País: Malásia
Língua: inglês
Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
GLYCOPYRRONIUM BROMIDE; FORMOTEROL FUMARATE
Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.
GLYCOPYRRONIUM BROMIDE; FORMOTEROL FUMARATE
3 X 10s Capsules
Glenmark Pharmaceuticals Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 GLENMARK AIRZ F Glycopyrronium 12.5mcg and Formoterol Fumarate 12mcg Powder for Inhalation WHAT IS IN THIS LEAFLET 1. What Glenmark Airz F is used for 2. How Glenmark Airz F works 3. Before you use Glenmark Airz F 4. How to use Glenmark Airz F 5. While you are using it 6. Side effects 7. Storage and Disposal of Glenmark Airz F 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT GLENMARK AIRZ F IS USED FOR Glenmark Airz F is used for maintenance treatment of _Chronic _ _Obstructive _ _Pulmonary _ _Disease_ (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. Glenmark Airz F is for long-term use and should be taken 2 times each day to improve symptoms of COPD for better breathing. HOW GLENMARK AIRZ F WORKS Anticholinergic medicines such as Glycopyrronium help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, coughing, chest tightness, and shortness of breath. Formoterol fumarate dihydrate makes breathing easier by relaxing muscle spasms in the air passages of the lungs. It is also used to treat breathing problems in patients with COPD. BEFORE YOU USE GLENMARK AIRZ F - _When you must not use it _ _ _ Do not use Glenmark Airz F • if you are allergic (hypersensitive) to Glycopyrronium or Formoterol Fumarate or any of the other ingredients of this medicine. • to treat sudden symptoms of COPD • In children Talk to your doctor if this applies to you. - _Before you start to use it _ _ _ Before you take Glenmark Airz F, make sure the prescribing doctor knows • Have kidney problems. • Have eye problems such as glaucoma. • Have prostate or bladder problems, or problems passing urine. • Have any other medical conditions. • suffer from any heart problems • have high blood pressure • have seizures • have an overactive thyroid gland • are diabetes • have an aneurysm (area where an artery is swollen because the wall of the Leia o documento completo
PANTONE BLACK PROCESS C SUPERSEDES ARTWORK CODE: PANTONE SHADE ICONGRAPHICS CODE: PHARMACODE: NOTE: “Dimensions, placement of text may change during commercialization of the product depending on machine feasibility.” SAME SIZE ARTWORK LEAFLET SIZE : 264 mm x 640 mm FOLDING SIZE: 66 mm x 40 mm SPACE FOR PHARMACODE SPACE FOR PHARMACODE NAME OF THE MEDICINAL PRODUCT Glycopyrronium 12.5mcg and Formoterol Fumarate 12mcg Powder for Inhalation QUALITATIVE AND QUANTITATIVE COMPOSITION Glycopyrronium 12.5mcg and Formoterol Fumarate 12mcg Powder for Inhalation Each capsule contains: Glycopyrrolate USP equivalent to Glycopyrronium . . . . . . . . . . . . . . . 12.5 mcg Formoterol Fumarate USP . . . . . . . . . 12 mcg Source of Capsule: Synthetic Cellulose PHARMACEUTICAL FORM Powder for Inhalation (In capsule) CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Fixed Dose Combination of Glycopyrronium and Formoterol Fumarate Powder for Inhalation is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Fixed Dose Combination of Glycopyrronium and Formoterol Fumarate Powder for Inhalation is not indicated for the relief of an acute deterioration of COPD. POSOLOGY AND METHOD OF ADMINISTRATION FOR ORAL INHALATION ONLY. DO NOT SWALLOW CAPSULES, AS THE INTENDED EFFECTS ON THE LUNGS WILL NOT BE OBTAINED. CAPSULES SHOULD ONLY BE USED WITH THE INHALER DEVICE. The recommended dose is the inhalation of the content of one capsule twice daily using the inhaler. Fixed Dose Combination of Glycopyrronium and Formoterol Fumarate Powder for Inhalation is recommended to be administered, at the same time of the day each day (1 capsule in the morning and 1 capsule in the evening). More frequent administration or a greater number of inhalations (more than 1 capsule twice- daily) of Fixed Dose Combination of Glycopyrronium and Formoterol Fumarate Powder for Inhalation is not recommended. USE IN SPECIAL POPULATIONS No dosage adjustment is required for geriatric pat Leia o documento completo