Ryaltris: Uses, Side Effects and Dosage

What is RYALTRIS used for?

RYALTRIS is used to treat symptoms of moderate to severe seasonal allergic rhinitis (also called “hay fever”) and related eye symptoms in adults, adolescents and children 6 years of age and older.

How does RYALTRIS work?

RYALTRIS works by decreasing inflammation in the nose, caused by seasonal allergies. When you spray RYALTRIS into your nose, it helps to reduce symptoms such as stuffy, runny or itchy nose, sneezing, eye redness and itchy or watery eyes.

What are the ingredients in RYALTRIS?

Medicinal ingredients: Olopatadine hydrochloride and Mometasone furoate

Non-medicinal ingredients: Benzalkonium Chloride (as preservative), Carboxymethyl Cellulose Sodium, Edetate Disodium, Hydrochloric Acid (for pH adjustment), Microcrystalline Cellulose, Polysorbate 80, Sodium Chloride, Sodium Hydroxide (for pH adjustment), Sodium Phosphate Dibasic Heptahydrate and Water for Injection

RYALTRIS comes in the following dosage forms:

Nasal spray, suspension; 665 mcg olopatadine hydrochloride and 25 mcg mometasone furoate (as monohydrate) per metered spray.

Do not use RYALTRIS if:

• You are allergic to any of the ingredients in RYALTRIS.
• You have an untreated fungal, bacterial, or tuberculosis infections of the respiratory tract.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take RYALTRIS. Talk about any health conditions or problems you may have, including if you:

• Are pregnant or planning to become pregnant. It is not known if RYALTRIS will harm your unborn baby.

• Are breastfeeding or plan to breast-feed. It is not known if RYALTRIS passes into your breast milk.
• Are allergic to any other corticosteroid or medications.
• Have green or yellow discharge from the nose.
• Have eye or vision problems, such as cataracts (clouding of the lens in the eye) or glaucoma (an increased pressure in your eyes).
• Are taking other steroid medicines by mouth or as an injection.
• Are recovering from recent nasal surgery, nasal trauma or nasal ulcers.
• Have been near someone who has chickenpox or measles.
• Have a problem with your thyroid.
• Suffer from liver disease.

Other warnings you should know about:

Eye disorders: Medications like RYALTRIS can cause eye disorders such as:

• Cataracts: clouding of the lens in the eye, blurry vision, eye pain;
• Glaucoma: An increased pressure in your eyes, eye pain. Untreated, it may lead to permanent vision loss;
• Central serous chorioretinopathy (CSCR): blurry vision or other changes in vision.

If you have any changes in your vision, tell your healthcare professional right away. You should have regular eye exams.

Growth in children: Slower growth in children using RYALTRIS can occur. You and your healthcare professional should monitor your child’s growth while using RYALTRIS.

Driving and using machines: RYALTRIS may cause drowsiness, dizziness or light-headedness. Before you perform tasks which may require alertness, wait until you know how you respond to RYALTRIS.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with RYALTRIS:

• Ketoconazole and itraconazole (for fungal infections).
• Ritonavir, cobicistat-containing products, atazanavir, indinavir, nelfinavir, or saquinavir (commonly used to treat HIV infection or AIDS).
• Clarithromycin (for bacterial infections).
• Nefazodone (antidepressant).
• Telithromycin (for pneumonia, an infection of the lungs).

• Alcohol. Do not drink alcohol or take any other medicines that may cause you to feel sleepy while taking RYALTRIS.

How to use RYALTRIS:

• Shake the bottle well for at least 20 seconds before each use.
• RYALTRIS is for use in your nose only. Do not spray it into your eyes or mouth.
• Use RYALTRIS exactly as recommended by your healthcare professional.
• RYALTRIS relieves symptoms within 15 minutes. However, you will get the best results if you keep using RYALTRIS at regular intervals.
• When RYALTRIS is not in use, the purple dust cap should always be kept tightly placed on the white nozzle tip.
• Read the Instructions for Use below to learn how to use RYALTRIS.

Instructions for use

Diagram of RYALTRIS nasal spray bottle (See Figure 1):

Figure 1

Step 1 – Prepare the nasal spray bottle

Remove the purple dust cap from the spray nozzle tip of the bottle. (See Figure 2)

Figure 2

Before you use a new RYALTRIS nasal spray bottle for the first time, the pump must be primed. To prime the pump:

• Shake the bottle well for at least 20 seconds.
• Hold the nasal spray bottle firmly and upright with your index and middle finger on either side of the applicator (on the finger rests) while supporting the grooved base of the bottle with your thumb (see Figure 3).
• Release 6 sprays into the air until a fine mist appears (away from the eyes and face), by pushing down on the pump quickly and firmly.

