Nasonex

PACKAGE LEAFLET

Package leaflet: Information for the user

NASONEX 50 micrograms/dose nasal spray, suspension

Mometasone furoate
Please read this leaflet carefully before using this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 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. When mometasone furoate is sprayed into the nose, it helps reduce inflammation (swelling and irritation of the nose), sneezing, itching, and symptoms of a blocked or runny nose.
What is Nasonex used for?
Hay fever and perennial rhinitis
Nasonex is used to treat symptoms of hay fever (also known as seasonal allergic rhinitis) and perennial rhinitis in adults and children aged 3 years and older.
Hay fever occurring at certain times of the year is an allergic reaction caused by inhaling pollen from trees, grass, weeds, as well as moulds and fungal spores.
Perennial rhinitis is present all year round, and symptoms may be triggered by sensitivity to various substances, including house dust mites, animal fur (or dander), feathers, and certain foods. Nasonex reduces nasal swelling and irritation, thereby relieving sneezing, itching, and a blocked 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 nasal mucosa and usually affect both nostrils. Nasonex reduces nasal inflammation, leading to a gradual shrinkage of the polyps, thereby relieving the sensation of nasal blockage and improving nasal breathing.

2. What you need to know before using Nasonex

Do not use Nasonex

• if you are allergic (hypersensitive) to mometasone furoate or to any of the excipients of this medicine (listed in section 6).
• if you have an untreated nasal infection. Using Nasonex during an untreated nasal infection, such as herpes, may worsen the infection. You must wait until the infection has resolved before starting to use the nasal spray.
• if you have recently had nasal surgery or nasal trauma. You must not use the nasal spray until the nasal condition has healed.

Warnings and precautions
Talk to your doctor or pharmacist before using 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, talk to your doctor

• if your immune system is not working properly (difficulty fighting infections) and if you are exposed to someone with measles or chickenpox. Avoid contact with people who have these infections.
• if you develop a nasal 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.

Prolonged use of corticosteroid nasal sprays at high doses may lead to unwanted effects due to absorption of the medicine into the body.
If you experience eye itching or irritation, your doctor may prescribe additional treatments to be used alongside Nasonex.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
When used at high doses and for prolonged periods, corticosteroid nasal sprays may cause certain adverse effects, such as delayed growth in children.
Regular monitoring of height is recommended in children undergoing long-term treatment with nasal corticosteroids, and you should inform your doctor if any changes are noticed.

Other medicines and Nasonex
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
If you are taking other corticosteroid medicines for allergy treatment, either orally or by injection, your doctor may advise you to stop that treatment when starting Nasonex. After stopping oral or injectable corticosteroid therapy, some people may experience adverse effects such as joint or muscle pain, weakness, and depression. You may also feel as though you are developing new allergies, such as itching, tearing eyes, or red, itchy skin rashes. Consult your doctor if you notice any of these effects.
Some medicines may increase the effects of Nasonex, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Pregnancy and breastfeeding
Information on the use of Nasonex in pregnant women is limited or unavailable. It is not known whether mometasone furoate passes into breast milk.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
There is no available information on the effects of Nasonex on the ability to drive or operate machinery.

Nasonex contains benzalkonium chloride
Benzalkonium chloride may cause irritation and swelling inside the nose, especially if used for prolonged periods.

3. How to use Nasonex

Use Nasonex exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. Do not use higher doses, more frequently, or for longer than prescribed by your doctor.

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 daily.

• Once symptoms are under control, your doctor may advise you to reduce the dose.
• If you do not notice any improvement, consult your doctor, who may prescribe an increase in dose; the maximum daily dose is four sprays in each nostril once daily.

Use in children aged 3 to 11 years
The usual dose is one spray in each nostril once daily.
In some patients, Nasonex begins to relieve symptoms within 12 hours after the first dose; however, the full therapeutic benefit may not be evident until after two days. Therefore, you must continue regular use to achieve the full benefit of treatment.
If you or your child suffers from severe hay fever, your doctor may advise you to start using Nasonex a few days before the expected start of pollen season: this will help prevent the onset of hay fever symptoms.

Nasal polyps
Use in adults over 18 years of age
The usual starting dose is two sprays in each nostril once daily.

• If symptoms are not controlled after 5 or 6 weeks, the dose may be increased to two sprays in each nostril twice daily. When symptoms are under control, your doctor may advise you to reduce the dose.
• If symptoms do not improve after 5 or 6 weeks of twice-daily dosing, contact your doctor.

