Package Leaflet: Information for the User

BRUSONEX 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this package leaflet:

What BRUSONEX is and what it is used for
What you need to know before using BRUSONEX
How to use BRUSONEX
Possible side effects
How to store BRUSONEX
Contents of the pack and other information

1. What is BRUSONEX and what is it used for

What is BRUSONEX?
BRUSONEX 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 in the nose), sneezing, itching, and symptoms of a blocked or runny nose.
Mometasone furoate should not be confused with the anabolic steroids inappropriately used by some athletes and taken as tablets or by injection.

What is BRUSONEX used for?

Hay fever and perennial rhinitis
BRUSONEX 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 occurs at certain times of the year and 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 a variety of substances, including house dust mites, animal fur (or dander), feathers, and certain foods. BRUSONEX reduces nasal swelling and irritation, thereby relieving sneezing, itching, and a blocked or runny nose caused by hay fever or perennial rhinitis.

Nasal polyps
BRUSONEX 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. BRUSONEX reduces nasal inflammation, leading to a gradual shrinkage of the polyps, thereby relieving nasal obstruction and improving nasal breathing.

2. What you need to know before using BRUSONEX

Do not use BRUSONEX

If you are allergic (hypersensitive) 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 BRUSONEX 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 BRUSONEX:

if you have or have had tuberculosis.
If you have an eye infection.
If you have any other infection.
If you are taking other corticosteroids, either orally or by injection.
If you have cystic fibrosis.

While using BRUSONEX, 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.

Using corticosteroid nasal sprays at high doses for long periods may lead to unwanted effects due to systemic absorption of the medicine.
If you experience eye itching or irritation, your doctor may prescribe additional treatments to use alongside BRUSONEX.
Use of this nasal spray may result in positive anti-doping test results.
Children
When used at high doses and for prolonged periods, corticosteroid nasal sprays may cause certain adverse effects, such as delayed growth in children.
It is recommended to regularly monitor the height of children undergoing long-term treatment with nasal corticosteroids and to inform your doctor if any changes are noticed.
Other medicines and BRUSONEX

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking other corticosteroid medicines for allergy treatment, either orally or by injection, your doctor may advise you to stop such treatment when starting BRUSONEX. After stopping oral or injectable corticosteroid therapy, some people may experience adverse effects such as joint or muscle pain, weakness, and depression. In such cases, inform your doctor, who will provide advice on using the nasal spray. You may also feel as though you are developing other allergies, such as itching, tearing, or red, itchy skin rashes. Consult your doctor if you notice any of these symptoms.

Pregnancy, breastfeeding, and fertility
Information on the use of BRUSONEX in pregnant women is limited or lacking. 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 breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
There is no information available on the effects of BRUSONEX on the ability to drive or operate machinery.
BRUSONEX contains benzalkonium chloride
BRUSONEX contains the excipient benzalkonium chloride in solution (20 micrograms per spray), which is irritating and may cause skin reactions. If used for prolonged periods, the preservative benzalkonium chloride may cause swelling of the nasal mucosa. If such a reaction occurs (persistent nasal congestion), use nasal medicines without benzalkonium chloride, if possible. If such medicines are not available, consider using another type of pharmaceutical formulation.

3. How to use BRUSONEX

BRUSONEX is for nasal use only.
Always use BRUSONEX exactly as advised by your doctor or pharmacist. If you are unsure, consult
your doctor or pharmacist. Do not use higher doses, more frequent doses, or use it 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 2 sprays into each nostril once daily.
Once symptoms are under control, your doctor may recommend reducing the dose to 1 spray into
each nostril once daily.
If you do not notice any improvement, consult your doctor, who may prescribe an increase in dose;
the maximum daily dose is 4 sprays into each nostril once daily.
Treatment of hay fever and perennial rhinitis
Use in children aged 3 to 11 years
The usual dose is 1 spray into each nostril once daily.
If you or your child suffers from severe hay fever, your doctor may advise you to start using
BRUSONEX before the pollen season begins, as this will help prevent the onset of hay fever
symptoms.
After the pollen season ends, hay fever symptoms may improve and treatment may no longer be
necessary.
Nasal polyposis
Use in adults over 18 years of age
The usual starting dose is 2 sprays into each nostril once daily.
If symptoms are not controlled after 5 or 6 weeks, the dose may be increased to 2 sprays into each
nostril twice daily. Once symptoms are under control, your doctor may recommend reducing the
dose.
If symptoms do not improve after 5 or 6 weeks of twice-daily administration, contact your doctor.
Method of administration
How to prepare the nasal spray for use
BRUSONEX 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 10 times until you observe a
uniform spray:

