RYALTRIS 600 mcg + 25 mcg/dose Aerosol

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Ryaltris, 25 micrograms/dose + 600 micrograms/dose
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Ryaltris and what is it used for
4. Important information before using Ryaltris
   1. When not to use Ryaltris
   2. Warnings and precautions
   3. Before starting to use Ryaltris, discuss this with your doctor or pharmacist
   4. While using Ryaltris, discuss this with your doctor or pharmacist
   5. Children and adolescents
   6. Ryaltris and other medicines
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Ryaltris contains benzalkonium chloride
5. How to use Ryaltris
   1. Adults and adolescents (12 years and older)
   2. Use in children under 12 years
   3. How to use the nasal spray
   4. Before each use, shake the bottle for at least 10 seconds.
   5. If Ryaltris is not in use, the purple protective cap must always be firmly placed on the white actuator.
   6. The Ryaltris nasal spray bottle,
   7. Preparing the nasal spray bottle
   8. How to use the nasal spray
   9. Cleaning the nasal spray bottle
   10. Using a higher dose of Ryaltris than recommended
   11. Missing a dose of Ryaltris
   12. Stopping the use of Ryaltris
6. Possible side effects
   1. Common (may affect up to 1 in 10 people):
   2. Uncommon (may affect up to 1 in 100 people):
   3. Rare (may affect up to 1 in 1000 people):
   4. Frequency not known (frequency cannot be estimated from the available data):
   5. Reporting side effects
7. How to store Ryaltris
8. Contents of the pack and other information
   1. What Ryaltris contains
   2. What Ryaltris looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:

Leaflet accompanying the packaging: patient information

Ryaltris, 25 micrograms/dose + 600 micrograms/dose

nasal spray, suspension
Mometasone furoate + Olopatadine

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ryaltris and what is it used for
• 2. Important information before using Ryaltris
• 3. How to use Ryaltris
• 4. Possible side effects
• 5. How to store Ryaltris
• 6. Contents of the pack and other information

1. What is Ryaltris and what is it used for

Ryaltris contains two active substances: mometasone furoate and olopatadine.

• Mometasone furoate belongs to a group of medicines called corticosteroids (steroids) that reduce inflammation, often found in allergic rhinitis.
• Olopatadine belongs to a group of medicines called antihistamines. Antihistamines prevent the action of substances such as histamine, which the body produces during an allergic reaction, thereby reducing the symptoms of allergic rhinitis.

Ryaltris is used to treat symptoms of moderate to severe seasonal
allergic rhinitis(also known as hay fever) and perennial
allergic rhinitisin adults and adolescents aged 12 years and older.
Seasonal allergic rhinitis(hay fever) is an allergic reaction that
occurs at certain times of the year and is caused by inhaling pollen from trees, grasses,
weeds, as well as mold and fungal spores.
Perennial allergic rhinitisoccurs throughout the year, and symptoms can be
caused by sensitivity to various factors, including house dust mites, animal dander (or
flakes), feathers, and some foods.
Ryaltris relieves allergy symptomssuch as runny nose, sneezing, itching, or stuffy nose.

2. Important information before using Ryaltris

When not to use Ryaltris

• if you are allergicto mometasone furoate, olopatadine, or any of the other ingredients of this medicine (listed in section 6).
• if you have an untreated nasal infection. Using Ryaltris during an untreated infection in the nasal passages, such as herpes, may worsen the infection symptoms. You should wait until the infection is cured before using the nasal spray.
• if you have recently had nasal surgeryor nasal injury. You should not use the nasal spray until the wounds have healed.

Warnings and precautions

Before starting to use Ryaltris, discuss this with your doctor or pharmacist

• if you currently have or have ever had tuberculosis.
• if you have any other infection.
• if you are taking other corticosteroidsorally or by injection.

While using Ryaltris, discuss this with your doctor or pharmacist

• if you have trouble fighting infections (your immune system is not working properly) and you have come into contact with someone with chickenpox or shingles. You should avoid contact with people who have these infections.
• if you have a nose or throat infection.
• if the medicine is used for several monthsor longer.
• if you have long-term irritation of the nose or throat.
• if you have blurred visionor other eye problems.

If inhaled corticosteroids are used in high doses for a long time, side effects may occur due to the absorption of the medicine into the body. Such side effects include weight loss, fatigue, muscle weakness, low blood sugar, craving for salty foods, joint pain, depression, and skin darkening. If these side effects occur, your doctor may prescribe a different medicine during periods of stress or planned surgery.
If you are in doubt whether the above situations apply to you, you should discuss this with your doctor or pharmacist before using Ryaltris.

Children and adolescents

Ryaltris is not recommended for use in children under 12 years of age.
Long-term use of Ryaltris may slow down the growth rate in children and adolescents. Your doctor will regularly monitor the child's growthand ensure that the child receives the lowest effective dose of the medicine.

Ryaltris and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
If you are taking other corticosteroids orally or by injection for allergy treatment, your doctor may advise you to stop taking them when you start using Ryaltris.
If you are taking other medicines orally or locally (nasal drops or eye drops) that contain olopatadine or other antihistamines, your doctor may advise you to stop taking them when you start using Ryaltris.
Some medicines may increase the effect of Ryaltris, and your doctor may closely monitor your condition if you are taking such medicines (including some HIV medicines: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Ryaltris should not be used during pregnancy unless your doctor considers it necessary.
If you are using Ryaltris, your doctor will discuss with you whether you should breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding for your baby. You should not do both.

Driving and using machines

Very rarely, you may experience dizziness, drowsiness, fatigue, and sleepiness. If these symptoms occur, do not drive or operate machinery. Be aware that drinking alcohol may increase these symptoms.

Ryaltris contains benzalkonium chloride

The medicine contains 0.02 mg of benzalkonium chloride per dose. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Ryaltris

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Avoid contact with the eyes.

Adults and adolescents (12 years and older)

The recommended dose is two sprays into each nostrilin the morning and evening.

Use in children under 12 years

This medicine is not recommended for use in children under 12 years of age.

How to use the nasal spray

The nasal spray is for intranasal use only.
Read the instructions carefully and follow the advice given.

Before each use, shake the bottle for at least 10 seconds.

If Ryaltris is not in use, the purple protective cap must always be firmly placed on the white actuator.

The Ryaltris nasal spray bottle,

Preparing the nasal spray bottle

• 1. Shake the bottle for at least 10 seconds and then remove the purple protective cap (see figure 1).

• 2. If the nasal spray is used for the first time, prepare the bottle by pressing the actuator pump into the air.
• 3. Hold the bottle upright with the actuator pump facing away from you and place your index and middle fingers on either side of the actuator (on the finger rests), supporting the bottle with your thumb.
• 4. Pointing the actuator away from you, press the actuator pump 6 times until a fine spray appears (see figure 2).

• 5. The actuator pump is now ready for use.
• 6. If the nasal spray has not been used for 14 days or more, shake the bottle well and prepare it again by pressing the actuator pump 2 times until a fine spray appears.

How to use the nasal spray

• 1. Before each use (morning and evening), shake the bottle for at least 10 seconds.
• 2. Gently blow your nose to clear your nostrils.
• 3. Hold the bottle upright with the actuator pump facing away from you and place your index and middle fingers on either side of the actuator (on the finger rests), supporting the bottle with your thumb.
• 4. Close one nostril with your finger and carefully insert the actuator tip into the other nostril, pointing it slightly outward (see figure 3).

• 5. Tilt your head slightly forward, quickly press the actuator pump to release the spray, and at the same time, breathe gently in through your nose.
• 6. After spraying, breathe out through your mouth (see figure 4).

• 7. Repeat the above steps to administer the second dose to the same nostril.
• 8. Repeat the steps to administer 2 sprays to the other nostril.
• 9. To prevent clogging of the actuator pump, after each use, gently wipe the actuator tip with a clean, dry tissue or cloth (see figure 5).
• 10. Holding the actuator pump, place the protective cap on the actuator until you hear a distinct click (see figure 6 ).

Cleaning the nasal spray bottle

If the actuator pump becomes clogged, perform the following steps:

• Remove the actuator pump by gently pulling it upward (see figure 7). Remove the purple protective cap and soak the actuator pump in warm water.
• Do not attempt to unblock the actuator pump by inserting a needle or other sharp object, as this will damage the actuator pump and it will not deliver the correct dose of medicine.

