CICLESONIDE 80 MICROGRAMS Pressurized solution for inhalation

Зміст інструкції

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

AIRVEN 80 micrograms per actuation, pressurised solution for inhalation
AIRVEN 160 micrograms per actuation, pressurised solution for inhalation
AIRVEN 320 micrograms per actuation, pressurised solution for inhalation

Ciclesonide

Equivalent medicinal product

Read this leaflet carefully before you start to use this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What AIRVEN is and what it is used for

What AIRVEN is:
AIRVEN contains the active ingredient ciclesonide. AIRVEN is an aerosol, clear and colorless, in
a spray pack to be inhaled through the mouth and into the lungs. It is a preventative medicine (corticosteroid) that must be taken every day and becomes active only after
being inhaled into the lungs.

What AIRVEN is used for:
AIRVEN is used to treat persistent asthma in adult and adolescent patients (12 years and older).

How AIRVEN works
AIRVEN helps you breathe more easily by reducing both asthma symptoms and the risk of an asthma attack.
The effect develops over time, so you need to use this medicine every day, even when you feel well.

This medicine should not be used during acute shortness of breath attacks. In these attacks
for quick relief, use only your usual inhaler therapy for acute attacks.

2. What you need to know before using AIRVEN

Do not use AIRVEN

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

Warnings and precautions
Talk to your doctor or pharmacist before using AIRVEN.

Before startingtreatment with this medicine, talk to your doctor if:

• you have been treated for, or are currently being treated for, pulmonary tuberculosis (TB), fungal, viral or bacterial infections.

If you are not sure, check with your doctor. It is important to make sure that AIRVEN is the right medicine
for you.
During treatment with AIRVEN, contact your doctor immediatelyif:

• your breathing becomes difficult and your symptoms, cough, shortness of breath, wheezing, chest tightness, increased noises (ronchi) or other symptoms of bronchial obstruction worsen. You should use your usual inhaler that normally brings rapid improvement.
• you wake up at night due to the aforementioned symptoms.
• you do not get relief from using your usual inhaled therapy for acute attacks. The doctor will decide on another treatment.

For those who play sports: the use of the medicine without therapeutic need constitutes doping and
may still result in a positive doping test

Specific groups of patients
Patients with severe asthmaare at risk of acute attacks. For these patients, the doctor will perform a
thorough and regular check of the asthmatic condition, including a pulmonary function test.

Patients who are already taking corticosteroid tablets:
AIRVEN can be used to replace the tablets, or to reduce the number of tablets you need. Carefully follow your doctor's instructions.

• This will begin about a week after you have started inhalations of AIRVEN.
• The number of tablets you take will be reduced cautiously over a certain period of time.
• During this period of time you may feel a sensation of general malaise.
• Despite this, it is important to continue both with the inhalations of AIRVEN and reducing the number of tablets to be taken slowly.
• If you experience severe symptoms such as nausea, vomiting, diarrhea or high fever, contact your doctor.
• This process can sometimes reveal minor allergies such as rhinitis (inflammation inside the nose) or eczema (itching, reddened skin).
• If you have switched from tablets, you will continue to be at risk of reduced adrenal function for some time, which is related to the corticosteroid tablets you have taken. Symptoms of reduced adrenal function (e.g. dizziness, weakness, nausea, loss of appetite, mood swings, decreased hair, inability to cope with stress, fatigue, headache, memory problems, allergies, strong craving for food, blood sugar abnormalities) may also continue for some time.
• You may also need to consult a specialist to determine the extent of the reduction in adrenal function.
• The doctor must also arrange a regular check of adrenal function.
• During periods of stress, for example, if you have to undergo surgery, worsening asthma attacks, you may need additional corticosteroid tablets. In this case, you must carry a user identification card for steroid usersspecifying the need for additional administration.

Patients with liver or kidney problems
No adjustment of the ciclesonide dose is necessary if you have liver or kidney problems.
If you suffer from severe liver problems, the doctor will monitor you more carefully for possible adverse effects
resulting from the alteration of normal steroid production.

Children:
This medicine is not indicated for children under 12years of age due to the lack of
information about possible effects.

Other medicines and AIRVEN
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
Before using AIRVEN, tell your doctor if you are being treated for any fungal or
viral infection with other medicines containing:

• ketoconazole,
• itraconazole,
• cobicistat,
• ritonavir,
• nelfinavir. These may intensify the action of AIRVEN so that the probability of adverse effects cannot be completely excluded.

AIRVEN with food and drink
There are no interactions between AIRVEN and food and drink.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.

