Momester

Package leaflet: Information for the user

Momester, 50 micrograms/dose, nasal spray, suspension
Mometasoni furoas
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Momester is and what it is used for
2. What you need to know 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 Momester is and what it is used for

What is Momester?
Momester contains mometasone furoate, which belongs to a group of medicines called
corticosteroids. Mometasone furoate, when administered intranasally, reduces inflammation (swelling
and irritation of the nasal mucosa), sneezing, itching, nasal congestion, and decreases nasal discharge.
What is Momester used for?
Hay fever and perennial allergic rhinitis
Momester is used to treat the 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 mould and fungal spores.
Perennial allergic rhinitis occurs throughout the year, and symptoms may be triggered by various allergens, including house dust mites, animal fur (or shed skin particles), feathers, and certain foods. Momester reduces swelling and irritation of the nasal mucosa, thereby relieving sneezing, itching, nasal congestion, or nasal discharge caused by hay fever or perennial allergic rhinitis.
Nasal polyps
Momester 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. Momester reduces nasal inflammation, leading to gradual shrinkage of nasal polyps, thus improving nasal congestion that may interfere with breathing through the nose.

2. Important information before using Momester

When not to use Momester

• If the patient is allergic (hypersensitive) to mometasone furoate or to 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 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 experienced nasal trauma. The nasal spray should not be used until wounds have healed.

Warnings and precautions
Before starting treatment with Momester, discuss with your doctor or pharmacist:

• If the patient currently has or has ever 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 with your doctor:

• If the patient’s immune system is not working properly (difficulty fighting infections) and the patient has been in contact with someone with measles or chickenpox. 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 persistent irritation of the nose or throat.
• If the patient experiences blurred vision or other vision disturbances.

If nasal corticosteroid sprays are used in high doses over a prolonged period,
adverse effects due to systemic absorption of the drug may occur.
If eye itching or irritation occurs, the doctor may recommend alternative treatment with Momester.

Children
If nasal corticosteroid sprays are used in high doses over a prolonged period,
they may cause certain adverse effects, such as slowed growth rate in children.
It is recommended that children receiving long-term treatment with intranasal corticosteroids have their growth monitored regularly. If any changes are noticed, inform the doctor.

Momester 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 take.

• If the patient is being treated for allergies with other corticosteroids taken orally or by injection, the treating doctor may advise discontinuing them when starting Momester. Some patients may experience adverse effects after stopping oral or injectable corticosteroids, such as joint or muscle pain, weakness, or depression. Other allergic symptoms may also reappear, such as itching, watery eyes, or red, itchy skin rashes. Contact your doctor if any of these symptoms occur.
• Some medicines may increase the effect of Momester, 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 Momester 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 become pregnant, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
There are no data on the effect of Momester on the ability to drive vehicles or operate machinery.

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 prolonged periods.

3. How to use Momester

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist. The nasal spray should not be used more frequently, for
a longer time, or in higher doses than recommended by a doctor.
Treatment of seasonal and perennial allergic rhinitis
Use in adults and children over 12 years of age
Typically, two sprays of the nasal spray into each nostril once daily are recommended.

• After improvement is achieved, the prescribing doctor may recommend reducing the dose.
• If the patient does not experience improvement, contact the prescribing doctor, who may recommend increasing the dose: the maximum daily dose is four sprays of the nasal spray into each nostril once daily.

Use in children aged 3 to 11 years
Typically, one spray of the nasal spray into each nostril once daily is recommended.
In some patients, symptom relief may occur within 12 hours after the first dose of Momester, but full benefits of treatment may not be evident during the first two days of treatment. Therefore, regular use should be continued to achieve full therapeutic benefits.
If the patient has severe seasonal rhinitis symptoms, the prescribing doctor may recommend starting treatment with Momester before the pollen season begins. This may help prevent the onset of seasonal rhinitis symptoms.
Nasal polyps
Use in adults over 18 years of age
Initially, two sprays of the nasal spray into each nostril once daily are typically recommended.

