Prospect: Information for the user

MometasonafuroateKern Pharma 50 micrograms suspension for nasal inhalation

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

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even 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 prospect. See section 4.

1.What is MometasonafuroateKern Pharma and for what it is used

2.What you need to know before starting to use MometasonafuroateKern Pharma

3.How to use MometasonafuroateKern Pharma

4.Possible adverse effects

5Storage of MometasonafuroateKern Pharma

6.Contents of the package and additional information

What is MometasonafuroatoKern Pharma?

Mometasona furoato Kern Pharma nasal spray suspension contains mometasona furoate, a medication that belongs to the class of drugs called corticosteroids. When mometasona furoate is sprayed into the nose, it may help to alleviate inflammation (swelling and irritation of the nose), sneezing, itching, and nasal congestion or discharge.

What is MometasonafuroatoKern Pharma used for?

Hay fever and perennial rhinitis

Mometasona furoato Kern Pharma is used to treat the symptoms of hay fever (also known as seasonal allergic rhinitis) and perennial rhinitis in adults and children 3years 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, herbs, weeds, and also fungal spores and molds. Perennial rhinitis occurs throughout the year and symptoms may be caused by sensitivity to a variety of things including dust mites, animal hair (or epithelium), feathers, and certain foods. Mometasona furoato Kern Pharma reduces inflammation and irritation of the nose and thereby relieves sneezing, itching, and nasal congestion or discharge caused by hay fever or perennial rhinitis.

Nasal polyps

Mometasona furoato Kern Pharma is used to treat nasal polyps in adults 18years of age and older.

Nasal polyps are small formations in the nasal mucosa and generally affect both nasal passages. Mometasona furoato Kern Pharma reduces inflammation in the nose, causing the polyps to decrease gradually, thereby relieving nasal congestion that may affect breathing through the nose.

No use Mometasona furoatoKern Pharma

-if you are allergic (hypersensitive) to mometasona furoato or to any of the other components of this medication (listed in section 6).

-if you have an untreated nasal infection. The use of Mometasona furoato Kern Pharma 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 undergone a recent operation or have had a recent injury to the nose. You should not use the nasal spray until your nose has healed.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Mometasona furoato Kern Pharma:

-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 Mometasona furoato Kern Pharma, 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.

If nasal corticosteroid sprays are used at high doses for long periods of time, adverse effects may occur, 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 Mometasona furoato Kern Pharma.

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

Children

When used at high doses for long periods of time, nasal corticosteroid 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 changes are noted, you should inform your doctor.

Use of Mometasona furoato Kern Pharma with other medications

Inform your doctor if you are taking or have recently taken other medications, including those obtained without a prescription.

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

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 Mometasona furoato Kern Pharma. When discontinuing corticosteroids, orally or by injection, some people may experience side 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 side effects, you should see your doctor.

Pregnancy, breastfeeding, and fertility

There is little or no information available on the use of mometasona furoato in pregnant women. It is unknown whether mometasona furoato 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 medication.

Driving and operating machinery

There is no known information about the effect of mometasona furoato on driving or operating machinery.

Mometasona furoato Kern Pharma contains benzalkonium chloridewhich may cause nasal irritation.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Do not use higher doses or use the sprayer 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 usual dose is two 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 maximum daily dose of four sprays in each nostril once a day.

Use in children between 3 and 11 years of age:

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

If you or your child has severe hay fever, your doctor may advise you to start using Mometasona furoato Kern Pharma before the start of the pollen season, as it will help you prevent hay fever symptoms before they occur. At the end of the pollen season, your hay fever symptoms should have improved and treatment may then not be necessary.

Nasal polyps

Use in adults over 18 years of age

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

-If after 5 to 6 weeks symptoms are not controlled, the dose may be increased to two sprays in each nostril twice a day. Once you have achieved control of symptoms, 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.

Preparation of the nasal spray for use

The nasal spray of Mometasona furoato Kern Pharma has a cap that protects the nozzle and keeps it clean. Remember to remove it before using the spray and put it back after using it. 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 gently shake the bottle.

2.Put your index and middle fingers on either side of the nozzle and your thumb under the bottle.Do not perforate 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 2 times until a fine spray is produced.

How to use your nasal spray

1. Gently shake the bottle and remove the cap (Figure 1).

2. Gently blow your nose.

3. Plug one nostril and place the nozzle in the other nostril as indicated (Figure 2) Incline your head slightly downward, keeping the bottle vertical.

4. Start to breathe in gently or slowly through your nose and while breathing in, press ONCE with 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.

6. Remove the nozzle from this nostril and breathe out through your mouth.

7. Repeat steps 3 to 6 in the other nostril (Figure 3).

Figure 1Figure 2Figure 3

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

Cleaning of your nasal spray

• It is essential to clean your nasal spray regularly, otherwise it may not work properly.
• Remove the cap and carefully pull out the nozzle.
• Wash the nozzle and cap with warm water and then rinse with running water.
• Do not try to unclog the nasal spray by inserting a needle or other pointed object, as it may damage the spray 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 and put the cap back on.
• The nasal spray will need to be primed again with 2 sprays when used for the first time after cleaning.

If you use more Mometasona furoato Kern Pharma than you should

If you accidentally use more than you should, tell your doctor.You can also call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount administered.

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

If you forgot to use Mometasona furoato Kern Pharma

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 rhythm. Do not apply a double dose to compensate for the missed doses.

If you interrupt treatment with Mometasona furoato Kern Pharma

In some patients, Mometasona furoato Kern Pharma may start to relieve symptoms 12 hours after the first dose; however, the full benefit of treatment may not be shown until two days after. It is very important to 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 Kern Pharma 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 MometasonafuroatoKern Pharma or other nasal corticosteroid sprays may experience:

Frequent side 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 mometasona furoato 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 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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for human use: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 store at a temperature above 30°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. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Mometasona furoateKern Pharma

-The active ingredient is mometasona furoate. Each nasal spray contains 50 micrograms of mometasona furoate as a monohydrate.

-The other components are: benzalkonium chloride, glycerol, polisorbate 80, microcrystalline cellulose and sodium carmellose, citric acid monohydrate, sodium citrate and purified water.

Appearance of the product and contents of the packaging

Mometasona furoate Kern Pharma is a nasal spray suspension.

Thecontainer contains140 nasal spraysandis suppliedinpackagingof1nasal spray device.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturing responsible:

FARMEA

10, rue Bouché Thomas

Z.A.C d’ Orgemont

49000 ANGERS

France

Last review date of this leaflet:September 2017

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMP S)http://www.aemps.gob.es/