Prospect: information for the patient

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

mometasona furoate/olopatadine

Read this prospect carefully before starting to use this medication, as it contains important information for you.

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

Ryaltris contains two active ingredients: furoate mometasone and olopatadine.

• Furoate mometasone belongs to a group of medicines called corticosteroids (steroids) that reduce inflammation, which often appears in allergic rhinitis.
• Olopatadine belongs to a group of medicines called antihistamines. Antihistamines act by preventing the effects of substances like histamine that the body produces as part of an allergic reaction, thus reducing the symptoms of allergic rhinitis.

Ryaltris is used totreat the symptoms of moderate to severe seasonal allergic rhinitis (also known as hay fever)and perennial rhinitisin adults and adolescents 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, and also mold and fungal spores).

Perennial rhinitisoccurs throughout the year and symptoms can be caused by sensitivity to a variety of things including dust mites, pet hair (or dander), feathers, and certain foods.

Ryaltrisrelieves allergy symptoms, such as nasal discharge, sneezing, itching, and nasal congestion.

Do not use Ryaltris

• if you areallergicto furoate mometasone, olopatadine, or any of the other ingredients in this medicine (listed in section 6).
• if you have anuntreated 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 up before starting to use the nasal spray.
• if you have hadsurgeryor have had a recent injury to your nose. 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 hadtuberculosis.
• if you have anyother infection.
• if you are taking othercorticosteroids, either by mouth or by injection.

Consult your doctor or pharmacist while using Ryaltris

• if you have difficulty overcoming infections (your immune system is not functioning properly) and come into contact with someone withmeasles or chickenpox. You should avoid contact with anyone who has these infections.
• if you havenasal or throat infection.
• if you have been using this medicine forseveral monthsor longer.
• if you havepersistent nasal or throat irritation.
• if you haveblurred visionor other visual disturbances.

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

If you are unsure whether this applies to you, consult your doctor or pharmacist before using Ryaltris.

Children and adolescents

Ryaltris is not recommended for children under 12 years old.

Using Ryaltris for a prolonged period may cause children and adolescents to grow more slowly. Your doctorwill regularly monitor your child's heightand ensure that they are taking the lowest effective dose possible.

Other medicines and Ryaltris

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

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

If you are taking other medicines by mouth or using locally (eye or nasal drops) that contain olopatadine or other antihistamines, your doctor may recommend that you stop taking them once you start using Ryaltris.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan 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 confirm with you whether you should breastfeed your baby, taking into account the benefit of treatment for you and the benefit of breastfeeding your baby. Do not do both.

Driving and operating machinery

Very rarely, you may experience dizziness, drowsiness, fatigue, and somnolence. If this happens, do not drive or operate machinery. Note that drinking alcohol may exacerbate these effects.

Ryaltris contains benzalkonium chloride

This medicine contains 0.02 mg of benzalkonium chloride in each nasal spray.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Avoid contact with the eyes.

Adults and adolescents (12 years of age and older)

The recommended dose istwo sprays in each nostrilin the morning and at night.

Use in children under 12 years of age

This medication is not recommended for children under 12 years of age.

Administration form

The sprayer is for nasal use.

Read the following instructions carefully and use the sprayer only according to the instructions.

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

When Ryaltris is not in use, the purple plug must always be kept well in place at 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 plug (see figure 1).

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

3.Hold the nasal sprayer firmly and in a vertical position with your index and middle fingers on either side of the nozzle (on the finger rests) while holding the bottle's ridged base with your thumb.

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

5.Now your pump is primed and ready to use.

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

How to use the nasal sprayer

1.Shake the bottle for at least 10 seconds before each use (morning and night).

2.Blow your nose gently to clear your nasal passages.

3. Holdthe bottlefirmly with your index and middle fingers on either side of the nozzlepulverizadora (on the finger rests) while holding the bottle's ridged base with your thumb.

4.Close one nostril with your finger and carefully insert the tip of the sprayer into the other nostril, pointing it slightly towards the outside of the nose (see figure 3).

5.Tilt your head slightly forward. Press once, quickly and firmly, the finger rests to activate the pump.

6.Breathe gently through your nose while spraying. Then, exhale through your mouth(see figure 4).

7.Repeat the previous steps and apply a second spray in the same nostril.

8.Repeat with 2 sprays in the other nostril.

9.To avoid any blockage, after each use, carefully clean the nozzle with a clean and dry cloth (see figure 5).

10. Hold the nozzle and push the purple plug towards the base, in the nozzle, until you hear a click (see figure 6).

Cleaning your nasal sprayer

If the nozzle becomes blocked, do the following steps:

-Remove the nozzle from the sprayer gently upwards(See figure 7). Remove the purple plug and place only the nozzle in warm water to soak it.

-Do not attempt to unblock the nasal sprayer by inserting a pin or other pointed object, as this will damage the sprayer and cause you to receive the wrong dose of medication.

-After soaking the tip of the nozzle for 15 minutes, rinse the nozzle and the purple plug with warm water and let them dry completely.

-Put the purple plug back in the nozzle and put it back inthe bottle.

-After following the steps to clean the blocked nozzle, consult the previous section ”Preparing the bottle for nasal spraying” and re-prime it using 2 sprays. Put the purple plug back 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 have any problems, but if you are concerned or if you have used doses higher than recommended for a prolonged period, consult your doctor.

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

If you have an overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Ryaltris

If you forget to use your nasal sprayer at the right time, use it as soon as you remember, following the normal administration rhythm. Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with Ryaltris

It is very important to use your nasal sprayer regularly. Do not interrupt your treatment even if you feel better unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

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

Less frequent (may affect up to 1 in 100 people):

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

Unknown frequency (frequency cannot be estimated from available data):

Systemic side effects (side effects that affect the entire body) may occur when this medicine is used in high doses for a prolonged period. It is much less likely to occur if you use a nasal steroid spray than if you take oral steroids. These side effects may vary from patient to patient.

Nasal steroids may affect the normal production of hormones in your body, particularly if you use high doses for a long time. In children and adolescents, this side effect may cause them to grow more slowly than others.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle and the box after “CAD”. The expiration date is the last day of the month indicated. Do not freeze. The inhaler must be used within 2 months from its first use.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

Composition of Ryaltris

- The active ingredients are: furoate of mometasone (as monohydrate) and olopatadine (as hydrochloride). Each dose released (dose released from the atomizer) contains furoate of mometasone monohydrate equivalent to 25 micrograms of furoate of mometasone and hydrochloride of olopatadine 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, polisorbate 80 (E 433), hydrochloric acid (E 507), sodium hydroxide (E 524), and water for injection preparations.

Appearance of the product and contents of the package

Ryaltris is a white and homogeneous suspension.

Ryaltris is presented in a white high-density polyethylene bottle with a manual polypropylene atomizer, calibrated dose. The nasal applicator is equipped with a violet PEAD cap.

Package sizes:

1 bottle of 20 ml with 56 sprays

1 bottle of 20 ml with 120 sprays

1 bottle of 30 ml with 240 sprays

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Glenmark Pharmaceuticals s.r.o.

Hvezdova 1716/2b

140 78 Praha 4

República Checa

Responsible for manufacturing

Glenmark Pharmaceuticals s.r.o.

Fibichova 143, 566 17 Vysoke Myto

República Checa

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Laboratorios Menarini, S.A.

Alfons XII, 587

08918 Badalona (Barcelona)

España

This medication is authorized in the EEA member states under the following names:

Last review date of this leaflet: July 2024.

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es ).