CYXEZON

Package leaflet: Information for the user

CYXEZON, 80 micrograms/dose, inhalation aerosol, solution
CYXEZON, 160 micrograms/dose, inhalation aerosol, solution
Ciclesonidum
Please read the entire leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What CYXEZON is and what it is used for

What CYXEZON is and what it is used for:
CYXEZON is a clear, colourless aerosol for oral inhalation into the lungs.
It is an asthma medicine (a corticosteroid) that must be used daily and is effective only when inhaled directly into the lungs.
This medicine is used for the treatment of chronic asthma in adults, adolescents, and children aged 12 years and older.

How CYXEZON works:
This medicine helps you breathe more easily by reducing the severity of asthma symptoms and the risk of asthma attacks. The effect of the medicine increases over time, so it must be taken daily, even when you feel well.

This medicine is not suitable for use during an acute asthma attack. To quickly relieve such an attack, only use a reliever inhaler medicine.

2. Important information before using CYXEZON

When not to use CYXEZON

• if the patient is allergic to ciclesonide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with CYXEZON, discuss this with your doctor or pharmacist.
Inhaled ciclesonide may lead to positive results in anti-doping tests.
Before starting treatment with this medicine, inform your doctor if:

• the patient has ever been treated or is currently being treated for tuberculosis, fungal, viral or bacterial infections of the lungs.

If in doubt, contact your doctor. It is important to ensure that the medicine
CYXEZON is appropriate for the individual patient.
During treatment with CYXEZON, contact your doctor immediately if:

• breathing becomes difficult and asthma symptoms worsen, such as coughing, shortness of breath, wheezing, chest tightness, increased auscultatory phenomena (rattling) or other symptoms of airway constriction.
• (Use a reliever inhaler, which usually leads to rapid improvement.)
• symptoms cause awakening from sleep.
• there is no improvement after using the reliever inhaler. Your doctor will decide on further treatment.

Contact your doctor if blurred vision or other visual disturbances occur.
Special patient groups
In patients with severe asthma, there is a risk of acute asthma attacks. In this group
of patients, the doctor will regularly perform thorough assessments of asthma control, including
lung function tests.
Patients who are already taking oral corticosteroids:
CYXEZON may be used instead of tablets or to reduce the number of tablets the patient needs to take. Follow your doctor's instructions exactly.

• Reduction in the number of tablets will begin approximately one week after starting CYXEZON.
• The number of tablets taken will be gradually reduced over a period of time.
• During this time, the patient may occasionally feel generally unwell.
• Despite this, it is important to continue both treatment with CYXEZON and the gradual reduction in the number of tablets taken.
• If severe symptoms occur, such as nausea, vomiting, diarrhoea or high fever, contact your doctor.
• Mild allergic reactions may occasionally appear, such as rhinitis (inflammation inside the nasal cavity) or rash (itchy red skin).
• After switching from tablets, the patient may remain at risk of reduced adrenal function for some time due to previous use of oral corticosteroids. Symptoms of reduced adrenal function (e.g. dizziness, fainting, nausea, loss of appetite, mood swings, hair loss, reduced stress tolerance, weakness, headache, memory disturbances, allergies, increased appetite and changes in blood sugar levels) may also persist for some time. The doctor will regularly monitor adrenal function and consultation with a specialist may also be necessary.

In stressful situations (e.g. during surgery or worsening asthma attacks),
additional treatment with oral corticosteroids may be required. For this reason,
the patient should carry a steroid warning card stating this.
Patients with liver or kidney disease
Dosage adjustment of ciclesonide is not necessary in patients with liver or kidney disease. If
the patient has severe liver disease, the doctor will perform a more detailed assessment to rule out
possible adverse effects resulting from impaired steroid production.
Children under 12 years of age
This medicine is not recommended for use in children under 12 years of age, due to lack of
information on possible effects.
CYXEZON and other medicines
Before using CYXEZON, inform your doctor if the patient is currently
being treated for any fungal or viral infection with a medicine containing
ketoconazole, itraconazole, ritonavir, nelfinavir.
These medicines may enhance the effect of CYXEZON and may increase the risk of adverse
reactions.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has taken recently, as well as any medicines the patient plans to take.
CYXEZON with food and drink
No interaction has been observed between the use of CYXEZON and food or drink.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, suspects she may be pregnant, or is breastfeeding, she should consult her
doctor to discuss the risks and benefits of using the inhaler.

• As there is insufficient information on the effects of CYXEZON in pregnant women, the doctor will discuss the risks and benefits of using CYXEZON with the patient.
• Ciclesonide (the active substance in CYXEZON) may be used during pregnancy only if the potential benefits to the mother outweigh the possible risks to the developing child. If the doctor decides that the patient may continue using CYXEZON, the lowest possible dose of ciclesonide that maintains asthma control will be used.
• Adrenal function will be closely monitored in children whose mothers received corticosteroids during pregnancy.
• If the patient intends to use CYXEZON while breastfeeding, she should discuss this with her doctor.
• It is not known whether inhaled ciclesonide passes into human milk.
• Prescribing CYXEZON to breastfeeding women may be considered only if the expected benefits to the mother outweigh the possible risks to the child.

Driving and operating machinery
CYXEZON, 80 or 160 micrograms, has no effect or negligible effect on the ability
to drive or operate machinery.
CYXEZON contains ethanol
This medicine contains less than 4.7 mg of alcohol (ethanol) per dose. The amount of alcohol in each dose
is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not
cause noticeable effects.

3. How to use CYXEZON

This medicine should always be used exactly as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
If the patient has started using this medicine instead of oral corticosteroids (or together with tablets),
see section 2 "Patients who are already using oral corticosteroids".
What dose of CYXEZON should be used each day?
The doctor will inform the patient about the dose to be used daily. This will depend on the
individual needs of the patient.

• The recommended dose of CYXEZON is 160 micrograms once daily.
• In some patients, a dose of 80 micrograms once daily may be sufficient to control asthma symptoms.
• In patients whose asthma symptoms have significantly worsened, a temporary increase in the dose of CYXEZON may be necessary. This could be up to 640 micrograms per day, administered as 320 micrograms twice daily; however, there are no data confirming additional therapeutic benefit after 3 months of using these higher doses.

If necessary, the doctor may also prescribe oral corticosteroids and (or) antibiotics in case of
infection.

• The doctor will adjust the dose appropriate for controlling asthma in the patient.
• Improvement in symptoms (wheezing, tightness in the chest, and cough) should be noticeable within 24 hours.

When to use CYXEZON
One or two inhalations should be taken once daily, in the morning or evening. Follow the doctor's
instructions. It is important to use CYXEZON regularly every day, even if the patient feels better.
If the patient finds that they need to use a reliever inhaler more than 2–3 times a week, they should
contact their doctor.
How to use CYXEZON
It is important that the doctor, nurse, or pharmacist shows the patient how to use the CYXEZON
inhaler. Proper technique ensures that the correct amount of medicine reaches the lungs. The doctor
will regularly check the inhalation technique to ensure the treatment is as effective as possible.
The instructions in this leaflet should be used as a reminder.
To ensure correct use of the CYXEZON inhaler, it may be helpful to perform the first few inhalations
in front of a mirror. Make sure the medicine does not escape from the top or sides of the mouth.
How to check the inhaler is working
A new inhaler or one that has not been used for a week or longer must be checked before use.
Remove the mouthpiece cover and press the three times on the pressurized canister inside the inhaler to release three sprays into the air, away from the face.

Do not shake the CYXEZON inhaler before use.
The patient may sit or stand while inhaling.
Instructions for using the inhaler

1. Remove the mouthpiece cover and inspect the mouthpiece both inside and outside to ensure it is clean and dry.

2. Hold the inhaler upright with the base pointing upwards (the base of the pressurized canister at the top), placing the index finger on top of the canister base and the thumb under the mouthpiece.
3. Breathe out as fully as possible. Do not exhale into the inhaler.

4. Place the mouthpiece in the mouth and close the lips firmly around it, sealing tightly.
5. As inhalation begins through the mouth, press down with the index finger on the top of the inhaler to release the dose, while simultaneously taking a slow and deep breath in. Be careful not to let the medicine escape through the top, bottom, or sides of the mouth.

6. Hold the breath, remove the inhaler from the mouth, and remove the index finger from the top of the inhaler. Continue holding the breath for about ten seconds, or as long as possible. Then breathe out slowly through the mouth. Do not exhale into the inhaler.

It is important not to rush when performing the steps described in points 3 to 6.

7. If a second dose is prescribed, wait about half a minute and repeat steps 3 to 6.
8. After use, always replace the mouthpiece cover to prevent dust from entering. Press the cover firmly and snap it into place.

9. To keep it clean:
   • Wipe the inner and outer surfaces of the mouthpiece weekly with a dry cloth.
   • Clean the front part of the small hole through which the medicine is released, using a dry folded cloth.

• Do not use water or any other liquids.

If the pressurized canister is completely empty, the spray will no longer be audible or felt.
If the patient experiences wheezing or tightness in the chest after using CYXEZON:

• Do not take further doses.
• Use a reliever inhaler to help breathing.
• Contact the doctor immediately.

If the patient has difficulty using the inhaler, the doctor may recommend using a device known as a spacer. If the patient uses a spacer, follow the instructions provided with it. Advice can be obtained from the doctor or pharmacist.
Using more than the recommended dose of CYXEZON
Discuss this with the doctor, who will decide what action to take.
Missing a dose of CYXEZON
Take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.
Stopping CYXEZON
Discuss this immediately with the doctor.
Do not stop using CYXEZON, even if the patient feels better.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Treatment should be discontinued and medical advice sought immediately if the patient
experiences any of the following serious adverse reactions:

• severe allergic reactions, such as swelling of the lips, tongue, and throat
• allergic reactions: skin rash, redness, itching, or skin eruptions in the form of hives and urticaria
• cough or wheezing worsening shortly after inhalation.

