Nasometin

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Nasometin (Mometasone Furoate - 1 A Pharma)

50 micrograms/dose, nasal spray, suspension

Mometasone Furoate
Nasometin and Mometasone Furoate - 1 A Pharma are different trade names for the same medicine.

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

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Nasometin and what is it used for

What is Nasometin?

Nasometin nasal spray contains mometasone furoate, which belongs to a group of medicines called corticosteroids. Mometasone furoate sprayed into the nose can help to relieve inflammation (swelling and irritation of the nasal mucosa), sneezing, itching, and a feeling of nasal congestion or runny nose.

What is Nasometin used for?

Hay fever and perennial allergic rhinitis
Nasometin 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 and older.
Hay fever, which occurs several times a year, is an allergic reaction caused by inhaled pollen from trees, grasses, weeds, as well as molds and fungal spores. Perennial allergic rhinitis occurs throughout the year, and symptoms can be caused by hypersensitivity to various factors, including house dust mites, animal dander or skin, feathers, and some foods.
Nasometin reduces swelling and irritation of the nasal mucosa, thereby relieving sneezing, itching, and nasal congestion or runny nose caused by hay fever or perennial allergic rhinitis.
Nasal polyps
Nasometin is used to treat nasal polyps in adults aged 18 and older.
Nasal polyps are small growths inside the nose, usually in both nostrils. Nasometin reduces inflammation, which causes the polyps to shrink gradually and relieve the feeling of nasal congestion, making it easier to breathe through the nose.

2. Important information before using Nasometin

When not to use Nasometin

Warnings and precautions

Before starting to use Nasometin, the patient should discuss it with their doctor or pharmacist if they:

• have or have had tuberculosis in the past,
• have any other infection,
• are taking other corticosteroids (orally or by injection),
• have cystic fibrosis.

While using Nasometin, the patient should consult their doctor if:

• their immune system is not working properly (if they have trouble fighting off infections) and they come into contact with someone who has chickenpox or shingles. They should avoid contact with such people.
• they have a nasal or throat infection,
• they have been using the medicine for several months or longer,
• they have persistent nasal or throat irritation.

If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.
Long-term use of high doses of corticosteroids in nasal sprays may cause side effects due to the absorption of the medicine into the body.
If the patient experiences itching or irritation of the eyes, the doctor may recommend using other medicines in addition to Nasometin.

Children

In children, long-term use of high doses of corticosteroids in nasal sprays may cause certain side effects, such as slowed growth rate.
It is recommended to regularly monitor the growth of children who are being treated with corticosteroids in nasal sprays for a long time, and if any changes are observed, to inform the doctor about it.

Nasometin and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.
Some medicines may enhance the effect of Nasometin. The doctor may want to closely monitor the condition of the patient taking such medicines (including some medicines used to treat HIV infection: ritonavir, cobicistat).
If the patient is taking other corticosteroids in oral or injectable form to treat allergies, the doctor may recommend stopping them when starting to use Nasometin. In some patients, after stopping the use of corticosteroids in oral or injectable form, certain side effects may occur, such as joint or muscle pain, weakness, and depression. Other allergic symptoms, such as itching, tearing, or red and itchy skin patches, may also occur. If the patient experiences any of these symptoms, they should contact their doctor.

Pregnancy and breastfeeding

There is limited or no data on the use of Nasometin in pregnant women. It is not known whether mometasone furoate passes into breast milk.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

The effect of Nasometin on the ability to drive and use machines is not known.

Nasometin contains benzalkonium chloride

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

3. How to use Nasometin

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The nasal spray should not be used in larger doses, more frequently, or for a longer period than recommended by the doctor.

Treatment of hay fever and perennial allergic rhinitis

Use in adults and children over 12 years of age

The recommended dose is 2 sprays into each nostril once a day.

• After improvement, the doctor may recommend reducing the dose of the medicine.
• However, if the patient does not feel better, they should contact their doctor, who may recommend increasing the dose: the maximum daily dose is 4 sprays into each nostril once a day.

Use in children from 3 to 11 years of age

The recommended dose is 1 spray into each nostril once a day.
In some patients, Nasometin may provide improvement within 12 hours of administration of the first dose, although the full benefits of treatment may only be apparent after 2 days of using the medicine. If the patient (adult or child) has severe symptoms of hay fever, it may be necessary to start treatment a few days before the start of the pollen season. After the end of the pollen season, the symptoms of hay fever should subside, and treatment may no longer be necessary.

Nasal polyps

Use in adults over 18 years of age

The recommended initial dose is 2 sprays into each nostril once a day.

• If after 5 to 6 weeks of using the medicine there is no improvement, the doctor may increase the dose to 2 sprays into 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 the medicine twice a day there is no improvement, the patient should contact their doctor.

