Brexcort

Package leaflet: Information for the user

BREXCORT 50 micrograms/dose Nasal Spray, suspension

Mometasone furoate
Generic medicine
Please read all of this leaflet carefully before you start 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 you use 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 BREXCORT is and what it is 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 the "anabolic" steroids abused by some athletes, which are taken in the form of tablets or injections. When mometasone furoate is sprayed into the nose, it can help relieve inflammation (swelling and irritation of the nose), sneezing, itching, and nasal congestion or runny nose.

What is BREXCORT Nasal Spray used for?
Allergic rhinitis and perennial rhinitis
BREXCORT is indicated for use in adults and children aged 3 years and older for the treatment of symptoms of seasonal allergic rhinitis (also known as hay fever) or perennial rhinitis.
Hay fever, which occurs during certain times of the year, is an allergic reaction caused by inhaling pollens from trees, grasses, weeds, as well as moulds and fungal spores. Perennial rhinitis occurs throughout the year, and symptoms may be triggered by sensitivity to a variety of allergens, including house dust mites, animal hair (or dander), feathers, and certain foods.
BREXCORT reduces nasal swelling and irritation, thereby relieving sneezing, itching, and nasal congestion 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 older.
Nasal polyps are small growths on the nasal mucosa and usually affect both nostrils. BREXCORT reduces inflammation in the nose, leading to a gradual shrinkage of the polyps, thus relieving the sensation of nasal obstruction that can impair 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 to 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 must wait until the infection has resolved before starting to use the nasal spray.
• if you have recently undergone nasal surgery or have experienced 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 BREXCORT:

• if you have or have had tuberculosis
• if you have 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 have cystic fibrosis.

While using BREXCORT, contact your doctor:

• if your immune system is not working properly (if you have difficulty fighting infections) and if you have been in contact with someone who has 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 experience persistent irritation of the nose or throat.

Prolonged use of high-dose corticosteroid nasal sprays may lead to unwanted effects due to absorption of the medicine into the body.
If you experience eye itching or irritation, your doctor may prescribe additional treatments to use alongside BREXCORT.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
When used at high doses for prolonged periods, corticosteroid nasal sprays may cause certain unwanted effects, such as slowed growth in children.
It is recommended that the height of children receiving long-term treatment with nasal corticosteroids be monitored regularly, and that your doctor be informed if any changes are noticed.

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 to treat allergies, either orally or by injection, your doctor may advise you to stop that treatment when you start using BREXCORT.
When stopping treatment with oral or injectable corticosteroids, some people may experience unwanted effects such as joint or muscle pain, weakness, and depression. You may also feel as though you are developing other allergies, such as itching, tearing eyes, or red, itchy skin rashes. Talk to your doctor if you notice any of these effects.
Some medicines may increase the effects of BREXCORT, and your doctor may want to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Pregnancy, breastfeeding and fertility
Information on the use of BREXCORT in pregnant women is limited or unavailable.
It is not known whether mometasone furoate is excreted in human breast milk.
BREXCORT must not be used during pregnancy or breastfeeding.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
BREXCORT does not affect the ability to drive or operate machinery.

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

3. How to use BREXCORT

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. Do not take higher, more frequent, or longer doses than prescribed by your doctor.

Treatment of hay fever and perennial rhinitis

Use in adults and children aged 12 years and older
The recommended dose is two sprays in each nostril once daily.
In some patients, BREXCORT begins to relieve symptoms within 12 hours of the first dose; however, complete therapeutic benefit may not be evident during the first two days. Therefore, you must continue regular use to achieve the full benefit of treatment.

• Once symptoms are under control, your doctor may advise you to reduce the dose to one spray in 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 four sprays in each nostril once daily.

Use in children aged 3 to 11 years
The recommended dose is one spray in each nostril once daily.
If you or your child suffer from severe hay fever, your doctor may advise starting treatment with mometasone furoate before the pollen season begins: this will help prevent the onset of hay fever symptoms. After the pollen season ends, hay fever symptoms should improve and treatment may no longer be necessary.

