PRONASAL 50 mcg/dose Aerosol

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Pronasal, 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 Pronasal is and what it is used for
   1. What is Pronasal?
   2. When is Pronasal used?
4. Important information before using Pronasal
   1. When not to use Pronasal
   2. Warnings and precautions
   3. Children
   4. Other medicines and Pronasal
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Pronasal contains benzalkonium chloride
5. How to use Pronasal
   1. Treatment of hay fever and year-round allergic rhinitis
   2. Use in adults and children over 12 years of age.
   3. Typically, two doses of the nasal spray are used in each nostril once a day.
   4. Use in children aged 3 to 11 years
   5. One dose of the nasal spray is recommended in each nostril once a day.
   6. Nasal polyps
   7. Use in adults over 18 years of age
   8. Preparing the nasal spray for use
   9. How long the package will last
   10. How to use the nasal spray:
   11. Cleaning the nasal spray
   12. Using a higher dose of Pronasal than recommended
   13. Missing a dose of Pronasal
   14. Stopping the use of Pronasal
6. Possible side effects
   1. Additional side effects in children and adolescents
   2. Reporting side effects
7. How to store Pronasal
8. Package contents and other information
   1. What Pronasal contains
   2. What Pronasal looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   8. Date of last revision of the leaflet: February 2024

Leaflet accompanying the packaging: patient information

Pronasal, 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, so you can read it again if you need to.
• Consult a doctor or pharmacist if you have any doubts.
• 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 any of the side effects get worse or if you notice any side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What Pronasal is and what it is used for
• 2. Important information before using Pronasal
• 3. How to use Pronasal
• 4. Possible side effects
• 5. How to store Pronasal
• 6. Package contents and other information

1. What Pronasal is and what it is used for

What is Pronasal?

Pronasal, 50 micrograms/dose, nasal spray, suspension contains mometasone furoate, which belongs to a group of medicines called corticosteroids. Mometasone furoate should not be confused with anabolic steroids in tablet or injection form, which are misused by some athletes. Mometasone furoate administered intranasally relieves the symptoms of nasal mucosa inflammation (swelling and irritation of the nasal mucosa), sneezing, itching, and a stuffy nose, and reduces the amount of nasal discharge.

When is Pronasal used?

Hay fever and year-round allergic rhinitis
Pronasal is used to treat the symptoms of hay fever (also known as seasonal allergic rhinitis) and year-round allergic rhinitis in adults and children aged 3 and over.
Hay fever, which occurs at certain times of the year, is an allergic reaction caused by inhaling pollen from trees, grasses, and other plants, as well as mold and fungus spores. Year-round allergic rhinitis occurs throughout the year, and symptoms may be caused by increased sensitivity to various factors, including house dust, animal dander (or shed skin), feathers, and some foods. Pronasal reduces swelling and irritation of the nasal mucosa, thereby relieving symptoms of sneezing, itching, stuffy nose, and reducing the amount of nasal discharge caused by hay fever or year-round allergic rhinitis.
Nasal polyps
Pronasal is used to treat nasal polyps in adults over 18 years of age.
Nasal polyps are small growths on the nasal mucosa, usually occurring in both nostrils.
Pronasal 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 Pronasal

When not to use Pronasal

• if the patient is allergic to mometasone furoate or any of the other ingredients of Pronasal (listed in section 6);
• if the patient has an untreated nasal mucosa infection. Using Pronasal 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 has cleared up;
• if the patient has recently undergone nasal surgery or has nasal injuries. Do not use the nasal spray until the wounds have healed.

Warnings and precautions

Before starting to use Pronasal, 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 Pronasal, discuss it with your doctor

• if the patient's immune system is not working properly (has difficulty fighting infection) and has come into contact with someone with chickenpox or shingles. Avoid contact with people who have these infections;
• if the patient has a nose or throat infection;
• if the medicine is used for several months or longer;
• if the patient has long-term nose or throat irritation.

If corticosteroids in the form of a nasal spray are taken in high doses for a long time, side effects may occur due to the absorption of the medicine into the body.
If itching or eye irritation occurs, the doctor may prescribe other treatment with Pronasal.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Children

If corticosteroids in the form of a nasal spray are taken in high 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 corticosteroid treatment, and if any changes are noticed, inform the doctor.

Other medicines and Pronasal

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, including those obtained without a prescription.

If you are being treated for allergies with other corticosteroids orally or by injection, your doctor may advise you to stop taking them when you start using Pronasal. 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, or red and itchy skin patches, may also appear. Contact your doctor if you experience any of these symptoms.
Some medicines may enhance the effect of Pronasal. Your doctor may then closely monitor your condition when taking such medicines (including certain HIV medicines: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility

There is no data or only limited data on the use of Pronasal 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 is no data on the effect of Pronasal on the ability to drive and use machines.

