Nasonex 50 micrograms nasal spray suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

NASONEX 50 micrograms nasal spray suspension

Mometasone furoate

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Nasonex is and what it is used for

What is Nasonex?

Nasonex nasal spray contains mometasone furoate, a medicine that belongs 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 Nasonex used for?

Hay fever and perennial rhinitis

Nasonex 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 inhaling tree, grass, and weed pollens, as well as mold and fungal spores. Perennial rhinitis occurs throughout the year, and symptoms may be triggered by sensitivities to a variety of substances, including house dust mites, animal hair (or epithelial particles), feathers, and certain foods. Nasonex 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

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

Nasal polyps are small growths on the lining of the nasal passages and usually affect both nostrils. Nasonex reduces inflammation in the nose, gradually shrinking the polyps and thereby relieving nasal congestion that may interfere with breathing through the nose.

2. What you need to know before using Nasonex

Do not use Nasonex

• if you are allergic 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 Nasonex 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 the 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 Nasonex:

• 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 Nasonex, consult your doctor:

• if your immune system is not working properly (if you have difficulty recovering from infection) 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 advise you to use other treatments alongside Nasonex.

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 Nasonex with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained 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 begin using Nasonex. 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 reactions, such as watery eyes, itchy eyes, or red, itchy skin rashes. If you experience any of these adverse effects, you should see your doctor.

Some medicines may increase the effects of Nasonex, so your doctor will monitor you closely if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

There is limited or no information available on the use of Nasonex in pregnant women. It is unknown whether Nasonex 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 using machines

There is no known information regarding 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 over long treatment periods.

3. How to use Nasonex

Follow exactly the instructions for administering 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.

In some patients, Nasonex begins to relieve symptoms within 12 hours of the first dose; however, optimal treatment effect is unlikely to be observed before the first two days. Therefore, you should maintain regular use to achieve the optimal treatment effect.

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

Nasal polyps

Use in adults over 18 years of age

The initial usual 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 Nasonex nasal spray has a cap that protects 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 is produced:

1. First, shake the bottle gently.
2. Place your index and middle fingers on either side of the nozzle and your thumb underneath 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 2 times until a fine mist is produced.

How to use your nasal spray

1. Shake the bottle gently and remove the cap (Figure 1).
2. Gently blow your nose.
3. Close one nostril and insert the nozzle into the other nostril as shown (Figure 2).

Tilt your head slightly forward, keeping the bottle upright.

1. Begin to inhale gently or slowly through your nose and, while inhaling, 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 into the same nostril, if applicable.
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 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 carefully pull off the nozzle.
• Wash the nozzle and cap with lukewarm water and then rinse with running water.
• Do not attempt 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 medication is not delivered.
• Allow 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 re-primed with 2 sprays the first time it is used after cleaning.

If you use more Nasonex than you should

If you accidentally use more than you should, inform your doctor.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, stating the medication and amount ingested. Telephone: 91 562 04 20

If you forget to use Nasonex

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 missed doses.

If you stop treatment with Nasonex

In some patients, Nasonex 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 your treatment even if you feel better, unless your doctor tells you to.

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 severe. You must stop treatment with Nasonex 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 the medicine being absorbed into the body.

Other adverse effects

Most people do not have any problems after using the nasal spray. However, some people using Nasonex or other corticosteroid nasal sprays may experience:

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 using two sprays of Nasonex 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 effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nasonex

• Keep this medicine out of the sight and reach of children.
• Do not store above 25°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 bottle should be used within 2 months of first use. Open only one bottle at a time.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at a pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nasonex

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

Appearance of the product and contents of the pack

Nasonex is a nasal spray suspension.

Each bottle contains 60 or 140 sprays.

Bottles containing 60 sprays are supplied in individual packs.

Bottles containing 140 sprays are supplied in packs of 1, 2 or 3 bottles.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

This medicinal product is authorised in the European Economic Area member states under 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 deguna aerosols,suspensija

Portugal: Nasomet

Spain: NASONEX 50 micrograms nasal spray suspension

Date of the most recent review of this leaflet: 03/2020

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