Mometasone EG

Package leaflet: Information for the user

Mometasone Eurogenerics 50 micrograms/dose Nasal Spray, Suspension

Mometasone furoate
Generic medicine (only for bottles with 60 and 140 doses)
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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Mometasone Eurogenerici is and what it is used for

What is Mometasone Eurogenerici?
Mometasone Eurogenerici contains mometasone furoate, which belongs to a group of medicines called
corticosteroids. When mometasone furoate is sprayed into the nose, it can help relieve inflammation
(swelling and irritation of the nose), sneezing, itching, and symptoms of a blocked or runny nose.
What is Mometasone Eurogenerici used for?
Hay fever and perennial rhinitis
Mometasone Eurogenerici 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, which occurs during certain times of the year, is an allergic reaction caused by inhaling pollen from trees, grass, weeds, as well as mould spores and fungal spores. Perennial rhinitis occurs throughout the year, and symptoms may be triggered by sensitivity to various allergens such as house dust mites, animal fur (or dander), feathers, and certain foods.
Mometasone Eurogenerici reduces swelling and irritation in the nose, providing relief from sneezing, itching, and a blocked or runny nose caused by hay fever or perennial rhinitis.
Nasal polyps
Mometasone Eurogenerici is used to treat nasal polyps in adults aged 18 years and older.
Nasal polyps are small growths on the lining of the nasal passages and usually affect both nostrils.
Mometasone Eurogenerici reduces nasal inflammation, leading to a gradual shrinkage of the polyps and providing relief from nasal congestion that can affect breathing through the nose.

2. What you need to know before using Mometasone Eurogenerici

Do not use Mometasone Eurogenerici

• 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 Mometasone Eurogenerici 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 suffered a nasal injury. You must wait until healing is complete before starting to use the nasal spray.

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

• if you have or have had tuberculosis;
• if you have any other infection;
• if you are taking other corticosteroid medicines by mouth or by injection;
• if you have cystic fibrosis (a genetic multi-organ disease primarily affecting the lungs and digestive system).

While using Mometasone Eurogenerici, talk to your doctor:

• if your immune system is not working properly (if you have difficulty fighting infections) and you have been in contact with someone who has measles or chickenpox. You should avoid contact with anyone who has 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;
• if you experience blurred vision or other visual disturbances.

When corticosteroid nasal sprays are used at high doses for prolonged periods, adverse effects due to systemic absorption of the drug may occur.
If you experience eye itching or irritation, your doctor may prescribe additional treatments to be used alongside Mometasone Eurogenerici.
Children
When corticosteroid nasal sprays are used at high doses and for prolonged periods, they may cause certain adverse effects, such as growth retardation in children.
Regular monitoring of height is recommended in children undergoing long-term treatment with nasal corticosteroids, and you should inform your doctor if you notice any changes.
Other medicines and Mometasone Eurogenerici
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
If you are taking other corticosteroid medicines for allergies, either orally or by injection, your doctor may advise you to discontinue them once you start using Mometasone Eurogenerici. Some people may experience certain adverse effects when stopping oral or injectable corticosteroid therapy, such as joint or muscle pain, weakness, and depression. You may also feel as though you are developing other allergic symptoms, such as itching, tearing eyes, or red, itchy skin rashes. If you experience any of these effects, contact your doctor.
Some medicines may increase the effects of Mometasone Eurogenerici, and your doctor may want to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Information on the use of Mometasone Eurogenerici in pregnant women is limited or lacking. It is not known whether mometasone furoate passes into breast milk.
Driving and using machines
There is no information available on the effects of Mometasone Eurogenerici on the ability to drive or operate machinery.
Mometasone Eurogenerici contains benzalkonium chloride
This medicine contains 0.02 mg of benzalkonium chloride per dose. Benzalkonium chloride may cause irritation and swelling inside the nose, especially if used for prolonged periods.

3. How to use Mometasone Eurogenerici

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Do not use the spray in higher doses, more frequently, or for longer than instructed 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 into each nostril once daily.

• Once symptoms are under control, your doctor may advise you to reduce the dose;
• if you do not start to feel better, contact your doctor, who may advise increasing the dose; the maximum daily dose is four sprays into each nostril once daily.