Pronasal contains benzalkonium chloride

This medicine contains 20 micrograms of benzalkonium chloride in each dose (0.1 ml), which may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Pronasal

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist. Do not use the nasal spray in larger doses, more frequently, or for longer than your doctor has prescribed.

Treatment of hay fever and year-round 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, your doctor may reduce the dose to one dose of the nasal spray in each nostril once a day.
• If the patient does not feel any improvement, they should consult their doctor, who may increase 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

One dose of the nasal spray is recommended in each nostril once a day.

In some patients, relief of symptoms occurs within 12 hours of administration of the first dose of Pronasal, but the full benefits of treatment may not be observed within the first two days of treatment. Therefore, it is necessary to continue regular use to achieve the full benefits of treatment.
If the patient has severe symptoms of hay fever, the doctor may recommend starting to use Pronasal a few days before the start of the pollen season. This will help prevent the symptoms of hay fever from occurring. At the end of the pollen season, an improvement may occur, and treatment may no longer be necessary.

Nasal polyps

Use in adults over 18 years of age

• If after 5 to 6 weeks of using Pronasal, 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 will recommend reducing the dose to the smallest dose that effectively relieves the symptoms.

If after 5 to 6 weeks of using the medicine twice a day, there is no improvement, the patient should consult their doctor, who may recommend changing Pronasal to another medicine.

Preparing the nasal spray for use

Pronasal nasal spray has a protective cap that protects the tip of the dispenser and prevents it from getting dirty. Remember to remove it before use and put it back on after use.
Before the first use, check the operation of the spray by pressing the bottle 10 times until a fine mist is obtained:

• 1. Shake the bottle vigorously.
• 2. Hold it as follows: place your index and middle fingers on either side of the tip of the dispenser, and your thumb under the bottle. Do notpuncture the nasal applicator.
• 3.With the tip of the dispenser pointing away from you, press your fingers to release 10 sprays, until a fine mist is obtained (Figure 1).

Figure 1
If the spray has not been used for 14 days or more, check its operation by pressing the bottle 2 times until a fine mist is obtained.

How long the package will last

If you use two doses of the nasal spray in each nostril once a day to treat hay fever, year-round allergic rhinitis, and nasal polyps, the medicine will last for 15 days of treatment (for bottles containing 60 measured doses), 30 days (for bottles containing 120 measured doses), or 35 days of treatment (for bottles containing 140 measured doses).

How to use the nasal spray:

• 1. Shake the bottle vigorously and remove the protective cap (Figure 2).
• 2. Gently blow your nose to clear your nostrils.
• 3. Close one nostril and insert the tip of the dispenser into the other nostril, as shown in the picture (Figure 3). Tilt your head slightly forward, holding the bottle upright. Direct the tip of the dispenser to the side of the nostril, not to the center (not to the nasal septum).

Protective cap Tip of the dispenser Bottle

Figure 2

Figure 3

• 4. Start a slow inhalation through the nose, during which you should spray the medicine (in the form of a fine mist) into the nose, pressing DOWN with your fingers ONCE (Figure 4).

Figure 4

• 5. Exhale through the mouth, then repeat the actions described in point 4 to administer a second dose of the nasal spray to the same nostril, if necessary.
• 6. Remove the tip of the dispenser from the nostril and exhale through the mouth.
• 7.Repeat the actions described in points 3-6 to administer the nasal spray to the other nostril (Figure 5).

Figure 5
After use, carefully wipe the tip of the dispenser with a clean tissue or cloth and put the protective cap back on to prevent dust from entering.

Cleaning the nasal spray

• The nasal spray bottle should be cleaned regularly, as it may not work properly otherwise.
• Remove the protective cap (Figure 6) and gently pull off the tip of the dispenser (Figure 7).

Protective cap

Figure 6

Tip of the dispenser

Figure 7

• Wash the protective cap (Figure 8) and the tip of the dispenser (Figure 9) in warm water, then rinse under running water.

Protective cap

Figure 8

Tip of the dispenser

Figure 9

• Do not try to unblock the nasal applicator by inserting a pin or other sharp object, as this may damage the applicator and cause the medicine to be administered incorrectly.
• Leave the protective cap and tip of the dispenser to dry in a warm place.
• Put the tip of the dispenser back on the bottle (Figure 10), then put the protective cap back on (Figure 11).
• After cleaning, check if the dispenser is working properly and 2 timesspray the medicine (Figure 12).

