BREXCORT 50 MICROGRAMS Spray do nosa, zawiesina

Treść ulotki

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

BREXCORT 50 micrograms/spray Nasal Spray, suspension

Mometasone furoate
Equivalent medicine

Read this leaflet carefully before 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 their symptoms are the same as yours, 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 BREXCORT is and what it is used for
• 2. What you need to know before using BREXCORT
• 3. How to use BREXCORT
• 4. Possible side effects
• 5. How to store BREXCORT
• 6. Contents of the pack and other information

1. What is BREXCORT and what is it used for

What is BREXCORT?
BREXCORT contains mometasone furoate, which belongs to a group of medicines called
corticosteroids. Mometasone furoate should not be confused with “anabolic” steroids abused by some athletes and taken in tablet or injection form. When mometasone
furoate is sprayed into the nose, it can help relieve inflammation (swelling and irritation of the
nose), sneezing, itching and a stuffy or runny nose.

What is BREXCORT Nasal Spray used for?
Seasonal allergic rhinitis and perennial rhinitis
BREXCORT is indicated for use in adults and children aged 3 years and over for the treatment
of symptoms of seasonal allergic rhinitis (also known as hay fever), or perennial rhinitis.
Hay fever, which occurs at certain times of the year, is an allergic reaction caused by
inhaling pollen from trees, grasses, weeds, and also molds and fungal spores. Perennial rhinitis
is present throughout the year and symptoms may be caused by sensitivity to a variety of elements,
including dust mites, animal dander (or flakes), feathers and certain foods.
BREXCORT reduces nasal swelling and irritation, thereby relieving sneezing, itching and conditions of a
stuffy or runny nose caused by hay fever or perennial rhinitis.
Nasal polyps
BREXCORT is used for the treatment of nasal polyps in adults aged 18 years and over.
Nasal polyps are small growths on the nasal mucosa and usually affect both nostrils.
BREXCORT reduces inflammation in the nose, causing a gradual shrinking of the polyps, relieving
thus the sensation of a stuffy nose that can affect breathing through the nose.

2. What you need to know before using BREXCORT

Do not use BREXCORT:

• if you are allergic to mometasone furoate or any of the other ingredients of this medicine (listed in section 6).
• if you have an untreated nasal infection. Using BREXCORT 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 BREXCORT:

• if you suffer from or have suffered from tuberculosis
• if you suffer from any other infection
• if you have a perforation of the nasal septum
• if you are taking other corticosteroids, either by mouth or by injection
• if you suffer from cystic fibrosis.

During the use of BREXCORT, consult your doctor:

• if your immune system is not functioning properly (if you have difficulty fighting infections) and if you have come into contact with a person suffering from 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
development of undesirable effects due to the absorption of the medicine inside the body.
If you experience itchy or irritated eyes, your doctor may prescribe other treatments to use together with
BREXCORT.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
If used at high doses for long periods of time, nasal sprays based on corticosteroids can cause
some undesirable effects, such as a slowing of growth in children.
It is recommended that the height of children receiving long-term treatment with nasal corticosteroids
is monitored regularly and that, if changes are noticed, their doctor is informed.

Other medicines and BREXCORT
Tell 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 the treatment of allergies, either by mouth or by injection, your
doctor may advise you to stop such treatment when you start using BREXCORT.
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. See
your doctor if you notice the appearance of any of these effects.
Some medicines can increase the effects of BREXCORT 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, breastfeeding and fertility
Information on the use of BREXCORT in pregnant women is limited or absent.
It is not known whether mometasone furoate is released into breast milk.
BREXCORT should not be used during pregnancy or breastfeeding.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
BREXCORT does not impair the ability to drive and use machines.

BREXCORT contains benzalkonium chloride
This medicine contains 20 micrograms of Benzalkonium chloride per delivery. Benzalkonium chloride
can cause irritation and swelling inside the nose, especially if used for long periods.

3. How to use BREXCORT

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor
or pharmacist. Do not take higher or more frequent doses 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 recommended dose is two sprays in each nostril once a day.
In some patients, BREXCORT starts to relieve symptoms within 12 hours of the first dose; however, a
complete benefit of treatment may not be seen within the first two days. Therefore, you should continue regular use
to obtain the full benefit of treatment.

