This information is for US audiences only

Important Safety Information

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

DYMISTA 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 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 healthcare provider 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.
  • Immune system problems that may increase your risk of infections. DYMISTA 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. 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: tiredness, weakness, nausea, vomiting, low blood pressure.
  • Slowed or delayed growth in children. A child’s growth should be checked regularly while using DYMISTA.

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 are changes in taste, nosebleeds, and 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. For more information, ask your healthcare provider or pharmacist.

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

Especially tell your healthcare provider if you take:
  • ritonavir (Norvir) or medicines that contain ritonavir (commonly used to treat HIV infection or AIDS)
  • ketoconazole, fluconazole, or itraconazole (for fungal infections)
  • Before using DYMISTA tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known
    if DYMISTA will harm your unborn baby.
 

APPROVED USES

DYMISTA is a prescription medicine used to treat symptoms of seasonal allergic rhinitis in people 6 years of age and older, who need treatment with both azelastine hydrochloride and fluticasone propionate. DYMISTA may help to reduce your nasal symptoms including stuffy nose, runny nose, itching, and sneezing.


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

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 runny nose, stuffy nose, itching, and sneezing. It is not known if Dymista Nasal Spray is safe or effective in children under 12 years of age.
Dymista
Manufactured by: Meda Pharmaceuticals