MOMETASONE ARISTO 50 micrograms/spray NASAL SUSPENSION

Introduction

Package Leaflet: Information for the Patient

Mometasona Aristo50 micrograms/spray suspension for nasal spray

mometasone furoate

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What is Mometasona Aristo and what is it used for
2. What you need to know before you use Mometasona Aristo
3. How to use Mometasona Aristo
4. Possible side effects
5. Storage of Mometasona Aristo
6. Contents of the pack and other information

1. What is Mometasona Aristo and what is it used for

Mometasona nasal spray suspension contains mometasone furoate, a medicine that belongs to a group of medicines called corticosteroids. When mometasone furoate is sprayed into the nose, it can help to relieve inflammation (swelling and irritation of the nose), sneezing, itching, and nasal congestion or discharge.

What is mometasone used for?

Hay fever and perennial rhinitis

Mometasone is used to treat the symptoms of hay fever (also known as seasonal allergic rhinitis) and perennial rhinitis in adults and children from 3 years of age.

Hay fever, which occurs at certain times of the year, is an allergic reaction caused by breathing in pollen from trees, grasses, weeds, and also mold and fungus spores. Perennial rhinitis occurs throughout the year and its symptoms can be due to sensitivity to various factors, such as house dust mites, animal hair (or dander), feathers, and certain foods. Mometasone reduces the inflammation and irritation of the nose and thus relieves sneezing, itching, and nasal congestion or discharge caused by hay fever or perennial rhinitis.

Nasal polyps

Mometasone is used to treat nasal polyps in adults over 18 years of age.

Nasal polyps are small growths in the lining of the nose and usually affect both nostrils. Mometasone reduces the inflammation of the nose, causing the polyps to shrink gradually, thus relieving the feeling of nasal congestion that can affect breathing through the nose.

2. What you need to know before you use Mometasona Aristo

Do not use Mometasona Aristo

• if you are allergic to mometasone furoate or any of the other ingredients of this medicine (listed in section 6);
• if you have an untreated nasal infection. Using mometasone while you have an untreated nasal infection, such as herpes, can make the infection worse. You should wait until the infection has cleared up before starting to use the nasal spray;
• if you have had recent nasal surgery or 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 this medicine.

• 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;
• if you have cystic fibrosis.

While you are using mometasone, consult your doctor

• if your immune system is not working properly (if you have difficulty getting over infections) and you come into contact with someone with measles or chickenpox. You should avoid contact with anyone who has these infections;
• if you have a nose 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.

When corticosteroid nasal sprays are used at high doses for long periods of time, side effects can occur due to the medicine being absorbed into the body.

If you feel itching or irritation in the eyes, your doctor may recommend that you use other treatments with mometasone.

Contact your doctor if you experience blurred vision or other visual disturbances.

Children

When used at high doses for long periods of time, corticosteroid nasal sprays can cause side effects, such as slowing down the growth rate in children.

It is recommended to monitor the height of children on long-term treatment with nasal corticosteroids, and if any changes are noticed, you should inform your doctor.

Other medicines and mometasone

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines, including those obtained without a prescription.

If you are taking other corticosteroids for allergies, either orally or by injection, your doctor may advise you to stop taking them once you start using this medicine. Some people may find that once they stop taking oral or injectable corticosteroids, they experience some side effects, such as muscle or joint pain, weakness, and depression. You may also develop other allergies, such as watery eyes, itchy eyes, or red, itchy rashes on the skin. If you develop any of these side effects, you should contact your doctor.

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

Pregnancy and breastfeeding

There is little or no information on the use of mometasone in pregnant women. It is not known whether this medicine is excreted in breast milk.

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

Driving and using machines

There is no known information on the effect of mometasone on driving or using machines.

This medicine contains benzalkonium chloride

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

3. How to use Mometasona Aristo

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again. Do not use higher doses or use the spray more often, or for longer than your doctor has told you.

Treatment of hay fever and perennial rhinitis

Use in adults and children over 12 years

The recommended dose is two sprays in each nostril once a day.

• Once the symptoms are under control, your doctor may recommend reducing the dose to one spray in each nostril once a day.
• If you do not start to feel better, you should consult your doctor and may be told to increase the dose to the maximum daily dose of four sprays in each nostril once a day.

Use in children from 3 to 11 years

The recommended dose is one spray in each nostril once a day.

In some patients, mometasone starts to relieve symptoms within 12 hours of the first dose; however, it is unlikely that the optimal effect of treatment will be seen before the first two days. Therefore, you should continue to use the spray regularly to achieve the full benefit of treatment.

If you or your child suffer from severe hay fever, your doctor may advise you to start using mometasone a few days before the expected start of the pollen season, as this will help prevent the appearance of hay fever symptoms. At the end of the pollen season, the symptoms of hay fever should improve, and treatment may no longer be necessary.

Nasal polyps

Use in adults over 18 years

The usual initial dose is two sprays in each nostril once a day.

• If after 5 to 6 weeks the symptoms are not controlled, the dose may be increased to two sprays in each nostril twice a day. Once the symptoms are under control, your doctor may advise you to reduce the dose.
• If there is no improvement in symptoms after 5-6 weeks of administering two sprays twice a day, you should consult your doctor.

