Zodgane

Leaflet accompanying the packaging: information for the user

Zodgane, 50 micrograms/dose, nasal spray, suspension

Mometasone furoate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Zodgane and what is it used for
• 2. Important information before using Zodgane
• 3. How to use Zodgane
• 4. Possible side effects
• 5. How to store Zodgane
• 6. Contents of the packaging and other information

1. What is Zodgane and what is it used for

Zodgane nasal spray contains mometasone furoate, which belongs to a group of medicines called corticosteroids. Mometasone furoate administered intranasally relieves symptoms of inflammation (swelling and irritation of the nasal mucosa), sneezing, itching, and a feeling of a blocked nose, and reduces the amount of nasal discharge.

What is Zodgane used for?

Zodgane is used to treat symptoms of hay fever (also known as seasonal allergic rhinitis) in adults, after a diagnosis of seasonal allergic rhinitis has been made by a doctor. Hay fever, which occurs at certain times of the year, is an allergic reaction caused by inhaling pollen from trees, grasses, weeds, as well as mold and fungal spores. Zodgane reduces swelling and irritation of the nasal mucosa and thus relieves sneezing, itching, a feeling of a blocked nose, or nasal discharge caused by hay fever.

2. Important information before using Zodgane

When not to use Zodgane

Warnings and precautions

Before starting to use Zodgane, you should discuss it with your doctor or pharmacist:

While using Zodgane, you should discuss it with your doctor if:

• the patient's immune system is not working properly (there are difficulties in fighting infection) and the patient has come into contact with someone who is sick with chickenpox or shingles. You should avoid contact with people who have these infections.
• the patient has a nasal or throat infection.
• the medicine is used for several months or longer.
• the patient has long-term nasal or throat irritation.

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

Children and adolescents

Zodgane should not be used in children and adolescents under the age of 18.

Zodgane and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those that are available without a prescription. If you are taking other corticosteroids orally or by injection to treat allergies, your doctor may recommend that you stop taking them when you start using Zodgane. 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 of the eyes, or red and itchy spots on the skin, may also appear. You should contact your doctor if you experience any of these symptoms. Some medicines may enhance the effect of Zodgane, and your doctor may want to monitor your condition closely while taking such medicines (including certain HIV medicines: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility

There are no data or only limited data available on the use of Zodgane 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, you should consult your doctor or pharmacist before using this medicine.

Driving and using machines

There are no data available on the effect of Zodgane on the ability to drive and use machines.

Zodgane contains benzalkonium chloride

This medicine contains 20 micrograms of benzalkonium chloride in one dose. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

3. How to use Zodgane

Zodgane should always be used as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist. The nasal spray should not be used more frequently, for a longer period, or in larger doses than recommended by your doctor. Using Zodgane in adults: The usual dose is two sprays into each nostril once daily. After improvement, your doctor may recommend a dose reduction. In some patients, relief of symptoms occurs within 12 hours of administration of the first dose of Zodgane; however, the full benefits of treatment may not be evident until after 2 days of treatment. Therefore, you should continue to use the medicine regularly to achieve full benefits. You should not stop treatment, even if you feel better, unless your doctor recommends it.

Method of administration

Preparing the nasal spray for use: Zodgane nasal spray contains a protective cap that protects the tip of the actuator and prevents it from becoming contaminated. You should remember to remove it before using the spray and put it back on after use. Before using the spray for the first time, you should check that it works by pressing the pump 10 times until a fine spray appears:

• 1. You should gently shake the bottle.
• 2. Place your index and middle fingers on either side of the nozzle, and your thumb under the bottle. Do not puncture the nasal spray actuator.
• 3. With the nozzle pointing away from you, press your fingers together to release a spray 10 times, until a fine spray appears. If the nasal spray has not been used for 14 days or more, you should press the pump 2 times, until a fine spray appears, before using it again. With the usual dosage of two sprays into each nostril once daily for the treatment of hay fever, this medicine should provide enough doses for 15 days (bottle containing 60 doses), 30 days (bottle containing 120 doses), or 35 days (bottle containing 140 doses).

