MOMETASONE 50 MICROGRAMS Назальный спрей, суспензия

Содержание инструкции

1. Mometasone Eurogenerici 50 micrograms/spray Nasal Spray, Suspension
   1. What is Mometasone Eurogenerici and what is it used for
   2. What you need to know before using Mometasone Eurogenerici
   3. How to use Mometasone Eurogenerici
   4. Possible side effects
   5. How to store Mometasone Eurogenerici
   6. Contents of the pack and other information

Mometasone Eurogenerici 50 micrograms/spray Nasal Spray, Suspension

Mometasone furoate

Generic medicine(only for bottles containing 60 and 140 sprays)

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 for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could 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 Mometasone Eurogenerici is and what it is used for
• 2. What you need to know before you use Mometasone Eurogenerici
• 3. How to use Mometasone Eurogenerici
• 4. Possible side effects
• 5. How to store Mometasone Eurogenerici
• 6. Contents of the pack and other information

1. What is Mometasone Eurogenerici and what is it 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 to relieve inflammation
(swelling and irritation of the nose), sneezing, itching and conditions of a blocked or runny nose.

What is Mometasone Eurogenerici used for?
Hay fever and perennial rhinitis
Mometasone Eurogenerici is used for the treatment of the symptoms of hay fever (also called
seasonal allergic rhinitis) and perennial rhinitis in adults and children from 3 years of age onwards.
Hay fever, which occurs during certain times of the year, is an allergic reaction caused
by inhaling pollen from trees, grass, weeds and also mold spores and fungal spores. Perennial rhinitis occurs throughout the year and symptoms may be caused by
sensitivity to a variety of things such as dust mites, animal hair (or dander), feathers and certain foods.
Mometasone Eurogenerici reduces swelling and irritation in the nose, providing relief from sneezing, itching
and conditions of a blocked or runny nose caused by hay fever or perennial rhinitis.
Nasal polyps
Mometasone Eurogenerici is used to treat nasal polyps in adults from 18 years of age.
Nasal polyps are small growths on the nasal lining and usually affect both
nostrils.
Mometasone Eurogenerici reduces nasal inflammation, resulting in a gradual reduction in polyps,
providing relief from the feeling of a blocked nose which can affect nasal breathing.

2. What you need to know before using Mometasone Eurogenerici

Do not use Mometasone Eurogenerici

• 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 infection in your nose. Using Mometasone Eurogenerici during an untreated infection in the nose, 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 injured your nose. You should 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 multi-organ genetic disease, which mainly affects the lungs and digestive system).

While you are using Mometasone Eurogenerici, see your doctor:

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

When using nasal sprays based on corticosteroids at high doses for long periods of time, adverse effects may occur due to the absorption of the drug into the body.
If you experience eye itching or irritation, your doctor may prescribe other treatments to use together with
Mometasone Eurogenerici.

Children
If used at high doses and for long periods of time, nasal sprays based on corticosteroids can
cause some adverse effects, such as delayed growth in the child.
It is recommended to regularly check the height of children undergoing prolonged treatment with
nasal corticosteroids and to inform the 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 available without a prescription.
If you are taking other medicines for allergies based on corticosteroids, either orally or by
injection, your doctor may advise you to stop them once you have started using Mometasone
Eurogenerici. Some people may experience some adverse effects when stopping
treatment with oral or injectable corticosteroids, such as joint or muscle pain, weakness, and
depression. You may also seem to develop other allergies, such as itching, watery eyes, or red and itchy patches
on the skin. If you experience any of these effects, contact your doctor.
Some medicines can increase the effects of Mometasone Eurogenerici 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 and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.
Information on the use of Mometasone Eurogenerici in pregnant women is limited or absent. It is
not known whether mometasone furoate passes into breast milk.

Driving and using machines
There is no information on the effects of Mometasone Eurogenerici on the ability to drive vehicles
or use machines.

Mometasone Eurogenerici contains benzalkonium chloride
This medicine contains 0.02 mg of benzalkonium chloride per actuation. Benzalkonium chloride can cause
irritation and swelling inside the nose, especially if used for long periods.

