BRUSONEX 50 MICROGRAMS Nasal spray, suspension

Зміст інструкції

1. BRUSONEX 50 micrograms/spray Nasal Spray, Suspension
   1. What BRUSONEX is and what it is used for
   2. What you need to know before using BRUSONEX
   3. How to use BRUSONEX
   4. Possible side effects
   5. How to store BRUSONEX
   6. Contents of the pack and other information

BRUSONEX 50 micrograms/spray Nasal Spray, Suspension

Mometasone Furoate

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 their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• 1. What BRUSONEX is and what it is used for
• 2. What you need to know before you use BRUSONEX
• 3. How to use BRUSONEX
• 4. Possible side effects
• 5. How to store BRUSONEX
• 6. Contents of the pack and other information

1. What BRUSONEX is and what it is 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 can help to reduce
inflammation (swelling and irritation of the nose), sneezing, itching and conditions of a
blocked or runny nose.
Mometasone furoate should not be confused with “anabolic” steroids improperly used
by some athletes and taken as tablets or by injection.

What is BRUSONEX used for?
Hay fever and perennial rhinitis
BRUSONEX is used for the treatment of the symptoms of hay fever(also known as seasonal allergic rhinitis )and perennial rhinitisin adults and children from 3 years of age.
Hay fever that occurs at 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. BRUSONEX reduces swelling and irritation of the nose, and thus sneezing, itching and conditions of a blocked or runny nose caused by hay fever or
perennial rhinitis.
Nasal polyps
BRUSONEX is used for the treatment of nasal polypsin adults from 18 years of age.
Nasal polyps are small growths on the nasal mucosa and usually affect both
nostrils. BRUSONEX 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 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 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
Talk to your doctor or pharmacist before using BRUSONEX:

• if you suffer from or have suffered from tuberculosis.
• If you suffer from an eye infection.
• 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 BRUSONEX, talk to your doctor

• if your immune system does not function 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 high doses of corticosteroids 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 BRUSONEX.
The use of this nasal spray may determine positive results in doping tests.

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 the child's growth.
It is recommended to regularly check the height of children undergoing prolonged treatment with
nasal corticosteroids and to inform the doctor if you notice any changes.

Other medicines and BRUSONEX

• Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicine.
• If you are taking other corticosteroid medicines to treat allergies, either orally or by injection, your doctor may advise you to stop such treatment when you start using BRUSONEX. When stopping treatment with oral or injectable corticosteroids, some people may experience undesirable effects, such as joint or muscle pain, weakness and depression. In this case, it is necessary to inform the doctor who will give you advice on the use of the nasal spray. 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 the appearance of any of these effects.

Pregnancy, breastfeeding and fertility
Information on the use of BRUSONEX in pregnant women is scarce or absent. It is not known
whether mometasone furoate passes into breast milk.
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 operating machinery
No information is available on the effects of BRUSONEX on the ability to drive vehicles or
operate machinery.

BRUSONEX contains benzalkonium chloride
BRUSONEX contains the excipient benzalkonium chloride in solution (20 micrograms per
delivery), which is irritating and can cause skin reactions. If used for long periods, the
preservative benzalkonium chloride can cause swelling of the nasal mucosa. If this
reaction occurs (persistent nasal congestion), if possible, use nasal medicines without benzalkonium chloride. If these types of medicines are not available, use
another type of pharmaceutical formulation.

3. How to use BRUSONEX

BRUSONEXis for nasal use only.
Always use BRUSONEX exactly as your doctor or pharmacist has told you. If you have any
doubts, ask 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 doseis 2 sprays in each nostril once a day.
Once your symptoms are under control, your doctor may advise you to administer
only one spray in each nostril once a day.
If you do not experience any improvement, consult your doctor, who may prescribe
an increase in the dose; the maximum daily dose is 4 sprays in each nostril once a
day.

Treatment of hay fever and perennial rhinitis
Use in children from 3 to 11 years of age.
The usual doseis one spray in each nostril once a day.
If you or your child suffers from severe hay fever, your doctor may advise you to start using
BRUSONEX before the start of the pollen season, as this will help prevent the
onset of hay fever symptoms.
At the end of the pollen season, the symptoms of hay fever may have improved and
treatment may no longer be necessary.

Nasal polyposis
Use in adults over 18 years of age
The usual starting doseis 2 sprays in each nostril once a day.
If, after 5 or 6 weeks, your symptoms are still not under control, the dose may be increased
to 2 sprays in each nostril twice a day. When your symptoms are under control, your
doctor may advise you to reduce the dose.
If your symptoms do not improve after 5 or 6 weeks of twice-daily administration,
contact your doctor.

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

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

How to use the nasal spray.

• 1. Gently shake the bottle and remove the dust cap
• 2. Gently blow your nose.
• 3. Close one nostril and insert the nozzle into the other. 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.
• 6. Remove the nozzle from the nostril and exhale through your mouth.

• 7. Repeat steps 3 to 6 for the other nostril. After using the product, clean the nozzle 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
correctly. Remove the dust cap and gently pull off the spray nozzle. Wash the
nozzle and dust cap with lukewarm water, then rinse under running water.
Let the dust cap and nozzle dry in a warm place.
Reposition the nozzle on the bottle and put the dust cap back on.
The spray needs to be re-primed with at least 2 sprays after the
cleaning.

If you use more BRUSONEX than you should
It is important that you take the dose following the instructions in this leaflet, or
according to your doctor's prescription. Using a higher or lower dose may worsen your symptoms.
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 BRUSONEX
If you forget to use the nasal spray at the right 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.

If you stop using BRUSONEX
In some patients, symptoms will begin to be relieved within 12 hours of administering
the first dose of BRUSONEX. However, 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 BRUSONEX and seek immediate medical
attention if any of the following symptoms occur:

• swelling of the face, tongue or throat
• difficulty swallowing
• urticaria
• 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 experience problems with the use of 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
• Nosebleed (epistaxis) [very common (may affect more than 1 in 10 people) in people with nasal
  polyps treated with two sprays of Brusonex in each nostril twice daily]
• Nose or throat pain
• Nasal ulcers
• Respiratory tract infections.

Not known (frequency cannot be estimated based on 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 shortness of breath

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through 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 at a temperature above 25°C
Do not use BRUSONEX after the expiry date which is stated on the bottle and the packaging. The expiry date
refers to the last day of that month.
Each bottle must be used within two months of first opening. Open only 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 BRUSONEX contains

• The active ingredient is:mometasone furoate. Each delivered dose contains 50 micrograms of mometasone furoate as monohydrate.
• The other ingredients 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.
Not all pack sizes may be marketed.

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

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Denmark – Rinometasone
Italy – BRUSONEX