Details

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Product Registration & Manufacturer Information

• Registration Number (MAL): MAL08031392ACRZ

• Product Holder: Chiesi Limited, UK

• Manufactured by: Chiesi Farmaceutici S.p.A., Italy

Active Ingredients

• Beclometasone Dipropionate: 100 mcg per dose

• Formoterol Fumarate Dihydrate: 6 mcg per dose

Indications

• Asthma: For regular treatment in patients where use of a combination product (inhaled corticosteroid and long-acting beta₂-agonist) is appropriate:

  • Patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting beta₂-agonist, or

  • Patients already adequately controlled on both inhaled corticosteroids and long-acting beta₂-agonists.

• Chronic Obstructive Pulmonary Disease (COPD): For symptomatic treatment of patients with severe COPD (FEV₁ <50%) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

Instructions for Use

1. Preparation:

   • Open the inhaler by fully lifting the cover.

   • Check the dose counter to ensure there are doses remaining.

2. Inhalation:

   • Hold the inhaler upright and breathe out gently away from the inhaler.

   • Place the mouthpiece between your teeth without biting and form a good seal with your lips.

   • Breathe in forcefully and deeply through your mouth.

   • Hold your breath for 5 to 10 seconds, then breathe out gently away from the inhaler.

3. Post-Inhalation Care:

   • Rinse your mouth or gargle with water after each use to reduce the risk of oral thrush.

   • Close the inhaler cover securely after use.

4. Storage:

   • Store the inhaler in a dry place, away from moisture.

   • Do not store the inhaler in the refrigerator or freezer.