Details

---

Ingredients, MAL, Manufacturer

• Active Ingredients: Each capsule contains Indacaterol Acetate 150 mcg, Glycopyrronium Bromide 50 mcg, and Mometasone Furoate 160 mcg.

• Marketing Authorisation (MAL): MAL20050297AZ.

• Manufacturer: Siegfried Barbera, S.L., Spain.

Content

• Active Ingredients per Capsule:

  • Indacaterol acetate: 150 mcg

  • Glycopyrronium bromide: 50 mcg

  • Mometasone furoate: 160 mcg

• Formulation: Powder for inhalation in hard capsules.

• Pack Size: 30 capsules per pack, each accompanied by a Breezhaler inhaler.

Indications

Enerzair Breezhaler is indicated for the maintenance treatment of asthma in adults:

• Not adequately controlled with a maintenance combination of a long-acting β₂-agonist (LABA) and a high-dose inhaled corticosteroid (ICS), and who have experienced at least one asthma exacerbation in the previous year.

Instructions

Dosage:

• Inhale the contents of one capsule daily, using the provided Breezhaler inhaler.

• Administer at the same time each day to maintain consistent symptom control.

Administration:

1. Remove a capsule from the blister pack immediately before use.

2. Insert the capsule into the Breezhaler inhaler.

3. Pierce the capsule by pressing both side buttons simultaneously.

4. Inhale deeply and steadily through the mouthpiece.

5. Hold your breath for up to 5 seconds, then exhale gently.

6. Rinse your mouth with water and spit it out after each use to reduce the risk of oral thrush.

Storage:

• Store capsules in the original blister pack to protect from moisture and light.

• Keep the inhaler and capsules in a dry place below 30°C.

• Keep out of reach of children.