Eztom

Leaflet attached to the packaging: patient information

Eztom, 50 micrograms/dose, nasal spray, suspension

Mometasone furoate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Eztom and what is it used for
• 2. Important information before using Eztom
• 3. How to use Eztom
• 4. Possible side effects
• 5. How to store Eztom
• 6. Contents of the pack and other information

1. What is Eztom and what is it used for

What is Eztom?

Eztom contains mometasone furoate, which belongs to a group of medicines called corticosteroids.
Mometasone furoate administered intranasally relieves symptoms of inflammation (swelling and irritation of the nasal mucosa), sneezing, itching, and a stuffy nose, and reduces nasal discharge.

What is Eztom 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 certain times of the year, is an allergic reaction caused by inhaling pollen from trees, grasses, weeds, as well as mold and fungal spores. Perennial allergic rhinitis occurs throughout the year, and symptoms may be caused by sensitivity to various factors, including house dust mites, animal dander (or shed skin), feathers, and some foods. Eztom reduces swelling and irritation of the nasal mucosa, thereby relieving sneezing, itching, and a stuffy nose or reducing nasal discharge caused by hay fever or perennial allergic rhinitis.
Nasal polyps
Eztom is used to treat 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, causing gradual reduction of polyps, thereby reducing the feeling of a stuffy nose, which can make breathing difficult.

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 mucosa infection. Using Eztom during an untreated infection in the nasal cavity, such as herpes, may worsen the symptoms of the infection. Before using the nasal spray, wait until the infection has healed.
• if the patient has recently had nasal surgery or a nasal injury. Do not use the nasal spray until the wounds have healed.

Warnings and precautions

Before starting to use Eztom, discuss it with your doctor or pharmacist:

• if the patient currently has or has had tuberculosis in the past.
• 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 it with your doctor:

• if the patient's immune system is not working properly (has difficulty fighting infection) and has come into contact with someone with chickenpox or shingles. Avoid contact with people who have these infections.
• if the patient has a nose or throat infection.
• if the medicine is used for several months or longer.
• if the patient has prolonged nasal or throat irritation.

If corticosteroids in the form of a nasal spray are taken in large doses for a long period, side effects may occur due to the absorption of the medicine into the body.
If itching or irritation of the eyes occurs, the doctor may prescribe other treatment with Eztom.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Children

If corticosteroids in the form of a nasal spray are taken in large doses for a long period, they may cause certain side effects, such as slowing down the growth rate in children.
It is recommended that the growth of children receiving long-term treatment with nasal corticosteroids be regularly monitored, and if any changes occur, the doctor should be informed.

Eztom and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription.
If you are taking other corticosteroids orally or by injection for allergy treatment, your doctor may advise you to stop taking them when you start using Eztom. In some patients, after stopping oral or injected corticosteroids, side effects such as joint or muscle pain, weakness, and depression may occur.
Other allergy symptoms, such as itching, tearing of the eyes, or red and itchy skin patches, may also appear. Contact your doctor if you experience any of these symptoms.
Some medicines may enhance the effect of Eztom, and your doctor may want to monitor your condition closely while taking such medicines (including certain HIV medicines: ritonavir, cobicistat).

Pregnancy and breastfeeding

There are no data or only limited data available on the use of mometasone furoate in pregnant women. It is not known whether mometasone furoate passes into human milk.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

There are no data available on the effect of mometasone furoate on the ability to drive and use machines.

Eztom contains benzalkonium chloride

This medicine contains 20 micrograms of benzalkonium chloride per dose.
Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Eztom

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Do not use more than the recommended dose or for longer than your doctor tells you.

Treatment of hay fever and perennial allergic rhinitis

Use in adults and children over 12 years of age

Usual dose is two sprays into each nostril once daily.

• If improvement occurs, your doctor may recommend a dose reduction.
• If no improvement occurs, contact your doctor, who may recommend an increased dose; the maximum daily dose is four sprays into each nostril once daily.

Use in children from 3 to 11 years of age

Usual dose is one spray into each nostril once daily.

In some patients, relief of symptoms occurs within 12 hours of the first dose of Eztom; however, full control of symptoms may not be achieved until after 2 days of treatment. It is very important that you use the nasal spray regularly. Do not stop treatment, even if you feel better, unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

Nasal polyps

Use in adults over 18 years of age

Usual initial dose is two sprays into each nostril once daily.

