MOMIL 50 MICROGRAMS Nasal spray, suspension

Зміст інструкції

1. MOMIL 50 micrograms/spray Nasal spray, suspension
   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. Contents of the pack and other information

MOMIL 50 micrograms/spray Nasal spray, suspension

Mometasone furoate
Equivalent medicine

Read this leaflet carefully before 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, 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 MOMIL Nasal Spray is and what it is 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, 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 relieve
inflammation (swelling and irritation of the nose), sneezing, itching, stuffy nose or runny nose.

What is MOMIL Nasal Spray used for?
Hay fever and perennial rhinitis
MOMIL Nasal Spray 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 that 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 all year round and symptoms can be caused by sensitivity to a variety
of elements, including dust mites, pet hair (or dander), feathers and some
foods. MOMIL Nasal Spray reduces nasal swelling and irritation, thus relieving sneezing, itching and
conditions of stuffy nose or runny nose caused by hay fever or perennial rhinitis.
Nasal polyps
MOMIL Nasal Spray 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.
MOMIL Nasal Spray reduces inflammation of the nose, causing a gradual reduction in polyps,
thus relieving the feeling of nasal obstruction and improving breathing through the nose.

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 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 should wait for the infection to resolve before starting to use the nasal spray.
• if you have recently had nasal surgery or 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 MOMIL Nasal Spray:

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

During the use of MOMIL Nasal Spray, contact your doctor:

• if your immune system does not function properly (you have 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, adverse effects due to 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 MOMIL 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 adverse effects, such as delayed growth in children.
It is recommended to regularly check the height of children undergoing prolonged treatment with
nasal corticosteroids and to inform the doctor if any changes are noticed.

Other medicines and MOMIL Nasal Spray
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 MOMIL
Nasal Spray. When stopping treatment with oral or injectable corticosteroids, some people
may experience adverse 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. Consult your doctor if you notice the appearance of any of these effects.
Some medicines may increase the effects of MOMIL Nasal Spray 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 MOMIL Nasal Spray 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 or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
There is no information on the effects of MOMIL Nasal Spray on the ability to drive or
operate machinery.

MOMIL Nasal Spray 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 MOMIL Nasal Spray

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist. Do not use higher doses or more frequently 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 two sprays in each nostril once a day
In some patients, MOMIL Nasal Spray starts 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 four sprays in each nostril once a day.

Use in children from 3 to 11 years of age
The recommended dose is one spray in each nostril once a day.
If you or your child suffers from severe hay fever, your doctor may advise you to start using
mometasone furoate 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 initial dose is two sprays in each nostril once a day.

• If after 5 or 6 weeks the symptoms are not under control, the dose may be increased to two sprays in each nostril twice a day. When the symptoms are under control, your doctor may advise you to reduce the dose.
• If symptoms do not improve 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 MOMIL Nasal Spray.

How to prepare the nasal spray for use
MOMIL Nasal Spray is equipped with a dust cap, which protects the spray nozzle 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 spray nozzle, your thumb under the base of the bottle. Do notpuncture the nasal applicator.
• 3. To prime the spray, point the nozzle away from yourself and press 10 times with your fingers until you get a uniform jet. If you have not used the spray for 14 days or more, you will need to re-prime the pump 2 times until you see a uniform mist.

Duration of 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 nozzle into the other, as illustrated (Figure 2). Tilt your head slightly forward, keeping the bottle upright.
• 4. Start inhaling 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 step 4 to inhale a second spray into the same nostril, if necessary.

• 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, carefully clean the nozzle 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 nozzle.
• Wash the nozzle 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 objectas this maneuver will damage the nasal applicator and prevent you from having the correctdose of the medicine.
• Let the dust cap and nozzle dry in a warm place.
• Reposition the nozzle 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 MOMIL Nasal Spray 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 use MOMIL Nasal Spray
If you forget to use the nasal spray at the right time, use it as soon as you remember, then continue the
therapy as usual. Do not use a double dose to make up for the missed one.

If you stop the treatment with MOMIL Nasal Spray
In some patients, symptoms will begin to be relieved after 12 hours of administering the
first dose of MOMIL 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 the
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 using MOMIL Nasal Spray 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 that side effects may 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 MOMIL Nasal Spray or 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 commonly occurred (may affect more than 1 in 10 people) in people with nasal polyps treated with two sprays of MOMIL Nasal Spray in each nostril twice a day]
• pain in the nose or throat
• ulcers in the nose
• respiratory tract infections.

Not known(frequency cannot be estimated based on available data)

• increased pressure inside the eye (glaucoma) and/or cataracts causing visual 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, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. 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 storeMOMIL 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 above 25°C. Do not freeze.
The bottle must be used within 8 weeks of first use. Open one bottle at a time.
Do not throw away any medicines via water 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 MOMILNasal Spraycontains

• 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 ingredients 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 MOMILNasal Spray and contents of the pack
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 Milano
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 with the following
names:
Italy Momil 50 micrograms/spray nasal spray, suspension Mometasone furoate
[to be completed with national data]