Product Information for the User

Momcort50 micrograms/dose Nasal Suspension for Nasal Spray

mometasona furoate

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

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the samesymptoms 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 product information. See section 4.

What isMomcort?

Momcortcontains furoate of mometasone, a medication that belongs to the medications calledcorticosteroids. When furoate ofmometasone is sprayed into the nose, it may help to relieve inflammation (swelling and irritation of the nose), sneezing, itching, and nasal congestion or runny nose.

What isMomcortused for?

Hay fever and perennial rhinitis

Momcort is used to treat the symptoms of hay fever (also known as seasonal 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 in pollen from trees,weeds, grasses, and also mold spores and fungi. Perennial rhinitis occurs throughout the year and symptomsmay be caused by sensitivity to a variety of things including dust mites, pet hair (or epithelium), feathers, and certain foods. Momcort reduces inflammation and irritation of your nose and thereby relieves sneezing, itching, and nasal congestion or runny nose caused by hay fever or perennial rhinitis.

Nasal polyps

Momcort is used to treat nasal polyps in adults 18 years of age and older.

Nasal polyps are small formations in the mucous membrane of the nose and generally affect both nasal passages. Furoate of mometasone reduces inflammation in the nose, causing the polyps to shrink gradually, thereby relieving nasal congestion that may affect your breathing through the nose.

No useMomcort

• If you are allergic to mometasone furoate or any of the other ingredients in this medication (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 up before starting to use the nasal spray.
• If you have recently undergone surgery or had a recent injury to the nose. You should not use the nasal spray until the nose has healed.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Momcort

• If you have or have 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 using mometasone furoate, 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 medication for several months or longer.
• If you have persistent nasal or throat irritation.

Long-term use of high doses of nasal corticosteroids can cause adverse effects, as the medication is absorbed into the body.

If your eyes itch or are irritated, your doctor may advise you to use other treatments in addition to mometasone furoate.

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

Children

Long-term use of high doses of nasal corticosteroids can cause side effects, such as slowed growth in children.

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

Other Medications and Momcort

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, 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 injected corticosteroids, some people may experience adverse effects such as muscle pain or joint pain, muscle weakness, and depression. You may also develop other allergies, such as itchy eyes, runny eyes, or red, itchy skin. If you develop any of these adverse effects, you should see your doctor.

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

Pregnancy and Breastfeeding

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 breast milk.

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

Driving and Operating Machines

There is no known information about the effect of mometasone furoate on driving or operating machines.

Momcort contains benzalkonium chloride

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

Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used during long-term treatment.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consultyour doctor or pharmacist again. Do not use higher doses or use the nasal spray more frequently or for a longer period thanyour 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 nasal sprays in each nostril once a day.

• Once you have achieved control of symptoms, your doctor may recommend reducing the dose.
• If you do not start to feel better, you must consult your doctor and they may tell you to increase the dose to the maximumdaily dose of four nasal sprays in each nostril once a day.

Use in children aged 3 to 11 years

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

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

If you or your child experiences severe hay fever, your doctor may advise you to start using mometasona furoate some days beforethe start of the pollen season, as this will help to prevent hay fever symptoms before they occur.

Nasal polyps

Use in adults over 18 years of ageof age

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

• If after 5 to 6 weeks symptoms are not controlled, the dose may be increased to two nasal sprays in each nostril twice aday. Once symptoms have been controlled, your doctor may advise you to reduce the dose.
• If no improvement of symptoms is observed after 5-6 weeks administering twice a day, you must consult your doctor.

Preparing the nasal spray for use

Momcort nasal spray has a cap that protects the nozzle and keeps it clean. Remember to remove it before using the spray andput it back on afterwards.

If you are going to use the spray for the first timeyou 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 under the bottle. Do notperforate the nasal spray.
3. Do not point the nozzle at yourself and then press the spray 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 2times until a fine spray is produced.

How to use your nasal spray

1. Shake the bottle carefully and remove the cap (Figure 1).
2. Blow your nose gently.
3. Plug one nostril and place the nozzle in the other nostril as indicated (Figure 2) Tilt your head slightly downwards, keeping the bottle vertical.
4. Start to breathe in slowly or gently through your nose and while breathing in, press ONCE with your fingers to allow themedication to enter your nose.
5. Breathe out through your mouth. Repeat step 4 to inhale a second spray in the same nostril, if necessary.

1. Remove the nozzle from this nostril and breathe out through your mouth.
2. Repeat steps 3 to 6 in the other nostril (Figure 3).

After using the spray, clean the nozzle carefully with a clean tissue or a paper tissue 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 thecap and carefully pull out the nozzle.
• Wash the nozzle and cap with warm water and then rinse with running water.
• Do not attempt to unclog the nasal spray by inserting a needle or other pointed object, as this may damage the sprayin such a way 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 and put the cap back on.
• The spray will need to be primed again with 2 sprays when it is used for the first time after cleaning.

If you use more Momcort than you should

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological InformationService, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Momcort

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

If you interrupt treatment with Momcort

In some patients, mometasona furoate may start to relieve symptoms within 12 hours after the first dose; however, it is unlikely thatthe full benefit of treatment will be observed before the first two days. It is very important to use your nasal spray regularly. Do notinterrupt 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 medications, this medication may produce adverse effects, although not all people may experience them.

Immediate hypersensitivity reactions (allergic) may occur after using this medication. These reactions can be severe. You must interrupt treatment with furoate mometasone and seek medical help immediately if you experience symptoms such as:

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

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

Other Adverse Effects

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

Frequent Adverse Effects (may affect up to 1 in 10 people)

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

Unknown Frequency (cannot be estimated from available data)

• increased intraocular pressure (glaucoma) and/or cataracts that may 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 Adverse Effects

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

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

Unopened packaging: this medication does not require any special storage temperature. Do not freeze.

Once opened: do not store at a temperature above 25°C. Do not freeze.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

The inhaler must be used within 2 months from its first administration.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Momcort

• The active principle is furoate of mometasone. Each spray (0.1 ml) contains 50 micrograms of furoate of mometasone (as monohydrate). The total weight of a spray is 100 mg.
• The other components are: glycerol, microcrystalline cellulose and sodium carmellose, sodium citrate, citric acid monohydrate, benzalkonium chloride, polisorbate 80 and water for injection preparations.

Appearance of the product and contents of the packaging

Momcort is an opaque white suspension for nasal spray.

Each bottle contains 60 or 140 sprays.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Teva Czech Industries s.r.o.

Ostravská 29, c.p. 305, 747 70 Opava–Komárov, Czech Republic

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: January 2020

The detailed information about this medicine 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 medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/82795/P_82795.html

QR code at: https://cima.aemps.es/cima/dochtml/p/82795/P_82795.html