Use in children aged 3 to 11 years
The recommended dose is one spray into each nostril once daily.
If you or your child suffers from severe hay fever, your doctor may advise you to start using Mometasone Eurogenerici before the start of the pollen season, as this will help prevent the onset of hay fever symptoms. After the pollen season ends, hay fever symptoms may 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 into each nostril once daily.

• If symptoms are not controlled after 5–6 weeks, the dose may be increased to two sprays into each nostril twice daily. Once symptoms are under control, your doctor may advise you to reduce the dose;
• if there is no improvement in symptoms after 5–6 weeks of twice-daily administration, you must consult your doctor.

Preparing the nasal spray for use

Mometasone Eurogenerici Nasal Spray has a dust cap that protects the spray nozzle and keeps it clean.
Remember to remove it before using the spray and replace it after use.
If you are using the spray for the first time, you must "prime" the bottle by pumping 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 nozzle and your thumb under the bottle. Do not pierce the nasal applicator;
3. point the nozzle away from yourself and press down 10 times with your fingers until a uniform spray is produced. If the spray has not been used for 14 days or more, re-prime the bottle by pumping the spray 2 times until a fine mist is produced.

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 nostril as shown (Figure 2). Tilt your head slightly forward, keeping the bottle upright.

4. Begin to inhale gently and slowly through your nose, and while inhaling, press down ONCE with your fingers to release one spray of fine mist into the nostril.
5. Breathe out through your mouth. Repeat step 4 to administer a second spray into the same nostril, if required.
6. Remove the 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.

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 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 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 2 sprays before first use.

If you use more Mometasone Eurogenerici than you should
Inform your doctor if you have accidentally used more than prescribed.
If used over long periods of time or in large quantities, corticosteroids may, rarely, affect levels of certain hormones. In children, this may affect growth and development.

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

If you stop using Mometasone Eurogenerici
In some patients, Mometasone Eurogenerici should begin to relieve symptoms within 12 hours after the first dose; however, the full benefit of treatment may not occur 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 hypersensitivity (allergic) reactions may occur with the use of this medicine. These reactions can be severe. You must stop using Mometasone Eurogenerici 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, adverse effects due to systemic absorption of the medicine may occur.
Other side effects
Most people do not experience problems with the use of the nasal spray. However, some people, after using Mometasone Eurogenerici or other corticosteroid nasal sprays, may experience:
Common side effects (may affect up to 1 in 10 people):

• headache;
• sneezing;
• nosebleeds [reported very commonly (may affect more than 1 in 10 people) in people with nasal polyps treated with two sprays of mometasone furoate in each nostril twice daily];
• pain in the nose or throat;
• nasal ulcers;
• respiratory tract infections.

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 shortness of breath;
• 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 Mometasone Eurogenerici

Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Do not freeze.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of that month.
Each bottle should be used within 2 months of first opening. Open one bottle at a time.
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 Mometasone Eurogenerics contains

• The active substance is: mometasone furoate. Each delivered dose contains 50 micrograms of mometasone furoate monohydrate;
• The other components are: benzalkonium chloride, glycerol, polysorbate 80, microcrystalline cellulose and sodium carmellose, citric acid monohydrate, sodium citrate, purified water.

Description of the appearance of Mometasone Eurogenerics and package contents
Mometasone Eurogenerics is a nasal spray, suspension.
The bottles contain 60 sprays (10 g), 120 sprays (16 g) or 140 sprays (18 g).
Bottles containing 60 sprays and 120 sprays are supplied in packs of 1 nasal spray.
Bottles containing 140 sprays are supplied in packs of 1 or 3 nasal sprays.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan, Italy
Manufacturer
FARMEA
10, rue Bouché Thomas
Z.A.C d’Orgemont
49000 ANGERS
France
STADA Arzneimittel AG
Stadastr. 2-18
61118 Bad Vilbel
Germany
Centrafarm Services BV
Nieuwe Donk 9
4879 AC Etten Leur
The Netherlands
This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium - Mometasone EG 50 microgram/spray, Neusspray, suspension
Italy - Mometasone Eurogenerics 50 micrograms/dose Nasal Spray, Suspension
Germany - Mometasonfuroat AL 50 micrograms/spray Nasal Spray, Suspension
Spain - Mometasona furoato STADA 50 micrograms/spray suspension for nasal spray