Central hole Tip of the dispenser Spraying system

Figure 10

Figure 11

Figure 12

Using a higher dose of Pronasal than recommended

Consult your doctor if you have accidentally used a higher dose of the medicine than recommended.
If corticosteroids are used for a long time or in high doses, they may have an adverse effect on the patient's hormones. In children, they may affect growth and development.

Missing a dose of Pronasal

If you forget to use the nasal spray at the usual time, use it as soon as you remember, then continue treatment at the usual time. Do not use a double dose to make up for the missed dose.

Stopping the use of Pronasal

In some patients, improvement occurs within 12 hours of administration of the first dose of Pronasal, although the full benefits of treatment may not be observed until after 2 days of treatment. It is very important to use the nasal spray regularly. Do not stop treatment, even if you feel better, unless your doctor has explicitly advised you to.
If you have any further doubts about using the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pronasal can cause side effects, although not everybody gets them.
After using the medicine, immediate allergic reactions (hypersensitivity) may occur. These reactions can be severe. Stop using Pronasal and seek medical help immediately if you experience symptoms such as:

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

If corticosteroids in the form of a nasal spray are taken in high 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 Pronasal do not report any side effects after using the nasal spray. However, some people using Pronasal or another corticosteroid nasal spray have reported the following side effects:
Common side effects (may affect up to 1 in 10 people):

• headache
• sneezing and irritation/burning of the nasal mucosa
• nasal bleeding [very common (may occur in more than 1 in 10 people) in patients with nasal polyps who used two doses of Pronasal in each nostril twice a day]
• nasal or throat pain
• 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
• taste and smell disturbances
• breathing difficulties and/or wheezing
• blurred vision

Additional side effects in children and adolescents

It is expected that the frequency and type of side effects in children will be the same as in adults.
Long-term use of high doses of corticosteroids in a nasal spray may cause side effects such as slowing down the growth rate in children. Regular monitoring of growth in children receiving long-term corticosteroid treatment is recommended. If any changes are noticed, inform the doctor.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor, pharmacist, or nurse. 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
Phone: +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 the medicine.

5. How to store Pronasal

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after: {Expiry date (EXP):} or {EXP:}. The expiry date refers to the last day of the month.
Do not store above 25°C. Do not freeze.
The nasal spray should be used within 8 weeks of first use.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Pronasal contains

• The active substance of Pronasal is mometasone furoate. One dose of the medicine (0.1 ml) delivers 50 micrograms of mometasone furoate, equivalent to 52 micrograms of mometasone furoate monohydrate. The total mass of one dose is 100 mg.
• The other ingredients are: a mixture (Avicel RC-591) consisting of: microcrystalline cellulose with sodium carmellose; glycerol; sodium citrate (dihydrate); citric acid monohydrate; polysorbate 80; benzalkonium chloride (see section 2); water for injections.

What Pronasal looks like and contents of the pack

Pronasal is a nasal spray, suspension.
Each bottle contains 60 or 140 doses of the medicine.
Bottles containing 60 doses are available in single packs.
Bottles containing 140 doses are available in packs of 1, 2, or 3 nasal sprays.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53; 00-113 Warsaw
phone: (22) 345 93 00

Manufacturer:

Teva Czech Industries s.r.o.
Ostravská 29, č.p. 305, 747 70 Opava-Komárov
Czech Republic
Merckle GmbH (manufacturer where batch release occurs - only for Germany)
Ludwig-Merckle-Str.3
89143 Blaubeuren
Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria:
Mometason Ratiopharm 50 µg/Dosis Nasenspray
Belgium:
Mometasone Teva 50 microgram per verstuiving, neusspray, suspensie
Denmark:
Mometasonfuroat Teva
Finland:
Momesonex 50 mikrog/annos nenäsumute, suspensie
France:
MOMETASONE TEVA 50 microgrammes/dose, suspension pour pulvérisation nasale.
Spain: Mometasona Teva 50 microgramos suspensión para pulverización nasal EFG
Netherlands:
Mometasonfuroaat Teva 50 microgram/verstuiving, neusspray, suspensie
Lithuania:
Mometasone Teva 50 mikrogramų/dozėje nosies purškalas (suspensija)
Germany:
Mometasonfuroat AbZ 50 Mikrogramm/Sprühstoß Nasenspray, Suspension
Poland:
Pronasal
Portugal: Mometasona Teva
Sweden:
Mometasone Teva 50 mikrogram/dos nässpray, suspension
Hungary:
Nasotasone 50 mcg szuszpenziós adagolt orrspray
Italy:
Mometasone TEVA

Date of last revision of the leaflet: February 2024