Nasometin

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Nasometin (Mometasonfuroat - 1 A Pharma)
50 micrograms per measured dose, nasal spray, suspension
Mometasoni furoas
Nasometin and Mometasonfuroat - 1 A Pharma are different trade names for the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Nasometin is and what it is 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 pack and other information

1. What Nasometin is and what it is 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 helps relieve inflammation (swelling and irritation of the nasal mucosa), sneezing, itching, nasal congestion, or watery nasal discharge.
What is Nasometin used for?
Hay fever and perennial rhinitis
Nasometin is used to treat symptoms of hay fever (also known as seasonal allergic rhinitis) and perennial rhinitis in adults and children aged 3 years and older.
Hay fever, which occurs several times a year, is an allergic reaction caused by inhaling pollen from trees, grasses, weeds, as well as moulds and fungal spores. Perennial rhinitis occurs throughout the year, and symptoms may be triggered by sensitivity to various factors, including house dust mites, animal fur (or dander), feathers, and certain foods.
Nasometin reduces swelling and irritation of the nasal mucosa, thereby relieving sneezing, itching, nasal congestion, or runny nose caused by hay fever or perennial rhinitis.
Nasal polyps
Nasometin is used in the treatment of nasal polyps in adults aged at least 18 years.
Nasal polyps are small growths inside the nose, usually in both nostrils. Nasometin reduces inflammation, leading to gradual shrinking of the polyps and relief from nasal congestion, thus improving nasal breathing.

2. Important information before using Nasometin

When not to use Nasometin

• if the patient is allergic to mometasone furoate or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has untreated nasal mucosal infection. Using Nasometin during such an infection (e.g. herpes) may worsen the course of the disease. Use of the nasal spray should be delayed until the infection has resolved.
• if the patient has recently undergone nasal surgery or nasal injury. The nasal spray should not be used until nasal wounds have healed.

Warnings and precautions
Before starting Nasometin, consult a doctor or pharmacist if the patient:

• has tuberculosis currently or in the past,
• has any other infection,
• is receiving other corticosteroids (orally or by injection),
• has cystic fibrosis.

During treatment with Nasometin, consult a doctor if:

• the patient's immune system is not functioning properly (if the patient has difficulty fighting infections), and the patient has contact with someone who has measles or chickenpox. Contact with such individuals should be avoided.
• the patient develops a nasal or throat infection,
• the patient uses the medicine for several months or longer,
• the patient experiences persistent nasal or throat irritation.

If the patient develops blurred vision or other visual disturbances, medical advice should be sought.
Prolonged use of high doses of corticosteroid nasal spray may lead to systemic adverse effects due to absorption of the drug into the body.
If the patient experiences eye itching or irritation, the doctor may recommend additional treatment alongside Nasometin.

Children
In children, prolonged use of high doses of intranasal corticosteroids may cause certain adverse effects, such as slowed growth rate.
Regular monitoring of growth is recommended in children receiving long-term intranasal corticosteroid therapy. Any observed changes should be reported to the doctor.

Nasometin with other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, including over-the-counter medicines and those planned for future use.
Some medicines may increase the effect of Nasometin. The doctor may wish to closely monitor the patient taking such medicines (including certain HIV medications: ritonavir, cobicistat).
If the patient is being treated for allergies with other corticosteroids taken orally or by injection, the doctor may recommend discontinuing them when starting Nasometin. After stopping oral or injectable corticosteroids, some patients may experience certain adverse effects such as joint or muscle pain, weakness, and depression. Other allergic symptoms such as itching, watery eyes, or red, itchy skin rashes may also occur. If any of these symptoms occur, contact a doctor.

Pregnancy and breastfeeding
There is no or very limited information 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, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
The effect of Nasometin on the ability to drive and operate machinery is unknown.

Nasometin contains benzalkonium chloride
This medicine contains benzalkonium chloride, which may cause nasal irritation or swelling, particularly if used for a prolonged period.

3. How to use Nasometin

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist. Do not use the nasal spray in larger amounts, more frequently, or for longer than prescribed by your doctor.

Treatment of seasonal and perennial allergic rhinitis

Use in adults and children over 12 years of age
The recommended dose is 2 sprays of the nasal spray into each nostril once daily.

• After improvement is achieved, your doctor may recommend reducing the dose.
• However, if symptoms do not improve, contact your doctor, who may recommend increasing the dose: the maximum daily dose is 4 sprays of the nasal spray into each nostril once daily.

Use in children aged 3 to 11 years
The recommended dose is 1 spray of the nasal spray into each nostril once daily.

