Nasonex

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Nasonex, 50 µg/dose, nasal spray, suspension
Mometasoni furoas
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Nasonex is and what it is 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 Nasonex is and what it is used for

What is Nasonex?
Nasonex nasal spray contains mometasone furoate, which belongs to a group of medicines called corticosteroids. Mometasone furoate administered intranasally reduces inflammation (swelling and irritation of the nasal mucosa), sneezing, itching, nasal congestion, and nasal discharge.
What is Nasonex used for?
Allergic rhinitis and perennial rhinitis
Nasonex is used to treat symptoms of seasonal allergic rhinitis (also known as hay fever) and perennial allergic rhinitis in adults and children aged 3 years and older.
Seasonal allergic rhinitis, 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 fungus spores.
Perennial rhinitis occurs throughout the year, and symptoms may be triggered by various allergens, including house dust mites, pet dander (or shed skin), feathers, and certain foods. Nasonex reduces swelling and irritation of the nasal mucosa, thereby relieving sneezing, itching, nasal congestion, or nasal discharge caused by hay fever or perennial rhinitis.
Nasal polyps
Nasonex is used in the treatment of nasal polyps in adults aged 18 years and older. Nasal polyps are small growths on the nasal mucosa, usually occurring in both nostrils.
Page 1 of 7
Nasonex reduces inflammation in the nose, leading to gradual shrinkage of nasal polyps, thus relieving nasal congestion that may impair breathing through the nose.

2. Important information before using Nasonex

When not to use Nasonex

• if the patient is allergic (hypersensitive) to mometasone furoate or any of the other ingredients of this medicine (listed in section 6).
• if the patient has an untreated nasal infection. Using Nasonex during an untreated nasal infection, such as herpes simplex, may worsen the symptoms of infection. Nasal spray should not be used until the infection has healed.
• if the patient has recently undergone nasal surgery or has suffered a nasal injury. The nasal spray should not be used until wounds have healed.

Warnings and precautions
Before starting to use Nasonex, discuss with your doctor or pharmacist:

• if the patient currently has or has ever had tuberculosis in the past.
• if the patient has any other infection.
• if the patient is taking other corticosteroids orally or by injection.
• if the patient has cystic fibrosis.

While using Nasonex, consult your doctor:

• if the patient's immune system is not functioning properly (difficulty fighting infections) and the patient has been in contact with someone who has measles or chickenpox. Contact with individuals who have these infections should be avoided.
• if the patient develops a nasal or throat infection.
• if the medicine is used for several months or longer.
• if the patient experiences prolonged irritation of the nose or throat.

If nasal corticosteroid sprays are used at high doses for a prolonged period,
adverse effects due to systemic absorption of the drug may occur.
If eye itching or irritation occurs, the doctor may recommend alternative treatment with Nasonex.
If the patient experiences blurred vision or other visual disturbances, they should contact the
doctor.
Children
If nasal corticosteroid sprays are used at high doses for a prolonged period,
they may cause certain adverse effects, such as slowed growth rate in children.
It is recommended that children receiving long-term treatment with intranasal corticosteroids have their growth regularly monitored, and any changes should be reported to the
doctor.
Nasonex and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those obtained without a prescription.
Page 2 of 7
If the patient is taking other corticosteroids orally or by injection for the treatment of allergies, the treating doctor may advise the patient to discontinue their use when starting Nasonex. In some patients, after stopping oral or injectable corticosteroids, adverse effects such as joint or muscle pain, weakness, and depression may occur. Other allergic symptoms such as itching, watery eyes, or red, itchy skin rashes may also appear. The patient should contact the doctor if any of these symptoms occur.
Some medicines may increase the effect of Nasonex, and the doctor may wish to closely monitor the patient taking such medicines (including certain HIV medications: ritonavir, cobicistat).
Pregnancy and breastfeeding
There are no data or only limited data on the use of Nasonex in pregnant women.
It is not known whether mometasone furoate passes into human milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
There are no data on the influence of Nasonex on the ability to drive or operate machinery.
Nasonex contains benzalkonium chloride
Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a prolonged period.

3. How to use Nasonex

Nasonex should always be used exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist. Do not use the nasal spray more often, for longer, or in higher doses than prescribed by your doctor.

Treatment of seasonal and perennial allergic rhinitis

Use in adults and children aged 12 years and older
The usual dose is two sprays into each nostril once daily.

• Once symptoms improve, your doctor may recommend reducing the dose.
• If you do not experience symptom relief, contact your doctor, who may recommend increasing the dose: the maximum daily dose is 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.

Some patients may experience symptom relief within 12 hours after the first dose of Nasonex, but full benefits of treatment may not be evident during the first two days of therapy. Therefore, it is important to continue regular use to achieve the full therapeutic benefit.

Page 3 of 7
If your seasonal allergy symptoms are severe, it may be necessary to start using Nasonex several days before the expected start of pollen season. This may help prevent the onset of seasonal allergy symptoms.

Nasal polyps

Use in adults aged 18 years and older
The usual initial dose is two sprays into each nostril once daily.

• If there is no improvement after 5 to 6 weeks of treatment, your doctor may recommend increasing the dose to two sprays into each nostril twice daily. Once improvement occurs, your doctor may then recommend reducing the dose.
• If there is no improvement after 5 to 6 weeks of twice-daily dosing, you should contact your doctor.

