Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Umeclidinium bromide
GlaxoSmithKline UK Ltd
R03BB07
Umeclidinium bromide
65microgram/1dose
Inhalation powder
Inhalation
No Controlled Drug Status
Valid as a prescribable product
BNF: 03010200; GTIN: 5000123114399
1 PACKAGE LEAFLET: INFORMATION FOR THE USER INCRUSE 55 MICROGRAMS INHALATION POWDER, PRE-DISPENSED umeclidinium (umeclidinium 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 Incruse is and what it is used for 2. What you need to know before you use Incruse 3. How to use Incruse 4. Possible side effects 5. How to store Incruse 6. Contents of the pack and other information Step-by-step instructions for use 1. WHAT INCRUSE IS AND WHAT IT IS USED FOR WHAT INCRUSE IS Incruse contains an active substance called umeclidinium bromide, which belongs to a group of medicines called _bronchodilators_ . WHAT INCRUSE IS USED FOR This medicine is used to treat _chronic obstructive pulmonary disease_ ( COPD ) in adults. COPD is a long- term condition in which the airways and air-sacs in the lungs gradually become blocked or damaged, leading to breathing difficulties that slowly get worse. Difficulties in breathing is added to by tightening of the muscles around the airways, which narrows the airways and so restricts the flow of air. This medicine blocks the tightening of these muscles, making it easier for air to get in and out of the lungs. When used regularly, it can help control your breathing difficulties and reduce the effects of COPD on your everyday life. INC Lire le document complet
OBJECT 1 INCRUSE 55 MICROGRAMS INHALATION POWDER, PRE- DISPENSED Summary of Product Characteristics Updated 20-Jul-2017 | GlaxoSmithKline UK 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 Incruse 55 micrograms inhalation powder, pre-dispensed 2. Qualitative and quantitative composition Each single inhalation provides a delivered dose (the dose leaving the mouthpiece of the inhaler) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) This corresponds to a pre-dispensed dose of 62.5 micrograms umeclidinium equivalent to 74.2 micrograms umeclidinium bromide. Excipient with known effect: Each delivered dose contains approximately 12.5 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Inhalation powder, pre-dispensed (inhalation powder). White powder in a grey inhaler (Ellipta) with a light green mouthpiece cover and a dose counter. 4. Clinical particulars 4.1 Therapeutic indications Incruse 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 _Adults _ The recommended dose is one inhalation of umeclidinium bromide once daily. Incruse should be administered once daily at the same time of the day each day to maintain bronchodilation. The maximum dose is one inhalation of umeclidinium bromide once daily. _Special populations _ Elderly patients No dosage adjustment is required in patients over 65 years (see section 5.2). Renal impairment No dosage adjustment is required in patients with renal impairment (see section 5.2). Hepatic impairment No dosage adjustment is required in patients with mild or moderate hepatic impairment. Incruse has not been studied in pa Lire le document complet