Label: information for theuser

MometasonafuroateTeva 50 micrograms nasal spray suspension

mometasona furoate

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

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to otherseven 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 label.Seesection4.

What is MometasonafuroateTeva?

MometasonafuroateTeva nasal spray contains furoate of mometasona, a medication from a group of medications called corticosteroids. Furoate of mometasona should not be confused with anabolic steroids used improperly by some athletes and administered in tablets or injection. When furoate of mometasona is sprayed in the nose, it may help to relieve the inflammation (swelling and irritation of the nose), sneezing, itching, and nasal congestion or runny nose.

What is MometasonafuroateTeva used for?

Hay fever and perennial rhinitis

MometasonafuroateTeva is used to treat the symptoms of hay fever (also called allergic rhinitis) and perennial rhinitis in adults and children 3 years of age and older.

Hay fever, which occurs at certain times of the year, is an allergic reaction caused by breathing pollen from trees, herbs, weeds, and also spores of molds and fungi. Perennial rhinitis occurs throughout the year and symptoms may be caused by sensitivity to a variety of things including dust mites, pet hair (or epithelium), feathers, and certain foods. MometasonafuroateTeva reduces the inflammation and irritation of your nose and also relieves sneezing, itching, and nasal congestion or runny nosecaused by hay fever or perennial rhinitis.

Nasal polyps

Mometasona furoate Teva is used to treat nasal polyps in adults 18 years and older.

Nasal polyps are small formations in the mucosa of the nose and generally affect both nasal cavities. MometasonafuroateTeva reduces the inflammation in the nose, making the polyps gradually decrease, thus relieving nasal congestion that may affect your breathing through the nose.

Do not use Mometasona furoateTeva:

• 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 Mometasona furoate Teva 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 recently undergone nasal surgery or have recently suffered a nasal injury. Do not use the nasal spray until your nose has healed.

Warnings and precautions

Consult your doctor or pharmacist before starting to userMometasonafuroate Teva.

• If you have or have had tuberculosis
• If you have any other infection
• If you are taking other corticosteroids, by mouth or by injection
• If you have cystic fibrosis

While using Mometasona furoate Teva, consult your doctor:

• If your immune system is not functioning properly (if you have difficulty recovering from an infection) 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 nasal or throat infection.
• If you have been using this medicine for several months or more.
• If you have persistent nasal or throat irritation.

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

If your eyes itch or are irritated, your doctor may advise you to use other treatments at the same time as Mometasona furoate Teva.

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 may cause side effects, such as slowing of growth rate in children.

It is recommended to monitor the height of children on long-term treatment with corticosteroids and if any change is noted, inform your doctor.

Use of Mometasona furoateTeva with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including those obtained without a prescription.

If you are taking other corticosteroids for allergies, by mouth or by injection, your doctor may advise you to stop taking them when you start using Mometasona Teva. When discontinuing oral or injectable corticosteroids, some people may experience adverse effects, such as muscle pain or joint pain, weakness, and depression. You may also develop other allergies, such as itchy, watery eyes, or red, itchy skin. If you develop any of these effects, consult your doctor.

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

Pregnancy, breastfeeding, and fertility

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

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

Driving and operating machinery

There is no known information about the effect of Mometasona furoate Teva on driving or operating machinery.

Mometasona furoate Tevacontains benzalkonium chloride

This medicine contains 20 micrograms of benzalkonium chloride in each spray (0.1 ml). Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for a long treatment.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Do not use higher doses or use the nasal spray more frequently or for a longer period than your doctor has told you.

Treatment of hay fever and perennial rhinitis

Use in adults and children over 12 years of age

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 must consult your doctor and may increase the dose to the maximum daily dose of four sprays in each nostril once a day.

Use in children aged 3 to 11 years

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

Mometasona furoato Teva may start to relieve symptoms within 12 hours after the first dose in some patients; however, it is unlikely that the optimal effect of treatment will be observed before the first two days. Therefore, you must maintain regular use to achieve the optimal effect of treatment.

If you or your child have severe hay fever, your doctor may advise you to start using Mometasona furoato Teva a few days before the start of the pollen season, as this will help prevent hay fever symptoms. At the end of the pollen season, your hay fever symptoms should improve and treatment may then not be necessary.

Nasal polyps

Use in adults over 18 years of age

The initial recommended 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 reduce the dose.
• If no improvement of symptoms is observed after 5-6 weeks administering twice a day, you must consult your doctor to consider alternative treatments to Mometasona furoato Teva.

Preparing the nasal spray for use

Mometasona furoato Teva nasal spray has a 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. First, shake the bottle carefully.
2. Place your index and middle fingers on either side of the nozzle and your thumb underneaththebottle.Do not pierce thenasalapplicator.
3. Do not point the nozzle towards you and then presswithyourfingerstospray10 times until a fine spray is produced (Figure 1).

Figure 1

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 long does your nasal spray last

At the normal dose of two sprays in each nostril once a day for the treatment of hay fever and perennial rhinitis and nasal polyps, this medication provides sufficient doses for 15 days (if the bottle contains 60 sprays), 30 days (if the bottle contains 120 sprays) and 35 days (if the bottle contains 140 sprays).