Preparing the nasal spray for use

Nasonex nasal spray comes with a protective cap that covers the spray nozzle and helps prevent contamination. Remember to remove the cap before using the spray and replace it after each use.

Before first use, prime the pump by pressing it 10 times until a fine mist appears:

1. Gently shake the bottle.
2. Place your index and middle fingers on either side of the spray nozzle and your thumb under the bottle. Do not pierce the nasal spray nozzle.
3. Point the nozzle away from you and press down with your fingers 10 times until a uniform mist is produced. If the nasal spray has not been used for 14 days or more, prime the pump by pressing it 2 times until a uniform mist appears before next use.

How to use the nasal spray

1. Gently shake the bottle and remove the protective cap. (Figure 1)
2. Gently blow your nose.
3. Close one nostril and insert the spray nozzle into the other nostril, as shown in the illustration. (Figure 2) Tilt your head slightly forward and hold the bottle upright.
4. Begin a gentle, slow inhalation through the nose while pressing down once with your fingers to release a spray (as a fine mist) into the nostril.
5. Breathe out through your mouth. Repeat step 4 to administer a second spray into the same nostril, if required.
6. Remove the spray nozzle from the nostril and breathe out through your mouth.
7. Repeat steps 3 to 6 to administer the spray into the other nostril. (Figure 3)

After using the nasal spray, carefully wipe the spray nozzle with a clean tissue or cloth and replace the protective cap.

Page 4 of 7

Cleaning

• It is important to clean the nasal spray bottle regularly, as blockage may prevent proper functioning.
• Remove the protective cap and gently pull off the spray nozzle.
• Wash the spray nozzle and protective cap with warm water, then rinse thoroughly under running water.
• Do not unblock the spray nozzle by piercing it with a needle or any other sharp object, as this may damage the spray device and result in incorrect dosing.
• Leave the protective cap and spray nozzle in a warm place to dry completely.
• Reattach the spray nozzle to the bottle, then replace the protective cap.
• After cleaning, check that the spray device works properly by spraying twice.

If you use more Nasonex than you should

If you accidentally use more Nasonex than prescribed, consult your doctor. Prolonged or high-dose use of corticosteroids may rarely affect hormone function. In children, this may affect growth and development.

If you forget to use Nasonex

If you forget to use the nasal spray at the scheduled time, use it as soon as you remember, then continue with your regular dosing schedule. Do not use a double dose to make up for a missed dose.

Stopping Nasonex

Some patients may experience symptom relief within 12 hours after the first dose of Nasonex, but full benefits of treatment may not be evident until after 2 days of use. It is very important to use the nasal spray regularly. Do not stop treatment, even if you feel better, unless instructed by your doctor.

If you have any further questions about the use of this medicine, consult 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 may be severe. You should stop using Nasonex and seek immediate medical help if you experience symptoms such as:

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

When nasal corticosteroid sprays are used at high doses for prolonged periods, adverse effects may occur due to systemic absorption of the medicine.
Other adverse effects
Page 5 of 7
Most people using nasal sprays do not report any adverse effects.
However, in some individuals, the following adverse effects have been reported after using Nasonex or other corticosteroid nasal sprays:
Common adverse effects (may occur in up to 1 in 10 people):

• headache
• sneezing
• nosebleeds [occurred very commonly (may affect more than 1 in 10 people) in patients with nasal polyps who used two doses of Nasonex in each nostril twice daily]
• irritated nose or sore throat
• nasal mucosal ulceration
• upper respiratory tract infection

Frequency unknown (frequency cannot be estimated from available data):

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Nasonex

• Do not store at temperatures above 25°C. Do not freeze.
• Keep the medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the stated month.
• The bottle should be used within 2 months of opening. Only one bottle should be opened within this period.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Nasonex contains
Page 6 of 7

• The active substance is mometasone furoate. One spray dose contains 50 micrograms of mometasone furoate in monohydrate form.
• The other ingredients are: dispersible cellulose (microcrystalline cellulose and sodium carmellose), glycerol, monohydrate citric acid, sodium citrate, polysorbate 80, benzalkonium chloride, purified water.
• This medicine contains 0.02 mg of benzalkonium chloride per spray dose.

What Nasonex looks like and contents of the pack
Nasonex is a nasal spray, suspension.
Each bottle contains 140 doses of medicine.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Belgium, country of export:
Organon Belgium, Handelsstraat 31/Rue du Commerce 31, B-1000 Brussels, Belgium
Manufacturer:
NV Schering-Plough Labo, Industriepark 30, B-2220 Heist-op-den-Berg, Belgium
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Belgium, country of export, Marketing Authorisation number: BE190854
Parallel import licence number: 168/22
This medicinal product is authorised for marketing 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, the Netherlands, Norway, Poland, Slovenia, Sweden, United Kingdom:
Nasonex
Bulgaria, Czech Republic, Romania, Slovakia: NASONEX
Latvia: Nasonex 50 micrograms/nasal aerosol, suspension
Portugal: Nasomet
Spain: NASONEX 50 micrograms suspension for nasal spray
Page 7 of 7