Momester Nasal

Before using the medicine, read the leaflet carefully and familiarize yourself with the materials

educational. This information is available in pharmacies, after scanning the QR code with a smartphone
and on the website www.momesternasal.pl (see also point 6 of the patient leaflet).

Leaflet attached to the packaging: patient information

Momester Nasal, 50 micrograms/dose, nasal spray, suspension

Mometasone furoate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• You should keep this leaflet, so that you can read it again if necessary.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Momester Nasal and what is it used for

What is Momester Nasal?

Momester Nasal contains mometasone furoate, which belongs to a group of medicines called corticosteroids, which, when used daily, reduce inflammation. Momester Nasal, when administered intranasally, relieves symptoms of inflammation (swelling and irritation of the nasal mucosa), sneezing, itching, feeling of a blocked nose, and reduces the amount of nasal discharge. Additionally, Momester Nasal relieves itching and tearing of the eyes.
The medicine Momester Nasal helps control the body's reaction to allergens (factors that trigger an allergic reaction) in the environment.

What is Momester Nasal used for?

Momester Nasal is used in adults aged 18 years and older for the treatment of symptoms of diagnosed allergic rhinitis caused by plant pollen (known as seasonal allergic rhinitis or hay fever) or other allergens in the air, such as house dust mites, animal dander (fur or flaked skin of animals) or mold and fungus spores (present in the environment throughout the year).
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 fungus spores.
Treatment should only be used during the period of exposure to the allergen.

2. Important information before using Momester Nasal

When not to use Momester Nasal

• 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 infection. Using Momester Nasal during an untreated infection in the nasal cavity, such as herpes, may worsen the symptoms of the infection. Before using the nasal spray, you should wait until the infection has healed.
• If the patient has recently had nasal surgery or a nasal injury. The nasal spray should not be used until the wounds have healed.

Warnings and precautions

Before starting to use Momester Nasal, you should discuss this 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 has cystic fibrosis
• If the patient is taking other medicines that contain corticosteroids, such as: tablets, creams, ointments, medicines used to treat asthma, injections, nasal sprays or eye drops or nasal drops
• If the patient has a nasal or sinus infection
• In case of recent injuries, nasal surgery, or nasal mucosa ulcers.

While using Momester Nasal, you should discuss this with your doctor:

• If the patient's immune system is not working properly (has difficulty fighting infection) and the patient has been in contact with someone who has chickenpox or shingles. You should avoid contact with people who have these infections.
• If the patient has a nasal or throat infection.
• If the medicine is used for 3 months without consulting a doctor.
• If the patient has persistent nasal or throat irritation.

You should contact your doctor if you experience blurred vision or other vision disturbances.
If corticosteroids in the form of a nasal spray are taken in large doses for a long time, side effects may occur due to the absorption of the medicine into the body.
Children and adolescents
Momester Nasal should not be used in children and adolescents under 18 years of age.

Momester Nasal and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those that are available without a prescription.

• In the case of allergy treatment with other corticosteroids in oral or injectable form, the doctor may recommend that you stop using them when you start using Momester Nasal. In some patients, after stopping the use of oral or injectable corticosteroids, side effects such as joint or muscle pain, weakness, and depression may occur. Other allergic symptoms, such as itching, tearing of the eyes, or red and itchy skin patches, may also appear. You should contact your doctor if you experience any of these symptoms.

and itchy skin patches. You should contact your doctor if you experience any of these symptoms.

• Some medicines may enhance the effect of Momester Nasal, and your doctor may want to closely monitor your condition while taking such medicines (including some HIV medicines: ritonavir, cobicistat).

No interaction has been shown between Momester Nasal and loratadine (used to treat allergies).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
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.

Driving and using machines

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

Momester Nasal contains benzalkonium chloride

Momester Nasal contains benzalkonium chloride, which may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Momester Nasal

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Do not use a higher dose or use the medicine more often or for a longer period than recommended in this leaflet.
Recommended dose

Use in adults (from 18 years of age, including the elderly)

Usually, two sprays are used for each nostril once a day.
After symptoms are under control, the dose should be reduced to one spray in each nostril once a day. Do not exceed the recommended doses.
In some patients, relief of symptoms occurs within 12 hours of administration of the first dose of Momester Nasal. However, the full benefits of treatment may take two days to develop.

If after 7 days of using the medicine there is no improvement, treatment should be discontinued or you should consult your doctor. If there is improvement, but not sufficient control of symptoms, you should consult your doctor or pharmacist.

Do not use the medicine for more than 3 months without consulting a doctor.

