Nasonex

Package Leaflet: Information for the User

Nasonex, 50 micrograms/dose, nasal spray, suspension

Mometasone furoate

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

1. What is Nasonex and what is it used for

What is Nasonex?

Nasonex nasal spray contains mometasone furoate, which belongs to a group of medicines called corticosteroids. Mometasone furoate administered intranasally relieves the symptoms of inflammation (swelling and irritation of the nasal mucosa), sneezing, itching, and a stuffy nose, and reduces the amount of nasal discharge.

What is Nasonex used for?

Hay fever and perennial allergic rhinitis
Nasonex is used to treat the symptoms of hay fever (also known as seasonal allergic rhinitis) and perennial allergic 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 pollen from trees, grasses, weeds, as well as mold and fungal spores.
Perennial allergic rhinitis occurs throughout the year, and symptoms can be caused by sensitivity to various factors, including house dust mites, pet hair (or dander), feathers, and some foods. Nasonex reduces swelling and irritation of the nasal mucosa, thereby relieving sneezing, itching, stuffy nose, or runny nose caused by hay fever or perennial allergic rhinitis.
Nasal polyps
Nasonex is used to treat nasal polyps in adults aged 18 years and older.
Nasal polyps are small growths on the nasal mucosa, usually occurring in both nostrils.
Nasonex reduces inflammation in the nose, causing a gradual reduction in the size of nasal polyps, thereby reducing the feeling of a stuffy nose, which can make breathing difficult.

2. Important information before using Nasonex

When not to use Nasonex

Warnings and precautions

Before starting to use Nasonex, you should discuss this with your doctor or pharmacist:

While using Nasonex, you should discuss this with your doctor

If corticosteroids are taken in large doses for a long time, side effects may occur due to the absorption of the medicine into the body.
If you experience itching or irritation of the eyes, your doctor may prescribe a different treatment with Nasonex.
If you experience blurred vision or other vision disturbances, you should contact your doctor.

Children

If corticosteroids are taken in large doses for a long time, they may cause certain side effects, such as slowing down the growth rate in children.
It is recommended that the growth of children receiving long-term treatment with intranasal corticosteroids be regularly monitored, and if any changes are observed, the doctor should be informed.

Nasonex and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take, including those available without a prescription..
If you are taking other corticosteroids orally or by injection to treat allergies, your doctor may advise you to stop taking them when you start using Nasonex. In some patients, after stopping oral or injectable corticosteroids, side effects such as joint or muscle pain, weakness, and depression may occur. Other allergic symptoms, such as itching, tearing of the eyes, or red and itchy skin patches, may also appear. You should contact your doctor if you experience any of these symptoms.
Some medicines may enhance the effect of Nasonex, and your doctor may want to monitor your condition closely if you are taking such medicines (including certain HIV medicines: ritonavir, cobicistat).

Pregnancy and breastfeeding

There are no data or only limited data available on the use of Nasonex in pregnant women.
It is not known whether mometasone furoate passes into breast milk.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.

Driving and using machines

There are no data available on the effect of Nasonex on the ability to drive or use machines.

Nasonex contains benzalkonium chloride

Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Nasonex

Nasonex should always be used as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist. The nasal spray should not be used more frequently, for a longer period, or in larger doses than prescribed by your doctor.

Treatment of hay fever and perennial allergic rhinitis

Use in adults and children over 12 years of age

Normally, two sprays are used in each nostril once a day.

• After improvement, your doctor may advise you to reduce the dose.
• If you do not feel any improvement, you should contact your doctor, who may advise you to increase the dose: the maximum daily dose is four sprays in each nostril once a day.

Use in children aged 3 to 11 years

Normally, one spray is used in each nostril once a day.

In some patients, relief of symptoms occurs within 12 hours of administration of the first dose of Nasonex, but the full benefits of treatment may not be observed until after 2 days of treatment. Therefore, you should continue to use the nasal spray regularly to achieve the full benefits of treatment.
If you have severe symptoms of hay fever, it may be necessary to start using Nasonex a few days before the expected start of the pollen season. This will help prevent the symptoms of hay fever.

Nasal polyps

Use in adults over 18 years of age

Normally, two sprays are used in each nostril once a day.

• If after 5 to 6 weeks of treatment with Nasonex no improvement occurs, your doctor may advise you to increase the dose to two sprays in each nostril twice a day. After improvement, your doctor may advise you to reduce the dose of the medicine.
• If after 5 to 6 weeks of treatment with Nasonex twice a day no improvement occurs, you should contact your doctor.

