ZheKort

Package leaflet: Information for the user

ZHEKORT 50 micrograms/dose nasal spray, suspension

Equivalent medicine
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.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Zhekort is and what it is used for
2. What you need to know before using Zhekort
3. How to use Zhekort
4. Possible side effects
5. How to store Zhekort
6. Contents of the pack and other information

1. What Zhekort is and what it is used for

What Zhekort is
Zhekort nasal spray contains mometasone furoate, which belongs to a group of medicines called corticosteroids. When mometasone furoate is sprayed into the nose, it helps relieve inflammation (swelling and irritation of the nose), sneezing, itching, and blocked or runny nose.
What Zhekort is used for
Hay fever and perennial rhinitis
Zhekort is used to treat symptoms of hay fever (also known as seasonal allergic rhinitis) or perennial rhinitis in adults and children aged 3 years and older.
Hay fever occurs at certain times of the year and is an allergic reaction caused by inhaling pollen from trees, grass, weeds, as well as moulds and fungal spores. Perennial rhinitis occurs throughout the year, and symptoms may be triggered by sensitivity to various substances including house dust mites, animal fur (or dander), feathers, and certain foods. Zhekort reduces swelling and irritation in the nose, thereby relieving sneezing, itching, and blocked or runny nose caused by hay fever or perennial rhinitis.
Nasal polyposis
Zhekort is used for the treatment of nasal polyps in adults aged 18 years and older.
Nasal polyps are small growths on the lining of the nose, which usually affect both nostrils.
Zhekort reduces nasal inflammation, leading to a gradual shrinkage of nasal polyps, thereby relieving the sensation of nasal blockage, which can affect breathing through the nose.

2. What you should know before using Zhekort

Do not use Zhekort:

• if you are allergic to mometasone furoate or to any of the other ingredients of this medicine (listed in section 6).
• if you have an untreated nasal infection. Using Zhekort concomitantly with an untreated infection, such as herpes, may worsen the infection. You must wait for the infection to resolve before using the nasal spray.
• if you have recently undergone nasal surgery or have a nasal injury. You must wait for complete healing before using the nasal spray.

Warnings and precautions
Talk to your doctor or pharmacist before using Zhekort:

• if you have or have ever had tuberculosis
• if you have any other type of infection
• if you are taking other corticosteroid medicines, either by mouth or by injection
• if you have cystic fibrosis.

While using Zhekort, contact your doctor:

• if your immune system does not work properly (if you have difficulty fighting infections) and you come into contact with people who have measles or chickenpox. Avoid contact with anyone who has these infections.
• if you develop a nasal or throat infection.
• if you use the medicine for several months or longer.
• if you experience persistent irritation of the nose or throat.

Contact your doctor if you experience blurred vision or any other visual disturbances.
When nasal corticosteroid sprays are used at high doses for prolonged periods, side effects due to absorption of the medicine into the body may occur.
If your eyes are itchy or irritated, your doctor may recommend additional treatments alongside Zhekort.

Children
Long-term use of high-dose nasal corticosteroids may cause adverse effects, such as slowed growth in children.
It is recommended to monitor your child's height at regular intervals during long-term treatment with nasal corticosteroids, and to inform your doctor if any changes are noticed.

Other medicines and Zhekort
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including over-the-counter medicines.
Some medicines may increase the effects of Zhekort, and your doctor may monitor you closely if you are taking these medicines (including certain HIV medications: ritonavir, cobicistat).
If you are taking other corticosteroid medicines for allergies, either orally or by injection, your doctor may advise you to stop taking them when you start using Zhekort. Some people, when stopping oral or injectable corticosteroids, may experience side effects such as joint or muscle pain, weakness, and depression. You may also develop other allergic reactions, such as itching, watery eyes, or red, itchy skin rashes. If you experience any of these side effects, consult your doctor.

