Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
formoterol fumarate dihydrate, aclidinium bromide
Covis Pharma Europe B.V.
R03AL05
aclidinium, formoterol fumarate dihydrate
Drugs for obstructive airway diseases,
Pulmonary Disease, Chronic Obstructive
Brimica Genuair is indicated as a maintenance bronchodilator treatment for airflow obstruction and relief of symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Revision: 14
Authorised
2014-11-19
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BRIMICA GENUAIR 340 MICROGRAMS /12 MICROGRAMS INHALATION POWDER aclidinium/formoterol fumarate dihydrate This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Brimica Genuair is and what it is used for 2. What you need to know before you use Brimica Genuair 3. How to use Brimica Genuair 4. Possible side effects 5. How to store Brimica Genuair 6. Contents of the pack and other information Instructions for Use 1. WHAT BRIMICA GENUAIR IS AND WHAT IT IS USED FOR WHAT BRIMICA GENUAIR IS This medicine contains two active ingredients called aclidinium and formoterol fumarate dihydrate. Both belong to a group of medicines called bronchodilators. Bronchodilators relax the muscles in your airways, which allows the airways to open more widely and helps you to breathe more easily. The Genuair inhaler delivers the active ingredients directly into your lungs as you breathe in. WHAT BRIMICA GENUAIR IS USED FOR Brimica Genuair is used for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD), in which the airways and air sacs in the lungs become damaged or blocked. By opening the airways, the medicine helps relieve symptoms such as shortness of b Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Brimica Genuair 340 micrograms /12 micrograms inhalation powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose leaving the mouthpiece) contains 396 micrograms of aclidinium bromide (equivalent to 340 micrograms of aclidinium) and 11.8 micrograms of formoterol fumarate dihydrate. This corresponds to a metered dose of 400 micrograms of aclidinium bromide (equivalent to 343 micrograms of aclidinium) and a metered dose of 12 micrograms of formoterol fumarate dihydrate. Excipients with known effect Each delivered dose contains approximately 11 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Inhalation powder. White or almost white powder in a white inhaler with an integral dose indicator and an orange dosage button. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Brimica Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one inhalation twice daily. If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time. A double dose should not be taken to make up for a forgotten dose. _Elderly _ No dose adjustments are required in elderly patients (see section 5.2). _ _ _Renal impairment _ No dose adjustments are required in patients with renal impairment (see section 5.2). _Hepatic impairment _ 3 No dose adjustments are required in patients with hepatic impairment (see section 5.2). _Paediatric population_ There is no relevant use of Brimica Genuair in children and adolescents (under 18 years Прочетете целия документ