NASONEX 50 MIKROGRAMÓW Spray do nosa, zawiesina

Treść ulotki

1. NASONEX 50 micrograms/spray nasal spray, suspension
   1. What is Nasonex and what is it 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

[Organon] Owner
[Organon] Owner

NASONEX 50 micrograms/spray nasal spray, suspension

Mometasone furoate

Read this leaflet carefully before you start using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 can help to reduce
inflammation (swelling and irritation of the nose), sneezing, itching and conditions of nasal congestion or
runny nose.

What is Nasonex used for?
Hay fever and perennial rhinitis
Nasonex is used for the treatment of symptoms of hay fever (also called seasonal allergic
rhinitis) and perennial rhinitis in adults and children starting from 3 years of age.
Hay fever that occurs during certain times of the year is an allergic reaction caused
by inhaling pollen from trees, grass, weeds, and also molds and fungal spores.
Perennial rhinitis is present all year round and symptoms can be caused by sensitivity to a
variety of elements, including house dust mites, animal hair (or dander), feathers
and certain foods. Nasonex reduces nasal swelling and irritation, thus relieving sneezing, itching and
conditions of nasal congestion or runny nose caused by hay fever or perennial rhinitis.
Nasal polyps
Nasonex is used for the treatment of nasal polyps in adults starting from 18 years of age.
Nasal polyps are small growths on the nasal mucosa and usually affect both nostrils.
Nasonex reduces inflammation of the nose, causing a gradual shrinking of the polyps,
thus relieving the feeling of nasal obstruction and improving breathing through the nose.

2. What you need to know before using Nasonex

Do not use Nasonex

• if you are allergic (hypersensitive) to mometasone furoate or any of the excipients of this medicine (listed in section 6).

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• if you have an untreated nasal infection. Using Nasonex during an untreated nasal infection, such as herpes, may worsen the infection. You should wait for the infection to resolve before starting to use the nasal spray.
• if you have recently had nasal surgery or suffered a nasal trauma. You should not use the nasal spray until the nasal problem has resolved.

Warnings and precautions
Consult your doctor or pharmacist before using Nasonex

• if you suffer or have suffered from tuberculosis.
• if you suffer from any other infection.
• if you are taking other corticosteroids, either orally or by injection.
• if you have cystic fibrosis.

During the use of Nasonex, consult your doctor

• if your immune system is not functioning properly (difficulty fighting infections) and if you should come into contact with a person affected by measles or chickenpox. Avoid contact with people who have these infections.
• if you have an infection of the nose or throat.
• if you use this medicine for several months or longer.
• if you have persistent irritation of the nose or throat.

The use of nasal sprays based on corticosteroids at high doses for long periods of time can lead to
the development of undesirable effects due to the absorption of the medicine within the body.
If you experience itching or irritation of the eyes, your doctor may prescribe other treatments to use
together with Nasonex.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
If used at high doses and for long periods of time, nasal sprays based on corticosteroids
can cause some undesirable effects, for example, a delay in growth in children.
It is recommended to regularly check the height of children undergoing prolonged treatment with
nasal corticosteroids and to inform the 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 medicine, including medicines obtained without a prescription.
If you are taking other corticosteroid medicines to treat allergies, either orally or by
injection, your doctor may advise you to stop that treatment when you start using
Nasonex. When stopping treatment with oral or injectable corticosteroids, some people
may experience undesirable effects, such as joint or muscle pain, weakness and depression. You
may also seem to develop other allergies, such as itching, tearing or red and
itchy patches on the skin. Consult your doctor if you notice any of these effects.
Some medicines can increase the effects of Nasonex and your doctor may want to keep you under
close observation if you are taking these medicines (including some medicines for the treatment
of HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding
Information on the use of Nasonex in pregnant women is limited or absent. It is not known whether
mometasone furoate passes into breast milk.
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If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

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

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

3. How to use Nasonex

Use Nasonex following the doctor's instructions exactly. If you have any doubts, consult your doctor or pharmacist. Do not use higher doses or 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 a day.

