Cyxezon

Package leaflet: Information for the user

CYXEZON, 80 micrograms per metered dose, inhalation aerosol, solution
CYXEZON, 160 micrograms per metered dose, inhalation aerosol, solution
Ciclesonidum
Please read this leaflet carefully before using this medicine, because it contains important
information for the patient.

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

Table of contents of the leaflet

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 inhalation through the mouth into the lungs.
It is an asthma medicine (a corticosteroid) that must be used daily and is effective only when inhaled 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 to breathe more easily by reducing the severity of asthma symptoms and the risk of asthma attacks. The effect of the medicine increases over time; therefore, it must be taken daily, even when the patient feels well.
This medicine is not suitable for use during an acute asthma attack. To quickly relieve such an attack,
only a reliever inhaler medicine should be used.

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 administration of 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 pulmonary tuberculosis, fungal, viral or bacterial infections.

If in doubt, contact your doctor. It is important to ensure that
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 (râles), or other symptoms of airway constriction.
• (A reliever inhaler should be used, which usually leads to rapid improvement.)
• symptoms cause awakening from sleep.
• there is no improvement after using a reliever inhaler. The 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 redness of the skin).
• After switching from tablets, the patient will remain at risk of adrenal insufficiency for some time due to previous treatment with oral corticosteroids. Symptoms of adrenal insufficiency (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 glucose 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 information.
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 due to 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 with 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 or nelfinavir.
These medicines may enhance the effect of CYXEZON and increase the risk of
adverse reactions.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
CYXEZON with food and drink
No interactions have been observed between 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 fetus. If the doctor decides that the patient may continue using CYXEZON, the lowest possible dose of ciclesonide necessary to maintain 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 infant.

Driving and using machines
CYXEZON, 80 or 160 micrograms, has no effect or has a negligible effect on the ability
to drive vehicles 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
of this medicine 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 as directed by a doctor or pharmacist. If in doubt,
consult a 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 of 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 a dose 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, chest tightness, 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 per week, they should contact their doctor.
How to use CYXEZON
It is important that the doctor, nurse, or pharmacist show 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 patient’s inhaler 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 an inhaler that has not been used for a week or longer must be
checked before use. Remove the mouthpiece cover and press the canister
inside the inhaler three times, releasing three sprays into the air, away from the
user.

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 inside and out to ensure it is clean and dry.

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

4. Place the mouthpiece in the mouth and close the lips firmly around it, sealing the mouthpiece tightly with the lips.
5. As inhalation begins through the mouth, press the index finger on the top of the inhaler to release the dose, while simultaneously taking a slow, deep breath in. Be careful not to let the dose 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 the steps described in points 3 to 6.

7. If a second dose is prescribed, wait approximately 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 the inhaler clean:
   • Wipe the inner and outer surfaces of the mouthpiece weekly with a dry cloth.
   • Wipe the front 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 canister is completely empty, the spray will no longer be audible or felt.
If the patient experiences wheezing or chest tightness after using CYXEZON:

• Do not take further doses.
• Use a reliever inhaler to help ease 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 treatment
Discuss this immediately with the doctor.
Do not stop using CYXEZON, even if the patient feels better.

4. Possible adverse effects

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

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

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

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

• sensation of rapid or irregular 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 effects are more likely to occur in children.)
• blurred vision.

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

• slowed growth in adolescents
• thinning of the bones
• possible clouding of the eye's 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 adolescents receiving long-term treatment. If growth has slowed, the doctor will adjust the dose, if possible, to the lowest dose that maintains effective asthma control.
Oral corticosteroid tablets may cause more adverse effects than inhaled corticosteroids such as CYXEZON. In patients who have previously taken or are currently taking steroid tablets while using CYXEZON, the risk of adverse effects associated with tablets may persist for some time. Regular medical check-ups will ensure that the dose of CYXEZON taken by the patient is appropriate. Regular monitoring will also allow early detection of any adverse effects and reduce the likelihood of their worsening.
Please remember:
If any adverse effect worsens or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to collect more information on the safety of the medicine.

5. How to store the medicine CYXEZON

Keep this medicine out of sight and reach of children.
Do not use this 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 contains pressurised liquid. Do not store 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 within the temperature range 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 some medicine left 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 required. Such measures will help protect the environment.

6. Contents of the pack and other information

What CYXEZON contains

• The active substance is cyklezonide.
• CYXEZON 80 micrograms per dose: Each actuation releases a spray (delivered dose via mouthpiece) containing 80 micrograms of cyklezonide.
• CYXEZON 160 micrograms per dose: Each actuation releases a spray (delivered dose via mouthpiece) containing 160 micrograms of cyklezonide.
• 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 canister 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 canister fitted with a metering valve and a white plastic actuator with a blue plastic protective cap, packed in a cardboard box.

Available pack sizes:
CYXEZON 80 micrograms per dose
Inhaler with capacity for 120 metered 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 60 metered doses; sufficient for one to two months of use.
Inhaler with capacity for 120 metered 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 Swarzędz

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

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