Preparing the nasal spray for use

Mometasona nasal spray has a dust cap that protects the nozzle and keeps it clean. Remember to remove it before using the spray and put it back on after use.

If you are going to use the spray for the first time, you need to "prime" the bottle by pressing the spray 10 times until a fine spray is produced:

1. Gently shake the bottle.
2. Put your index and middle fingers on either side of the nozzle and your thumb underneath the bottle. Do notpuncture the nasal spray.
3. Do not point the nozzle at yourself and then press the pump 10 times until a fine spray is produced.

If you have not used your nasal spray for 14 days or more, you need to "prime" the bottle again by pressing the spray 2 times until a fine spray is produced.

How to use your nasal spray

1. Gently shake the bottle and remove the cap (Figure 1).
2. Blow your nose gently.

1. Close one nostril and place the nozzle in the other nostril as shown (Figure 2). Tilt your head slightly downwards, keeping the bottle in a vertical position.
2. Start to breathe in slowly through your nose and while you are breathing in, press the pump ONCEwith your fingers to allow the spray to enter your nose.
3. Exhale through your mouth. Repeat step 4 to inhale a second spray in the same nostril, if necessary.
4. Remove the nozzle from this nostril and exhale through your mouth.

1. Repeat steps 3 to 6 for the other nostril (Figure 3).

After using the spray, carefully clean the nozzle with a clean cloth or paper tissue and put the cap back on.

Cleaning your nasal spray

• It is important that you clean your nasal spray regularly, otherwise, it may not work properly.
• Remove the cap and carefully pull the nozzle.
• Wash the nozzle and cap with warm water and then rinse with running water.
• Do not try to unblock the nasal applicator by inserting a needle or other pointed object as this could damage the applicator so that you do not receive the correct dose of medicine.
• Put the cap and nozzle to dry in a warm place.
• Press the nozzle onto the bottle and put the cap on.
• The spray will need to be primed again with 2 sprays when used for the first time after cleaning.

If you use more Mometasona Aristo than you should

Tell your doctor if you accidentally use more than prescribed.

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

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

If you forget to use Mometasona Aristo

If you forget to use your nasal spray at the right time, use it as soon as you remember, then follow your normal schedule of administration. Do not use a double dose to make up for forgotten doses.

If you stop treatment with Mometasona Aristo

In some patients, mometasone starts to relieve symptoms 12 hours after the first dose; however, the full benefit of treatment may not be seen until two days later. It is very important that you use your nasal spray regularly. Do not stop your treatment even if you feel better, unless your doctor tells you to.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Immediate hypersensitivity reactions (allergic reactions) can occur after using this medicine. These reactions can be serious. You should stop treatment with mometasone and seek medical help immediately if you experience symptoms such as:

• swollen face, tongue, or pharynx,
• difficulty swallowing,
• hives,
• fatigue or difficulty breathing.

If corticosteroid nasal sprays are used at high doses for long periods of time, side effects can occur due to the medicine being absorbed into the body.

Other side effects

Most people do not have any problems after using the nasal spray. However, some people after using mometasone or other corticosteroid nasal sprays may experience:

Common side effects (may affect up to 1 in 10 people)

• headache,
• sneezing,
• nasal bleeding [very common (may affect more than 1 in 10 people) in people with nasal polyps who are administering two sprays of mometasone in each nostril twice a day],
• pain in the nose or throat,
• ulcers in the nose,
• respiratory infection.

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

• increased eye pressure (glaucoma) and/or cataracts that can lead to visual disturbances,
• damage to the nasal septum that separates the nostrils,
• alterations in taste and smell,
• difficulty breathing and/or fatigue,
• blurred vision.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mometasona Aristo

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

Do not use this medicine after the expiry date which is stated on the carton and bottle after "EXP". The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions. Do not freeze.

The spray should be used within 8 weeks of first use.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. If you are unsure, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Contents of the pack and other information

• The active substance is mometasone furoate. Each spray (0.1 ml) delivers a measured dose of mometasone furoate monohydrate equivalent to 50 micrograms of mometasone furoate. The total weight of one spray is 100 mg.

• The other ingredients are: microcrystalline cellulose, sodium carmellose, glycerol, sodium citrate dihydrate (to adjust pH), citric acid monohydrate (to adjust pH), polysorbate 80, benzalkonium chloride, and water for injectable preparations.

Appearance of the product and pack contents

Mometasona Aristo is a nasal spray suspension and is presented in a white high-density polyethylene bottle, which contains 10 g (60 sprays) or 18 g (140 sprays) of the product formulation, supplied with a manual pump sprayer made of polypropylene, calibrated dose.

The 60-spray bottles are supplied in individual packs.

The 140-spray bottles are supplied in packs of 1 or 3 nasal sprays.

Not all pack sizes may be marketed.

Marketing authorisation holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

Teva Czech Industries s.r.o.

Ostravská 305/29, Komárov,

747 70 Opava

Czech Republic

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Denmark Mometasonfuroat Aristo 50 mikrogram/dosis næsespray, suspension

Germany Mometason Aristo 50 Mikrogramm / Sprühstoß Nasenspray, Suspension

Norway Mometasone Aristo 50 mikrogram/dose nesespray, suspensjon

Spain Mometasona Aristo 50 micrograms suspension for nasal spray

Date of last revision of this leaflet: February 2024

Other sources of information

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