cough
worsening of lung problems or cystic fibrosis
productive cough
shortness of breath
fever
sore throat
changes in your voice (hoarseness)
coughing up blood
headache
altered taste
Laboratory tests show reduced tobramycin activity against Pseudomonas aeruginosa bacteria in some patients with the use of TOBI Podhaler. The relationship between these lab results and how well TOBI Podhaler works is not clear. Let your healthcare provider know if your symptoms worsen.

Some patients may be unable to continue TOBI Podhaler and need to consider alternative therapies. Tell your healthcare provider about any side effect that bothers you enough to stop treatment or that does not go away.

These are not all of the possible side effects of TOBI Podhaler. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of TOBI Podhaler

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use TOBI Podhaler for a condition for which it was not prescribed. Do not give TOBI Podhaler to other people, even if they have the same problem you have. It may harm them.

This leaflet summarizes the most important information about TOBI Podhaler. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about TOBI Podhaler that was written for healthcare professionals.

For more information, go to www.TOBIPodhaler.com or call 1-877-999-TOBI (8624).

What are the ingredients in TOBI Podhaler?

Active ingredient: tobramycin

Inactive ingredients: 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), calcium chloride, and sulfuric acid (for pH adjustment)

What is Pseudomonas aeruginosa?

It is a very common bacterium that infects the lungs of nearly everyone with cystic fibrosis at some time during their lives. Some people do not get this infection until later in their lives, while others get it very young. It is one of the most damaging bacteria for people with cystic fibrosis. If the infection is not properly managed, it will continue to damage your lungs causing further problems to your breathing.

T2013-21
March 2013

Instructions for Use

TOBI Podhaler

Follow the instructions below for using your TOBI Podhaler. You will breathe in (inhale) the medicine in the TOBI Podhaler capsules using the Podhaler device. If you have any questions, ask your healthcare provider or pharmacist.

Each TOBI Podhaler package contains (See Figure A):

4 weekly packs (28-day supply), each containing:
56 capsules (7 blister cards of 8 capsules). Each blister card contains 8 TOBI Podhaler capsules (4 capsules for inhalation in the morning and 4 capsules for inhalation in the evening).
1 Podhaler device and its storage case
1 reserve Podhaler device (to be used if needed) and its storage case

Please note the f