Land: Europese Unie
Taal: Engels
Bron: EMA (European Medicines Agency)
aclidinium bromide
Covis Pharma Europe B.V.
R03BB
aclidinium bromide
Drugs for obstructive airway diseases,
Pulmonary Disease, Chronic Obstructive
Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Revision: 18
Authorised
2012-07-20
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BRETARIS GENUAIR 322 MICROGRAMS INHALATION POWDER Aclidinium (aclidinium bromide) 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 Bretaris Genuair is and what it is used for 2. What you need to know before you use Bretaris Genuair 3. How to use Bretaris Genuair 4. Possible side effects 5. How to store Bretaris Genuair 6. Contents of the pack and other information Instructions for Use 1. WHAT BRETARIS GENUAIR IS AND WHAT IT IS USED FOR WHAT BRETARIS GENUAIR IS The active ingredient of Bretaris Genuair is aclidinium bromide, which belongs to a group of medicines called bronchodilators. Bronchodilators relax airways and help keep bronchioles open. Bretaris Genuair is a dry powder inhaler that uses your breath to deliver the medicine directly into your lungs. This makes it easier for chronic obstructive pulmonary disease (COPD) patients to breathe. WHAT BRETARIS GENUAIR IS USED FOR Bretaris Genuair is indicated to help open the airways and relieve symptoms of COPD, a serious, long- term lung disease characterised by breathing difficulties. Regular use of Bretaris Genuair can help you when you have ongoing shortness of breath related to your disease to help you minimise the effects of the dise Lees het volledige document
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 Bretaris Genuair 322 micrograms inhalation powder 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each delivered dose (the dose leaving the mouthpiece) contains 375 µg aclidinium bromide equivalent to 322 µg of aclidinium. This corresponds to a metered dose of 400 µg aclidinium bromide equivalent to 343 µg aclidinium. Excipients with known effect Each delivered dose contains approximately 12 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 a green dosage button. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one inhalation of 322 micrograms aclidinium twice daily. If a dose is missed the next dose should be taken as soon as possible. However, if it is nearly time for the next dose, the missed dose should be skipped. _Elderly _ No dose adjustments are required for elderly patients (see section 5.2). _ _ _Renal impairment _ No dose adjustments are required for patients with renal impairment (see section 5.2). _Hepatic impairment _ No dose adjustments are required for patients with hepatic impairment (see section 5.2). _ _ _Paediatric population_ There is no relevant use of Bretaris Genuair in children and adolescents (under 18 years of age) for the indication of COPD. 3 _ _ Method of administration For inhalation use. Patients should be instructed on how to administer the product Lees het volledige document