Momecort

PACKAGE LEAFLET

Package leaflet: information for the user

MOMECORT 50 micrograms/spray Nasal Spray, suspension

Mometasone Furoate
Equivalent medicinal product
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What MOMECORT Nasal Spray is and what it is used for

What is MOMECORT Nasal Spray?
MOMECORT Nasal Spray contains mometasone furoate, which belongs to a group of medicines known as corticosteroids. Mometasone furoate must not be confused with "anabolic" steroids, which some athletes misuse and take 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, nasal congestion, or a runny nose.

What is MOMECORT Nasal Spray used for?
Hay fever and perennial rhinitis
MOMECORT Nasal Spray is used to treat 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 throughout the year, and symptoms may be triggered by sensitivity to various substances, including house dust mites, animal fur (or dander), feathers, and certain foods.
MOMECORT Nasal Spray reduces nasal swelling and irritation, thereby relieving sneezing, itching, and a blocked or runny nose caused by hay fever or perennial rhinitis.

Nasal polyps
MOMECORT Nasal Spray 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. MOMECORT Nasal Spray reduces inflammation in the nose, leading to a gradual shrinkage of the polyps, thus relieving nasal obstruction and improving nasal breathing.

2. What you need to know before using MOMECORT Nasal Spray

Do not use MOMECORT Nasal Spray

• 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 MOMECORT Nasal Spray 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 a nasal injury. You must not use the nasal spray until your nose has healed.

Warnings and precautions

• Consult your doctor or pharmacist before using MOMECORT Nasal Spray
• if you have or have had tuberculosis.
• if you have any other type of infection.
• if you are taking other corticosteroid medicines, either by mouth or by injection.
• if you have cystic fibrosis.

While using MOMECORT Nasal Spray, consult your doctor:

• if your immune system is not working properly (if you have difficulty fighting infections) and if you come into contact with people who have 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.

When corticosteroid nasal sprays are used at high doses for prolonged periods,
undesirable effects due to systemic absorption of the medicine may occur.
If you experience eye itching or irritation, your doctor may prescribe additional treatments to be used together
with MOMECORT Nasal Spray.
Consult your doctor if you experience blurred vision or other visual disturbances.
Children
When used at high doses and for prolonged periods, corticosteroid nasal sprays may
cause certain adverse effects, such as delayed growth in children.
Regular monitoring of height is recommended in children receiving long-term
nasal corticosteroid therapy. If you notice any changes, you must inform your doctor.
Other medicines and MOMECORT Nasal Spray
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 the treatment of allergies, either by mouth or by injection, your doctor may advise you to discontinue that treatment when starting MOMECORT Nasal Spray. After stopping oral or injectable corticosteroid treatment, some people may experience adverse effects such as joint or muscle pain, weakness, and depression. You may also feel as if you are developing other allergies, such as itching, tearing, or red, itchy skin rashes.
Consult your doctor if you experience any of these effects.
Some medicines may increase the effects of MOMECORT Nasal Spray, and your doctor may wish 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 MOMECORT Nasal Spray in pregnant women is limited or lacking.
It is not known whether mometasone furoate passes into breast milk.
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
No information is available regarding the effects of MOMECORT Nasal Spray on the ability to drive
vehicles or operate machinery.
MOMECORT Nasal Spray contains benzalkonium chloride
This medicine contains 20 micrograms of benzalkonium chloride per spray, which may cause
irritation or swelling inside the nose, especially if used for a prolonged period.

3. How to use MOMECORT Nasal Spray

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. Do not use a higher dose, or use the spray more frequently or for longer than prescribed by your doctor.
Treatment of hay fever and perennial rhinitis
Use in adults and children above 12 years of age
The recommended dose is 2 sprays in each nostril once daily.
In some patients, MOMECORT Nasal Spray begins to relieve symptoms within 12 hours of the first dose. However, it may take more than two days to achieve the full benefit of treatment. Therefore, it is necessary to continue using it regularly to fully benefit from its effectiveness.

