EMMARIN 50 MICROGRAMS Nasal spray, suspension

Зміст інструкції

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

EMMARIN 50 micrograms/spray nasal spray, suspension

Mometasone Furoate

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

1. What is EMMARIN and what is it used for

What is EMMARIN?
EMMARIN contains mometasone furoate, belonging 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 a stuffy or runny nose.

What is EMMARIN used for?
Hay fever and perennial rhinitis
EMMARIN is used to treat the symptoms of hay fever (also called seasonal allergic
rhinitis) and perennial rhinitis in adults and children 3 years of age and older.
Hay fever, which occurs during certain times of the year, is an allergic reaction caused by
breathing in pollen from trees, grasses, weeds, and also molds and fungal spores. Perennial rhinitis occurs
throughout the year and symptoms may be caused by a sensitivity to a variety of things
including dust mites, animal fur (or dandruff), feathers and some foods. EMMARIN reduces the
swelling and irritation in the nose and thus relieving sneezing, itching and a stuffy or runny nose caused by
hay fever or perennial rhinitis.
Nasal polyps
EMMARIN is used to treat nasal polyps in adults 18 years of age and older.
Nasal polyps are small growths on the lining of the nose and usually affect both
nostrils. EMMARIN reduces inflammation in the nose, causing a gradual reduction in polyps,
thus relieving a feeling of nasal blockage, which can affect breathing through
the nose.

2. What you need to know before using EMMARIN

Do not use EMMARIN

• 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 EMMARIN 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 had surgery on your nose or have injured your nose. You should not use the nasal spray until your nose has healed.

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

• 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.

While using EMMARIN, tell your doctor if

• If your immune system is not working properly (if you have difficulty fighting infections) and you come into contact with people with 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 the medicine for several months or more.
• if you have persistent irritation of the nose or throat.
• contact your doctor if you experience blurred vision or other visual disturbances.

When nasal sprays containing corticosteroids are used at high doses for long periods of time,
undesirable effects may occur due to absorption of the drug into the body.
If you have itchy or irritated eyes, your doctor may recommend using other treatments with
EMMARIN.

Children
Prolonged use of nasal steroids at high doses can cause some side effects, such as
slowing of growth in children.
It is recommended to regularly monitor the height of children receiving long-term
treatment with nasal corticosteroids and, if you notice any changes, you should inform your doctor.

Other medicines and EMMARIN
Tell your doctor or pharmacist if you are taking or have recently taken or may take
any other medicine.
If you are taking other corticosteroid medicines to treat allergies, either orally or by
injection, your doctor may advise you to stop that treatment when you start using
EMMARIN. When stopping treatment with oral or injectable corticosteroids, some people
suffer from side effects such as joint or muscle pain, weakness and depression. You may
also develop other allergies, such as itching, watery eyes, red spots on the skin and
itchy rashes. See your doctor if you experience any of these effects.

Pregnancy and breastfeeding
There is limited information on the use of EMMARIN in pregnant women. It is not known whether
mometasone furoate is excreted in breast milk.
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
There is no known information on the effect of EMMARIN on the ability to drive vehicles or use
machinery.

EMMARINcontains benzalkonium chloride
EMMARIN contains benzalkonium chloride, which may cause nasal irritation.

3. How to use EMMARIN

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 a higher dose or use 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.

• Once your symptoms are under control, your doctor may advise you to reduce the dose.
• If you do not start to feel better, you should return to your doctor, who may tell you to increase the dose; the maximum daily dose is 4 sprays in each nostril once a day.

Use in children between 3 and 11 years of age
The recommended dose is 1 spray in each nostril once a day.
In some patients, EMMARIN starts to relieve symptoms within 12 hours of the first dose; however, the full benefit of treatment may not be observed for the first two days. However, you should continue regular use to obtain the full benefit of treatment.
If you or your child suffer from severe hay fever, your doctor may tell you to start using EMMARIN before the start of the pollen season, as this will help prevent the onset of hay fever symptoms.

Nasal polyps
Use in adults over 18 years of age
The recommended initial dose is 2 sprays in each nostril once a day.