Preparing the nasal spray for use

Nasonex nasal spray contains a protective cap that protects the tip of the actuator and prevents it from becoming contaminated. Remember to remove it before using the spray and replace it after use.
Before using the spray for the first time, you should check its operation by pressing the pump 10 times until a fine mist is produced:

• 1. Gently shake the bottle.
• 2. Place your index and middle fingers on either side of the actuator and your thumb under the bottle. Do notpuncture the nasal spray actuator.
• 3. With the actuator pointing away from you, press your fingers together to release 10 sprays, until a fine mist is produced. If the nasal spray has not been used for 14 days or more, press the pump 2 times, until a fine mist is produced, before using it again.

How to use the nasal spray

• 1. Shake the bottle gently and remove the protective cap. (Figure 1)
• 2. Gently blow your nose.
• 3. Close one nostril and insert the actuator into the other nostril, as shown in the picture. (Figure 2) Tilt your head slightly forward, keeping the bottle upright.
• 4. Start to breathe in gently and slowly through your nose, while spraying the medicine (in the form of a fine mist) into your nose, pressing the pump ONCEwith your fingers.
• 5. Breathe out through your mouth. Repeat the steps described in point 4 to administer a second spray into the same nostril, if necessary.
• 6. Remove the actuator from your nostril and breathe out through your mouth.
• 7. Repeat the steps described in points 3 to 6 to administer the spray into the other nostril (Figure 3).

After using the spray, you should carefully wipe the actuator with a clean tissue or cloth and replace the protective cap.
Cleaning

• It is important to regularly clean the nasal spray bottle, as it may not work properly otherwise.
• Remove the protective cap and gently pull off the actuator.
• Wash the actuator and protective cap in warm water, then rinse under running water.

Fig. 1

Fig. 2

Fig. 3

• Do not attempt to unblock the actuator by puncturing it with a needle or other sharp object, as this will damage the actuator and the correct dose of medicine will not be delivered.
• Leave the protective cap and actuator in a warm place to dry.
• Replace the actuator on the bottle, then replace the protective cap.
• After cleaning, check that the actuator is working properly and spray the medicine 2 times.

Using a higher dose of Nasonex than recommended

If you accidentally use a higher dose of Nasonex than recommended, you should contact your doctor.
If steroids are used for a long period or in large doses, they may have an adverse effect on your hormones. In children, they may affect growth and development.

Missing a dose of Nasonex

If you forget to use your nasal spray at the right time, you should use it as soon as you remember, then continue with your normal routine. Do not use a double dose to make up for a missed dose.

Stopping treatment with Nasonex

In some patients, relief of symptoms occurs within 12 hours of administration of the first dose of Nasonex, but the full benefits of treatment may not be observed until after 2 days of treatment. It is very important that you use your nasal spray regularly. Do not stop treatment, even if you feel better, unless your doctor advises you to.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nasonex can cause side effects, although not everybody gets them.
After using this medicine, immediate allergic reactions (hypersensitivity) may occur. These reactions can be severe. You should stop using Nasonex and seek medical help immediately if you experience symptoms such as:

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives
• wheezing or difficulty breathing

If corticosteroids are taken in large doses for a long time, side effects may occur due to the absorption of the medicine into the body.
Other side effects
Most people using nasal sprays do not experience any side effects. However, in some people, after using Nasonex or another corticosteroid nasal spray, the following side effects have occurred:
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 patients with nasal polyps who used two sprays of Nasonex in each nostril twice a day]
• irritated nose or sore throat
• ulceration of the nasal mucosa
• upper respiratory tract infection

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

• increased intraocular pressure (glaucoma) and/or cataracts causing vision disturbances,
• damage to the nasal septum separating the nostrils
• disturbances of taste and smell
• breathing difficulties and/or wheezing
• blurred vision

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Pharmacovigilance Department, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl .
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nasonex

• Keep the medicine out of the sight and reach of children.
• Do not store the bottle in a temperature above 25°C. Do not freeze.
• Do not use this medicine after the expiry date stated on the bottle and carton after EXP. The expiry date refers to the last day of that month.
• The bottle should be used within 2 months of opening. Only open one bottle at a time.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nasonex contains

• The active substance is mometasone furoate. One dose of the nasal spray contains 50 micrograms of mometasone furoate as the monohydrate.
• The other ingredients 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 one dose of the nasal spray.

What Nasonex looks like and contents of the pack

Nasonex is a nasal spray, suspension.
Each bottle contains 140 doses of the medicine.

Marketing authorization holder and manufacturer

Marketing authorization holder

Organon Polska Sp. z o.o.
Marszałkowska 126/134
00-008 Warsaw
Tel.: + 48 22 105 50 01
[email protected]

Manufacturer

Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

This medicinal product is authorized in the Member States of the European Economic Area 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 microgramos suspensión para pulverización nasal

Date of last revision of the leaflet: 11/2022