Mometasone furoate Stada 50 micrograms/spray suspension for nasal spray

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mometasone furoate Stada 50 micrograms/spray suspension for nasal spray

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 effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Mometasone furoate Stada is and what it is used for
2. What you need to know before using Mometasone furoate Stada
3. How to use Mometasone furoate Stada
4. Possible side effects
5. How to store Mometasone furoate Stada
6. Contents of the pack and other information

1. What is Mometasone Furoate Stada and what is it used for

What is mometasone furoate?

Mometasone Furoate Stada nasal spray contains mometasone furoate, a medicine belonging to a group of medicines called corticosteroids. When mometasone furoate is sprayed into the nose, it helps relieve inflammation (swelling and irritation of the nose), sneezing, itching, and nasal congestion or runny nose.

What is mometasone furoate used for?

Hay fever and perennial rhinitis

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

Hay fever, which occurs during certain times of the year, is an allergic reaction caused by inhaling pollen from trees, grasses, weeds, as well as molds and fungal spores. Perennial rhinitis occurs throughout the year, and symptoms may be caused by sensitivity to various substances including house dust mites, animal hair (or epithelial particles), feathers, and certain foods. Mometasone furoate reduces inflammation and irritation in the nose, thereby relieving sneezing, itching, and nasal congestion or runny nose caused by hay fever or perennial rhinitis.

Nasal polyps

Mometasone furoate is used to treat nasal polyps in adults aged 18 years and older.

Nasal polyps are small growths on the lining of the nasal passages and usually affect both nostrils. Mometasone furoate reduces inflammation in the nose, gradually shrinking the polyps and thereby relieving nasal congestion that may interfere with nasal breathing.

2. What you need to know before using Mometasona furoato Stada

DO NOT use Mometasona furoato Stada

• if you are allergic (hypersensitive) to mometasone furoate or to any of the other ingredients of this medicine (listed in section 6)
• if you have an untreated nasal infection. Using mometasone furoate 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 recently had a nasal injury. You should not use the nasal spray until your nose has healed.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Mometasona furoato Stada:

• 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 (a multi-organ genetic disease, primarily affecting the lungs and digestive system).

While using mometasone furoate, consult your doctor:

• if your immune system is not working properly (if you have difficulty fighting infections) and you 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 experience 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 of time, adverse effects may occur because the medicine is absorbed into the body.

If your eyes are itchy or irritated, your doctor may recommend using other treatments in addition to mometasone furoate.

Children

When used at high doses over long periods of time, corticosteroid nasal sprays may cause side effects such as slowed growth rate in children.

It is recommended that the height of children receiving long-term treatment with nasal corticosteroids be monitored, and any changes should be reported to the doctor.

Other medicines and Mometasona furoato Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 when you start using mometasone furoate. When discontinuing oral or injectable corticosteroids, some people may experience adverse effects such as muscle or joint pain, weakness, and depression. You may also develop other allergic symptoms, such as watery eyes, itchy eyes, or red skin rashes. If you experience any of these adverse effects, you should see your doctor.

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

Pregnancy and breast-feeding

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

There is little or no information available on the use of mometasone furoate in pregnant women. It is unknown whether mometasone furoate is excreted in human breast milk.

Driving and using machines

There is no known information regarding the effect of mometasone furoate on driving or operating machinery.

Mometasona furoato Stada contains benzalkonium chloride

This medicine contains 0.02 mg of benzalkonium chloride per spray. Benzalkonium chloride may cause irritation or swelling of the nasal cavity, especially if used for a prolonged period of time.

3. How to use Mometasona furoato Stada

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If 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 of age

The usual dose is two sprays into each nostril once daily.

• Once symptoms are under control, your doctor may recommend reducing the dose.
• If you do not begin to feel better, you should consult your doctor, who may advise increasing the dose to the maximum daily dose of four sprays into each nostril once daily.

Use in children aged between 3 and 11 years

The usual dose is one spray into each nostril once daily.

If you or your child suffers from severe hay fever, your doctor may advise you to start using mometasone furoate before the pollen season begins, as this will help prevent hay fever symptoms before they occur. At the end of the pollen season, your hay fever symptoms should have improved and treatment may no longer be necessary.

Nasal polyps

Use in adults over 18 years of age

The initial usual dose is two sprays into each nostril once daily.

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

Preparing the nasal spray for use

Mometasone furoate comes with a cap that protects the nozzle and keeps it clean.

Remember to remove it before using the spray and replace it after use.

If you are using the spray for the first time, you need to "prime" the bottle by pumping the spray 10 times until a fine mist appears:

1. First, shake the bottle gently.
2. Place your index and middle fingers on either side of the nozzle and your thumb beneath the bottle.

