AirDuo RespiClick: Uses, Side Effects and Dosage

INSTRUCTIONS FOR USE

AIRDUO^® RESPICLICK^® (ayr´due oh res-pē-klik)

(fluticasone propionate and salmeterol) inhalation powder 55 mcg/14 mcg

AIRDUO^® RESPICLICK^® (ayr´due oh res-pē-klik)

(fluticasone propionate and salmeterol) inhalation powder 113 mcg/14 mcg

AIRDUO^® RESPICLICK^® (ayr´due oh res-pē-klik)

(fluticasone propionate and salmeterol) inhalation powder 232 mcg/14 mcg

for oral inhalation use

Your AIRDUO RESPICLICK Inhaler

When you are ready to use AIRDUO RESPICLICK for the first time, remove the AIRDUO RESPICLICK inhaler from the foil pouch.

There are 2 main parts of your AIRDUO RESPICLICK inhaler including the:

• white inhaler with the mouthpiece. See Figure A.
• yellow cap that covers the mouthpiece of the inhaler. See Figure A.

There is a dose counter in the back of the inhaler with a viewing window that shows you how many doses of medicine you have left. See Figure A.

Figure A

• Your AIRDUO RESPICLICK inhaler contains 60 doses (inhalations). See Figure B.
• The dose counter shows the number of doses left in your inhaler.
• When there are 20 doses left, the color of the numbers on the dose counter will change to red and you should refill your prescription or ask your healthcare provider for another prescription.
• When the dose counter displays ‘0’ your inhaler is empty and you should stop using the inhaler and throw it away. See Figure B.

Figure B

Important:

• Always close the cap after each inhalation so your inhaler will be ready for you to take your next dose. Do not open the cap unless you are ready for your next dose.
• You will hear a “click” sound when the cap is opened all the way. If you do not hear the “click” sound the inhaler may not be activated to give you a dose of medicine.
• AIRDUO RESPICLICK does not have an activation button or medicine canister. When you open the cap, a dose of AIRDUO RESPICLICK will be activated for delivery of the medicine.
• Do not use a spacer or volume holding chamber with AIRDUO RESPICLICK. AIRDUO RESPICLICK does not need priming.

Using your AIRDUO RESPICLICK inhaler:

Important: Make sure the cap is closed before you start using your inhaler.

Step 1. Open

Figure C

• Hold the inhaler upright and open the yellow cap all the way until it “clicks”. See Figure C.
• Each time you open the yellow cap and it “clicks”, 1 dose of AIRDUO RESPICLICK is ready to be inhaled.

Remember:

• For the correct use of AIRDUO RESPICLICK, hold the inhaler upright as you open the yellow cap. See Figure D.
• Do not hold the inhaler in any other way as you open the yellow cap.
• Do not open the yellow cap until you are ready to take a dose of AIRDUO RESPICLICK.

Figure D

Step 2. Inhale

Figure E

• Before you inhale, breathe out (exhale) through your mouth and push as much air from your lungs as you can. See Figure E.
• Do not exhale into the inhaler mouthpiece.

Figure F

• Put the mouthpiece in your mouth and close your lips tightly around it. See Figure F.

Figure G

• Do not block the vent above the mouthpiece with your lips or fingers. See Figure G.
• Breathe in quickly and deeply through your mouth to deliver the dose of medicine to your lungs.
• Remove the inhaler from your mouth.
• Hold your breath for about 10 seconds or for as long as you comfortably can.
• Your AIRDUO RESPICLICK inhaler delivers your dose of medicine as a very fine powder that you may or may not taste or feel. Do not take an extra dose from the inhaler even if you do not taste or feel the medicine.

Step 3. Close

Figure H

• Close the yellow cap firmly over the mouthpiece. See Figure H.
• Make sure you close the yellow cap after each inhalation so that the inhaler will be ready for your next dose.
• Rinse your mouth with water without swallowing after each inhalation.

How should I store AIRDUO RESPICLICK?

• Store AIRDUO RESPICLICK at room temperature between 59ºF and 77ºF (15ºC and 25ºC).
• Avoid exposure to extreme heat, cold, or humidity.
• Store AIRDUO RESPICLICK in the unopened foil pouch and only open when ready for use.
• Keep the yellow cap on the inhaler closed during storage.
• Keep your AIRDUO RESPICLICK inhaler dry and clean at all times.
• Keep your AIRDUO RESPICLICK inhaler and all medicines out of the reach of children.

Cleaning your AIRDUO RESPICLICK inhaler

• Do not wash or put any part of your AIRDUO RESPICLICK inhaler in water. Replace your inhaler if washed or placed in water.
• AIRDUO RESPICLICK contains a powder and must be kept clean and dry at all times.
• You can clean the mouthpiece if needed using a dry cloth or tissue. Routine cleaning is not required.

Replacing your AIRDUO RESPICLICK inhaler

• Immediately replace your inhaler if the mouthpiece cover is damaged or broken. Never take the inhaler apart.
• The dose counter on the back of your inhaler shows how many doses you have left.
• When there are 20 doses left, the color of the numbers on the dose counter will change to red and you should refill your prescription or ask your healthcare provider for another prescription.
• When the counter displays ‘0’ your AIRDUO RESPICLICK inhaler is empty and you should stop using the inhaler and throw it away.
• Throw away AIRDUO RESPICLICK 30 days after opening the foil pouch, when the dose counter displays ‘0’, or after the expiration date on the product, whichever comes first.

Important information

• Do not open the yellow cap unless you are taking a dose. Repeatedly opening and closing the cap without inhaling a dose will waste the medicine and may damage your inhaler.
• Your AIRDUO RESPICLICK inhaler contains dry powder so it is important that you do not blow or breathe into it.

Support

• If you have any questions about AIRDUO RESPICLICK or how to use your inhaler, go to www.AIRDUORESPICLICK.com, or call 1-888-482-9522.

These Instructions for Use have been approved by the U.S. Food and Drug Administration.

Distributed by:

Teva Pharmaceuticals USA, Inc.

Parsippany, NJ 07054

©2021 Teva Respiratory, LLC. All rights reserved.

AIRDIFU-006

Revised: July 2021