Package leaflet: Information for the patient

Eztom, 50 micrograms/dose, nasal spray, suspension
Mometasoni furoas
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Eztom is and what it is used for
Important information before using Eztom
How to use Eztom
Possible side effects
How to store Eztom
Contents of the pack and other information

1. What Eztom is and what it is used for

What is Eztom?
Eztom contains mometasone furoate, which belongs to a group of medicines called corticosteroids.
When administered intranasally, mometasone furoate reduces inflammation (swelling and irritation of the nasal mucosa), sneezing, itching, nasal congestion, and decreases nasal discharge.

What Eztom is used for
Hay fever and perennial allergic rhinitis
Eztom is used to treat symptoms of hay fever (also known as seasonal allergic rhinitis) and perennial allergic rhinitis in adults and children aged 3 years and older.
Hay fever, which occurs at specific times of the year, is an allergic reaction caused by inhaling pollen from trees, grasses, weeds, as well as spores of moulds and fungi. Perennial allergic rhinitis occurs throughout the year, and symptoms may be triggered by various allergens, including house dust mites, animal fur (or shed skin flakes), feathers, and certain foods. Eztom reduces swelling and irritation of the nasal mucosa, thereby relieving sneezing, itching, nasal congestion, and excessive nasal discharge caused by hay fever or perennial allergic rhinitis.

Nasal polyps
Eztom is used in the treatment of nasal polyps in adults aged 18 years and older.
Nasal polyps are small growths on the nasal mucosa, usually occurring in both nostrils. Eztom reduces inflammation in the nose, leading to gradual shrinkage of the polyps, thus reducing nasal congestion that may interfere with breathing through the nose.

2. Important information before using Eztom

When not to use Eztom:

if the patient is allergic to mometasone furoate or any of the other ingredients of this medicine (listed in section 6).
if the patient has an untreated nasal mucosal infection. Using Eztom during an untreated nasal infection, such as herpes simplex, may worsen the symptoms of infection. Nasal spray should not be used until the infection has healed.
if the patient has recently undergone nasal surgery or has sustained a nasal injury. Do not use the nasal spray until wounds have healed.

Warnings and precautions
Before starting Eztom, discuss with a doctor or pharmacist:

if the patient currently has or has ever had tuberculosis.
if the patient has any other infection.
if the patient is taking other corticosteroids orally or by injection.
if the patient has cystic fibrosis.

While using Eztom, discuss with a doctor:

if the patient's immune system is not functioning properly (difficulty fighting infections) and the patient has been in contact with someone who has measles or chickenpox. Avoid contact with people who have these infections.
if the patient has a nasal or throat infection.
if the medicine has been used for several months or longer.
if the patient has persistent nasal or throat irritation.

If nasal corticosteroid sprays are used at high doses for a prolonged period,
adverse effects due to systemic absorption of the medicine may occur.
If eye itching or irritation occurs, the doctor may recommend alternative treatment with Eztom.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.
Children
If nasal corticosteroid sprays are used at high doses for a prolonged period,
they may cause certain adverse effects, such as slowed growth rate in children.
It is recommended that the growth of children receiving long-term treatment with intranasal corticosteroids
be monitored regularly, and any changes should be reported to the doctor.
Eztom and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken,
including those obtained without a prescription, as well as any medicines the patient plans to use.
If the patient is taking other corticosteroids orally or by injection for allergy treatment, the treating doctor
may advise the patient to discontinue their use when starting Eztom.
In some patients, after stopping oral or injectable corticosteroids, adverse effects such as joint or muscle pain,
weakness, and depression may occur.
Other allergy symptoms such as itching, watery eyes, or red, itchy skin rashes may also appear.
Contact a doctor if any of these symptoms occur.
Some medicines may enhance the effect of Eztom, and the doctor may need to closely monitor the patient
taking such medicines (including certain HIV medications: ritonavir, cobicistat).
Pregnancy and breastfeeding
There are no data or only limited data on the use of mometasone furoate in pregnant women.
It is not known whether mometasone furoate passes into human milk.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child,
she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
There are no data on the effect of mometasone furoate on the ability to drive or operate machinery.
Eztom contains benzalkonium chloride
This medicine contains 20 micrograms of benzalkonium chloride per dose.
Benzalkonium chloride may cause nasal irritation or swelling, especially if used for a prolonged period.

3. How to use Eztom

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist. The nasal aerosol should not be used in higher doses, more frequently, or for longer than
recommended by your treating physician.
Treatment of seasonal and perennial allergic rhinitis
Use in adults and children over 12 years of age
The usual dose is two sprays into each nostril once daily.

If improvement occurs, your treating physician may recommend reducing the dose.
If no improvement occurs, consult your treating physician, who may recommend increasing the dose; the maximum daily dose is four sprays into each nostril once daily.

Use in children aged 3 to 11 years
The usual dose is one spray into each nostril once daily.
In some patients, symptom relief may occur within 12 hours after the first dose of
Eztom, but full therapeutic benefits may not be evident during the first two days of
treatment. Therefore, regular use should be continued to achieve full therapeutic benefits.
If a patient has severe seasonal rhinitis symptoms, the treating physician may recommend starting
Eztom before the expected start of pollen season. This may help prevent the onset of
symptoms of seasonal rhinitis.
Nasal polyps
Use in adults over 18 years of age
The usual initial dose is two sprays into each nostril once daily.

