Zodgane

Package leaflet: Information for the user

Zodgane, 50 micrograms/dose, nasal aerosol, suspension
Mometasoni furoas
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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Zodgane is and what it is used for

Zodgane nasal aerosol contains mometasone furoate, which belongs to a group of medicines called corticosteroids. Mometasone furoate administered intranasally reduces inflammation (swelling and irritation of the nasal mucosa), sneezing, itching, nasal congestion, and decreases 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 doctor has previously diagnosed seasonal allergic rhinitis.
Hay fever, which occurs at specific times of the year, is an allergic reaction caused by inhaling pollen from trees, grasses, weeds, as well as mould and fungal spores. Zodgane reduces swelling and irritation of the nasal mucosa and thereby relieves sneezing, itching, nasal congestion, or nasal discharge caused by hay fever.

2. Important information before using Zodgane

When not to use Zodgane

• if the patient is allergic (hypersensitive) to mometasone furoate or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has an untreated nasal infection. Using Zodgane nasal aerosol during an untreated nasal infection, such as herpes simplex, may worsen the symptoms of infection. Wait until the infection has healed before using the nasal aerosol.
• if the patient has recently undergone nasal surgery or experienced nasal trauma. Do not use the nasal aerosol until wounds have healed.

Warnings and precautions
Before starting to use Zodgane, discuss with your doctor or pharmacist if:

• the patient currently has or has previously had tuberculosis.
• the patient has any other infection.
• the patient is taking other corticosteroids orally or by injection.
• the patient has cystic fibrosis.

While using Zodgane, consult your doctor if:

• the patient’s immune system is not working 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.
• the patient develops a nasal or throat infection.
• the medicine has been used for several months or longer.
• the patient experiences prolonged nasal or throat irritation.

If nasal corticosteroid aerosols are used at high doses for prolonged periods,
adverse effects due to systemic absorption of the medicine may occur.
If eye itching or irritation occurs, the doctor may recommend alternative treatment with Zodgane.
If the patient experiences blurred vision or other visual disturbances, contact the doctor.

Children and adolescents
Zodgane must not be used in children and adolescents under 18 years of age.

Zodgane with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.
If the patient is taking other corticosteroids orally or by injection for allergy treatment, the treating doctor may advise the patient to discontinue their use when starting Zodgane. In some patients, after stopping oral or injectable corticosteroids, adverse effects 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.
Some medicines may increase the effect of Zodgane, and the doctor may need to monitor the patient closely when such medicines are used (including certain HIV medicines: ritonavir, cobicistat).

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

Driving and using machines
There are no data on the influence of Zodgane on the ability to drive or operate machinery.

Zodgane contains benzalkonium chloride
This medicine contains 20 micrograms of benzalkonium chloride per dose. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a prolonged period.

3. How to use Zodgane

Zodgane should always be used exactly as directed by the doctor. If in doubt, consult a doctor or pharmacist. The nasal aerosol should not be used more frequently, for longer than recommended, or in higher doses than prescribed by the physician.

Use in adults
The usual dose is two sprays into each nostril once daily.
After symptoms have improved, the prescribing doctor may recommend reducing the dose.
Some patients may experience symptom relief within 12 hours of the first dose of Zodgane, but the full benefits of treatment may not be evident until after the first 2 days of use. Therefore, regular use should be continued to achieve the full therapeutic effect. Do not stop treatment even if the patient feels better, unless otherwise instructed by the doctor.

Method of administration
Preparing the nasal aerosol for use
Zodgane nasal aerosol comes with a protective cap that covers the nozzle to prevent contamination. Remember to remove the cap before use and replace it after each use.

Before first use, prime the pump by pressing it 10 times until a fine mist appears:

1. Gently shake the bottle.
2. Place the index and middle fingers on either side of the nozzle and the thumb underneath the bottle. Do not pierce the nasal aerosol nozzle.
3. Pointing the nozzle away from yourself, press down with your fingers 10 times until a uniform mist is produced.

