Mometasone furoate Kern Pharma 50 micrograms nasal spray suspension

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Mometasone furoate Kern Pharma 50 micrograms nasal spray, suspension

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given 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 Kern Pharma is and what it is used for
2. What you need to know before using Mometasone furoate Kern Pharma
3. How to use Mometasone furoate Kern Pharma
4. Possible side effects
5. How to store Mometasone furoate Kern Pharma
6. Contents of the pack and other information

1. What Mometasona furoato Kern Pharma is and what it is used for

What is Mometasona furoato Kern Pharma?

Mometasona furoato Kern Pharma nasal spray suspension contains mometasonum furoas, a medicine belonging to a group of medicines called corticosteroids. 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 Mometasona furoato Kern Pharma used for?

Hay fever and perennial rhinitis

Mometasona furoato Kern Pharma 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 pollen from trees, grasses, weeds, as well as mold and fungus spores. Perennial rhinitis occurs throughout the year, and symptoms may be caused by sensitivity to a variety of substances including house dust mites, animal hair (or epithelial cells), feathers, and certain foods. Mometasona furoato Kern Pharma reduces inflammation and irritation in the nose, thereby relieving sneezing, itching, and nasal congestion or runny nose caused by hay fever or perennial rhinitis.

Nasal polyps

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

Nasal polyps are small growths in the lining of the nasal passages and usually affect both nostrils. Mometasona furoato Kern Pharma reduces inflammation in the nose, causing polyps to gradually shrink, thereby relieving nasal congestion that may interfere with breathing through the nose.

2. What you need to know before using Mometasona furoato Kern Pharma

Do not use Mometasona furoato Kern Pharma

• if you are allergic (hypersensitive) 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 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 before starting to use the nasal spray.
• if you have recently undergone nasal surgery or have had a recent injury to your nose. 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 Mometasona furoato Kern Pharma:

• if you have or 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 using Mometasona furoato Kern Pharma, consult your doctor:

• if your immune system is not working properly (if you have difficulty fighting 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 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 Mometasona furoato Kern Pharma.

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 Mometasona furoato Kern Pharma with other medicines

Tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Some medicines may increase the effects of Mometasona furoato Kern Pharma, so your doctor will monitor you closely if you are taking these medicines (including some used 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 begin using Mometasona furoato Kern Pharma. When discontinuing oral or injectable corticosteroids, some people may experience adverse effects such as muscle or joint pain, muscle weakness, and depression. You may also develop other allergic symptoms, such as watery eyes, itchy eyes, or red, itchy skin rashes. If you experience any of these adverse effects, you should see your doctor.

Pregnancy, breastfeeding, and fertility

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 human 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 use of machinery

There is no known information regarding the effect of mometasone furoate on driving or operating machinery. Mometasona furoato Kern Pharma contains benzalkonium chloride, which may cause nasal irritation.

3. How to use Mometasone furoate Kern Pharma

Follow exactly the instructions for using this medicine as given by your doctor. 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 hay fever and perennial rhinitis

Use in adults and children over 12 years of age:

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

• Once symptoms are under control, your doctor may recommend reducing the dose.
• If you do not begin to feel better, you should consult your doctor, who may advise increasing the dose to the maximum daily dose of four sprays into each nostril once daily.

Use in children aged 3 to 11 years:

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

If you or your child has severe hay fever, your doctor may advise starting treatment with Mometasone furoate Kern Pharma before the pollen season begins, as this will help prevent hay fever symptoms before they occur. At the end of the pollen season, hay fever symptoms should have improved and treatment may no longer be needed.

Nasal polyps

Use in adults over 18 years of age

The usual 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 symptoms are under control, your doctor may advise reducing the dose.
• If there is no improvement in symptoms after 5–6 weeks of twice-daily administration, you should consult your doctor.

Preparing the nasal spray for use

The Mometasone furoate Kern Pharma nasal spray has a protective cap that covers the nozzle and keeps it clean. Remember to remove it before using the spray and replace it after use. If you are using the spray for the first time, you need to "prime" the bottle by pressing the spray pump 10 times until a fine mist appears:

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

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

How to use your nasal spray

1. Gently shake the bottle and remove the cap (Figure 1).
2. Gently blow your nose.
3. Block one nostril and insert the nozzle into the other nostril as shown (Figure 2). Tilt your head slightly forward, keeping the bottle upright.
4. Begin to inhale gently or slowly through your nose and, while inhaling, press ONCE with your fingers to release the spray into your nose.
5. Breathe out through your mouth. Repeat step 4 to inhale a second spray into the same nostril, if required.
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, 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 and gently pull off the nozzle.
• Wash the nozzle and cap with lukewarm water, then rinse with running water.
• Do not try to unblock the nasal applicator by inserting a needle or any other sharp object, as this may damage the applicator so that the correct dose of medicine is not delivered.
• Allow the cap and nozzle to dry in a warm place.
• Reattach the nozzle to the bottle and replace the cap.
• The nasal spray will need to be re-primed with 2 sprays the first time it is used after cleaning.

If you use more Mometasone furoate Kern Pharma than you should

If you accidentally use more than you should, inform your doctor. You may also call the Toxicology Information Service at telephone number 91.562.04.20, stating the medicine and the amount administered.

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

If you forget to use Mometasone furoate Kern Pharma

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 use a double dose to make up for a missed dose.

If you stop using Mometasone furoate Kern Pharma

In some patients, Mometasone furoate Kern Pharma should begin to relieve symptoms within 12 hours of 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 treatment even if you feel better, unless your doctor tells you to do so.

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 Kern Pharma and seek immediate medical help if you experience symptoms such as:

• swollen face, tongue, or pharynx
• difficulty swallowing
• hives
• 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 experience any problems after using the nasal spray. However, some people may experience the following after using Mometasone furoate Kern Pharma or other corticosteroid nasal sprays:

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

• headache
• sneezing
• nosebleeds [very common (may affect more than 1 in 10 people) in people with nasal polyps who are receiving two sprays of mometasone furoate in each nostril twice daily]
• pain in the nose or throat
• nasal ulcers
• respiratory infection

Frequency not known (cannot be estimated from available data)

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mometasone furoate Kern Pharma

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

Do not store above 30°C. Do not freeze.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be handed in at the SIGRE point at your pharmacy. If you are in doubt, 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 Kern Pharma

• The active substance is mometasone furoate. Each spray contains 50 micrograms of mometasone furoate monohydrate.
• The other components are: benzalkonium chloride, glycerol, polysorbate 80, microcrystalline cellulose and sodium carboxymethylcellulose, citric acid monohydrate, sodium citrate and purified water.

Appearance of the product and contents of the pack

Mometasone Furoate Kern Pharma is a nasal spray suspension.

The bottle contains 140 sprays and is supplied in packs of 1 spray.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturers:

FARMEA

10, rue Bouché Thomas

Z.A.C d’ Orgemont

49000 ANGERS

France

Date of the most recent revision of this leaflet: September 2017

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/