3. How to use Mometasone Eurogenerici

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist. Do not use the spray in doses higher or more frequent or for longer than
indicated 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.

• Once your symptoms are under control, your doctor may advise you to reduce the dose;
• if you do not start to feel better, consult your doctor who may advise 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 Eurogenerici before the start of the pollen season, as this will help to prevent the
onset of hay fever symptoms. At the end of the pollen season, the symptoms of hay fever may improve and treatment may no longer be necessary.

Nasal polyps
Use in adults over 18 years of age
The recommended starting dose is two sprays in each nostril once a day.

• If symptoms are not controlled after 5 - 6 weeks, the dose may be increased to two sprays in each nostril twice a day. Once your symptoms are under control, your doctor may advise you to decrease the dose;
• if you do not see an improvement in symptoms after 5 - 6 weeks of twice-daily administration, you should consult your doctor.

Preparation of the nasal spray for use
Mometasone Eurogenerici Nasal Spray has a dust cap that protects the applicator and keeps it
clean.
Remember to remove it before using the spray and reposition it after use.
If you are using the spray for the first time, you must "activate" 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 finger on each side of the applicator and your thumb under the bottle. Do notpuncture the nasal applicator;
• 3. point the applicator away from yourself and press 10 times with your fingers until a uniform jet is obtained. If you have not used the spray for 14 days or more, you must reactivate 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 place the applicator in the other nostril as illustrated (Figure 2). Tilt your head slightly forward, keeping the bottle upright.

• 4. Start to inhale gently and slowly through your nose and while inhaling, deliver a spray of fine mist 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 applicator from the nostril and exhale through your mouth.
• 7. Repeat steps 3 to 6 for the other nostril (Figure 3).

After using the spray, clean the applicator thoroughly with a clean tissue or 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 correctly;
• remove the dust cap and gently pull the applicator;
• wash the applicator and dust cap in warm water and 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;
• allow the dust cap and vaporizer to dry in a warm place;
• push the applicator onto the bottle and reposition the dust cap;
• the spray will have to be activated again with 2 sprays at first use after cleaning.

If you use more Mometasone Eurogenerici than you should
Inform your doctor if you have accidentally used more than you have been told.
If taken for a long time or in large quantities, steroids can, rarely, affect
the levels of some hormones. In children this can 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
previously. Do not take a double dose to make up for the missed dose.

If you stop treatment with Mometasone Eurogenerici
In some patients Mometasone Eurogenerici should start to relieve symptoms 12 hours after the first
dose; however, the full benefit of treatment may not appear until two days. It is very
important that you use the nasal spray regularly.
Do not stop treatment even if you feel better unless you are told to do so by your doctor.
If you have any doubts about using 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.
With the use of this medicine, immediate hypersensitivity (allergic) reactions may occur. These
reactions can be serious. 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 difficulty breathing.

When nasal sprays containing 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 into the body.
Other side effects
Most people do not have 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 [occurred 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;
• ulcers in the nose;
• 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 get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system reported at the address 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 at a temperature above 30°C. Do not freeze.
Do not use this medicine after the expiry date which is stated on the package and the bottle. The expiry date refers to the last day of that month.
Each bottle must be used within 2 months of first opening. 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 Mometasone Eurogenerici contains

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

Description of the appearance of Mometasone Eurogenerici and contents of the pack
Mometasone Eurogenerici is a nasal spray, suspension.
The bottles contain 60 sprays (10 g), 120 sprays (16 g) or 140 sprays (18 g).
The bottles containing 60 sprays and 120 sprays are supplied in packs of 1 nasal spray.
The bottles containing 140 sprays are supplied in packs of 1 or 3 nasal sprays.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan

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
Netherlands

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Belgium - Mometasone EG 50 microgram/puff, Neusspray, suspension
Italy - Mometasone Eurogenerici 50 micrograms/spray Nasal Spray, Suspension
Germany - Mometasonfuroat AL 50 Microgram/spray Nasenspray, Suspension
Spain - Mometasona furoato STADA 50 micrograms/spray suspension for nasal spray