Ryaltris

Package leaflet: Information for the patient

Ryaltris

25 micrograms/dose + 600 micrograms/dose
Nasal spray, suspension
mometasone furoate/olopatadine
Please read this entire leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this package leaflet:

1. What Ryaltris is and what it is used for
2. What you need to know 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) that reduce inflammation, commonly present in allergic rhinitis.
• Olopatadine belongs to a group of medicines known as antihistamines. Antihistamines work by preventing the effects of substances such as histamine, which the body produces during an allergic reaction, thereby reducing the symptoms of allergic rhinitis.

Ryaltris is used for the treatment of symptoms of moderate to severe 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 during specific times of the year, triggered by inhaling tree, grass, or weed pollens, as well as moulds and fungal spores.
Perennial rhinitis occurs throughout the year, and symptoms may be caused by sensitivity to various allergens, including house dust mites, animal hair (or epidermal derivatives), feathers, and certain foods.
Ryaltris relieves allergy symptoms such as runny nose, sneezing, itching, and nasal congestion.

2. What you need to know before using Ryaltris

Do not use Ryaltris

• if you are allergic to 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 nasal infection, such as herpes, may worsen the infection. You must wait until the infection has resolved before starting to use the nasal spray.
• if you have recently undergone nasal surgery or have sustained a nasal injury. You must not use the nasal spray until the nasal condition has healed.

Warnings and precautions
Talk to your doctor or pharmacist before using Ryaltris

• if you have or have had tuberculosis.
• if you have any other infection.
• if you are taking other steroid medicines, either orally or by injection.

Talk to your doctor or pharmacist while using Ryaltris

• if you have difficulty fighting infections (due to a weakened immune system) and come into contact with someone who has measles or chickenpox. Avoid contact with people who have these infections.
• if you develop a nasal or throat infection.
• if you have been using this medicine for several months or longer.
• if you experience persistent irritation of the nose or throat.
• if you have blurred vision or other visual disturbances.

The prolonged use of high-dose steroid nasal sprays may lead to unwanted effects due to systemic absorption of the medicine. These unwanted effects may include weight loss, fatigue, muscle weakness, hypoglycemia, craving for salty foods, joint pain, depression, and skin hyperpigmentation. If you experience these symptoms, your doctor may recommend an alternative treatment during periods of stress or before elective surgery.
If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before using Ryaltris.
Children and adolescents
Ryaltris is not recommended for children under 12 years of age.
Long-term use of Ryaltris may cause delayed growth in children and adolescents. Your doctor will regularly monitor your child’s height and ensure they receive the lowest effective dose.
Other medicines and Ryaltris
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking other steroid medicines for allergies, taken orally or by injection, your doctor may advise you to stop them when you start using Ryaltris.
If you are taking other oral or topical medicines (nasal or eye drops) containing olopatadine or other antihistamines, your doctor may advise you to discontinue them when starting Ryaltris.
Some medicines may increase the effects of Ryaltris, so your doctor may wish to monitor you closely if you are taking them (including certain HIV treatments: ritonavir, cobicistat).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.
Driving and using machines
Dizziness, lethargy, fatigue, and somnolence may very rarely occur. Do not drive or operate machinery if you experience these symptoms. Be aware that alcohol may worsen these effects.
Ryaltris contains benzalkonium chloride.
This medicine contains 0.02 mg of benzalkonium chloride per spray. Benzalkonium chloride may cause irritation or swelling inside the nose, especially with prolonged use.

3. How to use Ryaltris

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Avoid contact with the eyes.
Adults and adolescents (aged 12 years and older)
The recommended dose is two sprays in each nostril in the morning and evening.
Use in children under 12 years of age
This medicine is not recommended for children under 12 years of age.
Method of administration
The spray is for nasal use only.
Read the following instructions carefully and use this medicine only as directed.
Preparing the nasal spray bottle

1. Shake the bottle for at least 10 seconds, then remove the protective cap (see figure 1).
2. If you are using the spray for the first time, you must "prime" the bottle by actuating the spray pump into the air.
3. Place your index and middle fingers on either side of the spray nozzle and your thumb at the base of the bottle.
4. Point the spray nozzle away from you, then press and release

the spray pump 6 times until a fine mist is produced
(see figure 2).

5. The spray pump is now primed and ready for use.
6. If the spray has not been used for 14 days or more, you must "re-prime" the bottle by actuating the spray pump twice until a fine mist is produced.

How to use the nasal spray

1. Shake the bottle for at least 10 seconds before each use (morning and evening).
2. Gently blow your nose to clear the nostrils.
3. Close one nostril with your finger and carefully insert the spray nozzle into the other nostril, directing the tip slightly towards the outer wall of the nose (see figure 3).

