EXICORT 50 MICROGRAMS Nasal spray, suspension

Зміст інструкції

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

EXICORT 50 micrograms/spray Nasal Spray, Suspension

Mometasone Furoate
Generic medicine

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 EXICORT is and what it is used for
• 2. What you need to know before you use EXICORT
• 3. How to use EXICORT
• 4. Possible side effects
• 5. How to store EXICORT
• 6. Contents of the pack and other information

1. What EXICORT is and what it is used for

What is EXICORT?
EXICORT nasal spray contains mometasone furoate, which belongs to a group of medicines
called corticosteroids. Mometasone Furoate should not be confused with "anabolic" steroids, that is
substances improperly used by some athletes and taken intravenously or in tablet form. When
mometasone furoate is sprayed into the nose, it can help to relieve inflammation (swelling and
irritation of the nose), sneezing, itching, stuffy nose or runny nose.

What is EXICORT used for?
Hay fever and perennial rhinitis
EXICORT is used for the treatment of symptoms of hay fever (also called seasonal allergic rhinitis) and
perennial rhinitis in adults and children aged 3 years and over. Hay fever, which 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 throughout the year and symptoms may be
caused by sensitivity to a variety of elements, including house dust mites, animal dander (or flakes),
feathers and certain foods. EXICORT reduces swelling and nasal irritation, thus relieving sneezing,
itching and conditions of stuffy or runny nose caused by hay fever or perennial rhinitis.
Nasal polyps
EXICORT 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. EXICORT reduces
inflammation in the nose causing a gradual reduction of the polyps, thereby relieving a feeling of
nasal obstruction and improving breathing through the nose.

2. What you need to know before using EXICORT

Do not use EXICORT

• 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 EXICORT 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 undergone nasal surgery or have suffered a nasal trauma. You should not use the nasal spray until the nose has healed.

Warnings and precautions
Talk to your doctor or pharmacist before using EXICORT:

• If you suffer from or have suffered from tuberculosis.
• If you suffer from any other type of infection.
• If you are taking other medicines containing corticosteroids, either orally or by injection.
• If you have cystic fibrosis.

During the use of EXICORT, contact your doctor:

• if your immune system does not function properly (difficulty fighting infections) and if you should come into contact with people 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.

When nasal sprays containing corticosteroids are used at high doses for long periods of time, undesirable effects due to the absorption of the medicine into the body may occur.
If you have itchy or irritated eyes, your doctor may prescribe other treatments to use together with EXICORT nasal spray.
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 containing corticosteroids can cause some undesirable effects, such as delayed growth in children.
It is recommended to regularly monitor the height of children undergoing prolonged treatment with nasal corticosteroids and, if you notice any changes, you should inform your doctor.

Other medicines and EXICORT
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 orally or by injection, your doctor may advise you to stop this treatment when you start using EXICORT. 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.
Contact your doctor if you experience any of these effects.
Some medicines can increase the effects of EXICORT and your doctor may want to monitor you closely 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 mometasone furoate in pregnant women is limited or absent. It is not known whether mometasone furoate passes into breast milk.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
No information is available on the effects of mometasone furoate on the ability to drive vehicles or operate machinery.

EXICORT contains benzalkonium chloride
This medicine contains 20 micrograms of benzalkonium chloride per actuation which can cause irritation or swelling inside the nose, especially if used for a long period.

3. How to use EXICORT

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist. Do not use a higher dose or use the spray more often 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 2 sprays in each nostril once a day
In some patients, EXICORT Nasal Spray begins to relieve symptoms within 12 hours of the first
dose. However, it may take more than two days to obtain the full benefit of
treatment. Therefore, it is necessary to continue using it regularly to fully benefit
from its effectiveness.

• Once the symptoms are under control, your doctor may advise you to reduce the dose to one spray, once a day in each nostril.
• If you do not experience any improvement, consult your doctor, who may prescribe you to increase the dose; the maximum daily dose is 4 sprays in each nostril once a day.