If no improvement occurs after 5 to 6 weeks of treatment, your physician may recommend increasing the dose to two sprays into each nostril twice daily. After improvement is achieved, your physician may recommend reducing the dose.
If no improvement occurs after 5 to 6 weeks of treatment twice daily, the patient should consult their treating physician.

Preparing the aerosol for use
Eztom nasal aerosol contains a protective cap that covers the spray nozzle and prevents contamination.
Remember to remove it before using the aerosol and replace it after use.
Before first use, test the spray by pressing the pump 10 times until a fine mist is produced:

Gently shake the bottle.
Place the index and middle fingers on either side of the spray nozzle, and the thumb under the bottle. DO NOT BEND the nasal aerosol spray nozzle.
Pointing the spray nozzle away from yourself, press the pump with your fingers 10 times until a uniform mist is produced. If the aerosol has not been used for 14 days or longer, press the pump 2 times before next use until a uniform mist is produced.

How to use the nasal aerosol

Gently shake the bottle and remove the protective cap.
Gently blow your nose.
Close one nostril and insert the spray nozzle into the other nostril. Tilt your head slightly forward, holding the bottle upright.
Begin a gentle and slow inhalation through the nose, while pressing down once with your fingers to release a fine mist of aerosol into the nostril.
Exhale through the mouth. Repeat step 4 to administer a second spray into the same nostril, if required.
Remove the spray nozzle from the nostril and exhale through the mouth.
Repeat steps 3 to 6 to administer the aerosol into the other nostril.

After using the aerosol, gently wipe the spray nozzle with a clean tissue or cloth and replace the protective cap.
Cleaning the nasal aerosol bottle

It is important to clean the nasal aerosol bottle regularly, otherwise it may not function properly.
Remove the protective cap and gently pull off the spray nozzle.
Wash the spray nozzle and protective cap in warm water, then rinse under running water.
Do not unblock the spray nozzle by piercing it with a needle or other sharp object, as this may damage the spray device and result in incorrect dosing.
Leave the protective cap and spray nozzle in a warm place to dry.
Reattach the spray nozzle to the bottle, then replace the protective cap.
After cleaning, check that the spray device works properly by spraying the aerosol twice.

Use of a higher than recommended dose of Eztom
If you accidentally use more Eztom than recommended, consult your doctor.
If corticosteroids are used for a long time or in high doses, they may rarely have an adverse effect on the patient's hormonal system. In children, they may affect growth and development.
Missed dose of Eztom
If the patient forgets to use the nasal aerosol at the scheduled time, they should take the medicine as soon as they remember, then continue treatment at the usual time. Do not use a double dose to make up for a missed dose.
Stopping Eztom treatment
In some patients, symptom relief occurs within 12 hours after the first dose of Eztom; however, full symptom control may only be achieved after 2 days of treatment. It is very important that the patient uses the nasal aerosol regularly. Do not stop treatment, even if the patient feels better, unless advised by the doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Immediate allergic (hypersensitivity) reactions may occur after using this medicine. These reactions
can be severe. You must stop using Eztom and seek immediate medical help if you experience symptoms such as:

swelling of the face, tongue or throat
difficulty swallowing
hives
wheezing or breathing difficulties

If nasal corticosteroid sprays are used at high doses for prolonged periods, side effects may occur due to systemic absorption of the medicine.
Other side effects:
Most people using nasal sprays do not report any side effects. However, in some individuals, the following side effects have been reported after using Eztom or another corticosteroid nasal spray:

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

headache
sneezing
nosebleeds [very common (may occur in more than 1 in 10 people) in patients with nasal polyps who used two doses of Eztom in each nostril twice daily]
nasal irritation or sore throat
nasal mucosal ulceration
upper respiratory tract infection

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

increased intraocular pressure (glaucoma) and/or cataract causing visual disturbances
damage to the nasal septum separating the nasal cavities
disturbances in taste and smell
breathing difficulties and/or wheezing
blurred vision

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: + 48 22 49 21 301; fax: + 48 22 49 21 309;
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Eztom

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the cardboard box after: expiry (EXP) or on the bottle label following the abbreviation: EXP. The expiry date refers to the last day of the stated month.
The bottle should be used within 2 months of opening. Only one bottle should be opened at any one time.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the package and other information

What Eztom contains

The active substance is mometasone furoate. Each spray contains 50 micrograms of mometasone furoate monohydrate.
The other ingredients are: benzalkonium chloride, glycerol, polysorbate 80, microcrystalline cellulose and sodium carmellose, citric acid monohydrate, sodium citrate, purified water.

What Eztom looks like and contents of the pack
Eztom is a nasal aerosol, suspension.
The bottle contains 140 doses of medication.
The pack contains 1 bottle or 3 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic
Manufacturer
Farmea
10, rue Bouche Thomas, Z.A.C d’Orgemont
49000 Angers
France
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonskiego Street 3
00-728 Warsaw
Email: [email protected]
This medicine is authorised in the European Economic Area countries under the following names:
Denmark: Aphiahsone 50 microgram/dose nasal spray, suspension
Sweden: Aphiahsone 50 microgram/dose nasal spray, suspension