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XHANCE is a prescription medicine used to treat:

• chronic rhinosinusitis with nasal polyps in adults.
• chronic rhinosinusitis without nasal polyps in adults.

It is not known if XHANCE is safe and effective in children.

Do not use XHANCE if you are allergic to fluticasone propionate or any of the ingredients in XHANCE.

Do not use XHANCE more often than prescribed.

Do not take more than your prescribed dose of XHANCE each day.

Before using XHANCE, tell your healthcare provider about all of your medical conditions, including if you:

• have an immune system problem
• have any type of viral, bacterial, or fungal infection
• are exposed to chickenpox or measles
• have liver problems
• are pregnant or plan to become pregnant. It is not known if XHANCE may harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if XHANCE passes into your breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take. Especially tell your healthcare provider if you take antifungal or anti-HIV medicines as they may interact with XHANCE. This may cause serious side effects.

XHANCE may cause serious side effects, including:

• Nasal problems. Symptoms of nasal problems may include nose bleeds, crusting in the nose, sores (ulcers) in the nose, or a whistling sound when you breathe.
• Fungal infections (thrush) in your nose and throat. Tell your healthcare provider if you have any redness or white colored patches in your nose or mouth.
• Slow wound healing. You should not use XHANCE until your nose has healed if you have a sore in your nose, have had surgery on your nose, or if your nose has been injured.
• Eye problems including glaucoma and cataracts. You should have regular eye exams while you use XHANCE. Call your healthcare provider if you have vision changes while using XHANCE.
• Serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following signs of a serious allergic reaction: rash, hives, swelling of your face, mouth, and tongue, breathing problems, or low blood pressure.
• Weakened immune system and increased chance of getting infections. Avoid contact with people who have a contagious disease such as chickenpox or measles while using XHANCE. If you come in contact with someone who has chickenpox or measles, call your healthcare provider right away. Tell your healthcare provider about any signs or symptoms of infection such as: fever, pain, aches, chills, feeling tired, nausea, or vomiting.
• Reduced adrenal function. This potentially life-threatening condition can happen when you stop taking oral corticosteroids (such as prednisone) and start taking inhaled corticosteroids. Reduced adrenal function can also happen when nasal corticosteroids, such as XHANCE, are used at a dose higher than the usual dose or in people who are susceptible at the usual dose. This may be more likely to happen after surgery or during periods of stress. Tell your healthcare provider right away about any signs and symptoms of reduced adrenal function, such as tiredness, weakness, nausea and vomiting, or low blood pressure.
• Weak bones (osteoporosis). Tell your healthcare provider if you have weak bones before using XHANCE.
• Slowed growth in children. A child’s growth should be checked often.

The most common side effects of XHANCE in adults with chronic rhinosinusitis with nasal polyps include: nose bleeds, sores (ulcers) in your nose, pain or swelling of your nose or throat, redness in your nose, nasal congestion, sinus infection, and headache.

The most common side effects of XHANCE in adults with chronic rhinosinusitis without nasal polyps include: nose bleeds, headache, and pain or swelling of your nose or throat (nasopharyngitis).

These are not all the side effects of XHANCE. Call your doctor for medical advice about side effects.

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.

Please see full Prescribing Information, including Patient Information and Instructions for Use.