Azelastine

What it is used for

• Azelastine HCl nasal spray, 0.1% is a prescription medicine used to treat symptoms of seasonal allergic rhinitis in people age 5 and older and vasomotor rhinitis in people age 12 and older.
• Azelastine HCl nasal spray, 0.1% may help to reduce your nasal symptoms including stuffy nose, runny nose, itching and sneezing.

It is not known if azelastine HCl nasal spray, 0.1% is safe and effective in children with seasonal allergic rhinitis under 5 years of age or in children with vasomotor rhinitis under 12 years of age.

How to take it

• Read the Instructions for Use at the end of this leaflet for information about the right way to use azelastine HCl nasal spray, 0.1%.
• Spray azelastine HCl nasal spray, 0.1% in your nose only. Do not spray it into your eyes or mouth.
• Use azelastine HCl nasal spray, 0.1% exactly as your healthcare provider tells you to use it.
• Do not use more than your healthcare provider tells you.
• Throw away your azelastine HCl nasal spray, 0.1% bottle after using 200 sprays. Even though the bottle may not be completely empty, you may not get the correct dose of medicine.
• If you use too much or a child accidentally swallows azelastine HCl nasal spray, 0.1%, call your healthcare provider or go to the nearest hospital emergency room right away.

Side effects, and when to stop

The most common side effects of azelastine HCl nasal spray, 0.1% include:

• unusual bitter taste
• headache
• sleepiness
• nose burning, pain or discomfort
• runny nose
• scratchy or sore throat
• nosebleeds
• inflammation or swelling of the sinuses
• sneezing
• nausea
• dry mouth
• fatigue
• dizziness
• weight increase

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

These are not all of the possible side effects of azelastine HCl nasal spray, 0.1%. 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.

What to say before you start

Before using azelastine HCl nasal spray, 0.1%, tell your healthcare provider if you are:

• allergic to any of the ingredients in azelastine HCl nasal spray, 0.1%. See the end of this leaflet for a complete list of ingredients in azelastine HCl nasal spray, 0.1%.
• pregnant, or plan to become pregnant.
• breastfeeding, or plan to breastfeed. It is not known if azelastine HCl passes into your breast milk. You and your healthcare provider should decide if you will use azelastine HCl nasal spray, 0.1% if you plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Azelastine HCl nasal spray, 0.1% and other medicines may affect each other, causing side effects.

What to avoid

Azelastine HCl nasal spray, 0.1% can cause sleepiness:

• Do not drive, operate machinery, or do other dangerous activities until you know how azelastine HCl nasal spray, 0.1% affects you.
• Do not drink alcohol or take other medicines that may cause you to feel sleepy while using azelastine HCl nasal spray, 0.1%. It may make your sleepiness worse.

Storing it

• Keep azelastine HCl nasal spray, 0.1% upright at 68° to 77°F (20° to 25°C).
• Do not freeze azelastine HCl nasal spray, 0.1%.
• Do not use azelastine HCl nasal spray, 0.1% after the expiration date “EXP” on the medicine label and box.

Keep azelastine HCl nasal spray, 0.1% and all medicines out of reach of children.

General information about the safe and effective use of azelastine HCl nasal spray, 0.1%.

Medicines are sometimes prescribed for conditions other than those listed in a Patient Information leaflet. Do not use azelastine HCl nasal spray, 0.1% for a condition for which it was not prescribed. Do not give azelastine HCl nasal spray, 0.1% to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about azelastine HCl nasal spray, 0.1%. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about azelastine HCl nasal spray, 0.1% that is written for health professionals.

For more information call 1-855-361-3993.