Figure N

Step 12: Inhale deeply with a single breath (See Figure O).

Figure O

Step 13: Remove the Podhaler device from your mouth, and hold your breath for about 5 seconds, then exhale normally away from the Podhaler device.

Step 14: Take a few normal breaths away from the Podhaler device. Do not blow or exhale into the mouthpiece.

Step 15: For your second inhalation, repeat steps 10 through 13 using the same capsule.

Step 16: Unscrew the mouthpiece and remove the TOBI Podhaler capsule from the capsule chamber (See Figure P).

Figure P

Step 17: Look at the used capsule. It should be pierced and empty. There will be a fine coating of powder remaining on the inside of the capsule (See Figure Q). If it is pierced and empty, throw it away and go to Step 18.

Figure Q

If the capsule is pierced but still contains more than just a fine coating of powder (See Figure R for an example):

Figure R

◦ Put the capsule back into the Podhaler device capsule-chamber (See Figure J) with the pierced side of the capsule pointing down (See Figure R). Put the mouthpiece back on and repeat Steps 10 to 13.

If the capsule does not look pierced (See Figure S):

Figure S

◦ Put the capsule back into the Podhaler device capsule-chamber (See Figure J). Put the mouthpiece back on and repeat Steps 9 to 17.

▪ If the capsule still does not look pierced and still has some powder in it, use the reserve Podhaler device provided in the TOBI Podhaler package and repeat Steps 1 to 3, then 7 to 17.

Step 18: Repeat Steps 6 to 17 for 3 more times until your whole dose (4 capsules) has been taken (See Figure T).

Figure T

After your TOBI Podhaler dose:

Step 19: Throw away all the empty TOBI Podhaler capsules. Do not store the TOBI Podhaler capsules in the Podhaler device.

Step 20: Put the mouthpiece back on to your Podhaler device and twist the mouthpiece in a clockwise direction until it is tight (See Figure K). Do not overtighten.

Step 21: Wipe the mouthpiece with a clean, dry cloth (See Figure U).

Figure U

Do not wash the Podhaler device with water. Your Podhaler device needs to stay dry at all times to work the right way.
Step 22: Place your Podhaler device back in the storage case base.

Step 23: Place the lid back on the storage case base and screw the cover in a clockwise direction until it is tight (See Figure V).

Figure V

How should I store TOBI Podhaler?

Store your Podhaler device and blister-packaged capsules at room temperature between 68°F to 77°F (20°C to 25°C).
Keep the TOBI Podhaler capsules and Podhaler device in a dry place.
Store the Podhaler device tightly closed in its case when you are not using it.
Keep TOBI Podhaler capsules, Podhaler device, and all medicines out of the reach of children.
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, NJ 07936

© Novartis

T2013-22
March 2013

PRINCIPAL DISPLAY PANEL

Package Label – 28 mg per capsule

Rx Only NDC 0078-0630-35

TOBI™ Podhaler™

(tobramycin inhalation powder)

28 mg per capsule