How to use your nasal spray

1. Shake the bottle carefully and remove the cap (Figure 2)

1. Blow your nose gently.
2. Plug one nostril and place the nozzle in the other nostril as indicated (Figure 3).

Tilt your head slightly downwards, keeping the bottle vertical.

Point the nozzle towards the side of the nasal cavity, not towards the center (nasal septum).

Figure 3

1. Start to breathe in gently or slowly through your nose and while breathing in, spray the fine spray into your nose by pressing ONCE with your fingers (Figure 4).

Figure 4

1. Breathe out through your mouth. Repeat step 4 to inhale a second spray in the same nostril, if necessary.
2. Remove the nozzle from this nostril and breathe out through your mouth.
3. Repeat steps 3 to 6 in the other nostril (Figure 5).

Figure 5

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

Cleaning your nasal spray

• It is essential to clean your nasal spray regularly, otherwise it may not work properly.
• Remove the cap (Figure 6) and carefully pull out the nozzle (Figure 7).

• Wash the cap (Figure 8) and nozzle (Figure 9) with warm water and then rinse with running water.

• Do not try to unclog the nasal applicator by inserting a needle or other pointed object, as this may damage the applicator so that the correct dose of medication is not received.
• Put the cap and nozzle to dry in a warm place.

Press the nozzle onto the bottle (Figure 10) and place the cap (Figure 11).

• The spray will need to be primed again with 2 sprays when it is used for the first time after cleaning (Figure 12).

Figure 12

If you use more Mometasona furoato Teva than you should

If you accidentally use more than you should, tell your doctor.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to use Mometasona furoato Teva

If you forgot to use your nasal spray at the right time, use it as soon as you remember, and then follow the normal administration schedule. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Mometasona furoato Teva

In some patients, Mometasona furoato Teva may start to relieve symptoms within 12 hours after the first dose; however, it is unlikely that the optimal effect of treatment will be observed before the first two days. It is very important that you use your nasal spray 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) may occur after using this medicine. These reactions can be severe. You must stop treatment with Mometasona furoato Teva and seek medical help immediately if you experience symptoms such as:

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

If nasal corticosteroid sprays are used at high doses for long periods of time, side effects may occur due to the medication 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 Mometasona furoato Teva or other nasal corticosteroid sprays may experience:

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

• headache

• runny nose andnasal irritation/burning sensation in the nose

• nasal bleeding[may be very frequent (may affect more than 1 in 10 people) in people with nasal polyps who are administering two sprays of Mometasona furoato Teva in each nostril twice a day.]

• nasal or throat pain
• ulcers in the nose
• respiratory infection

Unknown frequency

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

Otherside effects in children and adolescents

Itisexpectedthatthefrequency and type of adverse reactions in children will be the same as in adults. The prolonged use of nasal corticosteroids may cause certain side effects, such as growth retardation in children. In prolonged treatments with nasal corticosteroids, it is recommended to monitor the child's height at regular intervals and if changes are observed, inform the doctor.

Reporting of 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 on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Do not freeze.

The inhaler must be used within 8 weeks from its first administration.

Medicines should not be thrown into the drains or trash. Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Mometasona furoateTeva 50 micrograms nasal spray suspension

• The active ingredient is furoate of mometasona. Each spray (0.1 ml) contains 50 micrograms of furoate of mometasona (as monohydrate).
• The other components are microcrystalline cellulose and sodium carmelose, glycerol, sodium citrate, citric acid monohydrate, polisorbate 80, benzalkonium chloride (see section 2) and water for injectable preparations.

Appearance of the product and contents of the package

Mometasona furoate Teva is a nasal spray suspension.

Each bottle contains 60, 120 or 140 sprays.

The bottles containing 60 or 120 sprays are presented in packaging with a single bottle.

The bottles containing 140 sprays are presented in packaging with 1, 2 or 3 bottles.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11 Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid (Spain)

Manufacturer

Teva Czech Industries s.r.o

Ostravská 305/29,

Komárov 747 70 Opava

Czech Republic

or

Merckle GmbH

Ludwig-Merckle-Str. 3

89143 Blaubeuren, Germany

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

AustriaMometason Ratiopharm 50 mikrogramm/Spruhstoß Nasenspray, Suspension

GermanyMometasonfuroat AbZ 50 Mikrogramm/Sprühstoß Nasenspray, Suspension

BelgiumMometasone Teva 50 microgram per verstuiving, neusspray, suspensie

DenmarkMometasonfuroat Teva

SpainMometasona furoate Teva 50 microgramos suspension for nasal spray
FinlandMomesonex 50 mikrog/annos nenäsumute, suspensie

FranceMOMETASONE TEVA 50 microgrammes/dose, suspension for nasal spray.

HungaryNasotasone 50 mcg szuszpenziós adagolt orrspray

ItalyMometasone TEVA

LithuaniaMometasone Teva 50mikrogramu/dozeje nosies purškalas (suspensija)

NetherlandsMometasonfuroaat Teva 50 microgram/verstuiving, neusspray, suspensie

PolandPronasal

PortugalMometasona Teva, 50 μg/dose, Suspension for nasal spray

SwedenMometasone Teva 50 mikrogram/dos nasal spray, suspension

Last revision date of this leaflet: February 2024

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

You can access detailed and updated information about this medicinal product by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/77974/P_77974.html