Pregnancy and breastfeeding
There is little or no information available on the use of Zhekort in pregnant women. It is not known whether mometasone furoate passes into breast milk.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
There are no known effects of Zhekort on the ability to drive vehicles or operate machinery.

Zhekort contains benzalkonium chloride
Zhekort contains benzalkonium chloride, which may cause nasal irritation.

3. How to use Zhekort

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. Do not take a higher dose, or use the spray more frequently or for longer than prescribed by your doctor.

Treatment of hay fever and perennial rhinitis

Use in adults and children aged over 12 years
The recommended dose is 2 sprays into each nostril once daily.

• Once symptoms are under control, your doctor may advise you to reduce the dose.
• If you do not start to feel better, you should return to your doctor, who may instruct you to increase the dose. The maximum daily dose is 4 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, Zhekort begins to relieve symptoms 12 hours after the first dose; however, full benefit from treatment may not be achieved until after two days. If you or your child suffers from hay fever, it may be necessary to start treatment a few days before the pollen season begins. At the end of the pollen season, hay fever symptoms should improve and treatment may no longer be needed.

Nasal polyps

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

• If symptoms are not under control after 5–6 weeks, the dose may be increased to 2 sprays into each nostril twice daily. Once symptoms are under control, your doctor will reduce the dose.
• If there is no improvement in symptoms after 5 or 6 weeks of twice-daily use, you must consult your doctor.

Preparing the nasal spray for use

Your Zhekort nasal spray has a dust cap that protects the nozzle and keeps it clean. Remember to remove it before using the spray and replace it after use.
Shake the bottle well before each use.
Do not pierce the nasal applicator (nozzle) with a needle or any other sharp object.
If you are using the spray for the first time, you must "prime" the bottle by spraying 10 times into the air until a fine mist is produced:

1. Shake the bottle well.
2. Remove the plastic cap.
3. Place your index and middle fingers on either side of the spray nozzle and your thumb underneath the bottle (Figure 1). Do not pierce the nasal applicator.
4. Point the nozzle away from you and press down with your fingers to spray 10 times into the air until a fine mist is produced (Figure 1).

If you have not used the spray for 14 days or more, you must "re-prime" the bottle by spraying twice into the air until a fine mist is produced.

How to use the nasal spray

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

2. Gently blow your nose to clear the nostrils.
3. Close one nostril and insert the spray nozzle into the other nostril. Tilt your head slightly forward, keeping the bottle in an upright position.
4. Begin to breathe gently or slowly through your nose, and while inhaling, spray one puff into the nose by pressing ONCE with your fingers (Figure 3).

5. Breathe out through your mouth. Repeat step 4 to administer a second spray into the same nostril, if required.
6. Remove the spray nozzle from the nostril and breathe out through your mouth.
7. Repeat steps 3 to 6 for the other nostril.

After using the spray, clean the nozzle thoroughly with a tissue or clean cloth and replace the dust cap.

Cleaning the nasal spray

• It is important to clean the nasal spray regularly; otherwise, it may not work properly.
• Remove the protective cap and gently remove the spray nozzle.
• Wash the nozzle and dust cap in warm water, then rinse with running water.
• Do not attempt to unblock the nasal applicator by inserting a needle or any other sharp object, as this may damage the applicator and result in incorrect dosing.
• Allow the nozzle and dust cap to dry in a warm place.
• Reinsert the nozzle into the bottle and replace the dust cap.
• After cleaning, the spray will need to be re-primed with 2 sprays into the air before first use.

If you use more Zhekort than you should
Inform your doctor if you accidentally take more medicine than you should.
Long-term or high-dose use of steroids may, rarely, affect your hormones. In children, this may affect growth and development.

