Ryaltris 25 micrograms/600 micrograms/puff nasal spray suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ryaltris 25 micrograms/600 micrograms/dose, nasal spray suspension

mometasone furoate/olopatadine

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the 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, which often occurs in allergic rhinitis.
• Olopatadine belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of substances such as histamine that the body produces during an allergic reaction, thereby reducing the symptoms of allergic rhinitis.

Ryaltris is used to treat 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 that occurs at certain times of the year and is caused by inhaling pollen from trees, grasses, weeds, as well as moulds and fungal spores.

Perennial rhinitis occurs throughout the year, and symptoms may be triggered by sensitivity to a variety of allergens including house dust mites, animal hair (or dander), feathers, and certain foods.

Ryaltris relieves allergy symptoms such as runny nose, sneezing, nasal 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 while you have an untreated nasal infection, such as herpes, may worsen the infection. You should wait until the infection has cleared before starting to use the nasal spray.
• if you have recently undergone nasal surgery or have had a recent nasal injury. You should not use the nasal spray until your nose has healed.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Ryaltris

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

Consult your doctor or pharmacist while using Ryaltris

• if you have difficulty fighting infections (your immune system is not working properly) and come into contact with someone who has measles or chickenpox. You should avoid contact with anyone who has these infections.
• if you develop a nasal or throat infection.
• if you have been using this medicine for several months or longer.
• if you have persistent irritation of the nose or throat.
• if you experience blurred vision or other visual disturbances.

If corticosteroid nasal sprays are used at high doses over long periods, adverse effects may occur due to systemic absorption of the medicine. These adverse effects may include weight loss, fatigue, muscle weakness, low blood sugar, low sodium levels, joint pain, depression, and skin darkening. If you experience any of these adverse effects, your doctor may recommend an alternative treatment during periods of stress or scheduled surgeries.

If you are unsure whether any of the above applies 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 slower growth in children and adolescents. Your doctor will regularly monitor your child's height and ensure they are receiving the lowest effective dose.

Other medicines and Ryaltris

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you are taking other corticosteroids for allergies, either orally or by injection, your doctor may advise you to stop taking them when you start using Ryaltris.

If you are taking other oral medicines or using topical products (eye or nasal drops) containing olopatadine or other antihistamines, your doctor may recommend stopping them once you begin using Ryaltris.

Some medicines may increase the effects of Ryaltris, so your doctor will closely monitor you if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Ryaltris should not be used during pregnancy unless your doctor considers it appropriate.

If you are using Ryaltris, your doctor will discuss with you whether you should breastfeed, taking into account the benefit of treatment for you and the benefit of breastfeeding for your baby. You should not do both.

Driving and using machines

Very rarely, you may experience dizziness, lethargy, fatigue, or somnolence. If this occurs, do not drive or operate machinery. Be aware that alcohol may worsen these effects.

Ryaltris contains benzalkonium chloride

This medicine contains 0.02 mg of benzalkonium chloride per nasal spray.

Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for prolonged treatment periods.

3. How to use Ryaltris

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Contact with the eyes should be avoided.

Adults and adolescents (12 years of age 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 children under 12 years of age.

Method of administration

The spray is for nasal use.

Read the following instructions carefully and use the spray only as directed.

Shake the bottle for at least 10 seconds before each use.

When Ryaltris is not in use, the purple cap must always be securely placed on the white tip of the nozzle.

Ryaltris nasal spray bottle

Preparing the bottle for nasal spraying

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

2. If you are using the spray for the first time, you must "prime" the bottle by actuating it into the air.

3. Hold the nasal spray firmly in an upright position, with your index and middle fingers on either side of the spray nozzle (on the finger rests) while holding the ribbed base of the bottle with your thumb.

4. Point the nozzle away from you and press down and release the pump 6 times until a fine mist appears (see figure 2).

5. Your pump is now primed and ready to use.

6. If you have not used the spray for 14 days or more, shake the bottle well and "re-prime" it by actuating the spray 2 times or until a fine mist appears.