Gently shake the bottle.
Place your index and middle fingers on either side of the nozzle and your thumb at the base of the bottle.
To prime the spray, point the nozzle away from yourself and press down with your fingers until a uniform spray is produced. If you have not used the spray for 14 days or more, you must re-prime the pump 2 times until you observe a uniform spray. At the usual dose of 2 sprays into each nostril once daily, for the treatment of hay fever, perennial rhinitis, and nasal polyposis, this product is sufficient for a 30-day treatment (bottle containing 120 sprays) or 35 days (bottle containing 140 sprays).

How to use the nasal spray.

Gently shake the bottle and remove the dust cap.
Gently blow your nose.
Close one nostril and insert the nozzle into the other. Tilt your head slightly forward, keeping the bottle upright.
Begin to inhale gently or slowly through your nose and administer one spray into the nostril by pressing ONCE with your fingers.
Exhale through your mouth. Repeat step 4 to administer a second spray into the same nostril.
Remove the nozzle from the nostril and exhale through your mouth.
Repeat steps 3 to 6 for the other nostril. 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 remove the nozzle. Wash the nozzle and dust cap with lukewarm water, then
rinse under running water.
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 BRUSONEX than you should
It is important that you take the dose as instructed in this leaflet or as prescribed by your doctor.
Using a higher or lower dose may worsen your symptoms.
Inform your doctor if you have accidentally used more than prescribed.
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 BRUSONEX
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 a missed dose.
If you stop using BRUSONEX
In some patients, symptoms may begin to improve within 12 hours of the first dose of BRUSONEX.
However, a 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 experiences them.
Immediate hypersensitivity (allergic) reactions may occur with the use of this medicine. These reactions can be severe. You must stop using BRUSONEX and seek immediate medical assistance if any of the following symptoms occur:

swelling of the face, tongue or pharynx
difficulty swallowing
hives (urticaria)
shortness of breath or breathing difficulties

When corticosteroid nasal sprays are used at high doses for prolonged periods, adverse 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, after using BRUSONEX or other corticosteroid nasal sprays, may experience:
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 patients with nasal polyps treated with two sprays of Brusonex in each nostril twice daily]
Pain in the nose or throat
Nasal ulcers
Respiratory tract infections

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

Increased eye pressure (glaucoma) and/or cataracts causing visual disturbances
Damage to the nasal septum separating the nostrils
Alteration of taste or smell
Difficulty breathing and/or breathlessness

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

5. How to store BRUSONEX

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use BRUSONEX after the expiry date stated on the vial and the carton. The expiry date refers to the last day of that month.
Each vial should be used within two months of first opening. Open only one vial at a time.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BRUSONEX contains

The active substance is: mometasone furoate. Each delivered dose contains 50 micrograms of mometasone furoate monohydrate.
The other components are: benzalkonium chloride, glycerol, polysorbate 80, microcrystalline cellulose and sodium carboxymethylcellulose, citric acid monohydrate, sodium citrate, purified water.

Description of the appearance of BRUSONEX and contents of the pack
BRUSONEX is a nasal spray, suspension.
Each bottle may contain 120 or 140 sprays.
Bottles containing 120 or 140 sprays are sold in single packs.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Bruschettini s.r.l.
Via Isonzo, 6 – 16147 Genoa (GE) – ITALY

Manufacturer
FARMEA
10, rue Bouché Thomas
Z.A.C d’Orgemont
49000 ANGERS
France

This medicinal product is authorized in the European Economic Area countries under the
following names:
Denmark – Rinometasone
Italy – BRUSONEX