Use in children and adolescents

Momester Nasal should not be used in children and adolescents under 18 years of age.
Preparing the nasal spray for use
Momester Nasal nasal spray contains a cap on the bottle that protects the tip of the actuator and prevents it from getting dirty.
You should remember to remove it before using the spray and put it back on after use.
Before administering the first dose, you should shake the bottle well and press the pump 10 times (until a uniform mist is sprayed):

• 1. You should gently shake the bottle.
• 2. Place your index and middle fingers on either side of the pump and your thumb underneath the bottle (Figure 1). Do not piercethe nasal spray actuator.
• 3. With the actuator tip pointing away from you, press your fingers to spray the medicine 10 times, until a uniform mist is produced (Figure 1).

Figure 1.
If the spray has not been used for 14 days or more, before using it again, you should press the pump 2 times, until a uniform mist is produced.
How to use the nasal spray

• 1. Shake the bottle gently and remove the cap (Figure 2).

Figure 2.

• 2. Gently blow your nose.
• 3. Close one nostril and insert the actuator tip into the other nostril, away from the nasal septum. Tilt your head slightly forward, holding the bottle upright (Figure 3).

Figure 3.

IMPORTANT! Keeping the bottle upright is very important, as improper spraying may damage the nasal septum (Figure 4).

Figure 4.

• 4. Gently start to inhale slowly through your nose, while spraying the medicine (in the form of a fine mist) into your nose, pressing your fingers DOWN once.
• 5. Exhale through your mouth (Figure 5). Then repeat the steps described in point 4 to administer a second dose of the spray to the same nostril, if necessary.

Figure 5.

• 6. Remove the actuator tip from your nostril and exhale through your mouth.
• 7. You should repeat the steps described in points 3-6 to administer the spray to the other nostril.

After using the spray, you should carefully wipe the actuator tip with a clean tissue or cloth and put the cap back on to prevent dust from entering.
Cleaning the bottle

• It is important to regularly clean the spray bottle, as it may not work properly otherwise.
• You should remove the cap and gently pull off the actuator tip.
• Wash the actuator tip and cap in warm water, then rinse under running water.
• Do not unblock the actuator tip by piercing it with a needle or other sharp object, as this will damage the actuator and the correct dose of the medicine will not be delivered.
• Leave the cap and actuator tip in a warm place to dry.
• Put the actuator tip back on the bottle, then put the cap back on.
• After cleaning, you should check that the actuator is working properly and spray the medicine 2 times.

Using a higher dose of Momester Nasal than recommended

If you accidentally use a higher dose of the medicine than recommended, you should consult your doctor.
If corticosteroids are used for a long time or in high doses, they may have an adverse effect on the patient's hormones. In children, they may affect growth and development.

Missing a dose of Momester Nasal

If you forget to use the nasal spray at the usual time, you should take it as soon as you remember, and then continue treatment at the usual time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Momester Nasal

In some patients, relief of symptoms occurs within 12 hours of administration of the first dose of Momester Nasal, however, the full benefits of treatment may take two days to develop.
It is very important that you regularly use the nasal spray. You should contact your doctor if you do not see any improvement within 7 days.
If you have any further questions about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After using this medicine, immediate allergic reactions (allergic) of unknown frequency may occur. These reactions can be severe. You should stop using Momester Nasal 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 time, side effects may occur due to the absorption of the medicine into the body.

Other side effects:

Most people using nasal sprays do not report any side effects. However, in some people, after using Momester Nasal or another corticosteroid nasal spray, the following side effects may occur:
Common (occurring in less than 1 in 10 people)

• headache
• sneezing
• nasal bleeding
• irritated nose or sore throat
• ulceration of the nasal mucosa
• upper respiratory tract infection.

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

• increased intraocular pressure (glaucoma) and/or cataracts causing vision disturbances
• damage to the nasal septum separating the nostrils
• disturbances of taste and smell
• blurred vision.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 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 Momester Nasal

The medicine should be stored out of sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Momester Nasal contains

• The active substance of the medicine is mometasone furoate. Each dose of the medicine contains mometasone furoate monohydrate equivalent to 50 micrograms of mometasone furoate.
• The other ingredients of the medicine are: benzalkonium chloride, solution; glycerol; polysorbate 80; microcrystalline cellulose; sodium carmellose; citric acid monohydrate; sodium citrate; purified water.

What Momester Nasal looks like and what the pack contains

Momester Nasal is a nasal spray, suspension.
The bottle contains one spray mechanism.
Each bottle contains 60 doses, 120 doses, or 140 doses.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer:

FARMEA
10, rue Bouché Thomas
Z.A.C d’Orgemont
49000 ANGERS
France
Detailed and up-to-date information about this medicine is available after scanning the QR code on the leaflet below and on the packaging. The same information is also available on the website: www.momesternasal.pl
Date of last revision of the leaflet:April 2023
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