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

Use in children from 3 to 11 years of age
The usual dose is one spray in each nostril once a day.
In some patients, Nasonex begins to relieve symptoms within 12 hours of administration; however, the full benefit of treatment may not be seen for the first two days. Therefore, you must continue regular use to obtain 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 the pollen season: this will help prevent the onset of hay fever symptoms.

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

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

How to prepare the nasal spray for use
Nasonex nasal spray is equipped with a dust cap, which protects the sprayer and keeps it clean.
Remember to remove it before using the spray and reposition it after use.
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If you are using the spray for the first time, you will need to prime the pump 10 times until you see a uniform jet:

• 1. Gently shake the bottle.
• 2. Place your index and middle fingers on either side of the sprayer, your thumb under the base of the bottle. Do notpuncture the nasal applicator.
• 3. To prime the spray, point the sprayer away from yourself and press 10 times with your fingers until you get a uniform jet. If you have not used the spray for 14 days or more, you will need to prime the pump 2 times until you see a uniform jet.

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 sprayer into the other, as illustrated. (Figure 2) Tilt your head slightly forward, keeping the bottle upright.
• 4. Start inhaling gently or slowly through your nose and administer one spray of spray into your nose by pressing ONCE with your fingers.
• 5. Exhale through your mouth. Repeat step 4 to inhale a second spray into the same nostril, if necessary.
• 6. Remove the sprayer from the nostril and exhale through your mouth.
• 7. Repeat steps 3 to 6 for the other nostril. (Figure 3)

After using the product, clean the sprayer thoroughly with a tissue or clean cloth and reposition 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 sprayer.
• Wash the sprayer and dust cap with lukewarm water, then rinse under running water.
• Do not attempt to unblock the nasal applicator by inserting a pin or other sharp object as this maneuver will damage the nasal applicator and will not allow you to have the correct dose of the medicine.
• Let the dust cap and sprayer dry in a warm place.
• Reposition the sprayer on the bottle and put the dust cap back on.
• The spray needs to be re-primed with at least 2 sprays at first use after cleaning.

If you use more Nasonex than you should
Inform your doctor if you have accidentally used more than you should.
In rare cases, prolonged or high-dose use of steroids can affect the levels of some hormones. In children, this effect can affect growth and development.

If you forget to use Nasonex
If you forget to use the nasal spray at the correct time, use it as soon as you remember, then continue as usual. Do not use a double dose to make up for the missed one.

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If you stop using Nasonex
In some patients, symptoms will begin to be relieved within 12 hours of the first dose of Nasonex; however, a full therapeutic benefit may not be seen before two days. It is very important that you use the nasal spray regularly. Do not stop treatment, even if you feel better, until your doctor tells you to.
For further questions regarding 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 everybody gets them.
With the use of this medicine, immediate hypersensitivity (allergic) reactions may occur.
These reactions can be serious. You must stop using Nasonex and seek immediate
medical assistance if any of the following symptoms appear:

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

When nasal sprays containing corticosteroids are used at high doses for long periods of time,
side effects due to absorption of the medicine into the
body may occur.
Other side effects
Most people do not have problems with the use of the nasal spray. However, some people,
after using Nasonex or other corticosteroid nasal sprays, may experience:
Common side effects (may affect up to 1 in 10 people):

• headache
• sneezing
• nosebleed (epistaxis) [very common (may affect more than 1 in 10 people) in people with nasal polyps treated with two sprays of Nasonex in each nostril twice a day]
• pain in the nose or throat
• ulcers in the nose
• respiratory tract infections

Not known (frequency cannot be estimated from 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 shortness of breath
• blurred vision

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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.
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5. How to store Nasonex

• Keep this medicine out of the sight and reach of children.
• Do not store the bottle at a temperature above 25 °C. Do not freeze.
• Do not use this medicine after the expiry date stated on the bottle and the packaging box 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 in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Nasonex contains

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

Description of Nasonex 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.
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
Manufacturer:
Schering-Plough Labo NV,
Heist-op-den Berg, Belgium

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