Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Beclometasone dipropionate, formoterol fumarate dihydrate, glycopyrronium
Chiesi Farmaceutici S.p.A.
R03AL09
beclometasone, formoterol, glycopyrronium bromide
Drugs for obstructive airway diseases,
Pulmonary Disease, Chronic Obstructive
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).
Revision: 5
Authorised
2018-04-26
63 B. PACKAGE LEAFLET 64 PACKAGE LEAFLET: INFORMATION FOR THE USER TRYDONIS 87 MICROGRAMS/5 MICROGRAMS/9 MICROGRAMS PRESSURISED INHALATION, SOLUTION beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Trydonis is and what it is used for 2. What you need to know before you use Trydonis 3. How to use Trydonis 4. Possible side effects 5. How to store Trydonis 6. Contents of the pack and other information 1. WHAT TRYDONIS IS AND WHAT IT IS USED FOR Trydonis is a medicine to help breathing that contains the three active substances: • beclometasone dipropionate, • formoterol fumarate dihydrate and • glycopyrronium. Beclometasone dipropionate belongs to a group of medicines called corticosteroids which act to reduce the swelling and irritation in your lungs. Formoterol and glycopyrronium are medicines called long-acting bronchodilators. They act in different ways to relax the muscles in your airways, helping to open the airways wider and allowing you to breathe more easily. Regular treatment with these three active substances helps to relieve and prevent symptoms such as shortness of breath, wheezing and cough in adult patients with chronic obstructive pulmonary disease (COPD). Trydonis can reduce exacerbations (flare-ups) of COPD symptoms . COPD is a serious long- term disease in which the airways become blocked and air sacs inside the lungs become damaged, leading to difficulty breathing. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE T Read the complete document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Trydonis 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution 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). Excipient with known effect Trydonis contains 8.856 mg ethanol per actuation. 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 or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is two inhalations twice daily. The maximum dose is two inhalations twice daily. Special populations _ _ _Elderly _ No dose adjustment is required in elderly patients (65 years of age and older). _ _ _Renal impairment _ Trydonis can be used at the recommended dose in patients with mild (glomerular filtration rate [GFR] ≥50 to <80 mL/min/1.73 m 2 ) to moderate (GFR ≥30 to <50 mL/min/1.73 m 2 ) renal impairment. Use in patients with severe (GFR <30 mL/min/1.73 m 2 ) renal impairment or end-stage renal (GFR <15 mL/min/1.73 m 2 ) disease requiring dialysis, especially if associated with significant body weight Read the complete document