MOMETASONE FUROATE KERN PHARMA 50 micrograms NASAL SPRAY SUSPENSION

Introduction

Package Leaflet: Information for the User

MometasonefuroateKern Pharma 50 micrograms nasal spray suspension

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 and other information

1. What Mometasone furoate Kern Pharma is and what it is used for
2. What you need to know before you use Mometasone furoate Kern Pharma
3. How to use Mometasone furoate Kern Pharma
4. Possible side effects

5 Storage of Mometasone furoate Kern Pharma

1. Contents of the pack and other information

1. What Mometasone furoate Kern Pharma is and what it is used for

What is MometasonefuroateKern Pharma?

Mometasone furoate Kern Pharma nasal spray suspension 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 is MometasonefuroateKern Pharma used for?

Hay fever and perennial rhinitis

Mometasone furoate Kern Pharma 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 a sensitivity to a variety of things including house dust mites, animal hair (or dander), feathers and certain foods. Mometasone furoate Kern Pharma reduces the inflammation and irritation in your nose and in this way relieves the sneezing, itching and nasal congestion or runny nose caused by hay fever or perennial rhinitis.

Nasal polyps

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

Nasal polyps are small growths on the lining of the nose and usually affect both nostrils. Mometasone furoate Kern Pharma 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 Mometasone furoate Kern Pharma

Do not use MometasonefuroateKern Pharma

• if you are allergic (hypersensitive) 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 Kern Pharma 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 an operation or injury to the nose recently. You should not use the nasal spray until your nose has healed.

Warnings and precautions

Tell your doctor or pharmacist before you start using Mometasone furoate Kern Pharma:

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

While you are using Mometasone furoate Kern Pharma, tell your doctor:

• if your immune system is not working properly (if you have difficulty 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 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 can cause side effects, such as slowing down the growth rate in children.

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

Using MometasonefuroateKern 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 can increase the effects of Mometasone furoate Kern Pharma, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

If you are taking other corticosteroids for your allergy, either by mouth or by injection, your doctor may advise you to stop taking them when you start using Mometasone furoate Kern Pharma. When stopping corticosteroids by mouth or injection, 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, or itchy, red, scratchy skin. If you develop any of these side effects, you should see your doctor.

Pregnancy, breastfeeding and fertility

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 breastfeeding, 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 effect of mometasone furoate on driving or using machines.MometasonefuroateKern Pharma contains benzalkonium chloridewhich may cause nasal irritation.

3. How to use Mometasone furoate Kern Pharma

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, ask your doctor or pharmacist again. Do not use higher doses 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 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 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 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 very severe hay fever, your doctor may advise you to start using Mometasone furoate Kern Pharma before the start of the pollen season, as it will help to prevent the symptoms of hay fever 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 into each nostril once daily.

• If after 5 to 6 weeks the symptoms are not controlled, the dose may be increased to two sprays into 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 using two sprays into each nostril twice daily, you should talk to your doctor.

Preparing the nasal spray for use

The Mometasone furoate Kern Pharma 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 gently.
2. Put your index and middle fingers on either side of the nozzle and your thumb underneath 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. Gently shake the bottle 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 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 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 not try to unblock the nasal spray nozzle by inserting a needle or other pointed object as this could damage the nozzle so that you do not receive the correct dose of medicine.
• Put the cap and nozzle to dry in a warm place.
• Press the nozzle onto the bottle and put the cap on.
• The nasal spray will need to be primed again with 2 sprays when it is used for the first time after cleaning.

If you use more MometasonefuroateKern Pharma than you should

If you accidentally use more than you should, talk to your doctor. You can also contact the Toxicology Information Service, telephone 91.562.04.20, stating the medicine and the amount taken.

If you use steroids for a long time or in large amounts, they can, in rare cases, affect some of your hormones. In children, this can affect growth and development.

If you forget to use MometasonefuroateKern Pharma

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 apply a double dose to make up for forgotten doses.

If you stop treatment with MometasonefuroateKern Pharma

In some patients, Mometasone furoate Kern Pharma may start to relieve symptoms 12 hours after the first dose; however, the full benefit of treatment may not be seen until two days after. 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 on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Immediate allergic reactions (hypersensitivity) can occur after using this medicine. These reactions can be serious. You should stop using Mometasone furoate Kern Pharma 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 after using the nasal spray. However, some people after using Mometasone furoate Kern Pharma 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 taking two sprays of mometasone furoate into each nostril twice daily.]
• nasal or throat pain
• nasal ulcers
• respiratory infection

Frequency not known (cannot be estimated from the available data)

• increased eye pressure (glaucoma) and/or cataracts which can lead to visual disturbances
• 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaram.es. By reporting side 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 which is stated on the carton after “EXP”. The expiry date is the last day of the month stated.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

Composition of MometasonefuroateKern Pharma

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

Appearance of the product and pack contents

Mometasone furoate Kern Pharma is a nasal spray suspension.

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

Marketing authorisation holder and manufacturer

Marketing authorisation 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 last revision of this leaflet:September 2017

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