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

If you stop using Zhekort
In some patients, Zhekort begins to relieve symptoms 12 hours after the first dose; however, full benefit from treatment may not be evident within the first 2 days. It is very important to use the nasal spray regularly. Do not stop treatment even if you feel better, unless your doctor tells you to do so.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Immediate hypersensitivity (allergic) reactions may occur following the use of this medicine. These reactions can be severe. Stop treatment with Zhekort and contact your doctor immediately if you experience any of the following:

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

When corticosteroid nasal sprays are used at high doses for long periods of time, side effects may occur due to absorption of the drug into the body.

Other side effects
Many people do not experience any problems after using nasal sprays. However, some people may experience the following after using Zhekort or other corticosteroid nasal sprays:

Common side effects (may affect up to 1 in 10 users):

• headache
• sneezing
• nosebleeds [very common (may affect more than 1 in 10 people) in people with nasal polyps treated with Zhekort, 2 sprays per nostril twice daily]
• pain in the nose or throat
• nasal ulcers
• respiratory tract infections

Not known (frequency cannot be established from available data):

• increased eye pressure (glaucoma) and/or cataract, causing visual disturbances
• blurred vision
• damage to the nasal septum separating the nostrils
• changes in taste and smell
• difficulty breathing and/or wheezing

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zhekort

• Keep out of the sight and reach of children.
• Do not use Zhekort after the expiry date stated on the label after Exp. The expiry date refers to the last day of that month.
• Once the bottle has been opened, it must be used within two months. Open only one bottle at a time. Do not freeze.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Zhekort contains

• The active substance is mometasone furoate. Each spray pump delivers a measured dose of 50 micrograms of mometasone furoate (as mometasone furoate monohydrate).
• The other ingredients are: microcrystalline cellulose, sodium carmellose, glycerol, citric acid monohydrate, disodium citrate dihydrate, polysorbate 80, benzalkonium chloride, water for injections.

Description of the appearance of Zhekort and package contents
Zhekort is a nasal spray, a white suspension packed in a white plastic bottle equipped with a spray pump.
1 bottle containing 10 g of nasal spray suspension, equivalent to 60 sprays.
1 bottle containing 17 g of nasal spray suspension, equivalent to 120 sprays.
1 bottle containing 18 g of nasal spray suspension, equivalent to 140 sprays.
3 bottles each containing 18 g of nasal spray suspension, equivalent to 140 sprays.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA)

Manufacturers
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia
S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Netherlands: Mometasonfuroaat Sandoz 50 microgram/dosis, neusspray, suspensie
Belgium: Mometasone Sandoz 50 microgram/dosis neusspray, suspensie
Czech Republic: MOMMOX 0,05 MG/DÁVKU
Denmark: Mometasone Sandoz
Estonia: Nasometin
Finland: Mommox 50 mikrogrammaa/annos, nenäsumute, suspensio
France: MOMETASONE SANDOZ 50 microgrammes/dose, suspension pour pulvérisation nasale
Germany: Mometasonfuroat – 1 A Pharma 50 Mikrogramm/Sprühstoß Nasenspray, Suspension
Hungary: Mometason Sandoz 50 mikrogramm/adag szuszpenziós orrspray
Italy: Zhekort
Luxembourg: Mometasone Sandoz 50 microgrammes/dose suspension pour pulvérisation nasale
Norway: Mometasone Sandoz, 50 mikrogram/dose, nesespray, suspensjon
Poland: NASOMETIN, 50 MIKROGRAMÓW/DAWKĘ ODMIERZONĄ, AEROZOL DO NOSA, ZAWIESINA
Portugal: Mometasona Sandoz
Romania: Mometazonă furoat Sandoz 50 micrograme/doză spray nazal, suspensie
Slovakia: Mometasone Sandoz 50 mikrogramov
Slovenia: Mommox 50 mikrogramov/vpih pršilo za nos, suspenzija
Spain: Mometasona Sandoz 50 microgramos/dosis suspensión para pulverización nasal
Sweden: Mommox 50 mikrogram/dos, nässpray, suspension
United Kingdom: Mometasone Furoate 50 micrograms/dose Nasal Spray, suspension