Preparing the nasal spray for use
Nasometin has a protective cap that protects the tip of the actuator and prevents it from getting contaminated.
The patient should remember to remove it before using the spray and put it back on after use.

Before each use, shake the bottle.

Do not puncture the actuator (the hole in the tip of the actuator) with a needle or any other sharp object.

Before using the spray for the first time, the patient should check its operation by pressing the bottle 10 times until a fine mist is produced.

• 1. Shake the bottle vigorously.
• 2. Remove the plastic cap.
• 3. Place the index and middle fingers on either side of the actuator and the thumb under the bottle (Figure 1). Do notpuncture the actuator.
• 4. With the actuator pointing away from you, press it with your fingers 10 times until a fine mist is produced (Figure 1).

Figure 1
If the medicine has not been used for 14 days or longer, the patient should check its operation by pressing the bottle 2 times until a fine mist is produced.
How to use the nasal spray

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

Figure 2

• 2. Gently blow your nose to clear the nasal passages.
• 3. Close one nostril and insert the tip of the actuator into the other nostril. Tilt your head slightly forward, holding the bottle upright.
• 4. Press the actuator ONCEwith your fingers to spray a fine mist of the medicine into your nose and start a gentle or slow inhalation through your nose (Figure 3).

Figure 3

• 5. Exhale through your mouth, then repeat the steps described in point 4 to administer a second dose of the medicine to the same nostril (if such dosing is recommended).

• 6. Remove the actuator from the nostril and exhale through your mouth.
• 7. Repeat the steps described in points 3-6 to administer the medicine to the other nostril.

After using the spray, the patient should carefully wipe the tip of the actuator with a clean tissue or cloth and put the cap back on.
Cleaning

• It is important to regularly clean the actuator, as it may not work properly otherwise.
• The patient should remove the cap and gently pull off the actuator.
• Wash the actuator and cap in warm water, then rinse under running water.

Do not attempt to unblock the actuator by inserting a needle or any other sharp object into the hole, as this may damage the actuator and cause the medicine to be administered incorrectly.

• Leave the cap and actuator in a warm place to dry.
• Put the actuator back on the bottle, then put the cap back on.
• After cleaning, the patient should check the operation of the spray by pressing the bottle twice.

Using more than the recommended dose of Nasometin

The patient should consult their doctor if they have accidentally used a larger dose of the medicine than recommended.
If corticosteroids are used for a long time or in high doses, they may rarely have an adverse effect on the functioning of certain hormones. In children, they may affect growth and development.

Missing a dose of Nasometin

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

Stopping the use of Nasometin

In some patients, Nasometin may provide improvement within 12 hours of administration of the first dose, although the full benefits of treatment may only be apparent after 2 days of using the medicine. It is very important to use the nasal spray regularly. The patient should not stop treatment, even if they feel better, unless their doctor has explicitly recommended it.
If the patient has any further doubts about the use of this medicine, they should consult their 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 (hypersensitivity) may occur, including severe ones. If the patient experiences any of the following symptoms, they should stopusing the medicine and seek medical help immediately:

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

Long-term use of high doses of corticosteroids in nasal sprays may cause side effects due to the absorption of the medicine into the body.
Other side effects
In most people, using the nasal spray does not cause any problems. However, in some people, using Nasometin or other corticosteroids in nasal sprays may cause:

• headache,
• sneezing,
• nasal bleeding [occurred very frequently (more than 1 in 10 people) in people with nasal polyps, using 2 sprays of Nasometin into each nostril twice a day],
• nasal or throat pain,
• ulceration of the nasal mucosa,
• respiratory tract infections.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• increased intraocular pressure (glaucoma) and/or cataract causing vision disturbances, nasal septum damage,
• blurred vision,
• changes in taste and smell,
• difficulty breathing and/or wheezing.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Nasometin

• The medicine should be stored out of sight and reach of children.
• The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
• The shelf life after opening the bottle is 2 months.
• Do not freeze.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Nasometin contains

• The active substance is mometasone furoate. Each spray contains 50 micrograms of mometasone furoate in the form of mometasone furoate monohydrate.
• The other ingredients are: microcrystalline cellulose, sodium carmellose, glycerol, citric acid monohydrate, sodium citrate, polysorbate 80, benzalkonium chloride, water for injections.

What Nasometin looks like and what the packaging contains

This medicine is a white, homogeneous suspension, packaged in an HDPE bottle with a PE/PP spray pump in a cardboard box.
Pack size:
1x10g (60 sprays).
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the country of export:

1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Germany

Manufacturer:

Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia
S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, the country of export:82291.00.00

Parallel import authorization number: 65/22 Date of leaflet approval: 02.02.2022

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