• If after 5 to 6 weeks of treatment no improvement occurs, your doctor may recommend an increased dose to two sprays into each nostril twice daily. After improvement is achieved, your doctor may recommend a dose reduction of the medicine.
• If after 5 to 6 weeks of treatment twice daily no improvement occurs, you should contact your doctor.

Preparing the nasal spray for use

Eztom nasal spray contains a protective cap that protects the tip of the actuator and prevents it from becoming contaminated. Remember to remove it before use and replace it after use.
Before first use, check that the nasal spray is working by pressing the pump 10 times until a fine spray appears:

• 1. Gently shake the bottle.
• 2. Place your index and middle fingers on either side of the actuator and your thumb under the bottle. DO NOT TWIST THE ACTUATOR.
• 3. Pointing the actuator away from you, press the pump with your fingers to spray 10 times until a fine spray appears. If the nasal spray has not been used for 14 days or more, press the pump 2 times before use until a fine spray appears.

How to use the nasal spray

• 1. Shake the bottle gently and remove the protective cap.
• 2. Gently blow your nose.
• 3. Close one nostril and put the actuator into the other nostril. Tilt your head slightly forward, keeping the bottle upright.
• 4. Start to breathe in gently through your nose. While breathing in, press the pump 1 time to release a fine spray into your nose.
• 5. Breathe out through your mouth. Repeat steps 4 and 5 to administer a second spray into the same nostril, if necessary.
• 6. Remove the actuator from your nostril and breathe out through your mouth.
• 7. Repeat steps 3 to 6 to administer the spray into the other nostril.

After use, wipe the actuator with a clean tissue or cloth and replace the protective cap.
Cleaning the nasal spray bottle

• It is important to regularly clean the nasal spray bottle, as it may not work properly otherwise.
• Remove the protective cap and gently pull off the actuator.
• Wash the actuator and protective cap in warm water, then rinse under running water.

Do not unblock the actuator by piercing it with a needle or other sharp object, as this will damage the actuator and the correct dose of medicine will not be delivered.

• Leave the protective cap and actuator in a warm place to dry.
• Replace the actuator on the bottle, then put on the protective cap.
• After cleaning, check that the actuator is working properly and spray 2 times.

Using more Eztom than you should

If you accidentally use more than the recommended dose, contact your doctor.
If steroids are used for a long time or in high doses, they may have an adverse effect on the patient's hormonal system. In children, they may affect growth and development.

Forgetting to use Eztom

If you forget to use your nasal spray at the right time, use it as soon as you remember, then continue as before. Do not use a double dose to make up for a forgotten dose.

Stopping treatment with Eztom

In some patients, relief of symptoms occurs within 12 hours of the first dose of Eztom; however, full control of symptoms may not be achieved until after 2 days of treatment. It is very important that you use the nasal spray regularly. Do not stop treatment, even if you feel better, unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Eztom can cause side effects, although not everybody gets them.
After using this medicine, immediate allergic reactions (hypersensitivity) may occur. These reactions can be severe. Stop using Eztom and seek medical help immediately if you experience symptoms such as:

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

If corticosteroids in the form of a nasal spray are taken in large doses for a long period, side effects may occur due to the absorption of the medicine into the body.
Other side effects:
Most people using nasal sprays do not experience any side effects. However, some people using Eztom or other nasal corticosteroids may experience the following side effects:
Common side effects (may affect up to 1 in 10 people):

• headache
• sneezing
• nasal bleeding [very common (may affect more than 1 in 10 people) in patients with nasal polyps who used two sprays of Eztom into each nostril twice daily]
• irritated nose or sore throat
• ulceration of the nasal mucosa
• upper respiratory tract infection

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

• increased pressure in the eye (glaucoma) and/or cataracts causing vision problems
• damage to the nasal septum
• disturbances of taste and smell
• breathing difficulties and/or wheezing
• blurred vision

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw; phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eztom

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the carton after EXP. or on the label after EXP. The expiry date refers to the last day of that month.
The bottle should be used within 2 months of opening. Only open one bottle at a time.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Eztom contains

• The active substance ismometasone 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 spray, suspension.
The bottle contains 140 doses of the medicine.
The pack contains 1 bottle or 3 bottles.
Not all pack sizes may be marketed.

Marketing authorization 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 on this medicine, please contact the local representative of the marketing authorization holder:

Glenmark Pharmaceuticals Sp. z o. o.
Dziekońskiego 3
00-728 Warsaw
Email: [email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark:
Aphiahsone 50 micrograms/dose nasal spray, suspension
Sweden:
Aphiahsone 50 micrograms/dose nasal spray, suspension

Date of last revision of the leaflet: