Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FLUTICASONE PROPIONATE; SALMETEROL XINOFOATE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
FLUTICASONE PROPIONATE; SALMETEROL XINOFOATE
1Units Units
GLAXO WELLCOME PRODUCTION
_Consumer Medication Information Leaflet (RiMUP)_ _ _ 1 SERETIDE ACCUHALER Salmeterol xinofoate/ Fluticasone propionate (50/100, 50/250, 50/500 micrograms) 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 (linings of the air sacs in the lungs damaged beyond repair). 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). SERETIDE Accuhaler, at a dose of 50/500 micrograms, has been shown to increase survival and reduce the number of flare ups of COPD symptoms. 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 wh read_full_document
CONFIDENTIAL [GSK logo] SERETIDE ACCUHALER Salmeterol/fluticasone propionate QUALITATIVE AND QUANTITATIVE COMPOSITION Moulded plastic device containing a foil strip with 60 regularly placed blisters each containing 50 micrograms of salmeterol as salmeterol xinafoate and 100 micrograms of fluticasone propionate. Moulded plastic device containing a foil strip with 60 regularly placed blisters each containing 50 micrograms of salmeterol as salmeterol xinafoate and 250 micrograms of fluticasone propionate. Moulded plastic device containing a foil strip with 60 regularly placed blisters each containing 50 micrograms of salmeterol as salmeterol xinafoate and 500 micrograms of fluticasone propionate. CLINICAL INFORMATION Pharmaceutical form: Inhalation powder. INDICATIONS ASTHMA _SERETIDE _ is indicated in the regular treatment of asthma, 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. Patients on regular bronchodilator therapy who require inhaled corticosteroids. CONFIDENTIAL 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 _ Accuhaler is for inhalation only. Patients should be made aware that _SERETIDE _ Accuhaler must be used regularly for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of _SERETIDE _ they are receiving remains optimal and is only changed on medical advice. ASTHMA The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Where the control of symptoms is maintained with twice daily _SERETIDE_ , titration to the lowest effective dose could include _SERETIDE _ read_full_document