INSTRUCTIONS FOR USE PROVENTIL HFA ... - …

1 INSTRUCTIONS FOR USE1 PROVENTIL HFA(pr -vent -il)2(albuterol sulfate)3 inhalation Aerosolwith dose Indicator45 Read this INSTRUCTIONS for Use before you start using PROVENTIL HFA and each time you get a 6refill. There may be new information. This information does not take the place of talking to your 7doctor about your medical condition or treatment. Your doctor should show you how your child 8should use PROVENTIL Information:11 PROVENTIL HFA is for oral inhalation use Take PROVENTIL HFA exactly as your doctor tells you HFA inhalation aerosol comes as a canister with a dose indicator . The dose 15indicator is located on the top of the canister that fits into an actuator (See Figure A). The dose 16indicator display window will show you how many puffs of medicine you have left. A puff of 17medicine is released each time you press the center of the dose Do not use the PROVENTILHFA actuator with a canister of medicine from any other Do not use the PROVENTILHFA canister with an actuator from any other A2526 Before you use PROVENTILHFA for the first timemake sure that the pointer on the dose 27indicator is pointing to the right of the 200 inhalation mark in the dose indicator display window 28(See Figure A).

2 2930 Each canister of PROVENTIL HFA contains 200 puffs of medicine. This does not include the 31sprays ofmedicine used for priming your The dose indicator display window will continue to move after every 10 The number in the dose indicator display window will continue to change after every 20 The color in the dose indicator display window will change to red, as shown in the 37shaded area, when there are only 20 puffs of medicine left in your inhaler (See Figure 38B). This is when you need to refill your prescription or ask your doctor if you need 39another prescription for PROVENTIL B4344 Priming your PROVENTIL HFA inhaler:4546 Before using your PROVENTIL HFAfor the first time, you should prime your inhaler. If 47you do not use your PROVENTIL HFA for more than 2 weeks, you should re-prime it before Remove the cap from the mouthpiece (See Figure C).

3 Check inside the mouthpiece for 51objects before Make sure the canister is fully inserted into the Hold the inhaler in an upright position away from your face and shake the inhaler Press down fully on the center of the dose indicator to releasea spray of medicine. You 55may hear a soft click from the dose indicator as it counts down during use. 56 Repeat the priming step 3 more times to release a total of 4 sprays of medicine. Shake 57the inhaler well before each After the 4 priming sprays, the dose indicator should be pointing to 200. There are now 59200 puffs of medicine left in the Your inhaler is now ready to your PROVENTIL HFA inhaler:6364 Step 1:Shake the inhaler well before each use. Remove the cap from the mouthpiece(See 65 Figure C). Check inside the mouthpiece for objects beforeuse. Make sure the canister 66is fully inserted into the C6970 Step 2: Breathe out as fully as you comfortably can through your mouth.

4 Hold the inhaler in the 71upright position with the mouthpiece pointing towardsyou and place the mouthpiece 72fully into the mouth (See Figure D). Close yourlips around the D7677 Step 3: While breathing in deeply and slowly, press down on the center of the dose indicator78with your index finger until the canister stops moving in the actuatorand a puff of 79medicine has been released (See Figure D). Then stop pressing the dose 4: Hold your breath as long asyou comfortably can, up to 10 seconds. Remove the inhaler 82from your mouth, and then breathe out. 8384 Step 5: If your doctor has prescribed additional puffsof PROVENTIL HFA, wait 1 minute85then shake the inhaler well. Repeat steps 3 through 5in the section Using your 86 PROVENTIL HFA inhaler .8788 Step 6: Replace the cap right away after your PROVENTIL HFA inhaler:9192It is very important that you keep the mouthpiece clean so that medicine will not build up and 93block the spray through the mouthpiece.

5 Clean the mouthpiece1 time each weekor if your94mouthpiece becomes blocked (See Figure F).95 Step 1: Remove the canister from the actuator and take the cap off the mouthpiece. Do not 96clean the metal canister or let it get 2: Wash the mouthpiece through the top and bottom with warm running water for 30 99seconds (See Figure E).100101102 Figure E103104 Step 3: Shake off as much water from the mouthpiece as you 4: Look in the mouthpiece to make sure any medicine buildup has been completely 107washed away. If the mouthpiece is blocked with buildup, little to no medicine will come 108out of the mouthpiece (See Figure F). If there is any buildup, repeat Steps 2 through 4 109in the section Cleaning your PROVENTIL HFA inhaler .110111112 Figure F113114 Step 5: Let themouthpiece air-dry such asovernight(See Figure G). Do notput the canister 115back into the actuator if it is still G119120 Step 6: When the mouthpiece is dry,put the canisterback in the actuatorand put the cap on 121the mouthpiece.

6 122123 Note: If you need to use your PROVENTIL HFA inhaler before it is completely dry,put124the canisterback in the actuator and shake the inhaler down on the center 125of the dose indicator 2 times to release a total of 2 spraysinto the air, away from your 126face. Take your dose as prescribedthen clean and air-dry your inhaler as described in 127the section Cleaning your PROVENTIL HFA inhaler .128129 How should I store PROVENTIL HFA?130 Store PROVENTIL HFA at room temperature between 59 F and 77 F (15 C and 25 C).131 Store with the mouthpiece Avoid exposing PROVENTIL HFAto extreme heat and Do not puncture or burn the canister. 134 Keep your PROVENTILHFA inhalerand all medicines out of the reach of and Manufactured by:1383M Health Care Limited139 Loughborough UK140or1413M Drug Delivery Systems142 Northridge, CA 91324, USA143144 Copyright 1996, 2011, 2012, 2017 Merck Sharp& Dohme Corp.

7 , a subsidiary ofMerck & Co., rights INSTRUCTIONS for Use has been approved by the Food and Drug : 09/201734-8720-1598-6145