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 your nostrils.
3. Hold the bottle firmly with your index and middle fingers on either side of the spray nozzle (on the finger rests) while holding the ribbed base of the bottle with your thumb.
4. Close one nostril with your finger and carefully insert the spray tip into the other nostril, pointing it slightly outward from the nose (see figure 3).
5. Tilt your head slightly forward. Press quickly and firmly down on the finger rests to activate the pump.
6. Breathe in gently through your nose while spraying. Then, breathe out through your mouth (see figure 4).
7. Repeat the previous steps and administer a second spray into the same nostril.
8. Repeat with two sprays into the other nostril.
9. To prevent blockage, after each use, carefully clean the nozzle with a clean, dry tissue or cloth (see figure 5).
10. Hold the nozzle and push the purple cap onto the base of the nozzle until you hear a click (see figure 6).

Cleaning your nasal spray

If the nozzle becomes blocked, follow the steps below:

• Gently remove the spray nozzle upwards (see figure 7). Remove the purple cap and soak only the nozzle in warm water.
• Do not attempt to unblock the nasal spray by inserting a pin or any other sharp object, as this may damage the spray and result in you not receiving the correct dose of medication.
• After soaking the spray nozzle tip for 15 minutes, rinse the spray nozzle and purple cap with warm water and allow them to dry completely.
• Replace the purple cap onto the spray nozzle tip and reinsert it into the bottle.
• After following the steps to clean the blocked spray nozzle, refer to the previous section "Preparing the bottle for nasal spraying" and re-prime the spray with 2 sprays. Replace the purple cap and your Ryaltris will be ready for use.
• Repeat the unblocking steps if necessary.

If you use more Ryaltris than you should

It is unlikely that you will experience any problems, but if you are concerned or if you have used higher than recommended doses for a prolonged period, consult your doctor.

If you use steroids for a long time or in large amounts, this may, in rare cases, affect some of your hormones. In children, it may affect growth and development.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Ryaltris

If you forget to use your nasal spray at the correct time, use it as soon as you remember, then continue with your normal dosing schedule. Do not use a double dose to make up for missed doses.

If you stop using Ryaltris

It is very important that you use your 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, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Immediate hypersensitivity (allergic) reactions may occur after using this medicine. These reactions can be serious. You must stop treatment with Ryaltris and seek immediate medical help if you experience symptoms such as: swollen face, tongue or pharynx, difficulty swallowing, hives, fatigue, or difficulty breathing.

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

• A bitter taste in the mouth;
• Nosebleeds;
• Mild irritation inside the nose;

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

• Dizziness;
• Headaches;
• 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.

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

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

Systemic adverse effects (side effects affecting the whole body) may occur when this medicine is used at high doses over a prolonged period. These effects are much less likely to occur with a nasal steroid spray than with oral steroids. These effects may vary between patients.

Nasal steroids may affect the normal production of hormones in your body, particularly if high doses are used for a long time. In children and adolescents, this adverse effect may cause slower growth than in others.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 carton, following "EXP". The expiry date refers to the last day of the month indicated. Do not freeze. The spray must be used within 2 months of first use.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the container and other information

Composition of Ryaltris

• The active substances are: mometasone furoate (as monohydrate) and olopatadine (as hydrochloride). Each delivered dose (dose emitted from the spray) 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 (E 460), sodium carmellose (E 466), dibasic sodium phosphate heptahydrate (E 339), sodium chloride, benzalkonium chloride, glycerol, disodium edetate, polysorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524) and water for injections.

Presentation of the product and contents of the pack

Ryaltris is a white, homogeneous suspension.

Ryaltris is supplied in a white high-density polyethylene bottle with a metered-dose manual polypropylene spray pump. The nasal applicator is fitted with a violet HDPE cap.

Pack sizes:

1 bottle of 20 ml containing 56 sprays

1 bottle of 20 ml containing 120 sprays

1 bottle of 30 ml containing 240 sprays

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Glenmark Pharmaceuticals s.r.o.

Hvezdova 1716/2b

140 78 Praha 4

Czech Republic

Manufacturer

Glenmark Pharmaceuticals s.r.o.

Fibichova 143, 566 17 Vysoke Myto

Czech Republic

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Laboratorios Menarini, S.A.

Alfons XII, 587

08918 Badalona (Barcelona)

Spain

This medicinal product is authorised in the EEA Member States under the following names:

Date of the last revision of this leaflet: July 2024.

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).