Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
Beclometasone dipropionate, formoterol fumarate dihydrate, Glycopyrronium bromide
Chiesi Farmaceutici S.p.A.
R03AL09
beclometasone, formoterol, glycopyrronium bromide
Drugs for obstructive airway diseases,
Pulmonary Disease, Chronic Obstructive
Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and high dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.COPDMaintenance 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).AsthmaMaintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.
Revision: 7
Authorised
2017-07-17
95 B. PACKAGE LEAFLET 96 PACKAGE LEAFLET: INFORMATION FOR THE USER TRIMBOW 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 Trimbow is and what it is used for 2. What you need to know before you use Trimbow 3. How to use Trimbow 4. Possible side effects 5. How to store Trimbow 6. Contents of the pack and other information 1. WHAT TRIMBOW IS AND WHAT IT IS USED FOR Trimbow 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 obstructive lung disease. Trimbow is used for the regular treatment of • chronic obstructive pulmonary disease (COPD) in adults • asthma in adults. Trimbow can reduce exacerbations (flare-ups) of COPD and asthma symptoms. COPD is a serious long-term disease in which the airways become blocked and air sacs Leggi il documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Trimbow 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: Trimbow 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 Chronic obstructive pulmonary disease (COPD) Maintenance treatment in adult patients with moderate to severe 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). Asthma Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is two inhalations twice daily. The maximum dose is two inhalations twice daily. Patients should be advised to take Trimbow every day even when asymptomatic. If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be used for immediate relief. 3 _Asthma _ When choosing the starting dose strength of Trimbow (87/5/9 micro Leggi il documento completo