ARINIT 50 MICROGRAMS Nasal spray, suspension

Зміст інструкції

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

MOMETIC 50 micrograms/spray Nasal Spray, Suspension
mometasone furoate
Generic medicine

Read this leaflet carefully before you start 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 for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is MOMETIC nasal spray and what is it used for

What is MOMETIC Nasal Spray?
MOMETIC 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 MOMETIC Nasal Spray used for?
Hay fever and perennial rhinitis
MOMETIC 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
breathing in pollen from trees, grass, weeds and also molds and fungal spores. Perennial rhinitis is present all year round, and symptoms may be caused by sensitivity to a variety of
elements, including dust mites, animal dander (or dandruff), feathers and certain foods.
MOMETIC Nasal Spray reduces swelling and nasal irritation, thereby relieving sneezing, itching and
conditions of stuffy nose or runny nose caused by hay fever or perennial rhinitis.
Nasal polyps
MOMETIC 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,
MOMETIC Spray Nasale . reduces inflammation in the nose causing a gradual reduction of polyps,
thus relieving a feeling of nasal obstruction and improving breathing through the nose.

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

Do not use MOMETIC Nasal Spray:

• if you are allergic to mometasone furoate or any of the excipients of this medicine (listed in section 6).
• if you have an untreated nasal infection. The use of MOMETIC 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 undergone nasal surgery or have suffered a nasal trauma. You should not use the nasal spray until the nose has healed.

Warnings and precautions
Consult your doctor or pharmacist before using MOMETIC

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

During the use of MOMETIC, consult your doctor:

• if your immune system is not functioning properly (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.

The use of nasal sprays containing corticosteroids at high doses for long periods of time can lead to
the development of undesirable effects due to the absorption of the medicine into the body.
If you have itchy or irritated eyes, your doctor may prescribe other treatments to use together
with MOMETIC.
Consult 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 undesirable effects, such as delayed growth in children.
It is recommended to regularly monitor the height of children undergoing prolonged treatment with
nasal corticosteroids and, if you notice any changes, you should inform the doctor.

Other medicines and MOMETIC Nasal Spray
Inform your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
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
MOMETIC. When stopping treatment with oral or injectable corticosteroids, some people
may experience undesirable 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 experience any of these effects.
Some medicines can increase the effects of MOMETIC and your doctor may want to keep you under
close observation 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 MOMETIC 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 or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
No information is available on the effects of MOMETIC Nasal Spray on the ability to drive
vehicles or use machines.

MOMETIC Nasal Spray contains benzalkonium chloride
MOMETIC contains 20 micrograms of benzalkonium chloride per dose which can cause
irritation or swelling inside the nose, especially if used for a long period.

3. How to use MOMETIC Nasal Spray

Use MOMETIC Nasal Spray always following exactly the instructions of your doctor. If you have doubts consult your doctor or pharmacist. Do not use a higher dose or the spray more often 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 2 sprays in each nostril once a day
In some patients, MOMETIC Nasal Spray begins to relieve symptoms within 12 hours of the first dose.
However, it may take more than two days to obtain the full benefit of the 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 4 sprays in each nostril once a day.

Use in children from 3 to 11 years of age
The recommended dose is 1 spray in each nostril once a day.
If you or your child suffer 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 to prevent the onset of hay fever symptoms. At the end of the pollen season, the symptoms of hay fever may subside, making treatment unnecessary.
use MOMETIC Nasal Spray a few days before the expected start of the pollen season: this will help to prevent the onset of hay fever symptoms.

Nasal Polyposis
Use in adults over 18 years of age
The recommended initial dose is 2 sprays in each nostril once a day.
If symptoms are not controlled after 5 or 6 weeks, the dose may be increased to 2 sprays in each nostril twice a day. Once the symptoms are under control, your doctor may advise you to reduce the dose.

• If no improvements are observed after 5- or 6 weeks from the start of twice-daily administration, contact your doctor to discuss the application of other treatments as a substitute for MOMETIC Nasal Spray.

How to prepare the nasal spray for use
MOMETIC 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 either side 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 obtain 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 the 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 to inhale 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 spray 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 other sharp objectas this maneuver will damage the nasal applicator and will not allow you to have 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 MOMETIC 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 take MOMETIC
If you forget to take MOMETIC nasal spray at the right time, take it as soon as you remember, then continue therapy as usual. Do not use a double dose to make up for the missed dose.

If you stop the treatment with MOMETIC
In some patients, symptoms will begin to be relieved after 12 hours of the first dose of MOMETIC 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 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 taking MOMETIC Nasal Spray and
seek immediate medical attention if any of the following symptoms appear:

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

When nasal sprays based on corticosteroids are used at high doses for long periods of time, it is
possible that side effects occur due to the absorption of the medicine inside
the body.

Other side effects
Most people have no problems with the use of the nasal spray. However, some people,
after using MOMETIC Nasal Spray, or other nasal sprays based on corticosteroids may
experience:

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

• headache
• sneezing and irritation/burning sensation in the nose
• nose bleeding (epistaxis) [occurred very commonly (may affect more than 1 in 10 people) in people with nasal polyps treated with MOMETIC Nasal Spray two sprays in each nostril twice a day] Nose or throat pain Ulcers in the nose Upper respiratory tract infection.

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 of taste and smell Difficulty breathing and/or shortness of breath
• blurred vision.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. 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 store MOMETIC

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 packaging box after “Exp.”. The
expiry date refers to the last day of that month.
Do not store at a temperature 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 dispose of any medicine in 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 MOMETIC Nasal Spray contains

• 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 MOMETIC Nasal Spray and contents of the pack
MOMETIC is a nasal spray suspension.
Each bottle contains 60 or 140 sprays.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
DMG Italia SRL
Via Laurentina Km 26.700, Pomezia
Rome 00071, 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
United Kingdom: Mometasone Furoate Nasal Spray, 50 micrograms/actuation nasal spray suspension
Italy: MOMETIC
[to be completed with national data]