If the nasal aerosol has not been used for 14 days or longer, prime the pump by pressing it twice until a uniform mist appears before the next use.

With the typical dosage of two sprays into each nostril once daily for the treatment of hay fever, the bottle should provide sufficient medication 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 aerosol

1. Gently shake the bottle and remove the protective cap.
2. Gently blow the nose.
3. Close one nostril and insert the nozzle into the other nostril. Tilt the head slightly forward, keeping the bottle upright.
4. Begin a gentle and slow inhalation through the nose while pressing down once with the fingers to release a spray (as a fine mist) into the nostril.
5. Breathe out through the mouth. Repeat step 4 to administer a second spray into the same nostril, if required.
6. Remove the nozzle from the nostril and breathe out through the mouth.
7. Repeat steps 3 to 6 to administer the aerosol into the other nostril.

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

Cleaning the nasal aerosol
It is important to clean the nasal aerosol bottle regularly, otherwise it may not work properly.
Remove the protective cap and gently pull off the nozzle.
Wash the nozzle and protective cap with warm water, then rinse thoroughly under running water.
Do not unblock the nozzle by piercing it with a needle or other sharp object, as this may damage the spray mechanism and result in incorrect dosing.
Leave the protective cap and nozzle in a warm place to dry.
Reattach the nozzle to the bottle, then replace the protective cap.
After cleaning, check that the spray works properly by releasing two sprays.

If more Zodgane has been used than recommended
If you accidentally use more Zodgane than recommended, consult a doctor.
When steroids are used for long periods or in high doses, they may rarely have an adverse effect on the patient's hormones.

If a dose of Zodgane has been missed
If the patient forgets to use the nasal aerosol at the scheduled time, the dose should be taken as soon as remembered, then continue treatment at the usual time. Do not use a double dose to make up for a missed dose.

If there are any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Immediate hypersensitivity (allergic) reactions may occur after using this medicine.
These reactions can be severe. You must stop using Zodgane and seek medical help immediately if any of the following symptoms occur:

• Swelling of the face, tongue or throat
• Difficulty swallowing
• Urticaria (hives)
• Wheezing or difficulty breathing

If nasal corticosteroid aerosols are used at high doses over a long period, adverse reactions may occur due to systemic absorption of the drug.

Other adverse reactions
Most people using nasal aerosols do not report any adverse reactions. However, in some individuals, the following adverse reactions have been reported after using mometasone furoate (the active substance in the medicine) or another corticosteroid in the form of a nasal aerosol:

Common (may affect fewer than 1 in 10 people):

• Headache
• Sneezing
• Nosebleeds
• Nasal irritation
• Nasal mucosal ulceration
• Upper respiratory tract infection

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

• Increased intraocular pressure (glaucoma) and/or cataract causing visual disturbances
• Damage to the nasal septum separating the nostrils
• Taste and smell disturbances
• Breathing difficulties and/or wheezing
• Blurred vision

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

5. How to store Zodgane

Keep this medicine out of the 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 outer packaging after EXP. The expiry date refers to the last day of the stated month.
The shelf life after first opening the bottle is 2 months. Only one bottle should be opened within this period.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Zodgane contains

• The active substance is mometasone furoate. Each delivered dose of the aerosol contains 50 micrograms of mometasone furoate in monohydrate form.
• Other components 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 aerosol, suspension.
Bottles contain 60 doses, 120 doses or 140 doses (supplied in packages of 1 nasal aerosol bottle in a cardboard box).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic

Manufacturers
Farmea
Zac D Orgemont
10 Rue Bouche Thomas
49000 Angers, France
H2 PHARMA
Zac La Croix Bonnet
21 Rue Jacques Tati
78390 BOIS D’ARCY,
France

For further information, please contact the local representative of the Marketing Authorisation Holder:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Mometasonfuroat Zentiva
Czech Republic, Slovakia: Metsandia
Germany: MOMETASON ADGC 50 Microgram/Spray Actuation
Italy: Mometasone Zentiva
Poland: Zodgane
Portugal: Zenayr Rinus