Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Incruse Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
The recommended dose is one inhalation of umeclidinium bromide once daily.
It should be administered each day at the same time of the day to maintain bronchodilation. The maximum dose is one inhalation of umeclidinium bromide once daily.
No dose adjustment is required in patients 65 years of age or older (see section 5.2).
No dose adjustment is required in patients with renal impairment (see section 5.2).
No dose adjustment is required in patients with mild or moderate hepatic impairment. Umeclidinium bromide has not been studied in patients with severe hepatic impairment and should be used with caution (see section 5.2).
There is no relevant use of umeclidinium bromide in the paediatric population (under 18 years of age) for the indication of COPD.
For inhalation use only.
The following instructions for the 30 dose inhaler (30 day supply) also apply to the 7 dose inhaler (7 day supply).
The inhaler is packaged in a tray containing a desiccant sachet, to reduce moisture. The desiccant sachet should be thrown away and it should not be opened, eaten or inhaled.
The patient should be advised to not open the tray until they are ready to inhale a dose.
If the inhaler cover is opened and closed without inhaling the medicinal product, the dose will be lost. The lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled.
It is not possible to accidentally take extra medicinal product or a double dose in one inhalation.
a) Prepare a dose:
Open the cover when ready to inhale a dose. The inhaler should not be shaken.
Slide the cover down until a “click” is heard. The medicinal product is now ready to be inhaled.
The dose counter counts down by 1 to confirm. If the dose counter does not count down as the “click” is heard, the inhaler will not deliver a dose and should be taken back to a pharmacist for advice.
b) How to inhale the medicinal product:
The inhaler should be held away from the mouth breathing out as far as is comfortable. But not breathing out into the inhaler.
The mouthpiece should be placed between the lips and the lips should then be closed firmly around it. The air vents should not be blocked with fingers during use.
The medicinal product may not be tasted or felt, even when using the inhaler correctly.
The mouthpiece of the inhaler may be cleaned using a dry tissue before closing the cover.
c) Close the inhaler:
Slide the cover upwards as far as it will go, to cover the mouthpiece.
An overdose of umeclidinium bromide will likely produce signs and symptoms consistent with the known inhaled muscarinic antagonist adverse reactions (e.g. dry mouth, visual accommodation disturbances and tachycardia).
If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
2 years.
In-use shelf-life after opening the tray: 6 weeks.
Do not store above 30°C. If stored in the refrigerator, allow the inhaler to return to room temperature for at least an hour before use.
Keep the inhaler inside the sealed tray in order to protect from moisture and only remove immediately before first use.
Write the date the inhaler should be discarded on the label in the space provided. The date should be added as soon as the inhaler has been removed from the tray.
The Ellipta inhaler consists of a grey body, light green mouthpiece cover and a dose counter, packed into a foil laminate tray containing a silica gel desiccant sachet. The tray is sealed with a peelable foil lid.
The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel.
The inhaler contains one aluminium foil laminate blister of 7 or 30 doses.
Pack sizes of 7 and 30 dose inhaler.
Multipacks containing 90 (3 inhalers of 30) doses.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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