• Since there is insufficient information about the effects of AIRVEN on pregnant women, the doctor will discuss the risks and benefits of using AIRVEN with you.
• Ciclesonide (the active ingredient of AIRVEN) can be taken during pregnancy only when the possible benefits for the mother justify the possible risk to the development of the fetus. If the doctor decides that you can continue to use AIRVEN, the smallest possible dose of ciclesonide effective for maintaining adequate asthma control will be used.
• Adrenal function should be carefully monitored in children born to mothers treated with corticosteroids during pregnancy.
• Talk to your doctor if you want to use AIRVEN while breastfeeding.
• It is not known whether ciclesonide administered by inhalation passes into human breast milk.
• The prescription of AIRVEN to breastfeeding women should be considered only if the expected benefit for the mother is greater than the possible risk to the child.

Driving and using machines
AIRVEN and its components have no effects or negligible effects on the ability to drive
vehicles or use machines.

AIRVEN contains ethanol
This medicine contains 4.7 mg of alcohol (ethanol) in each actuation. The amount in a dose of
this medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in
this medicine will not produce significant effects.

3. How to use AIRVEN

Always use this medicine exactly as your doctor has instructed. If you have any doubts, consult your
doctor or pharmacist.

• If you have just started using this medicine instead of or together with corticosteroid tablets, see section 2, Patients who are already takingcorticosteroid tablets.

How much AIRVEN should I take each day?
Your doctor will have told you how much of this medicine you need to take each day. This depends
on your individual needs.

• The recommended dose of AIRVEN is 160 micrograms once a day, which leads to asthma control in the majority of patients.
• In some patients, a reduction of the dose to 80 micrograms, once a day, may be an adequate dose to maintain effective asthma control.
• An increase in the dose of AIRVEN may be necessary for a short period of time in patients who experience a severe worsening of their asthma symptoms. This can be up to 640 micrograms per day, taken as 320 micrograms twice a day, but there is no data to confirm an additional therapeutic effect after 3 months with these high doses.

If necessary, your doctor may also prescribe corticosteroid tablets and/or, in case of infection,
an antibiotic.

• The doctor will adjust the dose to the minimum necessary to control asthma.
• You will start to notice an improvement in symptoms (shortness of breath, chest tightness and cough) within 24 hours.

When should I use AIRVEN?
In most cases, in the morning or evening - one or two puffs once a day. Follow
your doctor's instructions exactly. It is important that you take AIRVEN regularly every day,
even if you feel better.
If you notice that you need your usual inhaler therapy for acute attacks more than 2-3 times a
week, consult your doctor to review the treatment.

How should I use AIRVEN?
It is important that a doctor, nurse or pharmacist initially show you how to use
the AIRVEN inhaler correctly. Good technique ensures that the right
amount of medicine reaches your lungs. Use the instructions contained in this leaflet as a reminder.
For the first few times, you can practice in front of a mirror, until you are sure you know how to use
the AIRVEN inhaler exactly. Make sure the medicine does not escape from the top or sides of your mouth.
If the inhaler is new or has not been used for a week or more, checkits operation
before use. Remove the mouthpiece cover and press down on the container
inside the inhaler threetimes to release threetest sprays, away from your face.

Do notshake the AIRVEN inhaler before use. The medicine is already in a very fine solution,
mixed so that you receive the correct dose with each puff.
During inhalation, you can be either sitting or standing.

Follow these instructions carefully and use the illustrations as a guide.

• 1. Remove the mouthpiece cover and check the inside and outside to make sure the mouthpiece is clean and dry.

• 2. Hold the inhaler upright (bottom of the container facing up), with your index finger on the top of the container and your thumb on the base, under the mouthpiece.
• 3. Exhaleas much air as possible. Do not exhale into the inhaler.

• 4. Put the mouthpiece in your mouth and close your lips tightly around the mouthpiece.
• 5. Immediately after starting to inhale with your mouth, press down on the top of the inhaler to release a puff of medicine, continuing to inhale steadily and deeply. Make sure the spray does not escape from the top, bottom or sides of your mouth.

Hold your breath, remove the inhaler mouthpiece from your mouth and remove your index finger from the top
of the inhaler. Continue to hold your breath for about ten seconds or as long as possible. Exhale
slowly through your mouth. Avoid exhaling into the inhaler.

It is important not to rush through steps 3 to 6.

• 6. If you have been instructed to take another puff, waitabout half a minute and repeatsteps 3 to 6.
• 7. After use, always put the cover back on the mouthpiece to protect it from dust. Press until you feel a click.

For hygiene reasons, clean the mouthpiece weekly with a dry cloth, both internally and
externally.

• 1. remove the mouthpiece cover, do not remove the inhaler from the plastic actuator;
• 2. using a folded dry cloth, dry the area of the small hole from which the medicine comes out.
• 3. do notuse water or other liquids.

Correct technique will ensure that the right amount of AIRVEN reaches your lungs every time
you use the inhaler. Your doctor will regularly check your inhalation technique to ensure that
the treatment can be most effective.
When the container is completely empty, you will not feel or hear the propellant escaping.