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

• If symptoms are not controlled after 5–6 weeks, the dose may be increased to two sprays in each nostril twice daily. Once 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 twice-daily administration, you must contact your doctor to discuss alternative treatments to replace BREXCORT.

Preparing the nasal spray for use
BREXCORT comes with a dust cap that protects the spray 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 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 either side of the spray nozzle and your thumb under the bottle. Do not pierce the nasal applicator.
3. Point the nozzle away from yourself and press down with your fingers to actuate the spray 10 times until a fine mist appears.
   If the spray has not been used for 14 days or more, you must "re-prime" the bottle by actuating the spray twice until a fine mist is produced.

How long the nasal spray will last
At a dose of two sprays in each nostril once daily, the product should provide sufficient doses for 15 days (for the 60-metered-spray bottle) and 35 days (for the 140-metered-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 insert the spray nozzle into the other nostril as shown (Figure 2).

Tilt your head slightly forward, keeping the bottle upright.

4. Gently or slowly inhale through your nose and, during inhalation, administer one spray into the nostril by pressing ONCE with your fingers.
5. Breathe out through your mouth. Repeat step 4 to inhale a second spray into the same nostril, if required.
6. Remove the spray nozzle from the nostril and breathe out through your mouth.

7. Repeat steps 3 to 6 for the other nostril (Figure 3). After using the spray, clean the nozzle thoroughly with a clean tissue or cloth and replace 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 spray nozzle.
• Wash the nozzle and dust cap with warm water and rinse under running water.
• Do not attempt to unblock the nasal applicator by inserting a pin or any other sharp object, as this may damage the applicator and prevent you from receiving the correct dose of medicine.
• Allow the dust cap and spray 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 two sprays before first use.

If you use more BREXCORT than you should
If you accidentally use more medicine than prescribed, inform your doctor.
If steroids are used for a long time or in large amounts, they may rarely affect certain hormones. In children, this may affect growth and development.

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

If you stop using BREXCORT
In some patients, BREXCORT begins to relieve symptoms 12 hours after the first dose; however, complete therapeutic benefit may not be evident until after two days. It is very important to continue using the nasal spray regularly. Do not stop treatment, even if you feel better, unless instructed by your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
After using this product, immediate hypersensitivity (allergic) reactions may occur. These reactions can be severe. You must stop using BREXCORT Nasal Spray and seek immediate medical help if any of the following symptoms occur:

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

When corticosteroid nasal sprays are used at high doses for prolonged periods, side effects due to drug absorption into the body may occur.
Other side effects
Some people, after using BREXCORT or other corticosteroid nasal sprays, may experience:
Common side effects (may affect up to 1 in 10 people):

• headache
• sneezing and nasal irritation/burning sensation
• nosebleeds [very commonly observed (may affect more than 1 in 10 people) in patients with nasal polyps treated with two sprays of BREXCORT in each nostril twice daily]
• nasal or throat pain
• nasal ulcerations
• respiratory tract infections

Not known (frequency cannot be determined from available data):

• increased eye pressure (glaucoma) and/or cataracts causing visual disturbances
• damage to the nasal septum (the wall separating the nostrils)
• changes in taste or smell
• difficulty breathing and/or breathlessness
• blurred vision

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 outer carton after 'Exp.'.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. Do not freeze.
The bottle should be used within 2 months of first opening.
Do not dispose of medicines 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 BREXCORT contains

• The active substance is mometasone furoate. Each spray (0.1 ml) 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, citric acid monohydrate, disodium citrate dihydrate, polysorbate 80, benzalkonium chloride solution (see section 2), and water for injections.

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

Marketing Authorization 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 European Economic Area Member States under the following names:
Denmark: LEDERCORT RX
Italy: BREXCORT