In some patients, Nasometin may provide improvement within 12 hours after the first dose, although full benefit from treatment may not be evident until after two days of use. If a patient (adult or child) has severe seasonal allergic rhinitis symptoms, treatment may need to be started several days before the pollen season begins. After the pollen season ends, symptoms of seasonal allergic rhinitis should subside, and treatment may no longer be necessary.

Nasal polyps

Use in adults over 18 years of age
The initial recommended dose is 2 sprays of the nasal spray into each nostril once daily.

• If no improvement is observed after 5 to 6 weeks of treatment, your doctor may increase the dose to 2 sprays into each nostril twice daily. After improvement is achieved, your doctor may recommend reducing the dose.
• If no improvement occurs after 5 to 6 weeks of treatment twice daily, contact your doctor.

Preparing the nasal spray for use

Nasometin comes with a protective cap that covers the nozzle and prevents contamination. Remember to remove it before using the spray and replace it after each use.

Shake the bottle well before each use.
Do not pierce the applicator (the opening in the nozzle) with a pin or any other sharp object.

Before first use, prime the spray by pressing the bottle 10 times until a fine mist is produced.

1. Shake the bottle vigorously.
2. Remove the plastic cap.
3. Place your index and middle fingers on either side of the pump, and your thumb under the bottle (Figure 1). Do not pierce the applicator.
4. Pointing the nozzle away from you, press the pump 10 times with your fingers until a fine mist is produced (Figure 1).

Figure 1

If the spray has not been used for 14 days or longer, re-prime by pressing the bottle twice 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 nozzle into the other nostril. Tilt your head slightly forward and hold the bottle upright.
4. Press the pump ONCE with your fingers to release a fine mist of the spray into the nose, while simultaneously beginning a gentle or slow inhalation through the nose (Figure 3).

Figure 3

5. Exhale through your mouth, then repeat step 4 to administer a second spray into the same nostril (if the prescribed dose requires it).
6. Remove the nozzle from the nostril and exhale through your mouth.
7. Repeat steps 3–6 to administer the spray into the other nostril.

After using the nasal spray, gently wipe the nozzle with a clean tissue or cloth and replace the cap.

Cleaning

• Regular cleaning of the pump is important, as blockage may prevent proper functioning.
• Remove the cap and gently pull off the nozzle.
• Wash the nozzle and cap with warm water, then rinse thoroughly under running water.
• Do not attempt to unblock the applicator by inserting a pin or any other sharp object into the opening, as this may damage the applicator and result in incorrect dosing.
• Leave the cap and nozzle in a warm place to dry completely.
• Reattach the nozzle to the bottle, then replace the cap.
• After cleaning, re-prime the spray by pressing the bottle twice.

Using more than the recommended dose of Nasometin

Contact your doctor if you accidentally use more than the prescribed dose of Nasometin.
If corticosteroids are used for long periods or in high doses, they may rarely affect the function of certain hormones. In children, they may affect growth and development.

Missing a dose of Nasometin

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

Stopping treatment with Nasometin

In some patients, Nasometin may bring improvement within 12 hours after the first dose, although full benefit from treatment may not be evident until after two days of use. It is very important to use the nasal spray regularly. Do not stop treatment, even if the patient feels better, unless specifically instructed by the doctor.

If you have any further questions about 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 experiences them.
Immediate hypersensitivity reactions (allergic reactions), including severe ones, may occur after using this medicine.
If any of the symptoms listed below occur in the patient, the medicine must be discontinued
and immediate medical help must be sought:

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

Prolonged use of high doses of corticosteroid nasal aerosol may lead to systemic adverse effects due to absorption of the medicine into the body.
Other adverse effects
Most people using nasal aerosol experience no disturbances. However, in some individuals, use of Nasometin or other intranasal corticosteroids may cause:
Common adverse effects (may affect fewer than 1 in 10 people):

• headache,
• sneezing,
• nosebleeds [occurred very commonly (in more than 1 in 10 people) in patients with nasal polyps using two sprays of Nasometin in each nostril twice daily],
• nasal or throat pain,
• ulceration of the nasal mucosa,
• respiratory tract infection.

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

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

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

5. How to store Nasometin

• Keep the medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
• The shelf life after first opening the bottle is 2 months.
• Do not freeze.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Nasometin contains

• The active substance is mometasone furoate. Each spray contains 50 micrograms of mometasone furoate as mometasone furoate monohydrate.
• 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, packed in an HDPE bottle with a PE/PP spray pump,
contained in a cardboard box.
Pack size:
1x10 g (60 sprays).
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Germany, the country of export: 82291.00.00
Parallel import licence number: 65/22