If your breathing becomes wheezy or you feel chest tightness after using AIRVEN:

• do not take any more puffs.
• use your usual reliever inhaler to improve your breathing.
• contact your doctor immediately.

If you have difficulty using the inhaler, your doctor may advise you to use a spacer. The
spacer suitable for AIRVEN is called AeroChamber Plus Flow-Vu. If you use the AeroChamber Plus Flow-Vu device,
follow the instructions provided with it.
Your doctor or pharmacist will be able to advise you on this device.

If you use more AIRVEN than you should
It is important that you take your dose as recommended by your doctor. Do not increase or decrease the
dose without medical advice.
If you have used too much AIRVEN, no specific treatment is necessary, but you should inform your
doctor. If high doses are used for long periods, some degree of adrenal suppression cannot be excluded and
adrenal function may need to be monitored.

If you forget to use AIRVEN
If you have forgotten to use AIRVEN, take the next dose at the scheduled time.

Do nottake a double dose to make up for a missed dose.

If you stop using AIRVEN
Even if you feel better, you should not stop treatment with AIRVEN.

If you stop treatment with this medicine, contact your doctor immediately.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop using this medicine
and contact your doctor immediately:

• serious allergic reactions such as swelling of lips, tongue and throat (may affect up to 1 in 1000 patients treated)
• allergic reactions: skin rash, redness, itching or flushing such as eczema and urticaria (may affect up to 1 in 100 patients treated)
• coughing, or wheezing, which worsens immediately after inhalation (may affect up to 1 in 100 patients treated)

Other side effects reported with AIRVEN are generally mild. In most
cases you will be able to continue treatment. The side effects that may occur are:
Uncommon side effects (may affect up to 1 in 100 patients treated):

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

Rare side effects (may affect up to 1 in 1000 patients treated):

• awareness of heartbeat (palpitations)
• feeling unwell or abdominal pain
• high blood pressure

With unknown frequency, but may also occur:

• sleep problems, depression or feeling unwell, restlessness, nervousness, overexcitement or irritability. These effects may more easily occur in children
• Blurred vision and eye diseases that cause visual disturbances (serous central chorioretinopathy)

AIRVEN may interfere with the normal production of corticosteroids in the body. This effect
usually occurs in patients who take high doses for long periods of time.
These effects may include:

• delayed growth in adolescents
• thinning of the bones
• possible clouding of the lens of the eye (cataract) with blurred vision
• loss of vision caused by abnormally high pressure inside the eye (glaucoma)
• moon face, weight gain in the upper part of the body and thinning of arms and legs (cushingoid features or Cushing's syndrome). Adolescents receiving treatment for long periods should be regularly checked by the doctor regarding height. If growth is slowed, the doctor will adjust the treatment if possible to the lowest dose that ensures adequate asthma control.

Corticosteroid tablets may give more side effects than corticosteroids by inhalation such as AIRVEN. If you have taken steroid tablets before or at the same time as
AIRVEN, the risk of side effects due to the tablets may persist for a certain period
of time. Regular visits to the doctor will ensure that the dose of AIRVEN you are taking is
correct. Regular visits also allow for the early identification of any side effects
and reduce the possibility that they worsen.
Remember:
If any of the side effects worsen, or if you notice any effect

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse .
By reporting side effects you can help provide more information on the safety
of this medicine

5. How to store AIRVEN

Keep this medicine out of sight and reach of children.
Do not use the medicine after the expiry date that is reported on the label and on the package
after EXP. The expiry date refers to the last day of the month.

The dispenser contains a pressurized solution. Do not expose to temperatures above 50°C.
The container must not be punctured, broken or burned even if it appears empty.
As with most medicines in pressurized containers, the therapeutic effect of this
medicine may decrease when the container is cold. However, AIRVEN delivers the same dose from
minus 10°C to plus 40°C.
If the inhaler becomes very cold, remove the inhaler from the plastic case and warm it between your
hands for a few minutes before use. Never use anything else to warm it.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What AIRVEN contains

• The active ingredient is ciclesonide. Each actuation delivers a spray (dose released through the mouthpiece) containing 80, 160 or 320 micrograms of ciclesonide.
• The excipients are anhydrous ethanol and propellant (Norflurane).

Description of the appearance of AIRVEN and contents of the pack
AIRVEN consists of a clear and colourless liquid in a pressurised aluminium container which
delivers an accurately measured dose of ciclesonide in the form of a spray through a mouthpiece.
The container is placed in a plastic casing incorporating a mouthpiece and fitted with a dust cap
green (AIRVEN 80 micrograms) or purple (AIRVEN 160 micrograms) or red (AIRVEN
320 micrograms).

Pack sizes:
1 inhaler with 120 metered doses

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Genetic S.p.A.
Via G. Della Monica 26
84083 Castel San Giorgio (SA)
Italy

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria Ciclesonid Genetic
Netherlands Ciclesonide ACE
Italy AIRVEN
Greece CICLAIR