Cixodil

Leaflet attached to the packaging: information for the user

Cyxodil, 80 micrograms/dose, inhalation aerosol, solution

Cyxodil, 160 micrograms/dose, inhalation aerosol, solution

Cyxodil, 320 micrograms/dose, inhalation aerosol, solution

Ciclesonide

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.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Cyxodil and what is it used for

What is Cyxodil:

Cyxodil contains ciclesonide as the active substance. Cyxodil is a clear and colorless inhalation aerosol intended for inhalation through the mouth into the lungs. It is a preventive medicine (corticosteroid) that should be used daily and its effect occurs only after inhalation into the lungs.

What is Cyxodil used for:

Cyxodil is used to treat chronic asthma in adult and adolescent patients (12 years and older).

How Cyxodil works

Cyxodil helps to make breathing easier by reducing the severity of asthma symptoms and reducing the likelihood of an asthma attack. The effect of the medicine increases over time, so it should be taken daily, even if the patient feels better. This medicine is not suitable for use during an acute asthma attack. To quickly relieve such an attack, only a bronchodilator inhaler should be used.

2. Important information before using Cyxodil

When not to use Cyxodil:

• 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 to use Cyxodil, you should discuss it with your doctor or pharmacist. Before startingtreatment with this medicine, you should inform your doctor if:

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

In case of doubts, you should contact your doctor. It is essential to ensure that Cyxodil is suitable for the patient. You should contact your doctor immediately if, while using Cyxodil, the patient:

• experiences difficulty breathing and worsening symptoms, such as coughing, shortness of breath, wheezing, feeling of pressure in the chest, increased wheezing, or other symptoms of bronchial constriction. A bronchodilator inhaler should be used, which usually results in rapid improvement.
• experiences symptoms that wake them up from sleep;
• does not experience improvement after using a bronchodilator inhaler. The doctor will determine further treatment for the patient.

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 examinations to assess asthma control, including lung function tests. Patients who are already taking corticosteroids in tablets:
Cyxodil may be used instead of tablets or to reduce the number of tablets required. You should follow the doctor's instructions exactly.

• The switch will start about a week after starting to use the Cyxodil inhaler.
• The number of tablets taken will be carefully reduced over a period.
• During this time, the patient may sometimes feel unwell.
• Despite this, it is essential to continue the inhalation treatment with Cyxodil and gradually reduce the number of tablets taken.
• If severe symptoms occur, such as nausea, vomiting, diarrhea, or high fever, you should contact your doctor.
• Switching from tablets to inhalation treatment may sometimes cause the emergence of mild allergies, such as rhinitis or rash (itchy redness of the skin).
• After switching from tablets to inhalation treatment, the patient may be at risk of reduced adrenal function for some time, related to the previously taken corticosteroids in tablet form. Symptoms of reduced adrenal function (e.g., dizziness, fainting, nausea, loss of appetite, mood changes, hair loss, reduced resistance to stress, weakness, headaches, memory disorders, allergies, increased appetite, and changes in blood sugar levels) may also persist for some time.
• It may also be necessary to consult a specialist to determine the degree of reduced adrenal function.
• The doctor will also regularly check the adrenal function.
• In stressful situations, such as during surgery, worsening of asthma attacks, additional corticosteroid tablets may be necessary. Therefore, the patient should carry a steroid warning card with this information.

Patients with liver or kidney disease
It is not necessary to adjust the dose of ciclesonide in patients with liver or kidney disease.
If the patient has severe liver disease, the doctor will carefully assess the risk of potential side effects related to impaired steroid production.

Children

This medicine is not recommended for use in children under 12 yearsof age, as there is no information on its potential effects in this age group.

Cyxodil and other medicines

You should 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, including those available without a prescription.
Before taking Cyxodil, you should inform your doctor if the patient is currently being treated for any fungal or viral infections with a medicine containing:

• ketokonazole,
• itraconazole,
• cobicistat,
• ritonavir,
• nelfinavir. These medicines may enhance the effect of Cyxodil, so it is not possible to completely rule out the possibility of side effects.

Cyxodil with food and drink

No interactions have been found between the use of Cyxodil and food or drink.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

• Since there is not enough information on the effects of Cyxodil in pregnant women, the doctor will discuss the risks and benefits of using Cyxodil with the patient.
• Ciclesonide (the active substance of Cyxodil) may be used during pregnancy only if the potential benefits to the mother outweigh the possible risk to the developing child. If the doctor decides that the patient can continue to use Cyxodil, the smallest possible dose of ciclesonide will be used to maintain control of asthma.
• Adrenal function will be carefully monitored in children whose mothers received corticosteroids during pregnancy.
• If the patient plans to use Cyxodil while breastfeeding, they should discuss it with their doctor.
• It is not known whether inhaled ciclesonide passes into human milk.
• Cyxodil will only be prescribed to breastfeeding women if the expected benefits to the mother outweigh the possible risk to the child.

