Azelastine Hydrochloride (ay-ze-LAS-teen hye-droe-KLOR-ide), Fluticasone Propionate (floo-TIK-a-sone PROE-pee-oh-nate)

Treats symptoms of hay fever (allergic rhinitis). This medicine contains an antihistamine and a steroid.

Brand Name(s):

Dymista

When This Medicine Should Not Be Used:

How to Use This Medicine:

Spray

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.
• If you are using the nasal spray for the first time, you will need to prime the spray. To do this, pump or squeeze the bottle until some of the medicine sprays out. Now it is ready to use. Prime the spray after each time you clean the pump, or if you have not used the medicine for 5 days or longer.
• Before using the medicine, gently blow your nose to clear the nostrils.
• After using the nasal spray, wipe the tip of the bottle with a clean tissue and put the cap back on.
• You may need to use this medicine for a few days before you start to feel better.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Keep the bottle tightly closed when not using it. Store at room temperature, away from heat and direct light. Do not store in the freezer or refrigerator.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed. Throw this medicine away after you use 120 sprays.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how azelastine/fluticasone works. Tell your doctor if you are taking fluconazole, itraconazole, ketoconazole, or ritonavir.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding or if you have adrenal problems, asthma, glaucoma, cataracts, tuberculosis, an eye infection caused by herpes, or any type of infection (including a cold or the flu).
• Tell your doctor if you had recent nose sores or ulcers, surgery, or injury. You may need to stop using the medicine to allow your nose to heal.
• This medicine may cause the following problems:
  • Weakened immune system that makes it easier to get infections
  • Slowed growth in children
  • Vision changes or problems
• This medicine may make you dizzy or drowsy. Do not drive, use machines, or do anything that could be dangerous until you know how this medicine affects you.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Burning, redness, swelling, or irritation around or inside your nose
• Eye pain or changes with vision
• Fever, chills, cough, runny nose, sore throat, and body aches
• Heavy nosebleeds
• Sores or white patches inside the nose or mouth
• Unusual tiredness or weakness, diarrhea, nausea, or vomiting

If you notice other side effects that you think are caused by this medicine, tell your doctor

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