• Once your symptoms are under control, your doctor may advise you to reduce the dose to one spray in each nostril once a day.
• 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 aged 3 to 11 years
The recommended dose is one spray in each nostril once a day.
If you or your child suffer from severe hay fever, your doctor may advise you to start using
mometasone furoate before the start of the pollen season: this will help prevent the onset of
hay fever symptoms. At the end of the pollen season, hay fever symptoms should
improve and treatment may no longer be necessary.

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

• If symptoms are not under control after 5-6 weeks, the dose may be increased to two sprays in each nostril twice a day. Once your symptoms are under control, your doctor will ask you to reduce the dose.
• If there is no improvement in symptoms after 5-6 weeks of administration twice a day, you should contact your doctor to discuss other treatments to replace BREXCORT.

Preparing the nasal spray for use
BREXCORT is equipped with a dust cap that protects the sprayer 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 need to “prime” the bottle by actuating the spray 10 times until
a fine mist is produced:

• 1. Gently shake the bottle
• 2. Place your index and middle fingers on the sides of the sprayer and your thumb under the bottle. Do notpuncture the nasal applicator
• 3. Point the sprayer away from yourself and press down with your fingers to actuate the spray 10 times until a light mist is obtained. If the spray has not been used for 14 days or more, you need to “re-prime” the bottle by actuating the spray 2 times until a fine mist is produced.

How long will the nasal spray last
At a dose of two sprays in each nostril once a day, the product should provide sufficient doses for 15 days (for the 60-dose spray bottle) and 35 days (for the 140-dose spray bottle).

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 position the sprayer in the other nostril as shown (Figure 2).

Tilt your head slightly forward, keeping the bottle upright.

• 4. Breathe in gently or slowly through your nose and, while inhaling, administer one spray into your nose by pressing down with your fingers ONCE.
• 5. Exhale through your mouth. Repeat step 4 to inhale a second spray into the same nostril, if necessary.
• 6. Remove the sprayer from your nostril and exhale through your mouth.

• 7. Repeat steps 3 to 6 for the other nostril (Figure 3). After using the spray, clean the sprayer thoroughly with a tissue or clean cloth and reposition the dust cap.

Cleaning 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 warm water and rinse with 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 prevent you from getting the correct doseof 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 2 sprays on first use after cleaning.

If you use more BREXCORT than you should
If you accidentally use more medicine than you should, inform your doctor.
If you use steroids for a long time or in large quantities, they can, rarely, affect some
hormones. In children, this can affect growth and development.

If you forget to use BREXCORT
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 a missed dose.

If you stop using BREXCORT
In some patients, BREXCORT starts to relieve symptoms 12 hours after the first dose; however, the complete benefit of treatment may not be seen before two days. It is very important to continue using
the nasal spray regularly. Do not stop taking it, even if you feel better, unless you are
told to do so by your doctor.
If you have any doubts about using 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.
After using this product, immediate hypersensitivity (allergic) reactions may occur. These
reactions can be serious. You must stop taking BREXCORT Nasal Spray and seek
immediate medical help if you experience symptoms such as:

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

side effects due to the absorption of the drug into the body may occur.

Other side effects
Some people, after using BREXCORT or other nasal sprays based on corticosteroids, may suffer
from:

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

• headache
• sneezing and irritation/burning sensation in the nose
• nosebleeds [very common (may affect more than 1 in 10 people) in people with nasal polyps treated with two sprays of BREXCORT 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 in the eye (glaucoma) and/or cataracts causing visual disturbances
• damage to the nasal septum separating the nostrils
• changes in taste or 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.

5. How to store BREXCORT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the packaging after ‘Exp.’ The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions. Do not freeze.
The bottle must be used within 2 months of first opening.
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 BREXCORT contains

• The active ingredient is mometasone furoate. Each spray (0.1ml) delivers 50 micrograms of mometasone furoate (as monohydrate). The total weight of one spray is 100 mg.
• The other components are microcrystalline cellulose and sodium carmellose, glycerol, disodium citrate dihydrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride solution (see section 2) and water for injectable preparations.

Description of the appearance of BREXCORT and contents of the pack
BREXCORT is an opaque suspension of white to off-white colour.
BREXCORT is a nasal spray, suspension.
Each bottle contains 60 or 140 sprays.

Marketing Authorisation Holder
Dymalife Pharmaceutical S.r.l.
Via Bagnulo, 95
80063 Piano di Sorrento (NA)

Manufacturer
Teva Czech Industries s.r.o.
Ostravská 29, č.p. 305
74770 Opava, Komárov
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Denmark: LEDERCORT RX
Italy: BREXCORT