Use in children from 3 to 11 years of age
The recommended dose is 1 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 EXICORT a few days before the expected start of the pollen season: this will help
prevent the onset of hay fever symptoms. At the end of the pollen season, the symptoms
of hay fever may subside, making treatment unnecessary.

Nasal polyps
Use in adults over 18 years of age
The recommended starting dose is 2 sprays in each nostril once a day.

• If symptoms are not controlled after 5 or 6 weeks, the dose may be increased to 2 sprays in each nostril twice a day. Once the symptoms are under control, your doctor may advise you to reduce the dose.
• If no improvement is observed after 5- or 6 weeks from the start of twice-daily administration, contact your doctor to discuss the application of other treatments in place of EXICORT Nasal Spray.

How to prepare the nasal spray for use
EXICORT Nasal Spray is equipped with a dust cap, which protects the vaporizer and keeps it
clean. Remember to remove the cap 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 jet:

• 1. Gently shake the bottle.
• 2. Place your index and middle fingers on both sides of the vaporizer, your thumb under the base of the bottle. Do notpuncture the nasal applicator.
• 3. To prime the spray, point the vaporizer away from yourself and press 10 times with your fingers until you obtain 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 mist.

Duration of the nasal spray
Applying two sprays in each nostril once a day, the product should provide a sufficient dose for 15 days (for the bottle containing 60 metered sprays) and 35 days (for the bottle
containing 140 metered sprays).

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 vaporizer into the other as illustrated (Figure 2).

Tilt your head slightly forward, keeping the bottle upright.

• 4. Start to inhale 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 point 4 to inhale a second spray into the same nostril, if necessary.
• 6. Remove the vaporizer from the nostril and exhale through your mouth.

• 7. Repeat points 3 to 6 for the other nostril (Figure 3). After using the product, carefully clean the vaporizer 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 vaporizer.
• Wash the vaporizer and dust cap with warm 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 tohave the correct dose of the medicine.
• Let the dust cap and vaporizer dry in a warm place.
• Reposition the vaporizer 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 EXICORT than you should
Inform your doctor if you have accidentally used a higher dose than prescribed.
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 take EXICORT
If you forget to take EXICORT nasal spray at the right time, take it as soon as you remember,
then continue therapy as usual. Do not use a double dose to make up for the missed dose.

If you stop the treatment with EXICORT
In some patients, symptoms will begin to be relieved after 12 hours from the administration of
the first dose of EXICORT Nasal Spray. However, a complete 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.
If you have any doubts 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 everybody gets them.
With the use of this medicine, immediate hypersensitivity (allergic) reactions may occur.
These reactions can be serious. You must stop taking EXICORT and seek
immediate medical attention if any of the following symptoms occur:

• 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, it is
possible for side effects to occur due to the absorption of the medicine into
the body.

Other side effects
Most people do not have problems with the use of the nasal spray. However, some people,
after using EXICORT and other corticosteroid nasal sprays may experience:

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

• headache
• sneezing and irritation/burning sensation in the nose
• nosebleeds (epistaxis) [very common (may affect more than 1 in 10 people) in people with nasal polyps treated with EXICORT two sprays in each nostril twice a day] Nose or throat pain Ulcers in the nose Respiratory tract infection. Not known(frequency cannot be estimated from available data) Increased pressure inside the eye (glaucoma) and/or cataracts causing vision disturbances Damage to the nasal septum separating the nostrils
• alterations in taste and smell Difficulty breathing and/or shortness of breath
• blurred vision.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store EXICORT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and the carton after “Exp.”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25° C. Do not freeze.
The bottle must be used within 8 weeks of first use.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What EXICORT contains

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

Description of the appearance of EXICORT and contents of the pack
EXICORT is a nasal spray suspension.
Each bottle contains: 60 sprays or 140 sprays.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Exipharma SRL
via del Giglio 40/A,

• 35133 - Padova (PD) ManufacturerTeva Czech Industries s.r.o. Ostravská 29, č.p. 305, 747 70 Opava, Komárov Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Italy: EXICORT