Driving and using machines

Cyxodil and its excipients do not affect or have a negligible effect on the ability to drive or use machines.

Cyxodil contains ethanol

This medicine contains 4.7 mg of alcohol (ethanol) in each 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 have noticeable effects.

3. How to use Cyxodil

This medicine should always be used exactly as prescribed by your doctor or pharmacist. In case of doubts, you should consult your doctor or pharmacist.

• If the patient started using this medicine instead of corticosteroids in tablets or together with corticosteroids in tablets, see section 2 "Patients who are already taking corticosteroids in tablets".

What dose of Cyxodil should be used each day?

The doctor will inform the patient about the dose of Cyxodil to be used each day. This will depend on the individual needs of the patient.

• The recommended dose of Cyxodil is 160 micrograms once a day and is the dose that controls asthma symptoms in most patients.
• In some patients, a reduced dose of 80 micrograms once a day may be an appropriate maintenance dose to control asthma.
• In patients with severe worsening of asthma symptoms, it may be necessary to increase the dose of Cyxodil for a short period. This may be up to 640 micrograms per day, taken in doses of 320 micrograms twice a day, but there are no data to support additional therapeutic effects after 3 months of using higher doses.

If necessary, the doctor may also prescribe corticosteroids in tablets and/or antibiotics in case of infection.

• The doctor will adjust the dose to the minimum necessary to control asthma in the patient.
• Improvement in symptoms (wheezing, feeling of pressure in the chest, and coughing) should be noticeable within 24 hours.

When to use Cyxodil?

In most cases, either in the morning or in the evening - one or two doses once a day. You should follow the doctor's instructions exactly. It is essential to use Cyxodil regularly every day, even if the patient feels better.
If the patient finds that they need to use a bronchodilator inhaler more often than 2-3 times a week, they should contact their doctor, who will reassess the treatment.

How to use Cyxodil?

It is essential that the doctor, nurse, or pharmacist shows the patient how to use the Cyxodil inhaler correctly. Good technique will ensure that the correct amount of medicine is delivered to the lungs. The instructions in this leaflet should be used as a reminder.
To ensure that the patient uses the Cyxodil inhaler correctly, it may be necessary to perform a few initial doses in front of a mirror. You should make sure that the medicine is not escaping from the top or sides of the patient's mouth.
A new inhaler or one that has not been used for a week or longer mustbe checked before use. You should remove the mouthpiece cover and press the canister threetimes to release threedoses, directing the spray into the air away from yourself.
Shaking the Cyxodil inhaler before use is notnecessary. The medicine is in the form of a uniform solution, which ensures that the patient receives the correct dose during each inhalation.

It is essential to follow the instructions below, using the accompanying diagrams.

• 1. Remove the mouthpiece cover and check the mouthpiece inside and outside to ensure it is clean and dry.

• 2. Hold the inhaler with the canister facing upwards (the base of the canister at the top), placing your index finger on the bottom of the canister and your thumb under the mouthpiece.
• 3. Exhale as long as it is comfortable. Do not breathe out into the inhaler.

• 4. Put the mouthpiece into your mouth and close your lips, firmlysurrounding the mouthpiece.
• 5. Just after starting to inhale through your mouth, press your index finger on the top of the inhaler to release a dose of medicine, taking a slow and deep breath at the same time. Make sure that the dose of medicine does not escape from the top, bottom, or sides of your mouth.

• 6. Hold your breath, remove the inhaler from your mouth, and release your index finger from the top of the inhaler. Continue to hold your breath for about 10 seconds or as long as it is comfortable. Breathe out slowly through your mouth. You should avoid blowing into the inhaler.

It is essential not to rush when performing the actions described in points 3 to 6.

• 7. If a second dose is prescribed, waitfor about half a minute and repeatsteps 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.

For hygiene reasons, the inner and outer surfaces of the mouthpiece should be cleaned with a drycloth every week.

• 1. Remove the mouthpiece cover, without removing the inhaler from the plastic casing;
• 2. Wipe the front of the small hole through which the medicine is released, using a dryfolded cloth;
• 3. Do not use water or other liquids.

Proper technique will ensure that the patient receives the correct dose of Cyxodil during each use of the inhaler. The doctor will regularly check the patient's inhalation technique to ensure the best treatment effect.
After the canister is completely empty, the spray will no longer be heard or felt.

If the patient experiences wheezing or a feeling of pressure in the chest after using Cyxodil:

• do not use additional doses.
• use a bronchodilator inhaler to relieve breathing.
• contact your doctor immediately.

