RYALTRIS (Olopatadine/Mometasone)

What is this medication?

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.

How should I use this medication?

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.

Dosing information:

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.

What if I miss a dose?

As soon as you realise that you have missed an injection, contact your doctor who will then advise when your next injection is to be given.

How should I store this medication?

Store Ryaltris upright with the dust cap on at room temperature between 68°F to 77°F (20°C to 25°C).

Do not freeze or refrigerate.

Safely throw away medicine that is out of date or no longer needed.

Throw away your Ryaltris bottle after using 240 sprays after the first 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 all medicines out of reach of children and pets.

What should I avoid 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.

What are the possible side effects of using this medication?

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.

What other drugs will affect Ryaltris?

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.