Uses of Azelastine and Fluticasone:

• It is used to ease allergy signs.

What do I need to tell my doctor BEFORE I take Azelastine and Fluticasone?

• If you have an allergy to azelastine, fluticasone, or any other part of azelastine and fluticasone.
• If you are allergic to azelastine and fluticasone; any part of azelastine and fluticasone; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are taking ritonavir.

This is not a list of all drugs or health problems that interact with azelastine and fluticasone.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take azelastine and fluticasone with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Azelastine and Fluticasone?

• Tell all of your health care providers that you take azelastine and fluticasone. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how azelastine and fluticasone affects you.
• When changing from an oral steroid to another form of a steroid, there may be very bad and sometimes deadly side effects. Signs like weakness, feeling tired, dizziness, upset stomach, throwing up, not thinking clearly, or low blood sugar may happen. Call your doctor right away if you have any of these signs. If you have a bad injury, have surgery, or any type of infection, you may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you may need extra steroids.
• Talk with your doctor if you come into contact with anyone who has chickenpox or measles and you have not had chickenpox, measles, or the vaccines for them.
• If you have had any recent nose surgery, injury, ulcers, or sores, talk with your doctor.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• This medicine may raise the chance of cataracts or glaucoma. Talk with the doctor.
• Have an eye exam as you have been told by your doctor.
• This medicine may cause harm if swallowed. If azelastine and fluticasone is swallowed, call a doctor or poison control center right away.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using azelastine and fluticasone while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Azelastine and Fluticasone) best taken?

Use azelastine and fluticasone as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take azelastine and fluticasone by mouth. Use in your nose only. Keep out of your mouth and eyes (may burn).
• Shake well before use.
• Prime pump before first use by spraying it 6 times or until you see a fine mist.
• If you have not used the spray for more than 14 days, you will need to prime the pump with 1 spray or until you see a fine mist.
• Blow your nose before use.
• Close 1 nostril.
• When using, tilt your head forward a little.
• Put nose spray tube into other nostril.
• While breathing in through the nose, press down once to release spray.
• Breathe out from your mouth.
• Spray up the nose only. Do not spray onto the wall joining the two nostrils.
• Put the cap back on after you are done using your dose.
• If you get azelastine and fluticasone in the eyes, flush right away with cool water and get medical help.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Bad nose irritation.
• Crusting in the nose.
• Runny nose.
• Whistling sound when you breathe.
• Change in eyesight, eye pain, or very bad eye irritation.
• Bad nosebleeds.
• Redness or white patches in mouth or throat.
• Feeling sleepy.

What are some other side effects of Azelastine and Fluticasone?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Nosebleed.
• Nose irritation.
• Change in taste.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Azelastine and Fluticasone?

• Store upright at room temperature. Do not freeze. Throw away any part not used after 120 sprays.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about azelastine and fluticasone, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.