Momil

Package leaflet: Information for the user

MOMIL 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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

What is MOMIL Nasal Spray?
MOMIL Nasal Spray contains mometasone furoate, which belongs to a group of medicines called corticosteroids. Mometasone furoate should not be confused with "anabolic" steroids, which are substances improperly used by some athletes and administered intravenously or taken orally in tablet form. 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 MOMIL Nasal Spray used for?

Hay fever and perennial rhinitis
MOMIL 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 occurring at certain times of the year 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 allergens, including house dust mites, animal fur (or dander), feathers, and certain foods. MOMIL Nasal Spray reduces nasal swelling and irritation, thereby relieving sneezing, itching, and nasal congestion or runny nose caused by hay fever or perennial rhinitis.

Nasal polyps
MOMIL 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. MOMIL Nasal Spray reduces nasal inflammation, leading to a gradual shrinkage of the polyps, thus relieving the sensation of nasal blockage and improving nasal breathing.

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

Do not use MOMIL 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 MOMIL 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 have suffered a nasal injury. You must not use the nasal spray until your nose has healed.

Warnings and precautions
Talk to your doctor or pharmacist before using MOMIL Nasal Spray:

• if you have or have had tuberculosis
• if you suffer from any other infection
• if you are taking other corticosteroid medicines, either by mouth or by injection
• if you have cystic fibrosis

While using MOMIL Nasal Spray, talk to your doctor:

• if your immune system is not working properly (difficulty fighting infections) and if you are exposed to people with 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, unwanted effects due to absorption of the medicine into the body may occur.

If you have itching or eye irritation, your doctor may prescribe additional treatments to be used together with MOMIL Nasal Spray.
Contact your doctor if you experience blurred vision or any other visual disturbances.
Children
When corticosteroid nasal sprays are used at high doses and for prolonged periods, they may cause unwanted effects, such as growth retardation in children.
Regular monitoring of children's height is recommended during long-term treatment with nasal corticosteroids, and you should inform your doctor if you notice any changes.
Other medicines and MOMIL 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 allergy treatment, either by mouth or by injection, your doctor may advise you to stop this treatment when you start using MOMIL Nasal Spray. After stopping oral or injectable corticosteroid treatment, 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, or red, itchy skin rashes. Consult your doctor if you notice any of these effects.
Some medicines may increase the effects of MOMIL Nasal Spray, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Pregnancy, breast-feeding and fertility
Information on the use of MOMIL 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, are planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
There is no information available on the effects of MOMIL Nasal Spray on the ability to drive or use machinery.
MOMIL Nasal Spray contains benzalkonium chloride
This medicine contains 20 micrograms of benzalkonium chloride per dose, which may cause irritation or swelling inside the nose, especially if used for a long period.

3. How to use MOMIL Nasal Spray

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist. Do not use higher doses, more frequent doses, 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 two sprays in each nostril once daily.
In some patients, MOMIL 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 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 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 further treatment unnecessary.
Nasal polyps
Use in adults above 18 years of age
The recommended initial dose is two sprays in each nostril once daily.

• If symptoms are not controlled after 5 or 6 weeks, the dose may be increased to two sprays in each nostril twice daily. When symptoms are under control, your doctor may advise you to reduce the dose.
• If symptoms do not improve after 5 or 6 weeks of twice-daily administration, contact your doctor to discuss alternative treatments instead of MOMIL Nasal Spray.

How to prepare the nasal spray for use
MOMIL Nasal Spray is equipped 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 fine, uniform mist:

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 you and press down 10 times with your fingers until a uniform spray appears. 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 two 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 nose by pressing ONCE with your fingers.
5. Exhale through your mouth. Repeat step 4 to inhale a second spray into the same nostril, if needed.
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 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, 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 nasal 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 MOMIL 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 the levels of certain hormones. In
children, this effect may influence growth and development.
If you forget to use MOMIL Nasal Spray
If you forget to use the nasal spray at the correct time, use 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 treatment with MOMIL Nasal Spray
In some patients, symptoms begin to improve within 12 hours after the first dose of MOMIL Nasal Spray.
However, a full therapeutic benefit may not be seen 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 your doctor tells you to do so.
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 everybody gets them.
Immediate hypersensitivity (allergic) reactions may occur with the use of this medicine.
These reactions can be severe. You must stop using MOMIL Nasal Spray and seek immediate medical attention if any of the following symptoms occur:

• swelling of the face, tongue or pharynx
• difficulty swallowing
• hives (urticaria)
• shortness of breath or breathing difficulties

When corticosteroid nasal sprays are used at high doses over long periods of time, 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 MOMIL 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 (epistaxis) [reported very commonly (may affect more than 1 in 10 people) in patients with nasal polyps treated with two sprays of MOMIL Nasal Spray in each nostril twice daily]
• nasal or throat pain
• 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 breathlessness
• blurred vision

Reporting of side effects
If you experience any side effects, 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:
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 MOMIL
   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. Open one bottle at a time.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What MOMIL 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 ingredients are microcrystalline cellulose and sodium carmellose, glycerol, disodium citrate dihydrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride (see section 2), and water for injections.

Description of the appearance of MOMIL Nasal Spray and package contents
MOMIL is a nasal spray suspension.
Each bottle contains 140 sprays.

Marketing Authorisation Holder and Manufacturer
Laboratorio Chimico Deca Dr. Capuani Srl
Via Balzaretti 17 - 20133 Milan, Italy

Manufacturer
Teva Czech Industries s.r.o.
Ostravská 305/29,
747 70 Opava–Komárov, Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Italy Momil 50 micrograms/dose nasal spray, suspension Mometasone furoate
[to be completed with national data]