Emmarin

Package Leaflet: Information for the User

EMMARIN 50 micrograms/dose nasal spray, suspension

Mometasone Furoate
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult 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 using 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 EMMARIN is and what it is used for

What is EMMARIN?
EMMARIN contains mometasone furoate, which belongs to a group of medicines called corticosteroids. When mometasone furoate is sprayed into the nose, it helps relieve inflammation (swelling and irritation of the nose), sneezing, itching, and blocked or runny nose.
What is EMMARIN used for?
Hay fever and perennial rhinitis
EMMARIN 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 above.
Hay fever occurs during certain times of the year and is an allergic reaction caused by inhaling pollen from trees, grasses, weeds, as well as moulds and fungal spores. Perennial rhinitis occurs throughout the year, and symptoms may be caused by sensitivity to a variety of substances, including house dust mites, animal hair (or dander), feathers, and certain foods. EMMARIN reduces swelling and irritation in the nose, thereby relieving sneezing, itching, and blocked or runny nose caused by hay fever or perennial rhinitis.
Nasal polyps
EMMARIN is used to treat nasal polyps in adults aged 18 years and above.
Nasal polyps are small growths on the lining of the nose and usually affect both nostrils. EMMARIN reduces inflammation in the nose, leading to a gradual shrinkage of the polyps, thus relieving the sensation of a blocked nose, 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 to any of the other ingredients of this medicine (listed in section 6)
• if you have an untreated nasal infection. Using EMMARIN 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 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 EMMARIN:

• If you have or have had tuberculosis.
• If you have any other type of infection.
• If you are taking other corticosteroid medicines, either by mouth or by injection.
• If you have cystic fibrosis.

While using EMMARIN, inform your doctor if:

• Your immune system is not working properly (if you have difficulty fighting infections) and you come into contact with people who have measles or chickenpox. You should avoid contact with anyone who has these infections.
• you develop a nasal or throat infection.
• you use the medicine for several months or longer.
• you experience persistent irritation of the nose or throat.
• contact your doctor if you develop blurred vision or other visual disturbances.

When corticosteroid nasal sprays are used at high doses for prolonged periods,
adverse effects due to absorption of the drug into the body may occur.
If you experience eye itching or irritation, your doctor may recommend discontinuing or changing
treatment with EMMARIN.
Children
Prolonged use of nasal steroids at high doses may cause certain side effects, such as
slowed growth in children.
Regular monitoring of height is recommended in children receiving long-term treatment with nasal corticosteroids. If you notice any changes, inform your doctor.
Other medicines and EMMARIN
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 orally or by injection, your doctor may advise you to stop such treatment when starting
EMMARIN. When stopping oral or injectable corticosteroid therapy, some people may experience adverse effects such as joint or muscle pain, weakness, and depression.
You may also develop other allergic reactions, such as itching, watery eyes, red skin patches, and itchy rashes. Consult 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 may be pregnant, planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Driving and using machines
There are no known effects of EMMARIN on the ability to drive or operate machinery.
EMMARIN contains benzalkonium chloride
EMMARIN contains benzalkonium chloride, which may cause nasal irritation.

3. How to use EMMARIN

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. Do not use a higher dose, or use the spray 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 2 sprays in each nostril once daily.

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

Use in children aged 3 to 11 years
The recommended dose is 1 spray in each nostril once daily.
In some patients, EMMARIN may start to relieve symptoms within 12 hours of the first dose; however,
the full benefit of treatment may not be evident during the first two days. Nevertheless, you must
continue regular use to achieve the full therapeutic benefit.
If you or your child suffer from severe hay fever, your doctor may advise you to start using
EMMARIN before the beginning of 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 daily.

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

How to prepare the nasal spray for use
EMMARIN 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 to replace 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 fine, uniform mist:

1. Gently shake the bottle.
2. Place your index and middle fingers on either side of the nozzle and your thumb at the base of the bottle. Do not pierce the nasal applicator.
3. Point the nozzle away from you and press the dispenser with your two 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 "re-prime" the pump by releasing 2 sprays until you observe 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 nozzle into the other as shown (Figure 2). Tilt your head slightly forward, keeping the bottle upright.

4. Begin to inhale gently or slowly through your nose, and while inhaling, administer one spray into the nostril by pressing ONCE with your fingers.
5. Breathe out through your mouth. Repeat step 4 to inhale a second spray into the same nostril if required.
6. Remove the nozzle from the nostril and breathe out 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 tissue or clean 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 function 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 other sharp objects, as this may damage the applicator and result in incorrect dosing of the medication.
• Allow the dust cap and nozzle to dry in a warm place.
• Reinsert the nozzle into the bottle and replace the dust cap.
• The spray must be re-primed with at least 2 sprays the first time it is used after cleaning.

If you use more EMMARIN than you should
Inform your doctor if you have accidentally taken more than the prescribed dose.
If you use steroids for a long time or at high doses, in rare cases they may affect levels of certain hormones. In children, this may affect 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 treatment as usual. Do not take a double dose to make up for the missed dose.
If you stop using EMMARIN
In some patients, use of EMMARIN may relieve symptoms starting 12 hours after the first dose. However, full benefit of treatment may not occur until up to 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 do so.
If you have any questions 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 allergic (hypersensitivity) reactions may occur 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 pharynx
• Difficulty swallowing
• Hives
• Shortness of breath or breathing difficulties

When intranasal corticosteroid sprays are used at high doses over long periods of time, side effects due to systemic absorption 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 experience:

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 patients with nasal polyps treated with two sprays of mometasone furoate in each nostril twice daily]
• Pain in the nose or throat
• Nasal ulcers
• Respiratory tract infection

Frequency not known (cannot be estimated from the available data):

• Increased pressure in the eye (glaucoma) and/or cataracts causing visual disturbances
• Damage to the nasal septum (the part of the nose separating the nostrils)
• Changes in taste and smell
• Difficulty breathing and/or wheezing
• Blurred vision

Reporting of side effects
If you experience any side effect, 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 the following website: 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 outer carton after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Each bottle should be used within two months of first opening. Open only one bottle at a time.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What EMMARIN contains

• The active substance is mometasone furoate. Each delivered dose contains 50 micrograms of mometasone furoate monohydrate.
• The other components 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).
Bottles containing 60 sprays, 120 sprays or 140 sprays are sold in single packs.
It is possible that not all pack sizes are marketed.

Marketing Authorization 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 authorized in the Member States of the European Economic Area under the following names: