Pronasal Control nasal suspension aerosol 10 g

Read the leaflet before use.

For use in adults.
Intranasal administration. Shake gently before use. Read the leaflet before using the drug.
Do not pierce the dispenser.
Storage: Store at ambient temperature.
Package: Box

Each dose (0.1 ml) contains 50 micrograms of mometasone furoate. The total weight of one dose is 100 mg, Excipients: microcrystalline cellulose and sodium caramelose (Avicel RC-591), glycerol, benzalkonium chloride, solution, polysorbate 80, citric acid monohydrate, sodium citrate, water for injection

Teva Pharmaceuticals Polska Sp. z o.o.

Responsible party:
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer:
Teva Czech Industries s.r.o.
Ostravská 305/29,
Komárov, 747 70 Opava,
Czech Republic

Merckle GmbH
Ludwig-Merckle-Str.3
89143 Blaubeuren
Germany

Teva Pharma B.V.
Swensweg 5
2031 GA Ha

Keep the drug out of sight and reach of children.

Before using the drug, read the leaflet carefully and read the educational materials. This information is available by scanning the QR code with a smartphone and on the website (see section 6.).

Carefully read the leaflet before using the drug, as it contains important information for the patient.
Always use this drug exactly as described in the patient leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or additional information, ask your pharmacist.
- If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
- If there is no improvement after 14 days, or if you feel worse, contact your doctor.

This medicine is suitable only for adults with doctor-diagnosed seasonal allergic rhinosinusitis (hay fever).
If you are unsure whether you have hay fever, you should consult your doctor.
Typical symptoms of hay fever include runny nose, sneezing and swelling of the nasal mucosa, causing a feeling of nasal congestion at certain times of the year.

Table of contents of the leaflet:
1. what is Pronasal Control and for what purpose it is used.
2. important information before using Pronasal Control
3. how to use Pronasal Control
4 Possible side effects
5. how to store Pronasal Control
6. package contents and other information

1 What is Pronasal Control and for what purpose it is used.

What is the drug Pronasal Control?
Pronasal Control, 50 micrograms/dose, nasal spray, suspension contains mometasone furoate, which belongs to a group of drugs called corticosteroids. Mometasone furoate should not be confused with anabolic steroids in tablet or injection form, which are used inappropriately by some athletes. Mometasone furoate administered nasally relieves the symptoms of nasal mucositis (swelling and irritation of the nasal mucosa), sneezing, itching and the feeling of a blocked nose, and reduces nasal discharge.

When is Pronasal Control used?
Pronasal Control is used in adults (over 18 years of age) to treat the symptoms of hay fever (also known as seasonal allergic rhinosinusitis) after prior diagnosis by a doctor.

Hay fever, which occurs at certain times during the year, is an allergic reaction caused by inhaling pollen from trees, grasses, and other plants, as well as mold and fungal spores. Pronasal Control reduces swelling and irritation of the nasal mucosa and thus relieves the symptoms caused by hay fever, such as sneezing, itching, a feeling of a blocked nose, and reduces nasal discharge.

Talk to your doctor if there is no improvement or if you feel worse after 14 days of using the drug.

3 How to use Pronasal Control

Always use this drug exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If in doubt, contact your doctor or pharmacist. Do not use this nasal spray in larger doses, more often or for longer periods of time than recommended by your healthcare provider.

It is recommended to use two doses of the aerosol into each nasal orifice once a day.

In some patients, symptom relief occurs within 12 hours of the first dose of Pronasal Control, but the full benefit of treatment may not be observed within the first two days of treatment. Therefore, regular use should be continued in order to obtain the full benefits of treatment.

- Once improvement has been achieved, the treating physician may recommend reducing the dose to one aerosol dose to each nasal orifice once daily.
- If the patient does not experience improvement, contact the treating physician.

If there is no improvement in symptoms or the improvement is insufficient after 14 days of use, consult a doctor.
The drug should not be used for more than 3 months without consulting a doctor.

If you have severe hay fever symptoms, your healthcare provider may recommend starting Pronasal Control before the pollen season begins. This will help prevent the onset of hay fever symptoms. At the end of the pollen season, improvement may occur and treatment may no longer be necessary.

Preparation of the nasal spray for use
Pronasal Control nasal spray contains a cap that protects the dispenser tip and prevents it from getting contaminated. Be sure to remove it before using the aerosol and reapply it after use.

Before using the aerosol for the first time, test the effect by pressing the bottle 10 times until you get a fine mist:
1. shake the bottle gently.
2. grasp as follows: place your index finger and middle finger on both sides of the dispenser tip, and thumb under the bottle. Do not perforate the nasal applicator.
3. pointing the dispenser tip away from you, press with your fingers to spray the aerosol 10 times until a uniform mist is formed.
If the aerosol has not been used for 14 days or more, test the effect by pressing the bottle 2 times until you get a fine mist.

For how long is the package of the drug enough
If the patient applies two doses of the aerosol to each nasal orifice once a day, the medicine is enough for 15 days of treatment (for bottles containing 60 measured doses) or for 30 days (for bottles containing 120 measured doses) or for 35 days (for bottles containing 140 measured doses).

How to use the nasal spray
1 Shake the bottle gently and remove the cap (Figure 1).
2.Gently blow your nose.
3.Close one nostril and insert the dispenser tip into the other nostril as shown (Figure 2). Tilt your head slightly forward, holding the bottle vertically upward. The dispenser tip should point toward the nostril and not medially (that is, not toward the nasal septum).
4. begin a slow inhalation through the nose, during which the aerosol should be sprayed as a fine mist into the nose, pressing downward with the fingers RAZ.
5. exhale through the mouth, then repeat the steps in step 4. to administer a second dose of aerosol into the same nasal orifice, if necessary.
6. remove the dispenser tip from the nasal opening and exhale through the mouth.
7. repeat steps 3.-6. to administer the aerosol into the second nasal opening (Figure 3).

After using the aerosol, carefully wipe the dispenser tip with a clean tissue or cloth and replace the cap to prevent dust from entering.

Cleaning the nasal spray bottle
- Clean the nasal spray bottle regularly, otherwise it may not work properly.
- Remove the cap and gently pull off the dispenser tip.
- Wash the dispenser tip and cap in warm water, then rinse under running water.
- Do not attempt to unlock the nasal applicator by inserting a pin or other sharp object, as this will damage the applicator and may result in not receiving the correct dose of medication.
- Leave the protective cap and dispenser tip in a warm place to dry.
- Put the dispenser tip on the bottle, and then insert the cap.
- After cleaning, check that the dispenser works properly and spray the aerosol 2 times.

Use of a larger dose of Pronasal Control than recommended.
Ask your doctor if you accidentally used a higher dose of the drug than recommended.

If steroids are used for a long period of time or in large doses, in rare cases they can have an adverse effect on the patient's hormones. In children, they can affect growth and development.

Omission of Pronasal Control medication.
In case the patient forgot to apply the nasal spray at the usual time, he should take the drug as soon as he remembers, and then continue the treatment with the drug at the usual time. Do not use a double dose to make up for a missed dose.

Discontinuation of Pronasal Control medication
In some patients, improvement occurs 12 hours after the first dose of Pronasal Control, although the full benefits of treatment may not be apparent until after 2 days of use. It is very important for the patient to use the nasal spray regularly. Do not discontinue treatment, even if the patient feels better, unless specifically instructed by the doctor.

If you have any further doubts about the use of the drug, ask your doctor or pharmacist.

5 How to store Pronasal Control.

Store the drug out of sight and reach of children.

Do not use this medicine after the expiration date on the bottle and box after: {expiration date (EXP):} or {EXP:}. Expiration date means the last day of the month stated.

Do not store at temperatures above 25˚C. Do not freeze.
Shelf life from first use: 8 weeks.

Medicines should not be disposed of in sewage or household waste containers. Ask your pharmacist how to dispose of medicines you no longer use. Such treatment will help protect the environment.

4 Possible side effects

Like any drug, this medication may cause side effects, although they will not occur in everyone.

After using the drug, immediate hypersensitivity (allergic) reactions may occur. These reactions can be severe. Discontinue Pronasal Control and seek immediate medical attention if you experience symptoms such as:
- swelling of the face, tongue or throat
- problems with swallowing
- hives
- wheezing or difficulty breathing.

If corticosteroids in the form of nasal spray are taken in large doses over a long period of time, side effects may occur due to absorption of the drug in the body.

Other side effects
Most people do not report any side effects after using the nasal spray. However, some people have experienced the following side effects after using Pronasal Control or another corticosteroid nasal spray:

Common side effects (may affect up to 1 in 10 people):
- headache
- sneezing and irritation/burning of the nasal mucosa
- nose bleeding [occurred very frequently (may occur in more than 1 in 10 people) in patients with nasal polyps who applied two doses of Pronasal Control to each nasal orifice twice daily]
- pain in the nose or throat
- ulceration of the nasal mucosa
- upper respiratory tract infection

Frequency unknown (frequency cannot be determined from available data):
- increase in eye pressure (glaucoma) and/or cataracts causing visual disturbances
- damage to the nasal septum separating the nostrils
- taste and smell disturbances
- difficulty breathing and/or wheezing
- blurred vision

Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Jerozolimskie 181C Al., 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 responsible party.
By reporting side effects, more information on the safety of the drug can be gathered.

6 Contents of the package and other information

What the drug Pronasal Control contains

- The active substance of the drug is mometasone furoate. Each dose of the drug (0.1 ml) contains 50 micrograms of mometasone furoate (in the form of mometasone furoate monohydrate). The total weight of one dose is 100 mg.
The other ingredients are: microcrystalline cellulose and sodium caramelose (Avicel RC-591), glycerol, benzalkonium chloride, solution, polysorbate 80, citric acid monohydrate, sodium citrate, water for injection


What Pronasal Control looks like and what it contains in the package

Pronasal Control is a nasal spray, suspension.

Each bottle contains 60, 120 or 140 doses of the drug.
Not all package sizes are necessarily on the market.

2 Information important before using Pronasal Control drug.

When not to use the drug Pronasal Control
- if the patient is allergic to mometasone furoate or any of the other ingredients of this drug (listed in section 6);
- if the patient has an untreated infection of the nasal mucosa. The use of Pronasal Control during an untreated infection in the nasal cavity, such as herpes, may exacerbate the symptoms of the infection. Wait until the infection has cleared before using the nasal spray;
- if the patient has recently undergone nasal surgery or nasal trauma. Do not use nasal spray until wounds have healed.

Warnings and precautions
Discuss with your doctor or pharmacist before taking Pronasal Control.
- if the patient currently has or has ever had tuberculosis;
- if the patient has any other infection;
- if the patient is taking other corticosteroids by mouth or injection;
- if the patient has cystic fibrosis.

When taking Pronasal Control, discuss this with your doctor
- if the patient's immune system is not functioning properly (there are difficulties in fighting infection) and the patient has had contact with a person with measles or chickenpox. Avoid contact with people who have these infections;
- if the patient has a nasal or throat infection;
- if the drug has been used for several months or longer;
- if the patient has long-term irritation of the nose or throat.

If corticosteroids in nasal spray form are taken in large doses over a long period of time, side effects may occur due to absorption of the drug in the body.

If you experience itching or irritation of the eyes, your doctor may recommend other treatment with Pronasal Control.
If you experience blurred vision or other visual disturbances, contact your doctor.

Children and adolescents
Pronasal Control should not be used in children and adolescents under 18 years of age.

Other drugs and Pronasal Control
Tell your doctor or pharmacist about all medications you are currently or recently taking, as well as over-the-counter medications.

If you are being treated for allergies with other oral corticosteroids or injections, your healthcare provider may advise you to stop taking them when you start Pronasal Control. Some patients may experience side effects such as joint or muscle pain, weakness and depression after stopping oral corticosteroids or injections. Other allergic symptoms such as itching, watery eyes or red and itchy patches on the skin may also surface. Contact your doctor if you experience any of these symptoms.

Some medications may exacerbate the effects of Pronasal Control. Your doctor may then carefully monitor the condition of a patient taking such drugs (including some HIV drugs: ritonavir, cobicistat).

Pregnancy, breastfeeding and effects on fertility
No data or only limited data exist on the use of Pronasal Control in pregnant women. It is not known whether mometasone furoate passes into human milk.

If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a baby, you should consult your doctor or pharmacist before taking this drug.

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

Pronasal Control contains benzalkonium chloride.
This medication contains 20 micrograms of benzalkonium chloride per dose.
Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

Pronasal Control contains sodium
This drug contains less than 1 mmol (23 mg) of sodium per dose, that is, the drug is considered "sodium free."

Pronasal Control, 50 micrograms/dose, nasal spray, suspension

For use in adults

Mometasoni furoas