How to prepare the nasal spray for use
Nasonex nasal spray is equipped with a dust cap that protects the nozzle and keeps it clean. Remember to remove it before using the spray and to replace it after use.
If you are using the spray for the first time, you must prime the pump by pressing it 10 times until you see a fine, uniform spray:

1. Gently shake the bottle.
2. Place your index and middle fingers on either side of the nozzle, and your thumb under the base of the bottle. Do not pierce the nasal applicator.
3. To prime the spray, point the nozzle away from yourself and press down 10 times with your fingers until you obtain a uniform spray. If you have not used the spray for 14 days or more, you must re-prime the pump by pressing it 2 times until you see a uniform spray.

How to use the nasal spray

1. Gently shake the bottle and remove the dust cap. (Figure 1)
2. Gently blow your nose.
3. Close one nostril and insert the nozzle into the other, as illustrated. (Figure 2) Tilt your head slightly forward, keeping the bottle upright.
4. Begin to inhale gently or slowly through your nose and administer one spray into the nostril by pressing ONCE with your fingers.
5. Breathe out through your mouth. Repeat step 4 to administer a second spray into the same nostril, if required.
6. Remove the nozzle from the nostril and breathe out through your mouth.
7. Repeat steps 3 to 6 for the other nostril. (Figure 3)

After using the product, clean the nozzle thoroughly with a tissue or clean cloth and replace the dust cap.
How to clean the nasal spray

• It is important to clean the nasal spray regularly; otherwise, it may not work properly.
• Remove the dust cap and gently pull off the nozzle.
• Wash the nozzle and dust cap with warm water, then rinse under running water.
• Do not attempt to unblock the nasal applicator by inserting a pin or any other sharp object, as this may damage the applicator and prevent you from receiving the correct dose of medication.
• Allow the dust cap and nozzle to dry in a warm place.
• Reattach the nozzle to the bottle and replace the dust cap.
• After cleaning, the spray must be re-primed with at least 2 sprays before first use.

If you use more Nasonex than you should
Inform your doctor if you have accidentally used more than the prescribed amount.
In rare cases, prolonged use or high doses of steroids may affect levels of certain hormones. In children, this effect may impact 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 as usual. Do not use a double dose to make up for the missed dose.

If you stop using Nasonex
In some patients, symptoms begin to improve within 12 hours after the first dose of Nasonex; however, full therapeutic benefit may not be evident until after two days. It is very important that you use the nasal spray regularly. Do not stop treatment, even if you feel better, unless instructed by your doctor.

For further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Immediate hypersensitivity (allergic) reactions may occur with the use of this medicine.
These reactions can be severe. You must stop using Nasonex and seek immediate medical help if any of the following symptoms occur:

• swelling of the face, tongue or pharynx
• difficulty swallowing
• hives
• shortness of breath or breathing difficulties

When corticosteroid nasal sprays are used at high doses for long periods of time, side effects due to systemic absorption of the medicine may occur.

Other side effects
Most people do not experience problems when using the nasal spray. However, some people may experience the following after using Nasonex or other corticosteroid nasal sprays:

Common side effects (may affect up to 1 in 10 people):

• headache
• sneezing
• nosebleeds (epistaxis) [reported very commonly (may affect more than 1 in 10 people) in people with nasal polyps treated with two sprays of Nasonex in each nostril twice daily]
• nasal or throat pain
• nasal ulcers
• respiratory tract infections

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

• increased pressure inside the eye (glaucoma) and/or cataracts causing visual disturbances
• damage to the nasal septum separating the nostrils
• changes in taste and smell
• difficulty breathing and/or breathlessness
• blurred vision

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nasonex

• Keep this medicine out of the sight and reach of children.
• Do not store the bottle 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 must be used within 2 months of first opening. Open one bottle at a time.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Nasonex contains

• The active substance is mometasone furoate. Each spray contains 50 micrograms of mometasone furoate monohydrate.
• The excipients are dispersible cellulose, glycerol, sodium citrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride, purified water.
• This medicinal product contains 0.02 mg of benzalkonium chloride per spray.

Description of the appearance of Nasonex and package contents
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.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Roma
Italy

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

This medicinal product is authorised in the European Economic Area countries 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, Slovak Republic: NASONEX
Latvia: Nasonex 50 mikrogrami/deva deguna aerosols, suspensija
Portugal: Nasomet
Spain: NASONEX 50 microgramos suspensión para pulverización nasal