Ryaltris

Patient Information Leaflet

Ryaltris, 25 micrograms/dose + 600 micrograms/dose
nasal spray, suspension
Mometasone furoate + Olopatadine
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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, inform your doctor or pharmacist. See section 4.

Leaflet Contents

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), which reduce inflammation commonly associated with allergic rhinitis.
• Olopatadine belongs to a group of medicines called antihistamines. Antihistamines prevent the action of substances such as histamine, which the body releases during an allergic reaction, thereby reducing the 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 allergic 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 moulds and fungal spores.
Perennial allergic rhinitis occurs throughout the year, and symptoms may be caused by sensitivity to various allergens, including house dust mites, pet dander (or fur), feathers, and certain foods.
Ryaltris relieves allergy symptoms such as runny nose, sneezing, nasal itching, or nasal congestion.

2. 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 a nasal injury. 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 in the past.
• 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 has been used for several months or longer.
• if the patient has persistent nasal or throat irritation.
• if the patient experiences blurred vision or other vision problems.

If nasal corticosteroid sprays are used at high doses over a prolonged period, adverse effects due to systemic absorption of the drug may occur. These adverse effects may include weight loss, fatigue, muscle weakness, low blood sugar, craving for salty foods, joint pain, depression, and skin darkening. If such adverse effects occur, the doctor may recommend an alternative treatment during periods of stress or planned surgery. If in doubt whether any of the above situations apply, consult 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 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 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient 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 oral or topical medicines (nasal or eye drops) containing olopatadine or other antihistamines, the treating doctor may advise the patient to discontinue their use when starting Ryaltris.
Some medicines may increase the effect of Ryaltris, and the treating doctor may closely monitor the patient's condition if the patient is taking such medicines (including certain HIV medications: ritonavir, cobicistat).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, 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 taking Ryaltris, the doctor will discuss whether she should breastfeed, taking into account the benefits of treatment and the benefits of breastfeeding for the child. Both should not be done simultaneously.

Driving and operating machinery
Very rarely, dizziness, somnolence, fatigue, and drowsiness may occur. If these symptoms occur, the patient should 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 irritation or swelling inside the nose, 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 Ryaltris is 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 the spray is being used for the first time, prime the bottle by pressing the pump dispenser 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 grooved base of the bottle with your thumb.
4. Pointing the spray nozzle away from you, press the pump dispenser 6 times until a fine, uniform mist is produced (see figure 2).

5. The pump dispenser 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 pressing the pump dispenser 2 times until a uniform 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, placing your index and middle fingers on either side of the spray nozzle (on the finger grips), while supporting the grooved base of the bottle with your thumb.
4. Close one nostril with a 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 dispenser at the finger grips to activate 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 dispenser, after each use, gently wipe the spray nozzle with a clean, dry tissue or cloth (see figure 5).
10. Holding the pump dispenser, replace the protective cap until a distinct click is heard (see figure 6).

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

• Remove the pump dispenser by gently pulling it upwards (see figure 7). Remove the purple protective cap and soak the pump dispenser in warm water.

• Do not unblock the spray nozzle by inserting a needle or any other sharp object,
  as this may damage the pump dispenser and prevent the correct dose of medicine from being delivered.

• After soaking the pump dispenser for 15 minutes, rinse it and the purple protective cap with warm water and allow them to dry completely.

• Replace the purple protective cap onto the spray nozzle and reattach the pump dispenser onto the bottle.

• After cleaning the blocked spray nozzle, refer to the section "Preparing the nasal spray bottle" above and re-prime the bottle by administering 2 sprays. Replace the purple protective cap—the Ryaltris nasal spray is now ready for use.

• If necessary, repeat the cleaning steps.

If you use more Ryaltris than you should
It is unlikely that any problems will occur, but if you are concerned or if you have used higher doses than recommended for a prolonged period, consult your doctor.
If corticosteroids 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.
If you forget to use Ryaltris
Use the nasal spray as soon as you remember, then continue using it at your usual time. Do not use a double dose to make up for a missed dose.
Stopping Ryaltris
It is very important that you use the nasal spray regularly. Do not stop treatment, even if you feel better, unless instructed by your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Immediate allergic (hypersensitivity) reactions may occur after using this medicine.
These reactions may be severe. Treatment with 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 fewer than 1 in 10 people):

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

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

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

Rare (may affect fewer 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
• swelling and ulceration inside the nose

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 long period of time, systemic adverse effects (affecting the whole body) may occur. The likelihood of such effects is considerably lower when corticosteroids are administered as a nasal aerosol than in oral form. These effects may vary between individual patients.
Nasal corticosteroids may affect the normal production of hormones in the body, particularly when used in high doses over a prolonged period. In children and adolescents, this adverse effect may result in slowed growth.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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
Adverse effects may also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the 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 cardboard box or on the bottle label following: EXP. The expiry date refers to the last day of the stated month.
Do not freeze.
The bottle should be used within 2 months of first opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ryaltris contains

• The active substances in this medicinal product are mometasone furoate (in monohydrate form) and olopatadine (in hydrochloride form). Each delivered dose (metered dose) 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 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 in a white high-density polyethylene bottle equipped with a polypropylene metering pump spray dispenser. The dispenser is protected by a violet high-density polyethylene cap.
Pack sizes available:
30 ml bottle containing 240 doses.
Marketing Authorisation 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
For further information about this medicinal product, contact the local representative of the
Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
ul. Dziekońskiego 3
00-728 Warsaw
Email: [email protected]
This medicinal product is authorised in the 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