Ryaltris

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Ryaltris, 25 micrograms/dose + 600 micrograms/dose
nasal spray, suspension
Mometasone furoate + Olopatadine
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Ryaltris is and what it is 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 Ryaltris is and what it is used for

Ryaltris contains two active substances: mometasone furoate and olopatadine.

• Mometasone furoate belongs to a group of medicines called corticosteroids (steroids), which reduce inflammation, commonly present 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 symptoms of allergic rhinitis.

Ryaltris is used for the treatment of moderate to severe symptoms of seasonal allergic rhinitis
(also known as hay fever) and perennial rhinitis in adults and adolescents aged 12 years and older.
Seasonal allergic rhinitis (hay fever) is an allergic reaction occurring at specific times of the year, triggered by inhaling pollen from trees, grasses, weeds, as well as mould spores and fungal spores.
Perennial rhinitis occurs throughout the year, and symptoms may be caused by sensitivity to various factors, including house dust mites, animal dander (or fur), feathers, and certain foods.
Ryaltris relieves allergy symptoms such as runny nose, sneezing, itchy nose, or nasal congestion.

2. Important information before using Ryaltris

When not to use Ryaltris

• if the patient is allergic to mometasone furoate, olopatadine, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has an untreated nasal mucosal infection. Using Ryaltris during an untreated nasal infection, such as herpes simplex, may worsen the infection symptoms. Nasal spray should not be used until the infection has healed;
• if the patient has recently undergone nasal surgery or experienced nasal trauma. Do not use the nasal spray until wounds have healed.

Warnings and precautions
Before starting to use Ryaltris, discuss with your doctor or pharmacist

• if the patient currently has or has ever had tuberculosis;
• if the patient has any other infection;
• if the patient is taking other corticosteroids orally or by injection.

While using Ryaltris, discuss with your doctor or pharmacist

• if the patient has difficulty fighting infections (the patient's immune system does not function properly) and has been in contact with someone with measles or chickenpox. Avoid contact with people who have these infections;
• if the patient has a nasal or throat infection;
• if the medicine is used for several months or longer;
• if the patient has long-term nasal or throat irritation;
• if the patient experiences blurred vision or other vision problems.

If nasal corticosteroid sprays are used in high doses over a long period,
systemic side effects due to absorption of the medicine into the body may occur. 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, the doctor may prescribe an alternative
medicine during periods of stress or planned surgery.
If in doubt whether any of the above situations apply to the patient, consult a 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 growth rate in children and adolescents. The doctor will regularly monitor the child's growth and ensure the child receives the lowest effective dose of the medicine.
Ryaltris and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
If the patient is taking other corticosteroids orally or by injection for allergy treatment,
the treating doctor may advise the patient to discontinue their use when starting Ryaltris.
If the patient is taking other medicines orally or locally (nasal or eye drops) containing
olopatadine or other antihistamines, the treating doctor may advise the patient to stop using them when starting Ryaltris.
Some medicines may increase the effect of Ryaltris, and the treating doctor may closely monitor the patient if they are taking such medicines (including certain HIV medicines: ritonavir, cobicistat).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Ryaltris should not be used during pregnancy unless the doctor considers it appropriate.
If the patient is using Ryaltris, the doctor will discuss with her whether she should breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding for the child. Do not do both.
Driving and operating machinery
Very rarely, the patient may experience dizziness, somnolence, fatigue, and drowsiness. If these symptoms occur, do not drive or operate machinery. Be aware that alcohol may worsen these symptoms.
Ryaltris contains benzalkonium chloride
The medicine contains 0.02 mg of benzalkonium chloride per dose. Benzalkonium chloride may
cause nasal irritation or swelling, especially if used for a prolonged period.

3. How to use Ryaltris

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Avoid contact with the eyes.
Adults and adolescents (aged 12 years and older)
The recommended dose is two sprays into each nostril in the morning and evening.
Use in children under 12 years of age
This medicine is not recommended for use in children under 12 years of age.
Method of administration
The nasal spray is for intranasal use only.
Read the instructions carefully and use as directed.
Shake the bottle well for at least 10 seconds before each use.
When not in use, the purple protective cap must always be securely placed over the white spray nozzle.
Ryaltris nasal spray bottle

Preparing the nasal spray bottle

1. Shake the bottle well for at least 10 seconds, then remove the purple protective cap (see Figure 1).

2. If using the spray for the first time, prime the bottle by actuating the pump into the air.
3. Hold the nasal spray bottle firmly in an upright position. Place your index and middle fingers on either side of the spray nozzle (on the finger grips), while supporting the ridged base of the bottle with your thumb.
4. Pointing the nozzle away from you, press down on the pump 6 times until a fine, consistent mist is produced (see Figure 2).

5. The pump is now primed and ready for use.
6. If the spray has not been used for 14 days or longer, shake the bottle well and re-prime by actuating the pump 2 times until a consistent mist is produced.

