MOMCORT 50 micrograms/spray nasal suspension

Introduction

Package Leaflet: Information for the User

Momcort50 micrograms/spray Nasal Spray Suspension

mometasone furoate

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

• Keep this 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.

Contents of the pack

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

1. What Momcort is and what it is used for

What isMomcort?

Momcort 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 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 aged 3 years and older.

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 mould and fungus spores. Perennial rhinitis occurs throughout the year and the symptoms can be caused by sensitivity to a variety of things including house dust mites, animal hair (or dander), feathers and certain foods. Momcort reduces the inflammation and irritation of your nose and in this way 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 aged 18 years and older.

Nasal polyps are small growths in the lining of the nose and usually affect both nostrils. Mometasone furoate reduces the inflammation in the nose, causing the polyps to shrink gradually, and in this way relieves the nasal congestion that can affect your breathing through your nose.

2. What you need to know before you use Momcort

Do not useMomcort

• 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 furoate 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

Tell your doctor or pharmacist before you start using Momcort

• if you 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 furoate, tell your doctor

• if your immune system is not working properly (if you have trouble getting over 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 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.

If nasal corticosteroid 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 your eyes are itchy or irritated, your doctor may advise you to use other treatments at the same time as mometasone furoate.

See your doctor if you have blurred vision or other changes in your vision.

Children

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

It is recommended that the height of children on long-term treatment with nasal corticosteroids is regularly monitored, and if any changes are observed, this should be reported to the doctor.

Other medicines andMomcort

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

If you are taking other corticosteroids for your allergy, either orally or by injection, your doctor may advise you to stop taking them when you start using mometasone furoate. When stopping oral or injected corticosteroids, some people may experience side effects such as muscle or joint pain, muscle weakness and depression. You may also develop other allergies, such as itchy, watery eyes, itchy eyes or skin with red, itchy rashes. If you develop any of these side effects, you should see 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 for HIV: ritonavir, cobicistat).

Pregnancy and breast-feeding

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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

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

Momcort contains benzalkonium chloride

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

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

3. How to use Momcort

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again. Do not use more than the recommended dose or use the spray more often, or for longer than your doctor tells 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 daily.

• Once symptoms are under control, your doctor may recommend reducing the dose.
• If you do not start to feel better, you should talk to your doctor and they may tell you to increase the dose to the maximum daily dose of four sprays in each nostril once daily.

Use in children aged 3 to 11 years

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

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

If you or your child has very severe hay fever, your doctor may advise you to start using mometasone furoate a few days before the start of the pollen season, as this will help to prevent the symptoms of hay fever before they occur.

Nasal polyps

Use in adults over 18 years of age

The recommended initial dose is two sprays in each nostril once daily.

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

Preparing your 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 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 pumping the spray 10 times until a fine spray is produced:

1. First, shake the bottle carefully.
2. Put your index and middle fingers on either side of the nozzle and your thumb under the bottle. Do not pierce 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 pumping the spray 2 times 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. Block one nostril and put the nozzle in the other nostril as shown (Figure 2). Tilt your head slightly forward, keeping the bottle upright.
4. 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.
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 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 gently pull off the nozzle.
• Wash the nozzle and cap with warm water and then rinse with running water.
• Do nottry to unblock the nasal spray by inserting a needle or other sharp object as this may damagethe spray and you may not get the correct dose of medicine.
• Put the cap and nozzle to dry in a warm place.
• Press the nozzle back onto the bottle and replace the cap.
• 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, talk to your doctor.

If you use steroids for a long time or in high doses, it can, in rare cases, affect some of your hormones. In children, it 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 taken.

If you forget to use Momcort

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

If you stop using Momcort

In some patients, mometasone furoate starts to relieve symptoms 12 hours after the first dose; however, it is unlikely that the full benefit of treatment will be seen before two days. 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 using mometasone furoate and seek medical help immediately if you experience symptoms such as:

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

If nasal corticosteroid 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 when using the nasal spray. However, some people after using Momcort or other nasal corticosteroid 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 furoate in each nostril twice daily.]
• 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 changes in vision
• damage to the nasal septum that separates the nostrils
• changes 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, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Momcort

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

Unopened pack: this medicine does not require any special storage conditions. Do not freeze.

After opening: do not store above 25°C. Do not freeze.

Do not use this medicine after the expiry date which is stated on the pack after “EXP”. The expiry date is the last day of the month shown.

The spray should be used within 2 months of first use.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and other information

What is in Momcort

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

Appearance and pack size

Momcort is a white opaque suspension for nasal spray.

Each bottle contains 60 or 140 sprays.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

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

Date of last revision of this leaflet:January 2020

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

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

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