Momester nasal

Before using the medicine, carefully read the package leaflet and educational materials.
These are available in pharmacies, by scanning the QR code with a smartphone,
and on the website www.momesternasal.pl (see also section 6 of the patient leaflet).

Package leaflet: information for the patient

Momester Nasal, 50 micrograms/dose, nasal spray, suspension
Mometasone furoate
Please read this leaflet carefully 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 advised by the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if your symptoms worsen, consult your doctor.

Contents of the leaflet

1. What Momester Nasal is and what it is 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 package and other information

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

What is Momester Nasal?
Momester Nasal contains mometasone furoate, which belongs to a group of medicines called corticosteroids. When used daily, it reduces inflammation. Administered intranasally, Momester Nasal relieves inflammatory symptoms (swelling and irritation of the nasal mucosa), sneezing, itching, nasal congestion, and reduces nasal discharge. Additionally, Momester Nasal helps relieve itchy and watery eyes.
Momester Nasal helps control the body's reaction to allergens (substances that trigger allergic reactions) present in the surrounding environment.

What is Momester Nasal used for?
Momester Nasal is used in adults aged 18 years and older for the treatment of diagnosed allergic rhinitis caused by pollen (known as seasonal allergic rhinitis or hay fever) or other airborne allergens such as house dust mites, pet dander (animal hair or shed skin particles), or mold and fungal spores (present in the environment throughout the year).
Hay fever, which occurs during specific times of the year, is an allergic reaction caused by inhaling pollen from trees, grasses, weeds, as well as mold and fungal spores.
Treatment should only be used during periods of allergen exposure.

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 nasal infection, such as herpes, 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 suffered a nasal injury. Do not use the nasal spray until wounds have healed.

Warnings and precautions
Before starting to use Momester Nasal, consult a 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 has cystic fibrosis
• If the patient is taking other medicines containing corticosteroids, such as tablets, creams, ointments, asthma medications, injections, nasal sprays, or eye or nasal drops
• If the patient has a nasal or sinus infection
• In case of recent nasal injury, surgery, or ulceration of the nasal mucosa.

While using Momester Nasal, consult 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 develops a nasal or throat infection.
• If the medicine has been used for 3 months without consulting a doctor.
• If the patient experiences prolonged irritation of the nose or throat.

Contact a doctor if the patient experiences blurred vision or other visual disturbances.
If nasal corticosteroid sprays are used at high doses for prolonged periods, systemic side effects due to absorption of the drug into the body may occur.

Children and adolescents
Momester Nasal should not be used in children and adolescents under 18 years of age.

Momester Nasal 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.

• When treating allergies with other corticosteroids taken orally or by injection, the treating physician may advise the patient to discontinue their use when starting Momester Nasal. 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 appear, such as itching, watery eyes, or red, itchy skin rashes. Contact a doctor if any of these symptoms occur.

• Some medicines may increase the effect of Momester Nasal, and the doctor may need to closely monitor the patient taking such medicines (including certain HIV medications: ritonavir, cobicistat).

No interaction has been demonstrated between Momester Nasal and loratadine (used in the treatment of allergies).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a 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 operating machinery
There are no data on the effect of mometasone furoate on the ability to drive or operate machinery.

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

3. How to use Momester Nasal

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

Recommended dose
Use in adults (aged 18 years and older, including elderly patients)
The usual dose is two sprays into each nostril once daily.
Once symptoms are under control, the dose should be reduced to one spray into each nostril once daily. Do not exceed the recommended doses.
In some patients, symptom relief may occur within 12 hours after the first dose of Momester Nasal. However, full benefit from treatment may not be achieved until after the first two days of use.
If there is no improvement after 7 days of treatment, discontinue use or consult your doctor. If symptoms improve but adequate control is not achieved, consult your doctor or pharmacist.
Do not use this medicine for longer than 3 months without consulting your 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 spray nozzle and prevents contamination.
Remember to remove the cap before using the spray and replace it after each use.

Before the first dose, shake the bottle well and prime the pump by pressing it 10 times (until a fine mist is produced):

1. 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 pierce the nasal spray nozzle.
3. Pointing the nozzle away from you, press down with your fingers 10 times until a uniform mist is produced (Figure 1).

Figure 1.
If the spray has not been used for 14 days or more, prime the pump by pressing it 2 times before the next use, until a uniform mist is produced.

How to use the nasal spray

1. Gently shake the bottle and remove the cap (Figure 2).

Figure 2.

2. Gently blow your nose.
3. Close one nostril and insert the spray nozzle into the other nostril, directing it away from the nasal septum. Tilt your head slightly forward and hold the bottle vertically upright (Figure 3).

Figure 3.
WARNING! Holding the bottle in an upright vertical position is very important, as incorrect spraying may cause damage to the nasal septum (Figure 4).

Figure 4.

4. Gently begin a slow inhalation through the nose while pressing down once on the pump to release a spray (fine mist) into the nostril.
5. Breathe out through your mouth (Figure 5). Then repeat step 4 to administer a second spray into the same nostril, if required.

Figure 5.

6. Remove the spray nozzle from the nostril and breathe out through your mouth.
7. Repeat steps 3–6 to administer the spray into the other nostril.

After using the nasal spray, carefully wipe the spray nozzle with a clean tissue or cloth and replace the cap to prevent dust contamination.

Cleaning the bottle

• It is important to clean the 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 pump and result in incorrect dosing.
• Allow the cap and spray nozzle to dry in a warm place.
• Reattach the spray nozzle to the bottle, then replace the cap.
• After cleaning, check that the spray pump works properly by priming it 2 times.

Accidental overdose of Momester Nasal
If you accidentally use more than the recommended dose, consult your doctor.
When corticosteroids are used long-term or at high doses, they may rarely affect the patient's hormone system. In children, they may affect growth and development.

Missed dose of Momester Nasal
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 Nasal
In some patients, symptom relief occurs within 12 hours after the first dose, but full benefit from treatment may not occur until after the first two days of use.
It is very important that the patient uses the nasal spray regularly. Contact your doctor if there is no improvement within 7 days.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Immediate hypersensitivity (allergic) reactions may occur after using this medicine, with unknown frequency. These reactions may be severe. The use of Momester Nasal should be discontinued and immediate medical help should be sought if symptoms such as the following occur:

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

If corticosteroids in the form of nasal aerosol are used in high doses over a long period of time, adverse reactions may occur due to systemic absorption of the medicine.
Other adverse reactions:
Most people using nasal aerosols do not report any adverse reactions. However, in some individuals, the following adverse reactions may occur after using Momester Nasal or another corticosteroid in the form of a nasal aerosol:
Common (occur in fewer than 1 out of 10 people)

• headache
• sneezing
• nosebleeds
• irritated nose 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
• blurred vision.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Momester Nasal

Keep this medicine out of sight and reach of children.
No special storage conditions apply for this medicine.
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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Momester Nasal contains

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

What Momester Nasal looks like and contents of the pack
Momester Nasal is a nasal aerosol, 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Zakłady Farmaceutyczne 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

Detailed and up-to-date information on this medicine is available by scanning with a smartphone the QR code printed in the leaflet below and on the packaging. The same information is also available on the website: www.momesternasal.pl
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