How to use the nasal spray

1. Before each use (morning and evening), shake the bottle well for at least 10 seconds.
2. Gently blow your nose to clear the nasal passages.
3. Hold the bottle firmly with your index and middle fingers on either side of the spray nozzle (on the finger grips), while supporting the ridged base of the bottle with your thumb.
4. Close one nostril with your finger and gently insert the spray nozzle into the other nostril, directing it slightly outward (see Figure 3).

5. Tilt your head slightly forward and quickly press down on the pump at the finger grips to release the spray.
6. While spraying, inhale gently through your nose, then exhale through your mouth (see Figure 4).

7. Repeat the above steps to administer a second spray into the same nostril.
8. Repeat the steps to administer 2 sprays into the other nostril.
9. To prevent contamination (blockage) of the pump, after each use, gently wipe the spray nozzle with a clean, dry tissue or cloth (see Figure 5).
10. While holding the pump in place, replace the protective cap securely until you hear a distinct click (see Figure 6).

Cleaning the nasal spray bottle
If the pump becomes contaminated or blocked, perform the following steps:

• Remove the pump by gently pulling it upwards (see Figure 7). Remove the purple protective cap and soak the pump in warm water.
• Do not unblock the spray nozzle by inserting a needle or any other sharp object, as this may damage the pump and result in incorrect dosing.
• After soaking the pump for 15 minutes, rinse both the pump and the purple protective cap with warm water and allow them to dry completely.
• Replace the purple protective cap onto the nozzle and reattach the pump to the bottle.
• After cleaning the blocked nozzle, refer to the section "Preparing the nasal spray bottle" above and re-prime the bottle by spraying twice. Replace the purple protective cap. The Ryaltris nasal spray is now ready for use.
• Repeat the cleaning procedure if necessary.

Use of more than the recommended dose of Ryaltris
It is unlikely that any problems will occur, but if you are concerned or if the patient has used higher than recommended doses for a prolonged period, consult your doctor.
If steroids are used for a long time or in high doses, they may rarely have an adverse effect on the patient's hormonal system. In children, they may affect growth and development.
Missed dose of Ryaltris
Use the nasal spray as soon as you remember, then continue at your usual time. Do not use a double dose to make up for a missed dose.
Stopping treatment with Ryaltris
It is very important to use the nasal spray regularly. Do not stop treatment, even if you feel better, unless advised by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Immediate allergic (hypersensitivity) reactions may occur after using this medicine.
These reactions can be severe. Ryaltris must be discontinued and immediate medical help sought if the patient experiences symptoms such as swelling of the face, tongue or throat; difficulty swallowing; hives; wheezing or breathing difficulties.

Common (may affect less than 1 in 10 people):

• bitter taste in the mouth
• nosebleeds
• mild irritation inside the nose

Uncommon (may affect less than 1 in 100 people):

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

Rare (may affect less than 1 in 1,000 people):

• bacterial vaginosis (bacterial vaginal infection)
• anxiety, depression, insomnia
• somnolence, migraine
• dry eye syndrome, blurred vision, eye discomfort
• ear pain
• sore throat
• sneezing
• throat irritation
• constipation
• tongue pain
• nasal septum swelling and ulceration

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

• increased intraocular pressure (glaucoma) and/or cataract causing visual disturbances
• damage to the nasal septum separating the nasal cavities
• breathing difficulties and/or wheezing
• respiratory tract infections

If this medicine is used in high doses over a prolonged period, systemic adverse reactions (affecting the whole body) may occur. The likelihood of such reactions is significantly lower when steroids are administered as a nasal aerosol compared to oral administration. These effects may vary between individual patients.
Intranasal steroids may affect the normal production of hormones in the body, particularly if used in high doses over a long period. In children and adolescents, this adverse effect may result in slower growth.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Ryaltris

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

6. Contents of the pack and other information

What Ryaltris contains

• The active substances are mometasone furoate (in the form of mometasone furoate monohydrate) and olopatadine (in the form of olopatadine hydrochloride). Each delivered dose (dose leaving the dispenser) contains mometasone furoate monohydrate equivalent to 25 micrograms of mometasone furoate and olopatadine hydrochloride equivalent to 600 micrograms of olopatadine.
• Other components are: microcrystalline cellulose, sodium carmellose, disodium hydrogen phosphate heptahydrate, sodium chloride, benzalkonium chloride solution, glycerol, disodium edetate, polysorbate 80, concentrated 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 supplied as a 30 ml HDPE bottle containing 240 doses, equipped with a metering pump, PP applicator, and a protective HDPE cap. The metering pump is protected by a purple HDPE cap. The pack includes a cardboard outer box.
For more detailed information, please contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in Spain, the country of export:
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer:
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoke Myto
Czech Republic

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Spain, the country of export: 731271.0
Parallel Import Authorisation Number: 390/25

This medicinal product is authorised in the following European Economic Area countries under the following names:
Austria, Belgium, Czech Republic, Denmark, Germany, Finland, France, Ireland, Italy, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden - RYALTRIS