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What is OLOPATADINE AND MOMETASONE (RYALTRIS) used for: OLOPATADINE AND MOMETASONE (RYALTRIS) is a prescription medicine used to treat symptoms of seasonal allergic rhinitis (also called "hay fever" caused by allergies to grass, pollen, ragweed, etc.) and perennial allergic rhinitis (year round allergies caused by dust mites, animal dander and molds) and related eye symptoms in patients 6 years of age and older.
How does OLOPATADINE AND MOMETASONE (RYALTRIS) work: OLOPATADINE AND MOMETASONE (RYALTRIS) helps reduce the symptoms of seasonal and perennial allergic rhinitis (inflammation of the lining of the nose), such as stuffy nose, runny nose, nasal itching, sneezing, eye redness, itchy and watery eyes.
What are the ingredients in OLOPATADINE AND MOMETASONE (RYALTRIS): Medicinal ingredients: Olopatadine Hydrochloride Mometasone Furoate Monohydrate.
Non-medicinal ingredients: Benzalkonium chloride, carboxymethyl cellulose sodium, Edetate disodium, Hydrochloric acid, Microcrystalline cellulose and carboxymethyl cellulose sodium, Polysorbate 80, Sodium chloride, sodium hydroxide, Dibasic Sodium Phosphate Heptahydrate and water for injection.
OLOPATADINE AND MOMETASONE (RYALTRIS) comes in the following dosage forms: Suspension for metered spray: 600 micrograms of olopatadine and 25 micrograms of mometasone furoate per spray.
Do not use OLOPATADINE AND MOMETASONE (RYALTRIS) if: you are allergic to any of the ingredients in RYALTRIS.
You have 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 OLOPATADINE AND MOMETASONE (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 medicine 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.
You should avoid coming into contact with measles or chickenpox while taking RYALTRIS. If you are exposed, tell your doctor.
Drugs like RYALTRIS can cause eye disorders: 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.
You should have regular eye exams.
Other warnings you should know about: OLOPATADINE AND MOMETASONE (RYALTRIS) can cause sleepiness or drowsiness. Do not drive, operate machinery, or do anything that needs you to be alert until you know how OLOPATADINE AND MOMETASONE (RYALTRIS) affects you.
Do not drink alcohol or take any other medicines that may cause you to feel sleepy while using OLOPATADINE AND MOMETASONE (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 OLOPATADINE AND MOMETASONE (RYALTRIS): Ketoconazole (for fungal infections); Ritonavir, cobicistat-containing products, atazanavir, indinavir, nelfinavir, or saquinavir (commonly used to treat HIV infection or AIDS); Clarithromycin (for bacterial infections); Itraconazole (for fungal infections); Nefazodone (antidepressant); Telithromycin (for pneumonia, an infection of the lungs).
How to take OLOPATADINE AND MOMETASONE (RYALTRIS): OLOPATADINE AND MOMETASONE (RYALTRIS) is for use in your nose only. Do not spray it into your eyes or mouth. Use OLOPATADINE AND MOMETASONE (RYALTRIS) exactly as recommended by your healthcare provider.
OLOPATADINE AND MOMETASONE (RYALTRIS) relieves the symptoms within 10 minutes. However, you will get the best results if you keep using OLOPATADINE AND MOMETASONE (RYALTRIS) at regular intervals.
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).
Preparing the nasal spray bottle: Before you use OLOPATADINE AND MOMETASONE (RYALTRIS) for the first time, you will need to shake the bottle well and prime the pump.
Priming your OLOPATADINE AND MOMETASONE (RYALTRIS) pump before first use: Before you prime the bottle, shake the bottle well.
Shake container well before each use. The bottle should be discarded after the labelled number of actuations.
Step 1: Remove the dust cap. Remove the purple plastic dust cap from the spray pump tip of the bottle.
Step 2: Preparing the nasal spray bottle: Hold the nasal spray bottle firmly and upright 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.
Before first use, push down on the pump quickly and firmly 6 times, releasing the spray into the air, away from the eyes and face until a fine mist appears.
If you do not use OLOPATADINE AND MOMETASONE (RYALTRIS) for 14 or more days, you will need to shake the bottle well, and prime the pump with 2 sprays or until a fine mist appears.
Your RYALTRIS is now ready for use.
Using your OLOPATADINE AND MOMETASONE (RYALTRIS): Step 3: Gently blow your nose to clear your nostrils.
Step 4: Using the nasal spray: lShake the bottle well 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.
Hold 1 nostril closed with a finger. Insert the end of the nasal 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).
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.
Try not to get any spray in your eyes or directly on your nasal septum (the wall between the 2 nostrils).
Children (6 to 11 years of age): Deliver 1 spray in each nostril.
Adults and Adolescents (12 years of age and older): Deliver 2 sprays in each nostril.
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.
After your finish using the medicine, wipe the tip with a clean dry tissue or cloth.
While holding the spray pump unit, push the dust cap back on the spray tip of the bottle until a noticeable click is observed.
RYALTRIS spray pump unit if it becomes clogged: 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 you may not get the correct dose of medicine.
If the spray pump unit becomes blocked, remove it by gently pulling upward. Remove the dust cap and place only the spray pump unit in warm water to soak.
After soaking for approximately 15 minutes, rinse the spray pump unit and cap with warm tap water, and allow them to dry completely.
When dry, place the dust cap on the spray pump tip and put the spray pump unit back on the bottle.
Following the unblocking procedure, review the "Priming your RYALTRIS pump before use" section as previously mentioned and re-prime using 2 sprays. Replace the dust cap, and your RYALTRIS is ready for use.
Repeat the unblocking steps if needed.
How to clean instructions: After use each time wipe the nozzle tip with a clean dry tissue or cloth.
After wiping the tip, hold the spray pump and push the dust cap back on the spray tip of bottle until noticeable click is observed.
Clearing instructions: If OLOPATADINE AND MOMETASONE (RYALTRIS) spray pump is clogged: Do not insert a pin or other sharp object.
Remove spray pump unit and separate protective cap and place spray pump unit in approximate 250 ml warm water (37-43°C) to soak for 15 minutes. Ensure spray pump unit is immersed in water.
After soaking, rinse both ends with warm tap water for 1-2 minutes.
Shake it and allow it to dry completely.
When dry, replace protective cap on spray tip and fix spray pump unit on bottle.
Overdose: With the nasal route of administration overdose reactions are not anticipated.
If a child accidentally swallows OLOPATADINE AND MOMETASONE (RYALTRIS) or you use too much OLOPATADINE AND MOMETASONE (RYALTRIS), call your doctor or go to the nearest hospital emergency room right away.
If you think you have taken too much OLOPATADINE AND MOMETASONE (RYALTRIS), contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed Dose: If you miss a dose, the next dose should be taken when it is due. Do not take a double dose.
What are possible side effects from using OLOPATADINE AND MOMETASONE (RYALTRIS): These are not all the possible side effects you may feel when taking OLOPATADINE AND MOMETASONE (RYALTRIS). If you experience any side effects not listed here, contact your healthcare professional.
Sleepiness or drowsiness; Unpleasant taste; Nasal problems, which may include the following: crusting in the nose; runny nose; nasal discomfort; Slow wound healing. You should not use OLOPATADINE AND MOMETASONE (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.
Slowed or delayed growth in children. A child's growth should be checked regularly while using OLOPATADINE AND MOMETASONE (RYALTRIS). (See Table 3.)
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