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

Use in children aged 3 to 11 years
The recommended dose is 1 spray in each nostril once daily.
If you or your child suffers from severe hay fever, your doctor may advise you to start using mometasone furoate several days before the expected start of pollen season: this will help prevent the onset of hay fever symptoms. At the end of the pollen season, hay fever symptoms may subside, making treatment unnecessary.
Nasal polyps
Use in adults above 18 years of age
The recommended initial dose is 2 sprays in each nostril once daily.

• If symptoms are not controlled after 5 or 6 weeks, the dose may be increased to 2 sprays in each nostril twice daily. Once symptoms are under control, your doctor may advise you to reduce the dose.
• If no improvement is observed after 5 or 6 weeks of twice-daily dosing, contact your doctor to discuss alternative treatments instead of MOMECORT Nasal Spray.

How to prepare the nasal spray for use
MOMECORT Nasal Spray comes with a dust cap that protects the nozzle and keeps it clean. Remember to remove the cap before using the spray and replace it after use.
If you are using the spray for the first time, you must 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 nozzle, and your thumb under the base of the bottle. Do not pierce the nasal applicator.
3. To prime the spray, point the nozzle away from yourself and press down 10 times with your fingers until you obtain a fine, uniform mist. If you have not used the spray for 14 days or more, you must re-prime the pump 2 times until you see a uniform mist.

Duration of the nasal spray
With 2 sprays in each nostril once daily, the product should provide 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 nozzle into the other, as illustrated (Figure 2). Tilt your head slightly forward, keeping the bottle upright.
4. Begin to inhale gently or slowly through your nose and administer one spray into the nostril by pressing down ONCE with your fingers.
5. Exhale through your mouth. Repeat step 4 to inhale a second spray into the same nostril, if required.
6. Remove the nozzle from the nostril and exhale through your mouth.

7. Repeat steps 3 to 6 for the other nostril (Figure 3). 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 pull off the nozzle.
• Wash the nozzle and dust cap with lukewarm water, then 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 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 MOMECORT Nasal Spray than you should
Inform your doctor if you have accidentally used more than the prescribed dose.
In rare cases, prolonged use or high doses of steroids may affect levels of certain hormones. In children, this effect may influence growth and development.
If you forget to take MOMECORT Nasal Spray
If you forget to take MOMECORT Nasal Spray at the correct time, take it as soon as you remember, then continue your treatment as usual. Do not use a double dose to make up for the missed dose.
If you stop using MOMECORT Nasal Spray
In some patients, symptoms begin to improve within 12 hours after the first dose of MOMECORT Nasal Spray. 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.
If you have any doubts about how to use 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.
Immediate allergic (hypersensitivity) reactions may occur with the use of this medicine.
These reactions can be severe. You must stop using MOMECORT Nasal Spray and seek immediate medical assistance if any of the following symptoms occur:

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

When corticosteroid nasal sprays are used at high doses for prolonged periods, side 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 may experience the following after using MOMECORT Nasal Spray or other corticosteroid nasal sprays:

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

• headache
• sneezing and nasal irritation/burning sensation
• nosebleeds [very commonly reported (may affect more than 1 in 10 people) in patients with nasal polyps treated with MOMECORT Nasal Spray, two sprays in each nostril twice daily]
• nasal or throat pain
• nasal ulcers
• respiratory tract infection

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

• increased pressure inside the eye (glaucoma) and/or cataracts causing visual disturbances
• damage to the nasal septum separating the nostrils
• changes in taste and 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, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: 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 MOMECORT

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 carton after "Exp.". The expiry date refers to the last day of that month.
Do not store above 25°C. Do not freeze.
The bottle should be used within 8 weeks of first use.
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. Contents of the pack and other information

What MOMECORT Nasal Spray contains

• The active substance 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 carmellose, glycerol, sodium citrate dihydrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride (see section 2), and water for injections.

Description of the appearance of MOMECORT Nasal Spray and contents of the pack
MOMECORT is a nasal spray suspension.
Each bottle contains 60 sprays.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farto SRL – Farmaco Biochimico Toscano
Viale Alessandro Guidoni 97
Firenze 50127
Italy
Manufacturer
Teva Czech Industries s.r.o.
Ostravská 29, č.p. 305, 747 70 Opava, Komárov
Czech Republic
This medicinal product is authorised in the European Economic Area Member States under the
following names:
MOMECORT