Ryaltris is a prescription nasal spray that contains 2 medicines, olopatadine hydrochloride, an antihistamine, and mometasone furoate, a corticosteroid. Ryaltris is used to treat symptoms of seasonal allergies in people 12 years of age and older.

It is not known if this medicine is safe and effective in children under 12 years of age.

Important: For use in your nose only. Do not spray into your eyes or mouth.

• Read the Instructions for Use at the end of this page for information about the right way to use Ryaltris.
• Ryaltris is for use in your nose only. Do not spray it into your eyes or mouth.
• Use Ryaltris exactly as your healthcare provider tells you to use it.
• If a child accidentally swallows Ryaltris or you use too much Ryaltris, call your healthcare provider or go to the nearest hospital emergency room right away.
• See your healthcare provider regularly to check your symptoms while using Ryaltris and to check for side effects.

Usual Adult Dose for Seasonal Allergic Rhinitis

- 2 sprays in each nostril twice daily

- Use: treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older.

Do not use Ryaltris if you are allergic to olopatadine hydrochloride, mometasone furoate monohydrate, or any of the ingredients. See the end of this page for a complete list of ingredients. Ask your healthcare provider if you are not sure.

Before you use Ryaltris

Before you use Ryaltris, tell your healthcare provider about all of your medical conditions, including 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 eyes).
• 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.
• are pregnant or plan to become pregnant. It is not known if Ryaltris will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Ryaltris passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using Ryaltris.

• Ryaltris can cause sleepiness or drowsiness. Do not drive, operate machinery, or do anything that needs you to be alert until you know how Ryaltris affects you. Do not drink alcohol or take any other medicines that may cause you to feel sleepy while using Ryaltris.

Ryaltris may cause serious side effects, including the following:

• nose and throat problems. Symptoms of nose and throat problems may include:
  • nosebleeds
  • sores (ulcers) in the nose
  • hole in the cartilage between your nose (nasal septal perforation). Symptoms of nasal septal perforation may include:
    • crusting in the nose
    • nosebleeds
    • runny nose
    • whistling sound when you breathe
  • slow wound healing. You should not use Ryaltris 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 certain 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, including glaucoma or cataracts. You should have regular eye exams when using Ryaltris.
• allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following signs of a serious allergic reaction:
  • wheezing
  • rash
  • hives
  • swelling of your face, mouth, and tongue
  • breathing problems
• immune system problems that may increase your risk of infections. Taking medicines that weaken your immune system makes you more likely to get infections. These infections may include tuberculosis (TB), ocular herpes simplex infections, and infections caused by fungi, bacteria, viruses, and parasites. Avoid contact with people who have contagious diseases, such as chickenpox or measles, while using Ryaltris. If you come in contact with someone who has chicken pox or measles call your healthcare provider right away. Symptoms of infection may include:
  • fever
  • aches or pains
  • chills
  • feeling tired
• adrenal insufficiency. Adrenal insufficiency happens when your adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency can include:
  • tiredness
  • weakness
  • nausea
  • vomiting
  • low blood pressure
• slowed growth in children. A child’s growth should be checked regularly while using Ryaltris.
• sleepiness or drowsiness.

The most common side effects include the following:

• unpleasant taste
• nosebleeds
• nasal discomfort

Tell your healthcare provider if you have any side effects that bother you or that do not go away. These are not all of the possible side effects. 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.

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

Especially tell your healthcare provider if you take:

• certain medicines for HIV (such as ritonavir, atazanavir, indinavir, nelfinavir, and saquinavir)
• cobicistat-containing products
• certain antifungals (such as ketoconazole or itraconazole)
• certain antibiotics (such as clarithromycin and telithromycin)
• certain antidepressants (such as nefazodone)

Ryaltris and other medicines may affect each other, causing side effects.

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