Figure 3

• Your RYALTRIS is now ready for use. You do not need to prime the bottle again unless the bottle becomes clogged, or if you don’t use it for 7 or more days.

Notes:

• If the bottle becomes clogged, read the section below on “How to clear the RYALTRIS spray nozzle tip if it becomes clogged”. After following the instructions, you will need to re-prime the bottle. Shake the bottle well for at least 20 seconds and release 2 sprays into the air (away from the eyes and face), or until a fine mist appears.
• If you do not use RYALTRIS for 7 or more days, shake the bottle well for at least 20 seconds and release 2 sprays into the air (away from the eyes and face), or until a fine mist appears.

Step 2 – Clear your nose

• Gently blow your nose to clear your nostrils. (See Figure 4)

Figure 4

Step 3 - Use the nasal spray

• Shake the bottle well for a minimum of 20 seconds before each use (morning and evening).
• Hold the bottle firmly with your index and middle finger on either side of the applicator (on finger rests) while supporting the grooved base of the bottle with your thumb. (See Figure 5)

Figure 5

• Hold 1 nostril closed with a finger. Insert the end of the spray nozzle tip into the other nostril, pointing it slightly toward the outside of the nose, away from the nasal septum (the wall between the 2 nostrils). (See Figure 6)

Figure 6

• Tilt your head forward slightly. Keep the bottle upright and press down once quickly and firmly on the finger rests to activate the pump. Breathe in (inhale) gently through your nose as you spray. Then breathe out through your mouth. (See Figure 7)
• Repeat in the other nostril, as many times as your healthcare professional has told you to.

• Try not to get any spray in your eyes or directly on your nasal septum (the wall between the 2 nostrils).

  Figure 7

• Avoid blowing your nose for the next 15 minutes to make sure RYALTRIS gets a chance to work. Do not tip your head back right after using to keep the medicine from going into your throat.

Step 4 – Clean and put away the nasal spray bottle

• After you finish using the medicine, wipe the tip with a clean dry tissue or cloth. (See Figure 8)

Figure 8

• While holding the spray nozzle unit, push the purple dust cap back on the spray tip of the bottle until you hear a click. You should hear this click every time. (See Figure 9)

  Figure 9

How to clear the RYALTRIS spray nozzle tip if it becomes clogged:

Do not try to unblock the spray nozzle tip by inserting a pin or other sharp object. This will damage the spray nozzle unit, and you may not get the correct dose of medicine. (See Figure 10)

Figure 10

If the spray nozzle unit becomes blocked, remove it by gently pulling upward (See Figure 11). Remove the purple dust cap and place only the spray nozzle unit in warm water to soak. (See Figure 12)

Figure 11

Figure 12

After soaking for approximately 15 minutes, rinse the spray nozzle unit and cap with warm tap water. (See Figure 13)

Figure 13

Allow the spray nozzle unit and purple dust cap to dry completely. When dry, place the purple dust cap on the spray nozzle tip and put the spray nozzle unit back on the bottle. (See Figure 14)

Figure 14

Following the unblocking procedure, you will need to re-prime the bottle. Review the section above on “How to use RYALTRIS: Step 1 – Prepare the nasal spray bottle” for how to re-prime the bottle. Once primed, place the purple dust cap back on, and your RYALTRIS is ready for use.

Repeat the unblocking steps if needed.

Usual dose:

• Adults and Adolescents (12 years of age and older): 2 sprays in each nostril twice a day (morning and evening).

• Children (6 to 11 years of age): 1 spray in each nostril twice a day (morning and evening).

Overdose:

With the nasal route of administration overdose reactions are not anticipated.

Missed Dose:

If you miss a dose, skip the missed dose and take the next dose at the regularly scheduled time. Do not take a double dose.

What are possible side effects from using RYALTRIS?

These are not all the possible side effects you may have when taking RYALTRIS. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Sleepiness or drowsiness
• Fatigue
• Headache
• Altered sense of taste
• Nosebleeds, nasal discomfort, crusting or sores in the nose
• Cough
• Throat irritation
• Upper respiratory tract infection

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store RYALTRIS upright with the dust cap on at room temperature between 15°C and 30°C. Protect from light. Do not freeze or refrigerate.
• Keep out of reach and sight of children.
• Use within 2 months of first opening.

If you want more information about RYALTRIS:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this

  • atient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); or the distributor’s website at www.bauschhealth.ca.

Importer:

Glenmark Pharmaceuticals Canada Inc.

Concord, ON L4K 4M2

RYALTRIS is a trademark of Glenmark Specialty S.A.; licensed to Glenmark Pharmaceuticals Canada Inc. and distributed by Bausch Health, Canada.

Last Revised DEC 17, 2024