The actuator pump will not deliver the correct dose of medicine.

• After soaking the actuator pump for 15 minutes, rinse it and the purple protective cap with warm water and let them air dry.
• Replace the purple protective cap on the actuator pump and put the actuator pump back on the bottle.
• After cleaning the clogged actuator pump, refer to the section "Preparing the nasal spray bottle" above and prepare the bottle again by performing 2 sprays. Replace the purple protective cap, and Ryaltris will be ready for use.
• If necessary, repeat the cleaning steps.

Using a higher dose of Ryaltris than recommended

It is unlikely that problems will occur, but if you are concerned or if you have used higher doses than recommended for a long time, contact your doctor.
If steroids are used for a long time or in high doses, they can rarely have an adverse effect on the patient's hormonal system. In children, they can affect growth and development.

Missing a dose of Ryaltris

Use the nasal spray as soon as you remember, then use the medicine at the usual time. Do not use a double dose to make up for a missed dose.

Stopping the use of Ryaltris

It is very important that you use the nasal spray regularly. Do not stop treatment, even if you feel better, unless your doctor tells you to.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After using this medicine, immediate allergic reactions (allergic reactions) may occur.
These reactions can be severe. You should stop using Ryaltris and seek medical help immediately if you experience symptoms such as swelling of the face, tongue, or throat; difficulty swallowing; hives; wheezing or difficulty breathing.

Common (may affect up to 1 in 10 people):

• bitter taste in the mouth
• nasal bleeding
• mild irritation inside the nose

Uncommon (may affect up to 1 in 100 people):

• dizziness
• headache
• drowsiness
• dryness of the nose
• dryness of the mouth
• abdominal pain
• nausea
• fatigue

Rare (may affect up to 1 in 1000 people):

• bacterial vaginosis (bacterial infection of the vagina)
• anxiety, depression, insomnia
• lethargy, migraine
• dry eye syndrome, blurred vision, eye discomfort
• ear pain
• sore throat
• sneezing
• throat irritation
• constipation
• tongue pain
• swelling and ulcers inside the nose

Frequency not known (frequency cannot be estimated from the available data):

• increased pressure in the eyeball (glaucoma) and/or cataract causing vision problems
• damage to the nasal septum separating the nasal passages
• difficulty breathing and/or wheezing
• respiratory tract infections

If inhaled corticosteroids are used in high doses for a long time, systemic side effects may occur. The likelihood of these side effects is much lower if steroids are used as a nasal spray than if they are taken orally. These side effects may vary from person to person.
Nasal steroids may affect the normal production of hormones in the body, especially if they are used in high doses for a long time. In children and adolescents, this side effect may cause slower growth.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw;phone: +48 22 49 21 301; fax: +48 22 49 21 309;
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ryaltris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or on the label of the bottle after EXP. The expiry date refers to the last day of that month.
Do not freeze.
The bottle should be used within 2 months after opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ryaltris contains

• The active substances are mometasone furoate (as monohydrate) and olopatadine (as hydrochloride). Each delivered dose (the dose leaving the actuator) contains mometasone furoate monohydrate equivalent to 25 micrograms of mometasone furoate and olopatadine hydrochloride equivalent to 600 micrograms of olopatadine.
• The other ingredients are: microcrystalline cellulose, sodium carmellose, disodium phosphate heptahydrate, sodium chloride, benzalkonium chloride, solution, glycerol, disodium edetate, polysorbate 80, hydrochloric acid, sodium hydroxide, and water for injections.

What Ryaltris looks like and contents of the pack

Ryaltris is a white, homogeneous suspension.
Ryaltris is a white high-density polyethylene bottle with a polypropylene actuator pump for manual metering of the dose. The actuator is protected by a purple high-density polyethylene cap.
Available pack sizes:
Bottle of 30 ml containing 240 doses.

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer/Importer

Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o.o.
Dziekońskiego 3
00-728 Warsaw
Email: [email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria, Belgium, Czech Republic, Denmark, Germany, Finland, France, Ireland, Italy, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden - RYALTRIS
Date of last revision of the leaflet:March 2025