Ryaltris Nasal Spray

RYALTRIS contains olopatadine (which is an antihistamine medicine), and mometasone furoate (which is a corticosteroid). RYALTRIS is sprayed into the nose to treat the symptoms of allergic rhinitis (hay fever or other year round allergies) and rhinoconjunctivitis (allergy induced by symptoms in the nose and eyes).

RYALTRIS relieves symptoms of allergies, including stuffiness (congestion) in the nose, runny nose, itchy nose, sneezing, as well as watering, itching and redness of the eye.

Do not take RYALTRIS:

• If you are hypersensitive (allergic) to olopatadine hydrochloride, mometasone furoate, or any of the other ingredients of RYALTRIS (see WHAT RYALTRIS CONTAINS).
• If you are pregnant or breastfeeding your baby.
• If you have been or are going to be immunized with a live viral or bacterial vaccine.
• If you have active or dormant tuberculosis of your respiratory tract.
• If you have any untreated fungal, bacterial, viral or parasitic infections anywhere in or on your body.

Warnings and precautions

Tell your doctor or healthcare provider before taking RYALTRIS. Special care should be taken with RYALTRIS:

• If you have been near someone who has chickenpox or measles. RYALTRIS may cause problems with the way your immune system protects your body against infection and increase your risk of infection. Avoid contact with people with contagious diseases.
• If you recently had nasal sores, nasal surgery, or nasal injury, you should not use RYALTRIS until your nose has healed.
• If you have eye or vision problems, such as cataracts or glaucoma (increased pressure in your eyes). You should have regular eye examinations when using RYALTRIS.
• If you are younger than 18 years of age, and still growing, as RYALTRIS can cause slowed or delayed growth in children.
• If your child is between 6 and 11 years the use of RYALTRIS for more than 2 weeks of use or in perennial allergic rhinitis has not been established.

Do not share medicines prescribed for you with any other person. Always use RYALTRIS exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

RYALTRIS is for use in your nose only. Do not spray it into your eyes or mouth.

Adults and Adolescents (12 Years of Age and Older)

The usual dosage of RYALTRIS is 2 sprays in each nostril twice daily.

Children (6 to 11 Years of Age)

The usual dosage of RYALTRIS is 1 spray in each nostril twice daily.

Components of RYALTRIS nasal spray:

Instructions for use: Before you use RYALTRIS, make sure your healthcare provider shows you the right way to use it.

1. Shake the bottle well and remove the purple plastic over cap from the spray pump tip of the bottle (see Figure 1).
2. Priming your RYALTRIS pump before first use: 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 (see Figure 2). If you don’t use RYALTRIS for 14 days, you will need to shake the bottle well and prime the pump with two sprays or until a fine mist appears. Your RYALTRIS is now ready for use.
3. Gently blow your nose to clear your nostrils (see Figure 3).
4. 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 4).
5. 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 inside wall between the 2 nostrils) (see Figure 5).
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 6). Try not to get any spray in your eyes or directly on your nasal septum (the wall between the 2 nostrils).
7. Repeat the above steps 4 – 6 and deliver a second spray in the same nostril.
8. Repeat with 2 sprays in the other 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 prevent RYALTRIS from going into your throat.

• After use, wipe the tip with a clean dry tissue or cloth (see Figure 7).

• Push the purple over cap back on the spray tip of the bottle, until a noticeable click sound is heard (see Figure 8).

• Each bottle of RYALTRIS contains enough medicine for 7 or 14 days of regular use (56 or 120 sprays after initial priming).

• Throw away the bottle after 30 days of use or upon expiration, whichever comes first. Even if the bottle seems to have medicine left in it, you may not receive the correct dose.

How to clear the 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 (see Figure 9).
• After soaking for approximately 15 minutes, rinse the spray pump unit and cap with warm tap water, and allow them to dry completely (see Figure 10).
• When dry, place the dust cap on the spray pump tip and put the spray pump unit back on the bottle (see Figure 11).
• Following the unblocking procedure, review the Priming your RYALTRIS pump before first use (Step 2) above and re-prime using 2 sprays.
• Replace the over cap, and your RYALTRIS is ready for use.
• Repeat the unblocking steps if needed.

RYALTRIS can have side effects. Not all side effects reported for RYALTRIS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using RYALTRIS, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking RYALTRIS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to RYALTRIS. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Eye problems such as increase in pressure in the eye (glaucoma) and/or cataracts causing visual disturbances.
• Immune system problems that may increase your risk of infections (see Take special care with RYALTRIS). Symptoms of infection may include the following: fever, aches or pains, chills, feeling tired.
• Adrenal insufficiency (a condition in which the adrenal glands do not make enough steroid hormones). Symptoms of adrenal insufficiency may include the following: tiredness, weakness, nausea, vomiting, low blood pressure.
• Slowed or delayed growth (see Take special care with RYALTRIS).
• Nasal septal sore or perforation (a hole in the cartilage between your nose, causing a whistling sound when you breathe through your nose).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor as soon as possible if you notice any of the following:

• Frequent: Unpleasant taste.
• Sleepiness or drowsiness.
• Anxiety or difficulty sleeping.
• Respiratory tract infections, inflammation at the back of the throat or tonsils.
• Throat irritation.
• Coughing, wheezing.
• Nasal dryness or discomfort.
• Dry mouth, stomach discomfort, vomiting.
• Red, inflamed, irritated or itching skin.

Less frequent:

• Red, itchy, irritable eyes.
• Diarrhoea, nausea, constipation.
• Headache.
• Fatigue.
• Nasal problems such as crusting in the nose, nosebleeds, runny nose.
• Slow wound healing.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (whoumc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of RYALTRIS.

Store at or below 25 °C. Store upright with over cap. Do not freeze or refrigerate. Once in use, discard the bottle after 30 days of use. Do not use after the expiry date printed on the bottle label or outer carton. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).