Momester

Leaflet attached to the packaging: information for the user

Momester, 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.
• In case of any doubts, consult a doctor, pharmacist or nurse.
• This medicine has been prescribed specifically for you. 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 side effects not listed in this leaflet, they should tell their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Momester and what is it used for

What is Momester?

Momester 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 the amount of nasal discharge.

What is Momester used for?

Hay fever and perennial allergic rhinitis Momester 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 fungus 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. Momester reduces swelling and irritation of the nasal mucosa and thus relieves sneezing, itching, stuffy nose, or nasal discharge caused by hay fever or perennial allergic rhinitis. Nasal polyps Momester 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. Momester reduces inflammation in the nose, causing a gradual reduction in nasal polyps, thereby reducing the feeling of a stuffy nose, which can make breathing difficult.

2. Important information before using Momester

When not to use Momester

• If the patient is allergic (hypersensitive) 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 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 is cured.
• 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 Momester, 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 Momester, discuss it with your doctor:

• If the patient's immune system is not working properly (has difficulty fighting infection) and the patient has come into contact with someone who has chickenpox or shingles. Avoid contact with people who have these infections.
• If the patient has a nasal or throat infection.
• If the medicine is used for several months or longer.
• If the patient has long-term irritation of the nose or throat.
• If the patient experiences 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. If itching or irritation of the eyes occurs, the doctor may recommend other treatment with Momester.

Children

If corticosteroids in the form of a nasal spray are taken in large doses for a long time, they may cause certain side effects, such as slowing down the growth rate in children. It is recommended to regularly monitor the growth of children receiving long-term treatment with nasal corticosteroids, and if any changes are noticed, inform the doctor.

Momester and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take, including those that are available without a prescription.

• In the case of allergy treatment with other corticosteroids orally or by injection, the doctor may recommend that the patient stop taking them when starting to use Momester. In some patients, after stopping 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 spots on the skin, may also appear. Contact your doctor if you experience any of these symptoms.
• Some medicines may enhance the effect of Momester, and the doctor may want to closely monitor the patient's condition when taking such medicines (including some HIV medicines: ritonavir, cobicistat).

Pregnancy and breastfeeding

There are no data or only limited data on the use of Momester in pregnant women. It is not known whether mometasone furoate passes into breast milk. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Momester contains benzalkonium chloride

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

3. How to use Momester

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. The nasal spray should not be used more frequently, for a longer period, or in larger doses than prescribed by your doctor.

Treatment of hay fever and perennial allergic rhinitis

Use in adults and children over 12 years of age

Typically, two doses of the nasal spray are used in each nostril once a day.

• After improvement, the doctor may recommend reducing the dose.
• If the patient does not feel better, they should contact their doctor, who may recommend increasing the dose: the maximum daily dose is four doses of the nasal spray in each nostril once a day.

Use in children aged 3 to 11 years

Typically, one dose of the nasal spray is used in each nostril once a day. In some patients, relief of symptoms occurs within 12 hours of administration of the first dose of Momester; however, full benefits of treatment may not be observed within the first two days of treatment. Therefore, regular use should be continued to achieve full benefits from treatment. If the patient has severe symptoms of hay fever, the doctor may recommend starting to use Momester before the start of the pollen season. This will help prevent the occurrence of hay fever symptoms.

Nasal polyps

Use in adults over 18 years of age

Typically, two doses of the nasal spray are used in each nostril once a day.

• If after 5 to 6 weeks of using Momester, there is no improvement, the doctor may recommend increasing the dose to two doses of the nasal spray in each nostril twice a day. After improvement, the doctor may recommend reducing the dose of the medicine.
• If after 5 to 6 weeks of using Momester twice a day, there is no improvement, the patient should contact their doctor.

Preparing the nasal spray for use Momester nasal spray contains a cap that protects the tip of the actuator and prevents it from getting dirty. Remember to remove it before using the spray and put it back on after use. Before administering the first dose, shake the bottle well and press the pump 10 times (until a uniform mist is sprayed):

• 1. Gently shake the bottle.
• 2. Place your index and middle fingers on either side of the pump and your thumb underneath the bottle. Do not puncture the nasal spray actuator.
• 3. With the actuator tip away from you, press your fingers so that 10 times the spray is sprayed, until a uniform mist is obtained. If the spray has not been used for 14 days or more, before the next use, press the pump 2 times, until a uniform mist is obtained.

How to use the nasal spray:

• 1. Shake the bottle gently and remove the cap.
• 2. Gently blow your nose.
• 3. Close one nostril and insert the actuator tip into the other nostril. Tilt your head slightly forward, holding the bottle upright.
• 4. Gently start slow inhalation through your nose, during which you should spray the aerosol (in the form of a fine mist) into your nose, pressing DOWN ONCE with your fingers.
• 5. Exhale through your mouth, then repeat the actions described in point 4 to administer a second dose of the spray to the same nostril, if necessary.
• 6. Remove the actuator tip from the nostril and exhale through your mouth.
• 7. Repeat the actions described in points 3-6 to administer the spray to the other nostril.

After using the spray, 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 nasal spray bottle, as it may not work properly otherwise. 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 unclog 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, check that the actuator is working properly and spray the aerosol 2 times.

Using a higher dose of Momester than recommended

If a higher dose of Momester than recommended is accidentally used, consult a doctor. If corticosteroids are used for a long period or in large 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

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

Stopping the use of Momester

In some patients, relief of symptoms occurs within 12 hours of administration of the first dose of Momester; however, full benefits of treatment may not be observed within the first two days of treatment. It is very important that the patient regularly uses the nasal spray. Do not stop treatment, even if the patient feels better, unless explicitly recommended by the doctor. If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Momester 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 Momester and seek medical help immediately if symptoms such as:

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

occur. 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 or another corticosteroid nasal spray, the following side effects have occurred: Common (occurring in less than 1 in 10 patients)

• headache
• sneezing
• nasal bleeding [occurred very commonly (may occur in more than 1 in 10 people) in patients with nasal polyps who used two doses of Momester in each nostril twice a day]
• 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
• difficulty breathing and/or wheezing
• blurred vision.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Momester

Keep the medicine out of the sight and reach of children. Do not store above 25°C. Do not use this medicine after the expiry date stated on the bottle and carton after EXP. The expiry date refers to the last day of the month. The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number. The bottle should be used within 2 months after 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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Momester contains

• The active substance of the medicine is mometasone furoate. Each dose of the medicine contains 50 micrograms of mometasone furoate, equivalent to 52 micrograms of mometasone furoate monohydrate.
• The other ingredients of the medicine are: benzalkonium chloride, glycerol (E422), polysorbate 80 (E433), microcrystalline cellulose (E460), and sodium carmellose (E468), citric acid monohydrate (E330), sodium citrate (E331), purified water.

What Momester looks like and contents of the pack

Momester is a nasal spray, suspension. Each bottle contains 60, 120, or 140 doses. Bottles containing 60, 120, or 140 doses contain one actuator.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Polpharma S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Manufacturer:

FARMEA, 10, rue Bouché Thomas, Z.A.C d’Orgemont, 49000 ANGERS, France, Date of last revision of the leaflet:August 2021