and inflammation (swelling and irritation of the airways). Chronic obstructive pulmonary disease (COPD) is a long-term, progressively worsening condition affecting the lungs, resulting from chronic bronchitis or emphysema. Symptoms of COPD include shortness of breath, cough, chest discomfort and coughing up mucus. The primary cause of COPD symptoms are bronchoconstriction (tightening of the muscle surrounding the airways) and inflammation (swelling and irritation of the airways). HOW SERETIDE WORKS Salmeterol xinafoate is one of a group of medicines called bronchodilators. It relaxes the muscles in the walls of the small air passages in the lungs. This helps to open the airways and makes it easier for air to get in and out of the lungs. The effects of salmeterol xinafoate last for at least 12 hours. When it is taken regularly it helps the small air passages to remain open. Fluticasone propionate is one of a group of medicines called corticosteroids which are often referred to simply as steroids. Corticosteroids are used to treat breathing problems because they have an anti-inflammatory action. They reduce the swelling and irrita Baca dokumen lengkap
CONFIDENTIAL [GSK logo] SERETIDE EVOHALER DOSE COUNTER Salmeterol/fluticasone propionate PRODUCT DESCRIPTION _Seretide Evohaler Dose Counter 25/50 mcg _ _Seretide Evohaler Dose Counter 25/125 mcg _ _Seretide Evohaler Dose Counter 25/250 mcg_ _SERETIDE_ Evohaler comprises a suspension of salmeterol and fluticasone propionate in the non- CFC propellant HFA 134a. The suspension is contained in an aluminium alloy can sealed with a metering valve. The canisters are fitted into plastic actuators incorporating an atomising orifice and fitted with dustcaps. The canister has a dose counter attached to it, which shows how many actuations of medicine are left. The number will show through a window in the back of the plastic actuator. _SERETIDE_ Evohaler has been formulated in three strengths and one pack sizes, delivering 120 actuations per inhaler. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single actuation of _SERETIDE _ provides: Salmeterol xinafoate equivalent to 25 micrograms of salmeterol and 50, 125 or 250 micrograms of fluticasone propionate. CLINICAL INFORMATION INDICATIONS Pharmaceutical form: Inhalation aerosol. ASTHMA (REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE) _SERETIDE _ is indicated in the regular treatment of reversible obstructive airways disease (ROAD), including asthma in children and adults, where use of a combination (bronchodilator and inhaled corticosteroid) is appropriate. This may include: Patients on effective maintenance doses of long-acting beta-agonists and inhaled corticosteroids. Patients who are symptomatic on current inhaled corticosteroid therapy. CONFIDENTIAL Patients on regular bronchodilator therapy who require inhaled corticosteroids. CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) _SERETIDE _ is indicated for the regular treatment of chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema. DOSAGE AND ADMINISTRATION _SERETIDE _ Evohaler is for inhalation only. Patients should be made aware that _SERETIDE _ Evohaler must be used regularly for optimum benefit, Baca dokumen lengkap