Do not pierce the nasal spray.

1. Point the nozzle away from yourself and press the spray pump 10 times until a fine mist is produced.

If you have not used your nasal spray for 14 days or more, you need to re-prime the bottle by pumping the spray 2 times until a fine mist appears.

How to use your nasal spray

1. Shake the bottle gently and remove the cap (Figure 1)

1. Gently blow your nose.
2. Block one nostril and insert the nozzle into the other nostril as shown (Figure 2). Tilt your head slightly forward, keeping the bottle upright.

1. Begin to inhale gently and slowly through your nose, and while inhaling, press ONCE with your fingers to spray the fine mist into your nose.
2. Breathe out through your mouth. Repeat step 4 to inhale a second spray into the same nostril, if required.
3. Remove the nozzle from this nostril and breathe out through your mouth.
4. Repeat steps 3 to 6 in the other nostril (Figure 3).

After using the spray, clean the nozzle carefully with a clean tissue or paper towel and replace the cap.

Cleaning your nasal spray

• It is important to clean your nasal spray regularly; otherwise, it may not work properly.
• Remove the cap and carefully pull off the nozzle.
• Wash the 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 result in an incorrect dose of medicine being delivered.
• Allow the cap and nozzle to dry in a warm place.
• Reattach the nozzle to the bottle and replace the cap.
• The spray will need to be re-primed with 2 sprays the first time it is used after cleaning.

If you use more Mometasona furoato Stada than you should

If you accidentally use more than you should, inform 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, this may affect growth and development.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, providing details of the medicine and the amount ingested. Telephone: 91 562 04 20

If you forget to use Mometasona furoato Stada

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 a missed dose.

If you stop using Mometasona furoato Stada

In some patients, mometasone furoate should begin to relieve symptoms within 12 hours of the first dose; however, the full benefit of treatment may not be evident 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 do so.

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 mometasone furoate and seek immediate medical help if you experience symptoms such as:

• swollen face, tongue, or throat
• difficulty swallowing
• hives
• fatigue or difficulty breathing

If corticosteroid nasal sprays are used at high doses for long periods of time, adverse effects may occur due to absorption of the medicine into the body.

Other adverse effects

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

Frequent adverse effects (may affect up to 1 in 10 people)

• headache
• sneezing
• nosebleeds [very common (may affect more than 1 in 10 people) in people with nasal polyps who are receiving two sprays of mometasone furoate in each nostril twice daily.]
• nasal or throat pain
• nasal ulcers
• respiratory infection

Frequency not known (cannot be estimated from available data)

• increased intraocular pressure (glaucoma) and/or cataracts, which may lead to visual disturbances

• damage to the nasal septum separating the nostrils

• taste and smell disturbances

• difficulty breathing and/or fatigue

• blurred vision

Reporting of adverse effects

If you experience any type of 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 through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mometasone furoate Stada

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

Do not store above 30°C. Do not freeze.

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

The spray should be used within 2 months of first opening. Only open one bottle at a time.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mometasona furoato Stada

• The active substance is: mometasona furoato. Each spray contains 50 micrograms of mometasona furoato as monohydrate.
• The other components are: benzalkonium chloride, glycerol, polysorbate 80, microcrystalline cellulose and sodium carboxymethylcellulose, citric acid monohydrate, sodium citrate, purified water.

Appearance of Mometasona furoato Stada and contents of the pack

Mometasona furoato Stada is a nasal spray suspension.

Bottles containing 60 sprays (10 g), 120 sprays (16 g), or 140 sprays (18 g).

Bottles containing 60 sprays and 120 sprays are supplied in packages containing 1 nasal spray device.

Bottles containing 140 sprays are supplied in packages containing 1 or 3 nasal spray devices.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Farmea

10, rue Bouché Thomas

Z.A.C d’Orgemont

49000 Angers

France

or

STADA Arzneimittel AG

Stadastrasse 2-18

D-61118 Bad Vilbel

Germany

or

H2 PHARMA

21 rue Jacques Tati

ZAC La Croix Bonnet

78390 Bois D’Arcy

France

This medicinal product is authorized in the European Economic Area member states under the following names:

Belgium: Mometasone EG 50 microgram/spray, nasal spray, suspension

Germany: Mometasonfuroat AL 50 Mikrogramm/Sprühstoß Nasenspray, Suspension

Italy: Mometasone EG 50 microgrammi / erogazione, Spray nasale, sospensione

Spain: Mometasona furoato Stada 50 microgramos / pulverización, suspensión para pulverización nasal

Date of the most recent review of this leaflet: April 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es