• If your symptoms are not controlled after 5-6 weeks, the dose may be increased to 2 sprays in each nostril twice a day. Once your symptoms are under control, your doctor may advise you to reduce the dose.
• If no improvement is observed after 5-6 weeks of administration twice a day, you should contact your doctor.

How to prepare the nasal spray for use
EMMARIN Nasal Spray is equipped with a dust cap that protects the vaporizer 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 must “prime” the bottle by actuating the pump 10 times until you see a uniform mist:

• 1. Gently shake the bottle.
• 2. Position your index and middle fingers on either side of the vaporizer and your thumb at the base of the bottle. Do notpuncture the nasal applicator.
• 3. Direct the vaporizer away from you and press the dispenser with both fingers, releasing the spray 10 times until a fine mist is produced.

If you do not use the spray for more than 14 days, you must “reprime” the pump of the bottle by releasing 2 sprays, until you see a uniform mist.

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 vaporizer into the other as shown (figure 2). Tilt your head slightly forward, keeping the container upright.

• 4. Start to inhale gently or slowly through your nose, and while inhaling administer one spray of spray into your nose by pressing the fingers ONCE.
• 5. Exhale through your mouth. Repeat point 4 to inhale a second spray into the same nostril if applicable.
• 6. Remove the vaporizer from the nostril and exhale through your mouth.
• 7. Repeat points 3 and 6 for the other nostril (Figure 3).

After using the product, carefully clean the vaporizer with a handkerchief or a 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 correctly.
• Remove the dust cap and gently pull off the vaporizer.
• Wash the vaporizer and dust cap with lukewarm water, then rinse under running water.
• Do not try to unblock the nasal applicator by inserting a pin or other sharp objectsas this may damage the applicator and cause an incorrect dose of the drug to be dispensed.
• Let the dust cap and vaporizer dry in a warm place.
• Reinsert the vaporizer into the container and reposition the dust cap.
• The spray needs to be reloaded with at least 2 sprays at first use after cleaning.

If you use more EMMARIN than you should
Inform your doctor if you have accidentally taken a higher dose than prescribed.
If you use steroids for a long time or at high doses, these can, in rare cases, have an effect on the levels of some hormones. In children, this can have an effect on development and growth.

If you forget to take EMMARIN
If you forget to take EMMARIN nasal spray when scheduled, take it as soon as you remember, then continue therapy as usual. Do not take a double dose to make up for the missed dose.

If you stop treatment with EMMARIN
In some patients, the use of EMMARIN may relieve symptoms starting from 12 hours after taking the first dose. However, a full benefit of treatment may not appear until two days after the first administration. 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.
Hypersensitivity (allergic) reactions may occur immediately after using this product.
These reactions can be serious. You must stop taking EMMARIN and seek
immediate medical attention if you experience symptoms such as:

• Swelling of the face, tongue or throat
• Difficulty swallowing
• Hives
• Shortness of breath or breathing problems When corticosteroid nasal sprays are used at high doses for long periods of time, side effects due to absorption into the body may occur.

Other side effects
Most patients do not experience problems after using the nasal spray. However, some
people, after using EMMARIN and other corticosteroid nasal sprays may suffer from:
Common side effects (may affect up to 1 in 10 people):

• Headache
• Sneezing
• Shortness of breath
• Nosebleeds [very common (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]
• Nose or throat pain
• Nasal ulcers
• Upper respiratory tract infection

Not known (frequency cannot be estimated from the available data):

• Increased pressure in the eye (glaucoma) and/or cataracts causing visual disturbances
• Damage to the part of the nose that separates 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, 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 EMMARIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the package after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Each bottle must be used within two months of first opening. Open only 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 EMMARIN 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 EMMARIN and contents of the pack
EMMARIN 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, 120 sprays or 140 sprays are sold in single packs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Farma Group SRL
Via N. Strampelli, 18
63074, San Benedetto del Tronto (AP) Italy
Manufacturer
FARMEA
10, rue Bouché Thomas
Z.A.C d’Orgemont
49000 ANGERS
FRANCE

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations: