Mometasone furoate Teva 50 micrograms nasal spray suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mometasone furoate Teva 50 micrograms nasal spray suspension

mometasone furoate

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.

Leaflet contents

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

1. What is Mometasone furoate Teva and what is it used for?

What is Mometasone furoate Teva?

Mometasone furoate Teva nasal spray contains mometasone furoate, a medicine belonging to a group of medicines called corticosteroids. Mometasone furoate should not be confused with the “anabolic” steroids that are misused by some athletes and administered in tablet or injectable form. 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 Teva used for?

Hay fever and perennial rhinitis

Mometasone furoate Teva 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 occurs at certain times of the year and is an allergic reaction caused by inhaling tree, grass, and weed pollens, as well as mold and fungal spores. Perennial rhinitis occurs throughout the year, and symptoms may be triggered by sensitivity to various substances including house dust mites, animal hair (or epithelial particles), feathers, and certain foods. Mometasone furoate Teva reduces inflammation and irritation in the nose and also relieves sneezing, itching, and nasal congestion or runny nose caused by hay fever or perennial rhinitis.

Nasal polyps

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

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

2. What you need to know before starting to take Mometasone furoate Teva

Do not use Mometasone furoate Teva:

• if you are allergic 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 Teva 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 suffered 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 Mometasone furoate Teva:

• if you have or have ever had tuberculosis
• if you have any other infection
• if you are taking other corticosteroids, taken orally or by injection
• if you have cystic fibrosis

While using Mometasone furoate Teva, consult your doctor:

• if your immune system is not working properly (if you have difficulty recovering from infection) 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 nasal corticosteroid 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 alongside Mometasone furoate Teva.

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

Children

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

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

Using Mometasone furoate Teva with other medicines

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, taken orally or by injection, your doctor may advise you to stop taking them when you start using Mometasone Teva. 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 reactions, such as watery and itchy eyes or red, itchy skin rashes. If you experience any of these effects, consult your doctor.

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

Pregnancy, breastfeeding and fertility

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

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.

Driving and using machines

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

Mometasone furoate Teva contains benzalkonium chloride

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

3. How to take Mometasone Teva

Follow exactly the instructions for use of 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 seasonal allergic rhinitis and perennial rhinitis

Use in adults and children over 12 years of age

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

• Once symptom control has been achieved, your doctor may recommend reducing the dose to one spray into each nostril once daily.
• If you do not begin to feel better, consult your doctor, who may increase the dose to the maximum daily dose of four sprays into each nostril once daily.

Use in children aged 3 to 11 years

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

In some patients, Mometasone furoate Teva begins to relieve symptoms within 12 hours of the first dose; however, optimal treatment effect is unlikely to be seen before the first two days. Therefore, you should maintain regular use to achieve the optimal treatment effect.

If you or your child suffer from severe hay fever, your doctor may advise you to start using Mometasone furoate Teva a few days before the pollen season begins, 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 no longer be necessary.

Nasal polyps

Use in adults over 18 years of age

The recommended initial 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 symptom control has been achieved, your doctor may reduce your dose.
• If there is no improvement in symptoms after 5–6 weeks of twice-daily dosing, you should consult your doctor to consider alternative treatments to Mometasone furoate Teva.

Preparing the nasal spray for use

Mometasone furoate Teva nasal spray has a cap that protects the nozzle and keeps it clean. Remember to remove it before using the spray and to replace it after use.

If you are using the spray for the first time, you need to “prime” the bottle by pressing the spray 10 times until a fine mist is produced:

1. First, gently shake the bottle.
2. Place your index and middle fingers on either side of the nozzle and your thumb under the bottle. Do not pierce the nasal applicator.
3. Point the nozzle away from you and then press with your fingers to spray 10 times until a fine mist is produced (Figure 1).

Figure 1

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

How long your nasal spray lasts

At the normal dose of two sprays into each nostril once daily for the treatment of hay fever, perennial rhinitis, and nasal polyps, this medicine provides enough 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. Gently shake the bottle and remove the cap (Figure 2)

1. Gently blow your nose.
2. Close one nostril and insert the nozzle into the other nostril as shown (Figure 3).

Tilt your head slightly forward, keeping the bottle in an upright position.

Direct the nozzle toward the side of the nasal passage, not toward the center (nasal septum).

Figure 3

1. Begin to inhale gently or slowly through your nose, and while inhaling, spray the fine mist into the 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 into the same nostril, if prescribed.
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, carefully clean the nozzle 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 (Figure 6) and carefully pull off the nozzle (Figure 7).

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

• Do not attempt to unblock the nasal applicator by inserting a needle or any other sharp object, as this may damage the applicator and result in not receiving the correct dose of medication.
• Allow the cap and nozzle to dry in a warm place.

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

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

Figure 12

If you use more MometasonafuroatoTeva than you should

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

If you use steroids over a long period of time or in large amounts, this may rarely 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 at telephone number: 91 562 04 20, stating the medication and the amount ingested. It is recommended to bring the medication’s packaging and leaflet to the healthcare professional.

If you forget to use MometasonafuroatoTeva

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 take a double dose to make up for forgotten doses.

If you stop using MometasonafuroatoTeva

In some patients, Mometasone furoate Teva should start relieving symptoms within 12 hours after 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.

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 can cause adverse effects, although not everyone will experience them.

Immediate hypersensitivity (allergic) reactions may occur after using this medicine. These reactions can be serious. You must stop treatment with Mometasone furoate Teva and seek immediate medical help if you experience symptoms such as:

• swollen face, tongue or pharynx
• difficulty swallowing
• urticaria
• fatigue or difficulty breathing

If corticosteroid nasal sprays are used at high doses over 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 after using Mometasone furoate Teva or other corticosteroid nasal sprays may experience:

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

• headache
• sneezing and nasal irritation/burning sensation in the nose
• nosebleeds [very common (may affect more than 1 in 10 people) in people with nasal polyps who are using two sprays of Mometasone furoate Teva in each nostril twice daily.]
• pain in the nose or throat
• ulcers in the nose
• respiratory infection

Frequency not known

• increased intraocular pressure (glaucoma) and/or cataracts which may lead to visual disturbances
• damage to the nasal septum separating the nostrils
• disturbances of taste and smell
• difficulty breathing and/or fatigue
• blurred vision

Other adverse effects in children and adolescents

The frequency and type of adverse reactions in children are expected to be the same as in adults. Prolonged use of nasal corticosteroids may cause certain adverse effects, such as slowed growth in children. During prolonged treatment with nasal corticosteroids, it is recommended to monitor the child's height periodically, and if any changes are observed, inform your doctor.

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 Mometasone furoate Teva

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 on the outer packaging following EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Do not freeze.

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines or waste materials, including containers, should be taken 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 Mometasone furoate Teva 50 micrograms nasal spray suspension

• The active substance is mometasone furoate. Each spray (0.1 ml) contains 50 micrograms of mometasone furoate (as monohydrate).
• The other components are microcrystalline cellulose and sodium carboxymethylcellulose, glycerol, sodium citrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride (see section 2), and water for injections.

Nature of the product and contents of the container

Mometasone furoate Teva is a nasal spray suspension.

Each bottle contains 60, 120 or 140 sprays.

Bottles containing 60 or 120 sprays are supplied in packs containing one bottle.

Bottles containing 140 sprays are supplied in packs containing 1, 2 or 3 bottles.

Only certain pack sizes may be marketed.

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 European Economic Area member states under the following names:

Austria: Mometason Ratiopharm 50 mikrogramm/Sprühstoß Nasenspray, Suspension
Germany: Mometasonfuroat AbZ 50 Mikrogramm/Sprühstoß Nasenspray, Suspension
Belgium: Mometasone Teva 50 microgram per verstuiving, neusspray, suspensie
Denmark: Mometasonfuroat Teva
Spain: Mometasona furoato Teva 50 microgramos suspensión para pulverización nasal
Finland: Momesonex 50 mikrog/annos nenäsumute, suspensio
France: MOMETASONE TEVA 50 microgrammes/dose, suspension pour pulvérisation nasale
Hungary: Nasotasone 50 mcg szuszpenziós adagolt orrspray
Italy: Mometasone TEVA
Lithuania: Mometasone Teva 50 mikrogramų/dozė nosies purškalas (suspensija)
Netherlands: Mometasonfuroaat Teva 50 microgram/verstuiving, neusspray, suspensie
Poland: Pronasal
Portugal: Mometasona Teva, 50 μg/dose, Suspensão para pulverização nasal
Sweden: Mometasone Teva 50 mikrogram/dos nässpray, suspension

Date of the most recent revision of this leaflet: February 2024

Detailed 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/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77974/P_77974.html