PRONASAL

Package leaflet: Information for the patient

Pronasal, 50 micrograms/dose, nasal spray, suspension
Mometasone furoate
Please read all of this leaflet carefully before you start using this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• Talk to your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If any side effects worsen or if you notice any side effects not listed in this leaflet, including any possible side effects not mentioned, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Pronasal is and what it is used for
2. What you need to know before you use Pronasal
3. How to use Pronasal
4. Possible side effects
5. How to store Pronasal
6. Contents of the pack 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 taken in tablet or injectable form and misused by some athletes. Mometasone furoate administered into the nose reduces symptoms of nasal mucosal inflammation (swelling and irritation of the nasal mucosa), sneezing, itching, nasal congestion, and decreases nasal discharge.
When is Pronasal used?
Hay fever and perennial allergic rhinitis
Pronasal is used to treat 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 specific times of the year, is an allergic reaction caused by inhaling pollen from trees, grasses, and other plants, as well as mould and fungal spores. Perennial allergic rhinitis occurs throughout the year, and symptoms may be triggered by increased sensitivity to various allergens, including house dust mites, animal fur (or shed skin flakes), feathers, and certain foods. Pronasal reduces swelling and irritation of the nasal mucosa and thereby relieves symptoms such as sneezing, itching, nasal congestion, and excessive nasal discharge caused by hay fever or perennial allergic rhinitis.
Nasal polyps
Pronasal is used in the treatment of 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, leading to gradual shrinkage of nasal polyps, thus reducing nasal congestion that may impair breathing through the nose.

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 mucosal nasal infection. Using Pronasal 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 resolved;
• if the patient has recently undergone nasal surgery or nasal trauma. Do not use the nasal spray until wounds have healed.

Warnings and precautions
Before starting to use Pronasal, discuss this 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 Pronasal, discuss with your 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 has a nasal or throat infection;
• if the medication is used for several months or longer;
• if the patient has persistent irritation of the nose or throat.

If nasal corticosteroid sprays are used in high doses for a prolonged period,
systemic side effects due to absorption of the drug into the body may occur.
If eye itching or irritation occurs, the doctor may recommend alternative treatment with Pronasal.
If the patient experiences blurred vision or other visual disturbances, contact the
doctor.

Children
If nasal corticosteroid sprays are used in high doses for a prolonged period,
they may cause certain adverse effects, such as slowed growth rate in children.
It is recommended that the growth of children receiving long-term treatment with intranasal corticosteroids be monitored regularly, and if any changes are observed, the doctor should be informed.

Other medicines and Pronasal
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including over-the-counter medicines.

When treating allergies with other corticosteroids taken orally or by injection, the treating doctor may advise the patient to discontinue their use when starting Pronasal. In some patients, after stopping oral or injectable corticosteroids, adverse symptoms such as joint or muscle pain, weakness, and depression may occur. Other allergic symptoms may also appear, such as itching, watery eyes, or red, itchy skin rashes. Contact the doctor if any of these symptoms occur in the patient.

Some medicines may increase the effect of Pronasal. The doctor may then closely monitor the patient taking such medicines (including certain HIV medications: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility
There are no data or only limited data on the use of Pronasal 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 have a child, she should consult her doctor or pharmacist before using this medicine.

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

Pronasal contains benzalkonium chloride
This medicine contains 20 micrograms of benzalkonium chloride per dose (0.1 ml), which may cause irritation or swelling inside the nose, especially if used for a prolonged period.

3. How to use Pronasal

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
contact your doctor or pharmacist. The nasal aerosol should not be used in higher doses, more
frequently, or for longer than recommended by your physician.
Treatment of seasonal and perennial allergic rhinitis
Use in adults and children aged 12 years and older.
The usual dose is two sprays into each nostril once daily.

• Once symptoms improve, your physician may recommend reducing the dose to one spray into each nostril once daily.
• If no improvement is observed, contact your physician, who may recommend increasing the dose: the maximum daily dose is four sprays into each nostril once daily.

Use in children aged 3 to 11 years
The recommended dose is one spray into each nostril once daily.
In some patients, symptom relief may occur within 12 hours after the first dose of Pronasal, but the full benefits of treatment may not be evident within the first two days of therapy. Therefore, regular use should be continued to achieve the full therapeutic effect.
If a patient has severe seasonal allergic rhinitis symptoms, the physician may recommend starting Pronasal treatment several days before the start of the pollen season. This may help prevent the onset of hay fever symptoms. Improvement may occur toward the end of the pollen season, and treatment may no longer be necessary.
Nasal polyps
Use in adults aged over 18 years

• If there is no improvement after 5 to 6 weeks of treatment, the physician may recommend increasing the dose to two sprays into each nostril twice daily. After improvement is achieved, the physician will recommend reducing the dose to the lowest dose that effectively controls symptoms.

• If no improvement occurs after 5 to 6 weeks of treatment twice daily, the patient should contact their physician, who may recommend switching from Pronasal to another medication.

