Olopatadine and mometasone (Nasal)

Olopatadine and mometasone combination nasal spray is used to relieve symptoms (like a stuffy or runny nose, itching, and sneezing) of seasonal (short-term) allergic rhinitis (hay fever).

Olopatadine is an antihistamine. It stops the effects of a substance called histamine, which the body produces. Histamine can lead to itching, sneezing, a runny nose, and watery eyes.

Mometasone is part of a group of medicines known as corticosteroids (cortisone-like medicines). It works by stopping certain cells from releasing substances that cause an allergic reaction.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your or your child's progress during regular visits to make sure this medicine is working correctly and to look for any unwanted effects.

If your or your child's symptoms do not get better within a few days or if they worsen, contact your doctor.

This medicine may increase your risk of having nose problems. Contact your doctor immediately if you or your child have bloody mucus, sores inside the nose, or unexplained nosebleeds while using this medicine.

This medicine will increase the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, other allergies, or colds, sedatives, tranquilizers, sleeping medicine, prescription pain medicine or narcotics, medicines for seizures, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these while using this medicine.

This medicine may cause some people to feel dizzy, drowsy, or less alert than usual. Even if taken at bedtime, it may make some people feel drowsy or less alert upon waking. Make sure you know how this medicine affects you before driving, using machines, or doing anything else that could be dangerous if you are dizzy or not alert.

This medicine may cause a fungus infection in the mouth or throat (thrush). Inform your doctor right away if you have white patches in the mouth or throat, or pain when eating or swallowing.

Contact your doctor immediately if you experience blurred vision, difficulty reading, or any other changes in vision during or after treatment. Your doctor may want an ophthalmologist (eye doctor) to check your eyes.

If you or your child have trouble breathing or any allergic reaction to this medicine, contact your doctor immediately.

Avoid close contact with anyone who has chickenpox or measles if you have never had these illnesses before. This is especially important for children. Inform your doctor right away if you think you have been exposed to chickenpox or measles.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you or your child experience darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or weight loss.

This medicine may cause children to grow more slowly than usual. Discuss any concerns with your child's doctor.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider both the risks of taking the medicine and the benefits it may provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems that would limit the use of olopatadine and mometasone combination nasal spray in children aged 12 years and older. However, safety and effectiveness have not been proven in children younger than 12 years.

Geriatric

Studies have not shown any specific problems that would limit the use of olopatadine and mometasone combination nasal spray in older adults.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if an interaction might happen. In these cases, your doctor may adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions are highlighted due to their possible significance and are not a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to prescribe this medication or may change some of the other medicines you are taking.

• Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or frequency of use for one or both medicines.

• Amifampridine
• Aspirin
• Atazanavir
• Bemiparin
• Bupropion
• Cobicistat
• Darunavir
• Donepezil
• Lutetium Lu 177 Dotatate
• Macimorelin
• Nadroparin
• Nirmatrelvir
• Pitolisant
• Ritonavir
• Sargramostim
• Somatrogon-ghla

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may still be the best treatment for you. If both medicines are prescribed, your doctor may change the dose or how often you use one or both medicines.

• Auranofin
• Ketoconazole

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtimes or with certain foods due to potential interactions. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about how to take your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Cataracts, history of or
• Glaucoma, history of or
• Increased intraocular pressure, history of—Use with caution. May worsen these conditions.

• Recent exposure to chickenpox or
• Herpes simplex (virus) infection of the eye or
• Infections (viral, bacterial, or fungal) or
• Recent exposure to measles or
• Active or history of tuberculosis—This medicine can weaken the body's ability to fight off these infections.

• Recent injury to the nose or
• Recent nose surgery or
• Recent sores or ulcers in the nose—This medicine may hinder proper healing of these conditions.

• Liver disease—Use with caution. The effects may be stronger due to slower elimination of the medicine from the body.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Bloody nose
• Nose discomfort

Rare

• Sleepiness or unusual drowsiness

Incidence not known

• Blindness
• Bloody mucus or unexplained nosebleeds
• Blurred vision
• Cough or hoarseness
• Darkening of the skin
• Decreased vision
• Diarrhea
• Difficulty in swallowing
• Dizziness
• Eye pain
• Fainting
• Fast heartbeat
• Fever or chills
• Headache
• Loss of appetite
• Lower back or side pain
• Mental depression
• Nausea or vomiting
• Painful or difficult urination
• Skin rash
• Slow growth in children
• Sore mouth or tongue
• Sores inside the nose
• Swelling of the face, throat, or tongue
• Tearing
• Trouble breathing
• Unusual tiredness or weakness
• White patches in the mouth, tongue, or throat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common

• Change in taste
• Loss of taste

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Ryaltris

Available Dosage Forms:

• Spray

Therapeutic Class: Antihistamine/Anti-Inflammatory Combination

Pharmacologic Class: Olopatadine

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

This medicine usually comes with patient information leaflet and patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is for use only in the nose. Do not get any of it in your eyes or on your mouth. If it does get on these areas, rinse it off with water and call your doctor right away.

To use the spray:

• Shake the bottle thoroughly before each use.
• When you use Ryaltris™ for the first time, you must prime the spray. To do this, pump the bottle 6 times or until a fine spray comes out. Now it is ready to use.
• If you have not used the medicine for 14 days or longer, prime it again by releasing 2 sprays.
• Before using the spray, gently blow your nose to clear the nostrils.
• Sit or stand up straight and tilt your head slightly forward. Insert the tip of the bottle into your right nostril. Spray into your right nostril.
• Breathe gently inward through the nostril and then breathe out through your mouth.
• Spray into your left nostril the same way.
• Do not blow your nose for at least 15 minutes or tip your head back after using the spray.
• After using the spray, wipe the tip of the bottle with a clean tissue and put the cap back on.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal dosage form (spray):For treatment of seasonal allergic rhinitis: Adults and children 12 years of age and older—2 sprays in each nostril 2 times a day. Each spray contains 665 micrograms (mcg) olopatadine and 25 mcg mometasone. Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away the bottle after you have used 240 sprays, even if there is still some medicine left in it. It is best to keep track of the number of sprays used so you will know when it is time to throw the bottle away.