Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE DIHYDRATE; GLYCOPYRRONIUM BROMIDE
Orient Europharma (M) Sdn Bhd
BECLOMETHASONE DIPROPIONATE; FORMOTEROL FUMARATE DIHYDRATE; GLYCOPYRRONIUM BROMIDE
120 ACTUATIONS
CHIESI FARMACEUTICI SPA
TRIMBOW PRESSURISED INHALATION SOLUTION Beclometasone dipropionate / Formoterol Fumarate Dihydrate / Glycopyrronium bromide ( 100/6/12.5 mcg/dose) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Trimbow is used for 2. How Trimbow works 3. Before you use Trimbow 4. How to use Trimbow 5. While you are using Trimbow 6. Side effects 7. Storage and disposal of Trimbow 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number _ _ HOW TRIMBOW WORKS Trimbow is a pressurised inhalation solution containing beclometasone diproprionate, formoterol fumarate dehydrate and glycopyrronium bromide. Beclometasone dipropionate is a glucocorticoid with anti-inflammatory action to reduce the swelling and irritation in the walls of the small air passage in the lungs. Formoterol fumarate and glycopyrronium are long- acting bronchodilators which act in different ways to relax the muscle in your airways, helping to open the airways wider and allowing to breathe more easily. The combination of these three active substances make breathing easier, by providing relieve and prevent symptoms such as shortness of breath, wheezing and cough in adult patients with chronic obstructive pulmonary disease (COPD). Trimbow can reduce flare-ups of COPD symptoms. _ _ BEFORE YOU USE TRIMBOW - When you must not use it: _ _ _Warnings and precautions_ Trimbow is used as a maintenance treatment for your COPD. Do not use this medicine to treat a sudden attack of breathlessness or wheezing. -If you are allergic or think you are allergic to one or other of the active ingredients of Trimbow, or if you are allergic to other medicines or inhalers used to treat asthma or to any of the other ingredients of Trimbow, contact your doctor for advice. _Pregnancy and breast feeding _ If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. You should only use Trimbow during pregn Soma hati kamili
2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose leaving the mouthpiece) contains 87 micrograms of beclometasone dipropionate, 5 micrograms of formoterol fumarate dihydrate and 9 micrograms of glycopyrronium (as 11 micrograms glycopyrronium bromide). Each metered dose (the dose leaving the valve) contains 100 micrograms of beclometasone dipropionate, 6 micrograms of formoterol fumarate dihydrate and 10 micrograms of glycopyrronium (as 12.5 micrograms glycopyrronium bromide). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pressurised inhalation, solution (pressurised inhalation). Colourless to yellowish liquid solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist (for effects on symptoms control and prevention of exacerbations see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ The recommended dose is two inhalations of Trimbow twice daily. The maximum dose is two inhalations of Trimbow twice daily. Special populations _Elderly _ No dosage adjustment is required in elderly patients (65 years of age and older). _Renal impairment _ Trimbow can be used at the recommended dose in patients with mild to moderate renal impairment. Use of Trimbow in patients with severe renal impairment or end-stage renal disease requiring dialysis, especially if associated with significant body weight reduction, should be considered only if the expected benefit outweighs the potential risk (see section 4.4 and section 5.2). _Hepatic impairment _ There are no relevant data on the use of Trimbow in patients with severe hepatic impairment and the medicinal product should be used with caution in these patients (see section 4.4 and section 5.2). _Paediatric population _ There is no relevant use of Trimbow in the paediatric population (under 18 Soma hati kamili