Preparing the nasal aerosol for use
Pronasal nasal aerosol contains a cap that protects the spray nozzle and prevents contamination. Remember to remove it before using the aerosol and replace it after use.
Before first use, prime the spray by pressing the bottle 10 times until a fine mist is produced:

1. Shake the bottle vigorously.
2. Hold as follows: place the index and middle fingers on either side of the spray nozzle, and the thumb under the bottle. Do not pierce the nasal applicator.
3. Pointing the spray nozzle away from you, press with your fingers to spray 10 times until a uniform mist is obtained (Figure 1).

Figure 1
If the aerosol has not been used for 14 days or more, re-prime by pressing the bottle 2 times until a fine mist is obtained.
How long will the medicine last
If the patient uses two sprays into each nostril once daily for treatment of hay fever, perennial allergic rhinitis, or nasal polyps, the medicine will last for 15 days (for bottles containing 60 metered doses), 30 days (for bottles containing 120 metered doses), or 35 days (for bottles containing 140 metered doses).
How to use the nasal aerosol:

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

Adapter Dispenser nozzle Bottle

Figure 2

2. Gently blow your nose to clear the nostrils.
3. Close one nostril and insert the spray nozzle into the other nostril, as shown in the illustration (Figure 3). Tilt your head slightly forward, holding the bottle vertically upright. Direct the spray nozzle toward the side of the nostril, not toward the center (not toward the nasal septum).

Figure 3

4. Begin a slow inhalation through the nose, and during inhalation press down once with your fingers to spray the aerosol (as a fine mist) into the nose (Figure 4).

Figure 4

5. Exhale through the mouth, then repeat the steps described in point 4 to administer a second spray into the same nostril, if necessary.
6. Remove the spray nozzle from the nostril and exhale through the mouth.
7. Repeat the steps described in points 3–6 to administer the aerosol into the other nostril (Figure 5).

Figure 5

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

Cleaning the nasal spray

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

Adapter

Figure 6

Dosing nozzle

Figure 7

• Wash the nozzle (Figure 8) and the dispenser tip (Figure 9) with warm water, then rinse under running water.

Adapter

Figure 8

Dosing nozzle

Figure 9

• Do not attempt to unblock the nasal applicator by inserting a pin or other sharp object, as this may damage the applicator and could result in not receiving the correct dose of the medicine.
• Leave the protective cap and the spray nozzle in a warm place to dry.
• Attach the spray nozzle to the bottle (Figure 10), then insert the cap (Figure 11).

Central orifice Dosing tip Dispensing system

Figure 10

Figure 11

• After cleaning, check whether the dispenser is working properly and spray the aerosol twice (Figure 12).

Figure 12
Use of a higher than recommended dose of Pronasal
If you have accidentally used more of the medicine than recommended, consult your doctor.
If glucocorticosteroids are used for a prolonged 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.
Missing a dose of Pronasal
If the patient forgets to use the nasal aerosol at the usual time, they should take the medicine 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 the use of Pronasal
In some patients, improvement occurs within 12 hours after the first dose of Pronasal, although full benefits of treatment may not be evident until after 2 days of use. It is very important that the patient uses the nasal aerosol regularly. Do not stop treatment, even if the patient feels better, unless the doctor has specifically advised to do so.
If you have any further questions regarding 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 everybody will experience them.
Immediate allergic (hypersensitivity) reactions may occur after using the medicine. These reactions
can be severe. You must stop using Pronasal and seek immediate medical help if you experience
symptoms such as:

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

If nasal corticosteroid spray is used in high doses for a prolonged period, adverse effects may occur
due to absorption of the medicine into the body.

Other adverse effects
Most people using Pronasal do not report any adverse effects after using the nasal spray. However,
the following adverse effects have been reported in some people after using Pronasal or another
corticosteroid nasal spray:

Common adverse effects (may affect up to 1 in 10 people):

• headache
• sneezing and irritation/burning of the nasal mucosa
• nosebleeds [very common (may affect more than 1 in 10 people) in patients with nasal polyps who used two doses of Pronasal into each nostril twice daily]
• pain in the nose or throat
• nasal mucosal ulceration
• upper respiratory tract infection

Frequency not known (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
• difficulty breathing and/or wheezing
• blurred vision

Additional adverse effects in children and adolescents
The frequency and type of adverse effects in children are expected to be the same as in adults.
Prolonged use of high doses of corticosteroids in nasal spray may cause adverse effects such as
slowed growth in children. Regular monitoring of growth is recommended in children receiving
long-term treatment with intranasal corticosteroids. If any changes are observed, inform your doctor.

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

5. How to store Pronasal

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

6. Contents of the pack and other information

What Pronasal contains

• The active substance is mometasone furoate. One dose (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.
• Other components are: mixture (Avicel RC-591) composed of microcrystalline cellulose and sodium carboxymethylcellulose; 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 medication.
Bottles containing 60 doses are available in single packs.
Bottles containing 140 doses are available in packs containing 1, 2 or 3 nasal sprays.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53; 00-113 Warsaw
tel.: (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 responsible for batch release – Germany only)
Ludwig-Merckle-Str.3
89143 Blaubeuren
Germany

This medicinal product is authorised in the European Economic Area countries 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 pulverizacion 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