If using the inhaler is difficult for the patient, the doctor may recommend using a spacer. The spacer that fits the Cyxodil inhaler is called AeroChamber Plus Flow-Vu.
When using the AeroChamber Plus Flow-Vu device, you should follow the instructions provided with it.
The doctor or pharmacist will advise on the use of this device.

Using a higher dose of Cyxodil than recommended

It is essential to use the dose of Cyxodil prescribed by the doctor. Do not increase or decrease the dose of the medicine without consulting your doctor.
In case of overdose, there is no need for special treatment, but you should inform your doctor. When using high doses for an extended period, it is not possible to rule out the risk of reduced adrenal function, and it may be necessary to monitor their function.

Missing a dose of Cyxodil

If the patient forgets to use Cyxodil, they should take the next dose at the scheduled time. Do not use a double dose to make up for the missed dose.

Stopping the use of Cyxodil

Do not stop using the Cyxodil inhaler, even if the patient feels better.

If you stop using this medicine, you should tell your doctor immediately.

In case of any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Cyxodil can cause side effects, although not everybody gets them.
You should stop using the medicine and consult your doctor immediately if the patient experiences any of the following serious side effects:

• severe allergic reactions, such as swelling of the mouth, tongue, and throat (occurring in less than 1 in 1000 patients),
• allergic reactions: skin rash, redness, itching, or skin eruptions in the form of hives and urticaria (occurring in less than 1 in 100 patients),
• coughing or wheezing worsening shortly after inhalation (occurring in less than 1 in 100 patients).

Other side effects observed during the use of Cyxodil are usually mild. In most cases, the patient can continue treatment. Side effects that may occur include:

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

Rare side effects (occurring in less than 1 in 1000 patients):

• palpitations (heart pounding)
• discomfort or abdominal pain
• high blood pressure.

Side effects with unknown frequency, but also possible:

• sleep disturbances, depression, or feelings of anxiety, restlessness, nervousness, increased agitation, or irritability. The occurrence of these effects is more likely in children.
• blurred vision and eye diseases causing vision disturbances (central serous chorioretinopathy).

Cyxodil may affect the normal production of corticosteroids in the patient's body. This is usually observed in patients taking high doses for an extended period. This effect may include:

• slowed growth in adolescents
• thinning of bones
• possible cataract (causing blurred vision)
• vision loss due to abnormally high pressure in the eye (glaucoma)
• moon-shaped face, increased weight in the upper body, and thinning of the arms and legs (Cushing's syndrome). The doctor will regularly check the growth of adolescents receiving long-term treatment. If growth slows down, the doctor will adjust the dose, if possible, to the smallest dose that maintains effective control of asthma.

Corticosteroids in tablets may cause more side effects than inhaled corticosteroids, such as Cyxodil. In patients who took steroid tablets before or during the use of Cyxodil, there may be a risk of side effects related to the use of tablets for some time. Regular medical check-ups will ensure that the doses of Cyxodil used by the patient are appropriate. Regular check-ups will also allow for early detection of any side effects and reduce the likelihood of their worsening.
Remember that:
if any of the side effects worsen or if you experience any side effects not listed in this leaflet, you should inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Cyxodil

The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the carton and label after EXP. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot, it indicates the batch number.
Pressurized container. Do not expose to temperatures above 50°C.
Do not pierce, damage, or burn, even if the canister appears to be empty.
Like most inhalation medicines in pressurized containers, the effectiveness of this medicine may be lower if the canister is cold. However, Cyxodil delivers the same dose within a temperature range of -10°C to 40°C.
If the inhaler is very cold, you should remove it from the plastic packaging and warm it in your hands for a few minutes before use. Never use anything else to heat it.
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 Cyxodil contains:

• The active substance of Cyxodil is ciclesonide. Each actuation of the inhaler delivers a dose (delivered through the mouthpiece) that contains 80, 160, or 320 micrograms of ciclesonide.
• The other ingredients are ethanol anhydrous and norflurane (HFA-134a). This medicine contains fluorinated greenhouse gases. Each inhaler contains 8.8 g of HFA-134a, which corresponds to 0.013 tons of CO2 equivalent (GWP = 1430).

What Cyxodil looks like and what the packaging contains

Cyxodil is a clear and colorless liquid in an aluminum pressurized container that delivers a precisely measured dose of ciclesonide in the form of an aerosol through the mouthpiece.
The container is placed in a plastic casing consisting of a mouthpiece with a green (Cyxodil 80 micrograms) or purple (Cyxodil 160 micrograms) or red (Cyxodil 320 micrograms) protective cap.
Pack sizes:
1 inhaler containing 120 metered doses.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Genetic S.p.A.
Contrada Canfora
84084 Fisciano (SA)
Italy

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

Poland: Cyxodil
Czech Republic: Ciclesonide Polpharma
Date of last revision of the leaflet:February 2025