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Dymista

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Dymista

PATIENT INFORMATION

Dymista Nasal Spray
(Dy-Mist-A)
(azelastine hydrochloride and fluticasone propionate) Nasal Spray

Important: For use in your nose only

Read this Patient Information before you start using Dymista Nasal Spray and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is Dymista Nasal Spray?

Dymista Nasal Spray is a prescription medicine used to treat symptoms of seasonal allergic rhinitis in people 12 years of age and older, who need treatment with both azelastine hydrochloride and fluticasone propionate. It helps reduce the symptoms of seasonal allergic rhinitis (inflammation of the lining of the nose), such as stuffy nose, itching, and sneezing.

It is not known if Dymista Nasal Spray is safe or effective in children under 12 years of age.

What should I tell my healthcare provider before using Dymista Nasal Spray?

Before using Dymista Nasal Spray tell your healthcare provider if you:

  • have had recent nasal sores, nasal surgery, or nasal injury
  • have eye or vision problems, such as cataracts or glaucoma (increased pressure in your eye)
  • have tuberculosis or any untreated fungal, bacterial, viral infections or eye infections caused by herpes
  • have been near someone who has chickenpox or measles
  • are not feeling well or have any other symptoms that you do not understand
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if Dymista Nasal Spray will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if Dymista Nasal Spray passes into your breast milk. Talk to your doctor about the best way to feed your baby while using Dymista Nasal Spray.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Dymista Nasal Spray may affect the way other medicines work, and other medicines may affect how Dymista Nasal Spray works.

Especially tell your healthcare provider if you take:

  • ritanovir (Norvir) or medicines that contain ritanovir (commonly used to treat HIV infection or AIDS)
  • ketoconazole, fluconazole, or itraconazole (for fungal infections)

Ask your healthcare provider or pharmacist for a list of these medications, if you are not sure.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use Dymista Nasal Spray?

  • See the Patient Instructions for Use at the end of this leaflet for information about the right way to use Dymista Nasal Spray.
  • Dymista Nasal Spray is for use in your nose only. Do not spray it into your eyes or mouth. If you spray Dymista Nasal Spray into your eyes, flush your eye(s) with large amounts of water for 10 minutes and then call your doctor.
  • Use Dymista Nasal Spray exactly as your healthcare provider tells you to use it. Your healthcare provider will tell you how much Dymista Nasal Spray to use and when to use it.
  • If a child accidentally swallows Dymista Nasal Spray or you use too much Dymista Nasal Spray, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while using Dymista Nasal Spray?

  • Dymista Nasal Spray can cause sleepiness or drowsiness. Do not drive, operate machinery, or do anything that needs you to be alert until you know how Dymista Nasal Spray affects you.
  • Do not drink alcohol or take any other medicines that may cause you to feel sleepy while using Dymista Nasal Spray. It can increase your chances of having serious side effects.

What are the possible side effects of Dymista Nasal Spray?

Dymista Nasal Spray may cause serious side effects including:

  • Sleepiness or drowsiness.
  • Nasal Problems. Symptoms of nasal problems may include:
    • crusting in the nose
    • nosebleeds
    • runny nose
    • hole in the cartilage between your nose (nasal septal perforation). A whistling sound when you breathe may be a symptom of nasal septal perforation.
  • Slow wound healing. You should not use Dymista Nasal Spray until your nose has healed if you have a sore in your nose, if you have had surgery on your nose, or if your nose has been injured.
  • Thrush (candida), a fungal infection in your nose and throat. Tell your doctor if you have any redness or white colored patches in your nose or mouth.
  • Eye problems, such as glaucoma or cataracts. Some people may have eye problems, including glaucoma and cataracts. You should have regular eye exams when using Dymista Nasal Spray.
  • Immune system problems that may increase your risk of infections. Dymista Nasal Spray may cause problems with the way your immune system protects your body against infection and increase your risk of infection. Avoid contact with people who have contagious diseases such as chickenpox or measles while you use Dymista Nasal Spray. Symptoms of infection may include:
    • fever
    • aches or pains
    • chills
    • feeling tired
  • Adrenal Insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency may include:
  • Slowed or delayed growth in children. A child's growth should be checked regularly while using Dymista Nasal Spray.

Call your healthcare provider or get medical help right away if you have symptoms of any of the serious side effects listed above.

The most common side effects of Dymista Nasal Spray include:

  • changes in taste
  • nosebleeds
  • headache

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 Dymista Nasal Spray. 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.

How should I store Dymista Nasal Spray?

  • Store Dymista Nasal Spray upright at controlled room temperature 68° to 77°F (20° to 25°C).
  • Do not freeze or refrigerate Dymista Nasal Spray.
  • Protect Dymista Nasal Spray from light.
  • Safely throw away medicine that is out of date or no longer needed.
  • Throw away your Dymista Nasal Spray bottle after using 120 sprays after initial priming. Even though the bottle may not be completely empty, you may not get the correct dose of medicine if you continue to use it.

Keep Dymista Nasal Spray and all medicines out of reach of children.