How to use the nasal spray

• 1. Shake the bottle gently and remove the protective cap.
• 2. Gently blow your nose.
• 3. Close one nostril and put the tip of the actuator into the other nostril. Tilt your head slightly forward, keeping the bottle upright.
• 4. Start to breathe in gently and slowly through your nose, and while doing so, release a spray (in the form of a fine mist) into your nose by pressing your fingers once.
• 5. Breathe out through your mouth. Repeat steps 4 to give a second spray into the same nostril, if necessary.
• 6. Remove the tip of the actuator from your nostril and breathe out through your mouth.
• 7. Repeat steps 3 to 6 to give the spray into the other nostril.

After using the spray, you should gently wipe the tip of the actuator with a clean tissue or cloth and replace the protective cap. Cleaning the nasal spray: It is important to regularly clean the nasal spray bottle, as it may not work properly otherwise. You should remove the protective cap and gently pull off the tip of the actuator. Wash the tip of the actuator and the protective cap in warm water, then rinse under running water. Do not attempt to unblock the tip of the actuator by piercing it with a needle or other sharp object, as this will damage the actuator and the correct dose of the medicine will not be delivered. Leave the protective cap and the tip of the actuator to dry in a warm place. Replace the tip of the actuator on the bottle, then put on the protective cap. After cleaning, you should check that the actuator is working properly and release 2 sprays.

Using a higher dose of Zodgane than recommended

If you accidentally use a higher dose of the medicine than recommended, you should consult your doctor. If steroids are used for a long time or in high doses, they may rarely have an adverse effect on the patient's hormones.

Missing a dose of Zodgane

If you forget to use the nasal spray at the right time, you should take it as soon as you remember, and then continue treatment at the usual time. You should not take a double dose to make up for a missed dose. If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zodgane can cause side effects, although not everybody gets them. After using this medicine, immediate allergic reactions (hypersensitivity) may occur. These reactions can be severe. You should stop using Zodgane and seek immediate medical attention 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 large 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 nasal sprays do not report any side effects. However, in some people, after using mometasone furoate (the active substance of Zodgane) or another corticosteroid nasal spray, the following side effects have occurred: Common (may affect up to 1 in 10 people):

• Headache
• Sneezing
• Nosebleeds
• Irritated nose
• Ulcers of the nasal mucosa
• Upper respiratory tract infections

Frequency not known (cannot be estimated from the available data):

• Increased pressure in the eyeball (glaucoma) and/or cataracts causing vision disturbances
• Damage to the nasal septum separating the nostrils
• Disturbances of taste and smell
• Breathing difficulties and/or wheezing
• Blurred vision

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. 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 this medicine.

5. How to store Zodgane

The medicine should be stored out of sight and reach of children. Do not store above 25°C. Do not use this medicine after the expiry date stated on the bottle and carton after EXP. The expiry date refers to the last day of that month. The shelf life after opening the bottle is 2 months. Only one bottle should be opened at a time. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Zodgane contains

• The active substance of Zodgane is mometasone furoate. Each delivered dose of the spray contains 50 micrograms of mometasone furoate in the form of a monohydrate.
• The other ingredients of the medicine are: benzalkonium chloride, solution, glycerol, polysorbate 80, microcrystalline cellulose, and sodium carmellose, citric acid monohydrate, sodium citrate, purified water.

What Zodgane looks like and contents of the pack

Zodgane is a nasal spray, suspension. The bottles contain 60 doses, 120 doses, or 140 doses (supplied in packs of 1 bottle of nasal spray in a cardboard box). Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zentiva k.s.

U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic. Manufacturer

Farmea

Zac D Orgemont, 10 Rue Bouche Thomas, 49000 Angers, France. For more detailed information, you should contact your local representative of the marketing authorization holder: Zentiva Polska Sp. z o.o., ul. Bonifraterska 17, 00-203 Warsaw, tel.: +48 22 375 92 00.

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

Denmark: Mometasonfuroat Zentiva, Czech Republic, Slovakia: Metsandia, Germany: MOMETASON ADGC 50 Mikrogramm/Sprühstoß, Italy: Mometasone Zentiva, Poland: Zodgane, Portugal: Zenayr Rinus, Date of last revision of the leaflet:February 2025