ATECTURA BREEZHALER Inhalation powder, hard capsule Ref.[51244] Active ingredients: Indacaterol Indacaterol and Mometasone Mometasone

Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules.

Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules.

Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules.

Pharmaceutical Form
Inhalation powder, hard capsule (inhalation powder). Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules: Transparent (uncoloured) capsules containing a white powder, with the product code “IM150-80” printed in blue above one blue bar on the body and with the product logo printed in blue and surrounded by two blue bars on the cap. Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules: Transparent (uncoloured) capsules containing a white powder, with the product code “IM150-160” printed in grey on the body and with the product logo printed in grey on the cap. Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules: Transparent (uncoloured) capsules containing a white powder, with the product code “IM150-320” printed in black above two black bars on the body and with the product logo printed in black and surrounded by two black bars on the cap.

Qualitative and quantitative composition

Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules:

Each capsule contains 150 mcg of indacaterol (as acetate) and 80 mcg of mometasone furoate.

Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg of indacaterol (as acetate) and 62.5 mcg of mometasone furoate.

Atectura Breezhaler 125 micrograms/127.5 micrograms inhalation powder, hard capsules:

Each capsule contains 150 mcg of indacaterol (as acetate) and 160 mcg of mometasone furoate.

Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg of indacaterol (as acetate) and 127.5 mcg of mometasone furoate.

Atectura Breezhaler 125 micrograms/260 micrograms inhalation powder, hard capsules:

Each capsule contains 150 mcg of indacaterol (as acetate) and 320 mcg of mometasone furoate.

Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 125 mcg of indacaterol (as acetate) and 260 mcg of mometasone furoate.

Excipient(s) with known effect:

Each capsule contains approximately 25 mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Indacaterol	Indacaterol is a partial agonist at the human beta₂-adrenergic receptor with nanomolar potency. When inhaled, indacaterol acts locally in the lung as a bronchodilator. In isolated human bronchus, indacaterol has a rapid onset of action and a long duration of action.
Indacaterol and Mometasone	When inhaled, indacaterol acts locally in the lung as a bronchodilator. Indacaterol is a partial agonist at the human beta₂-adrenergic receptor with nanomolar potency. In isolated human bronchus, indacaterol has a rapid onset of action and a long duration of action. Mometasone furoate is a synthetic corticosteroid with high affinity for glucocorticoid receptors and local anti-inflammatory properties. In vitro, mometasone furoate inhibits the release of leukotrienes from leukocytes of allergic patients.
Mometasone	Mometasone is a topical glucocorticoid with local anti-inflammatory properties. It is likely that much of the mechanism for the effects of mometasone lies in its ability to inhibit the release of mediators of the inflammatory cascade.

List of Excipients
Capsule content: Lactose monohydrate Capsule shell: Gelatin Printing ink

Pack sizes and marketing

Inhaler body and cap are made from acrylonitrile butadiene styrene, push buttons are made from methyl metacrylate acrylonitrile butadiene styrene. Needles and springs are made from stainless steel.

PA/Alu/PVC – Alu perforated unit-dose blister. Each blister contains 10 hard capsules.

Atectura Breezhaler 125 micrograms/62.5 micrograms inhalation powder, hard capsules:

Single pack containing 10 × 1 or 30 × 1 hard capsules, together with 1 inhaler.

Pack containing 30 × 1 hard capsules, together with 1 inhaler and 1 sensor.

Multipacks containing 90 (3 packs of 30 × 1) hard capsules and 3 inhalers.

Multipacks containing 150 (15 packs of 10 × 1) hard capsules and 15 inhalers.