Other adverse reactions of CYXEZON are listed below and are usually mild. In
most patients, treatment may be continued.
Uncommon adverse reactions (occur in no more than 1 in 100 people):

• hoarseness
• burning sensation, inflammation, irritation of the mouth or throat
• oral thrush (fungal infection of the mouth)
• headache
• unpleasant taste in the mouth
• dryness in the mouth or throat
• nausea or vomiting.

Rare adverse reactions (occur in no more than 1 in 1000 people):

• sensation of rapid heartbeat (palpitations)
• discomfort or abdominal pain
• high blood pressure.

Frequency not known, but also possible:

• sleep disorders, depression, or feelings of worry, anxiety, nervousness, increased excitability, or irritability. (These reactions are more likely to occur in children).
• blurred vision.

CYXEZON may affect the body's normal production of corticosteroids in the patient.
This has usually been observed in patients taking high doses over a long period of time. Symptoms
may include:

• slowed growth in children and adolescents
• thinning of the bones
• possible clouding of the eye lens (cataract), causing blurred vision
• loss of vision due to abnormally high pressure in the eye (glaucoma)
• moon-shaped face, increased mass of the upper body, and thinning of arms and legs (cushingoid syndrome or Cushing's syndrome).

The doctor will regularly monitor the growth of children and adolescents receiving long-term treatment. If
growth retardation occurs, the doctor will adjust the dose, if possible, to the lowest dose allowing effective asthma control.
Oral corticosteroids may cause more adverse reactions than inhaled corticosteroids such as CYXEZON. In patients who have taken steroid tablets before or during treatment with CYXEZON, there may be a continued risk of adverse reactions related to tablet use for some time. Regular medical check-ups will ensure that the CYXEZON dose taken by the individual patient is appropriate. Regular monitoring will also allow early detection of any adverse reactions and reduce the likelihood of their worsening.
Please note:
If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.
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 to provide more information on the safety of the medicine.

5. How to store the medicine CYXEZON

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the stated month.
The container holds contents under pressure. Do not store at temperatures above 50°C.
Do not pierce, damage, or burn the container, even if it appears to be empty.
As with most pressurised inhalation medicines, the effectiveness of this medicine may be reduced if the container is cold. However, CYXEZON delivers the same dose across temperatures ranging from minus 10°C to plus 40°C.
If your doctor decides to discontinue treatment or if the inhaler is empty, return it to a pharmacist for safe disposal. This is important because there may still be residual medicine in the container, even if it appears to be empty.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What CYXEZON contains

• The active substance is ciclesonide.
• CYXEZON 80 micrograms per dose: Each actuation releases a spray (delivered dose via mouthpiece) containing 80 micrograms of ciclesonide.
• CYXEZON 160 micrograms per dose: Each actuation releases a spray (delivered dose via mouthpiece) containing 160 micrograms of ciclesonide.
• Other ingredients are: anhydrous ethanol and propellant gas (HFC-134a, norflurane).

This medicine contains fluorinated greenhouse gases.
CYXEZON 80 micrograms per dose, 120 metered doses:
Each inhaler contains 8.893 g of HFC-134a, equivalent to 0.012 tonnes of CO(_2)
(global warming potential GWP = 1430).
CYXEZON 160 micrograms per dose, 60 metered doses:
Each inhaler contains 7.028 g of HFC-134a, equivalent to 0.009 tonnes of CO(_2)
(global warming potential GWP = 1430).
CYXEZON 160 micrograms per dose, 120 metered doses:
Each inhaler contains 11.053 g of HFC-134a, equivalent to 0.014 tonnes of CO(_2)
(global warming potential GWP = 1430).

What CYXEZON looks like and contents of the pack
CYXEZON 80 micrograms, inhalation aerosol, solution: a clear, colourless liquid in an aluminium pressurised container fitted with a metering valve and a grey plastic actuator with a blue plastic protective cap, packed in a cardboard box.
CYXEZON 160 micrograms, inhalation aerosol, solution: a clear, colourless liquid in an aluminium pressurised container fitted with a metering valve and a white plastic actuator with a blue plastic protective cap, packed in a cardboard box.

Pack sizes available:
CYXEZON 80 micrograms per dose
Inhaler with capacity for precisely metering 120 doses; sufficient for two to four months of use.
1 x 120 metered doses
Hospital pack
10 x 120 metered doses

CYXEZON 160 micrograms per dose
Inhaler with capacity for precisely metering 60 doses; sufficient for one to two months of use.
Inhaler with capacity for precisely metering 120 doses; sufficient for two to four months of use.
60 metered doses
1 x 120 metered doses
Hospital pack
10 x 60 metered doses
10 x 120 metered doses

Not all pack sizes may be marketed in all countries.

Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer and Importer
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoke Myto
Czech Republic
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzedz
Poland

This medicine is authorised for sale in the European Economic Area countries under the following names:

For more detailed information on this medicinal product, please contact
the local representative of the marketing authorisation holder:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonskiego 3
00-728 Warsaw
Email: [email protected]