General information about Dymista Nasal Spray

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Dymista Nasal Spray for a condition for which it was not prescribed. Do not give Dymista Nasal Spray 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 Dymista Nasal Spray. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Dymista Nasal Spray that is written for health professionals.

For more information, go to www.DYMISTA.com or call Meda Pharmaceuticals Inc. at 1-888-939-6478.

What are the ingredients in Dymista Nasal Spray?

Active ingredients: azelastine hydrochloride and fluticasone propionate

Inactive ingredients: glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, phenylethyl alcohol, edetate disodium, benzalkonium chloride, polysorbate 80, and purified water.

Instructions for Use

For use in your nose only. Do not spray in your eyes.

Read the Instructions for Use before you start to use Dymista Nasal Spray and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment. Before you use Dymista Nasal Spray, make sure your healthcare provider shows you the right way to use it.

Shake the bottle gently before each use.

Your Dymista Nasal Spray pump. (See Figure A)

Figure A

Dymista Nasal Spray pump - Illustration

Instructions for Using Your Dymista Nasal Spray Pump. Before you use Dymista Nasal Spray for the first time, you will need to prime the bottle.

Before you prime the bottle, shake it gently.

Step 1.

Remove the clear plastic dust cap from the spray pump tip of the bottle. (See Figure B)

Figure B

Remove the clear plastic dust cap - Illustration

Step 2.

Hold the bottle upright with two fingers on the shoulders of the spray pump unit and put your thumb on the bottom of the bottle. Press upward with your thumb and release for the pumping action.

  • Repeat the pumping action until you see a fine mist. You should see a fine mist of the medicine after 6 pumps or less. (See Figure C)
  • To get a fine mist of medicine, you must repeat the pumping action fast and use firm pressure against the bottom of the bottle.
  • If you see a stream of liquid, the spray will not work right and may cause nasal discomfort.
  • If you do not use Dymista Nasal Spray for 14 or more days, you will need to prime the pump with 1 spray or until you see a fine mist. If you do not see a fine mist, clean the tip of the spray nozzle. See the cleaning section below.
  • Once you see the fine mist of medicine, your Dymista Nasal Spray pump is ready for use.

Figure C

Pump until you see a fine mist - Illustration

To Use Dymista Nasal Spray:

Step 3. Gently blow your nose to clear nostrils. (See Figure D)

Figure D

Clear nostrils - Illustration

Step 4.

Shake the bottle gently. Close 1 nostril with a finger. Tilt your head forward slightly. Keep the bottle upright and carefully place the spray pump tip ¼ to ½ inch into your other nostril. (See Figure E)

Figure E

Close 1 nostril with a finger - Illustration

Step 5.

For each spray firmly press the pump 1 time. Keep your head tilted down and at the same time, gently breathe in through your nostril. (See Figure F) Do not spray directly onto the nasal septum (the wall between your 2 nostrils).

  • Repeat Step 5 in your other nostril.
  • Do not tilt your head back. This will help to keep the medicine from going into your throat.
  • If the medicine goes into your throat you may get a bitter taste in your mouth. This is normal.

Figure F

Gently breathe in - Illustration

Step 6.

When you finish using Dymista Nasal Spray, wipe the spray tip with a clean tissue or cloth. Put the dust cap back on the spray pump tip of the bottle. (See Figure G)

Figure G

Put the dust cap back on - Illustration

Each bottle of Dymista Nasal Spray contains enough medicine for you to spray medicine from the bottle 120 times. After initial priming, do not use your bottle of Dymista Nasal Spray after 120 sprays. You may not receive the right amount of medicine. Keep track of the number of sprays you use from your bottle of Dymista Nasal Spray and throw away the bottle even if it has medicine left in it. Do not count any sprays used for initially priming the bottle.

To Clean the Spray Pump Tip:

Your Dymista Nasal Spray should be cleaned at least 1 time each week. To do this:

Step 7.

Remove the dust cap and then gently pull upward on the spray pump unit to remove it from the bottle. (See Figure H)

Figure H

Remove the dust cap - Illustration

Step 8. Wash the spray pump unit and dust cap in warm tap water. (See Figure I)

Figure I

Wash the spray pump unit - Illustration

Step 9.

Allow to dry completely. When dry, place the spray pump unit and dust cap back on the bottle. (See Figure J)

Figure J

Spray pump unit and dust cap - Illustration

Step 10.

If the spray pump unit becomes blocked, it can be removed as instructed above in Step 7 and placed in warm water to soak.

Do not try to unblock the spray pump unit by inserting a pin or other sharp object. This will damage the spray pump unit and cause you not to get the right dose of medicine.

Step 11.

After the spray pump unit is unblocked, rinse the applicator and cap with cold water, and allow them to dry as in Step 10 above. When dry, place the spray pump unit back on the bottle and put the dust cap on the spray pump tip.

Step 12.

Reprime the bottle as in Steps 1 and 2 above. Replace the dust cap and your Dymista Nasal Spray is ready for use.

This Patient Package Insert and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 9/13/2012
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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