Label: Information for the User

NASONEX 50 micrograms nasal spray suspension

Mometasone furoate

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others 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 label. See section 4.

1. What is Nasonex and how is it used

2. What you need to know before starting to use Nasonex

3. How to use Nasonex

4. Possible adverse effects

5. Storage of Nasonex

6. Contents of the package and additional information

What is Nasonex?

Nasonex nasal spray contains mometasone furoate, a medication 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 Nasonex used for?

Hay fever and perennial rhinitis

Nasonex is used to treat the symptoms of hay fever (also known as allergic rhinitis

seasonal) 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 tree, grass, weed, and mold spores and fungi pollen. Perennial rhinitis occurs throughout the year and symptoms can be caused by sensitivity to a variety of things including dust mites, animal hair (or epithelium), feathers, and certain foods. Nasonex reduces inflammation and irritation of the nose and thereby relieves sneezing, itching, and nasal congestion or runny nose caused by hay fever or perennial rhinitis.

Nasal polyps

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

Nasal polyps are small formations in the nasal mucosa and generally affect both nasal passages. Nasonex reduces inflammation in the nose, causing the polyps to shrink gradually, thereby relieving nasal congestion that can affect breathing through the nose.

Do not use Nasonex

• 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 Nasonex 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 your 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 Nasonex.

• 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 Nasonex, 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 corticosteroid nasal 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 Nasonex.

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

Children

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

Using Nasonex with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased 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 Nasonex. When discontinuing corticosteroids, orally or by injection, 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 Nasonex, 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 Nasonex in pregnant women. It is unknown whether Nasonex is excreted in breast milk.

If you are pregnant or breastfeeding, or think you may be pregnant, or plan 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 Nasonex on driving or operating machinery.

Nasonex contains benzalkonium chloride

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

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 nasal spray 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 aged 3 to 11 years

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

Nasonex may start to relieve symptoms in the 12 hours following the first dose in some patients; however, it is unlikely that the optimal effect of treatment will be observed before the first two days. Therefore, you must maintain regular use to achieve the optimal effect of treatment.

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

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 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

Nasonex 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 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 towards you 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. 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).

Incline your head slightly downwards, keeping the bottle vertical.

1. 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.
2. Breathe out through your mouth. Repeat step 4 to inhale a second spray in the same nostril, if necessary.
3. Remove the nozzle from this nostril and breathe out through your mouth.
4. 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 the cap 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 spray and prevent the correct dose of medication from being received.
• Place 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 used for the first time after cleaning.

If you use more Nasonex 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, it may affect growth and development.

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

If you forget to use Nasonex

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

If you interrupt treatment with Nasonex

In some patients, Nasonex may start to relieve symptoms 12 hours after the first dose; however, it may take two days for the full benefit of treatment to be observed. 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 medications, this medication may produce adverse effects, although not all people may experience them.

Immediate hypersensitivity reactions (allergic) may occur after use of this medication. These reactions can be severe. You must interrupt treatment with Nasonex and seek immediate medical help 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 Nasonex 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 Nasonex in each nostril twice a day.]
• nasal or throat pain
• ulcers in the nose
• respiratory infection

Unknown Frequency (cannot be estimated from available data)

• increase in intraocular pressure (glaucoma) and/or cataracts that may lead to visual disturbances

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 of Pharmacovigilance of Medicines 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.
• 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 bottle should be used within 2 months from the first administration. Open only one bottle at a time.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and

medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Nasonex

• The active ingredient is furoate of mometasone. Each spray contains 50 micrograms of furoate of mometasone as monohydrate.
• The other components are dispersible cellulose, glycerol, sodium citrate, citric acid monohydrate, polisorbate 80, benzalkonium chloride, purified water.
• This medication contains 0.02 mg of benzalkonium chloride in each spray.

Appearance of the product and contents of the package

Nasonex is a nasal spray suspension.

Each bottle contains 60 or 140 sprays.

Bottles containing 60 sprays are presented in individual packaging.

Bottles containing 140 sprays are presented in packaging of 1, 2, or 3 bottles.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

This medication is authorized in the member states of the European Economic Area with the following names:

Austria: Nasonex aquosum – Nasenspray

Belgium, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Slovenia, Sweden, United Kingdom: Nasonex

Bulgaria, Czech Republic, Romania, Slovakia: NASONEX

Latvia: Nasonex 50 mikrogrami/deva deva aerosols, suspensija

Portugal: Nasomet

Spain: NASONEX 50 microgramos suspension for nasal spray

Last review date of this prospectus:03/2020

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