Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Trelegy Ellipta is indicated as a maintenance 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 β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1).
The recommended and maximum dose is one inhalation once daily, each day at the same time.
If a dose is missed the next dose should be inhaled at the usual time the next day.
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, moderate or severe hepatic impairment. Trelegy Ellipta should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
There is no relevant use of Trelegy Ellipta in the paediatric population (under 18 years of age) for the indication of COPD.
For inhalation use only.
Instructions for use:
The following instructions for the 30 dose (30 day supply) inhaler also apply to the 14 dose (14 day supply) inhaler.
a) Prepare a dose
Open the cover when ready to inhale a dose. The inhaler should not be shaken.
Slide the cover down fully 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 and rinse your mouth
Slide the cover upwards as far as it will go, to cover the mouthpiece.
Rinse your mouth with water after you have used the inhaler, do not swallow.
This will make it less likely to develop a sore mouth or throat as side effects.
For further instructions on handling the device, see section 6.6.
An overdose will likely produce signs, symptoms or adverse reactions associated with the individual components' pharmacological actions (e.g. Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, dry mouth, visual accommodation disturbances, tachycardia, arrhythmias, tremor, headache, palpitations, nausea, hyperglycaemia and hypokalaemia).
There is no specific treatment for an overdose with Trelegy Ellipta. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
Cardioselective beta-blockade should only be considered for profound vilanterol overdose effects that are clinically concerning and unresponsive to supportive measures. Cardioselective beta-blocking medicinal products should be used with caution in patients with a history of bronchospasm.
Further management should be clinically indicated or as recommended by the national poisons centre, where available.
2 years.
Shelf-life after opening the tray: 6 weeks.
Do not store above 30°C.
If stored in a 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.
The Ellipta inhaler consists of a light grey body, beige 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 two aluminium foil laminate blister strips that deliver a total of 14 or 30 doses (14 or 30 day supply). Each blister in one strip contains fluticasone furoate, each blister in the other strip contains umeclidinium (as bromide) and vilanterol (as trifenatate).
Pack sizes of 1 inhaler with 14 or 30 doses.
Multipacks containing 90 (3 inhalers of 30) doses.
Not all pack sizes may be marketed.
After inhalation, patients should rinse their mouth with water without swallowing.
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.
The inhaler will be in the 'closed' position when it is first taken out of its sealed tray. The "Discard by" date should be written on the inhaler label and carton in the space provided. The date should be added as soon as the inhaler has been removed from the tray. The "Discard by" date is 6 weeks from the date of opening the tray. After this date the inhaler should no longer be used. The tray can be discarded after first opening.
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 an extra dose or a double dose in one inhalation.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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