• If there is no improvement after 5 to 6 weeks of treatment, the doctor may recommend increasing the dose to two sprays into each nostril twice daily. After improvement is achieved, the doctor may recommend reducing the dose.
• If there is no improvement after 5 to 6 weeks of treatment twice daily, the patient

should contact the prescribing doctor.
Preparing the nasal spray for use
Momester nasal spray contains a protective cap that covers the spray nozzle and prevents its contamination.
Remember to remove it before using the spray and replace it after use.
Before the first dose is administered, shake the bottle well and prime the pump by pressing it 10 times (to produce a uniform mist):

1. Gently shake the bottle.
2. Place the index and middle fingers on both sides of the pump and the thumb underneath the bottle. Do not pierce the nasal spray dispenser.
3. Pointing the spray nozzle away from you, press down with your fingers 10 times until a fine, uniform mist is produced. If the spray has not been used for 14 days or more, prime the pump by pressing it 2 times before next use until a uniform mist is produced.

How to use the nasal spray:

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

After using the nasal spray, gently wipe the spray nozzle with a clean tissue or cloth and replace the cap to prevent dust accumulation.
Cleaning the bottle

• It is important to clean the nasal spray bottle regularly, as failure to do so may result in improper functioning.
• Remove the cap and gently pull off the spray nozzle.
• Wash the spray nozzle and cap with warm water, then rinse thoroughly under running water.
• Do not unblock the spray nozzle by piercing it with a needle or any sharp object, as this may damage the dispenser and result in incorrect dosing.
• Leave the cap and spray nozzle in a warm place to dry.
• Reattach the spray nozzle to the bottle, then replace the cap.
• After cleaning, check that the dispenser is working properly by spraying twice.

Use of a higher than recommended dose of Momester
If a larger dose of Momester is accidentally used than recommended, consult a doctor.
If corticosteroids are used for a long period or in high doses, they may rarely have an adverse effect on the patient's hormones. In children, they may affect growth and development.
Missed 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, then continue treatment at the usual time. Do not use a double dose to make up for a missed dose.
Stopping treatment with Momester
In some patients, symptom relief may occur within 12 hours after the first dose of the medicine, but full benefits of treatment may not be evident during the first two days of treatment. It is very important that the patient uses the nasal spray regularly. Do not stop treatment, even if the patient feels better, unless specifically instructed by a doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Immediate allergic (hypersensitivity) reactions may occur after using this medicine.
These reactions can be severe. You should stop using Momester and seek immediate medical help if any of the following symptoms occur:

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

If nasal corticosteroid sprays are used at high doses for a prolonged period, adverse effects may occur due to systemic absorption of the medicine.
Other adverse effects:
Most people using nasal sprays do not report any adverse effects. However, in some patients, the following adverse effects have been reported after using Momester or other corticosteroid nasal sprays:
Common (affects less than 1 in 10 patients)

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

Frequency unknown (frequency cannot be estimated from available data)

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Momester

Keep the 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 bottle and carton after: EXP.
The expiry date refers to the last day of the stated month.
The marking on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot indicates the batch number.
The bottle should be used up within two months of first opening.
Only open one bottle at a time.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Momester contains

• The active substance is mometasone furoate. Each dose contains 50 micrograms of mometasone furoate, equivalent to 52 micrograms of mometasone furoate monohydrate.
• The other ingredients 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 aerosol, suspension.
Each bottle contains 60, 120 or 140 doses.
Bottles containing 60, 120 or 140 doses each contain one spray mechanism.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
POLPHARMA Pharmaceutical Works S.A.
19 Pelplińska Street, 83-200 Starogard Gdański
tel. +48 22 364 61 01

Manufacturer:
FARMEA
10, rue Bouché Thomas
Z.A.C d’Orgemont
49000 ANGERS
France