NASOMETIN 50 mcg/measured dose Aerosol

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Nasometin, 50 micrograms/dose, nasal spray, suspension
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Nasometin and what is it used for
   1. What is Nasometin?
   2. What is Nasometin used for?
4. Important information before using Nasometin
   1. When not to use Nasometin
   2. Warnings and precautions
   3. Children
   4. Nasometin and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Nasometin contains benzalkonium chloride
5. How to use Nasometin
   1. Treatment of hay fever and perennial allergic rhinitis
   2. Use in adults and children over 12 years of age
   3. Use in children from 3 to 11 years of age
   4. Nasal polyps
   5. Use in adults over 18 years of age
   6. Before each use, shake the bottle.
   7. Do not puncture the actuator (the hole in the tip of the actuator) with a needle or other sharp object.
   8. Do not attempt to unblock the actuator by inserting a needle or other sharp object into the hole, as this may damage the actuator and cause the medicine to be administered incorrectly.
   9. Using a higher dose of Nasometin than recommended
   10. Missing a dose of Nasometin
   11. Stopping the use of Nasometin
6. Possible side effects
   1. Reporting side effects
7. How to store Nasometin
8. Contents of the packaging and other information
   1. What Nasometin contains
   2. What Nasometin looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. For more information about this medicine and its names in the Member States of the European Economic Area, please contact:

Leaflet attached to the packaging: patient information

Nasometin, 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.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. 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 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 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 years 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 years 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

3. How to use Nasometin

This medicine should always be used as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist. The nasal spray should not be used in larger doses, more frequently, or for longer than prescribed 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 daily.

Use in children from 3 to 11 years of age

The recommended dose is 1 spray into each nostril once daily.

Nasal polyps

Use in adults over 18 years of age

The recommended initial dose is 2 sprays into each nostril once daily.Preparing the nasal spray for use
Nasometin has a cap that protects the tip of the actuator and prevents it from getting dirty. 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 other sharp object.

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

• 1. Shake the bottle well.
• 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 the actuator with your fingers to spray the medicine 10 times until a fine mist is produced (Figure 1).

If the medicine has not been used for 14 days or longer, the patient should check that it is working by pressing the bottle 2 times until a fine mist is produced.

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

• 2. Gently blow your nose to clear your nasal passages.
• 3. Close one nostril and insert the tip of the actuator into the other nostril. Tilt your head slightly forward, keeping the bottle upright.
• 4. Press the actuator with your fingers ONCEto spray a fine mist of medicine into your nose, and at the same time, start breathing in gently through your nose (Figure 3). Figure 2

Figure 3

• 5. Breathe out through your mouth, then repeat the steps described in point 4 to administer a second dose of medicine to the same nostril (if such dosing is recommended).
• 6. Remove the actuator from the nostril and breathe out 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 replace the cap.

Do not attempt to unblock the actuator by inserting a needle or 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.

Using a higher dose of Nasometin than recommended

The patient should contact their doctor if they have accidentally used a higher dose of the medicine than recommended.

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 with the treatment as recommended.

Stopping the use of Nasometin

In some patients, Nasometin may provide improvement within 12 hours of the first dose, although the full benefits of treatment may only be apparent after 2 days of using the medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.stopusing the medicine and seek medical help immediately:

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 Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

5. How to store Nasometin

Keep the medicine out of the sight and reach of children.

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 as 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 contents of the pack

This medicine is a white, homogeneous suspension, packaged in white plastic bottles with a pump and actuator, and placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

For more information about this medicine and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.Date of last revision of the leaflet:06/2022