Indication and Dosage

ZETONNA® (ciclesonide) Nasal Aerosol is a prescription medicine that treats seasonal and year-round allergy symptoms in adults and children 12 years of age and older. It is for use in the nose only. ZETONNA Nasal Aerosol is used 1 time each day, 1 spray per nostril.

Important Safety Information

Do not spray ZETONNA® (ciclesonide) Nasal Aerosol in your eyes or directly onto your nasal septum (the wall inside your nose between your two nostrils).

ZETONNA Nasal Aerosol may cause serious side effects, including:

• • nose bleeds and nasal ulcers. Call your healthcare provider right away if you start to have more nose bleeds or nasal ulcers.
• • hole in the cartilage in the nose (nasal septal perforation). Stop using ZETONNA Nasal Aerosol and call your doctor right away if you have symptoms of a nasal perforation. Symptoms of nasal perforation may include: crusting in the nose, nosebleeds, runny nose, and a whistling sound when you breathe.
• • thrush (Candida), a fungal infection in your nose, mouth, or throat. Tell your healthcare provider if you have any redness or white colored patches in your mouth or throat.
• • slow wound healing. You should not use ZETONNA Nasal Aerosol until your nose has healed, if you have a sore in your nose, if you have had surgery in your nose, or if your nose has been injured.
• • eye problems such as glaucoma and cataracts. If you have a history of glaucoma or cataracts or have a family history of eye problems, you should have regular eye exams while you use ZETONNA Nasal Aerosol.
• • immune system problems that may increase your risk of infections. You are more likely to get infections if you take medicines that may weaken your body's ability to fight infections. Avoid contact with people who have contagious diseases such as chicken pox or measles while you use ZETONNA Nasal Aerosol. Symptoms of an infection may include: fever, pain, aches, chills, feeling tired, nausea, and vomiting.
• • adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Call your healthcare provider right away if you experience the following symptoms of adrenal insufficiency: tiredness, weakness, dizziness, nausea, and vomiting.
• • slowed or delayed growth in children. A child's growth should be checked regularly while using ZETONNA Nasal Aerosol.
• • allergic reactions. Call your healthcare provider right away if you experience swelling of the lips, tongue, or throat.

The most common side effects with ZETONNA Nasal Aerosol include nasal discomfort, headache and nose bleeds.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ZETONNA Nasal Aerosol.

For more information, please see the ZETONNA Full Prescribing Information and the ZETONNA Patient Information. You may also call 1-888-394-7377.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

ZETONNA® (ciclesonide) Nasal Aerosol is available by prescription. Ask your healthcare professional if ZETONNA is right for you.

The health information contained on this website is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. This site is intended only for U.S. residents 18 years of age and older. The product discussed on this site may have different product labeling in different countries. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient.

Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma Co. Ltd., and is a registered trademark of Dainippon Sumitomo Pharma Co. Ltd.

© 2013 Sunovion Pharmaceuticals Inc. All rights reserved. 01/13 ZETV342-12