4. Tilt your head slightly forward, press the spray pump quickly once, while gently inhaling at the same time.
5. Breathe out through your mouth (see figure 4).
6. Repeat the above steps and spray a second time into the same nostril.
7. Repeat the procedure, administering 2 sprays into the other nostril.

After using the spray, clean the spray nozzle thoroughly with a clean tissue or wipe and replace the cap to prevent blockage of the spray nozzle.
How to clean the nasal spray
If the spray nozzle becomes blocked, follow the instructions in the steps below:

• Remove the cap and gently pull off the spray nozzle.
• Wash the spray nozzle and cap with lukewarm water, then rinse under running water.
• Do not try to unblock the nasal applicator by inserting a needle or any other sharp object, as this may damage the applicator and prevent the correct dose of medicine from being delivered.
• Allow the cap and spray nozzle to dry in a warm place.
• Reattach the spray nozzle to the bottle and replace the cap.
• After cleaning, the spray must be re-primed with 2 sprays before first use.

If you use more Ryaltris than you should
Problems are unlikely, but if you are concerned or have taken more than the recommended dose for a prolonged period, inform your doctor.
If you use steroids for a long time or at high doses, in rare cases they may affect certain
hormones. In children, this may affect development and growth.
If you forget to use Ryaltris
Use the nasal spray as soon as you remember, then take the next dose at the usual scheduled time. Do not use a double dose to make up for a forgotten dose.
If you stop using 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Immediate hypersensitivity (allergic) reactions may occur with the use of this medicine. These reactions can be severe. You must stop using Ryaltris and seek immediate medical attention if any of the following symptoms occur: swelling of the face, tongue or throat, difficulty swallowing, hives, wheezing or breathing difficulties.

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

• Bitter taste in the mouth
• Nosebleeds
• Mild irritation inside the nose

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

• Dizziness
• Headache
• Drowsiness
• Nasal dryness
• Dry mouth
• Abdominal pain
• Nausea
• Fatigue

Rare (may affect up to 1 in 1,000 people):

• Bacterial vaginosis (bacterial infection of the vagina)
• Anxiety, depression, insomnia
• Lethargy, migraine
• Dry eyes, blurred vision, eye discomfort
• Ear pain
• Sore throat
• Sneezing
• Throat irritation
• Constipation
• Tongue pain
• Swelling and ulcers inside the nose

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

• Increased intraocular pressure (glaucoma) and/or cataracts causing visual disturbances
• Damage to the nasal septum separating the nostrils
• Breathing difficulties and/or wheezing
• Respiratory tract infection

Systemic side effects (side effects affecting the whole body) may occur when this medicine is used at high doses over long periods of time. It is much less likely for these effects to occur when using a steroid nasal spray compared to taking oral steroids. These effects may vary between individual patients.
Nasal steroids may affect the normal production of hormones in your body, particularly if you use high doses for a prolonged period. In children and adolescents, this side effect may cause delayed growth.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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 stated on the bottle and the outer carton following "Exp".
The expiry date refers to the last day of that month.
Do not freeze.
The bottle must be used within 2 months of first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ryaltris contains

• The active substances are: mometasone furoate (as monohydrate) and olopatadine (as hydrochloride). Each spray actuation (delivered dose) contains mometasone furoate monohydrate equivalent to 25 micrograms of mometasone furoate and olopatadine hydrochloride equivalent to 600 micrograms of olopatadine.
• The other components are: microcrystalline cellulose (E460), sodium carboxymethylcellulose (E 466), dibasic sodium phosphate heptahydrate (E 339), sodium chloride, benzalkonium chloride, disodium edetate, polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections.

Description of the appearance of Ryaltris and contents of the pack
Ryaltris is a white, homogeneous suspension.
Ryaltris is contained in a white high-density polyethylene bottle equipped with a metered-dose spray pump dispenser made of polypropylene. The dispenser is protected by a purple HDPE cap.
Pack sizes:
1 bottle of 20 ml containing 9 g of suspension (56 actuations),
1 bottle of 20 ml containing 18 g of suspension (120 actuations),
1 bottle of 30 ml containing 29 g of suspension (240 actuations).
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder:
Glenmark Pharmaceuticals s.r.o.,
Hvezdova 1716/2b, Prague 4, 140 78,
Czech Republic

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

This medicinal product is authorised in the EEA Member States under the following names:
Austria, Belgium, Czech Republic, Denmark, Germany, Finland, France,
Ireland, Italy, Netherlands, Norway, Poland, Romania, Slovakia, Spain, RYALTRIS
Sweden: