Airven

Patient Information Leaflet: Information for the User

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

Ciclesonide
Generic medicine
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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including 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 using 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 substance ciclesonide. AIRVEN is an aerosol, clear and colourless, in a spray pack for inhalation through the mouth and into the lungs. It is a preventive medicine (corticosteroid) which 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 must use this medicine every day, even when you feel well.
This medicine must not be used during acute attacks of shortness of breath. For immediate relief during such attacks, use only your usual inhaled treatment for acute attacks.

2. What you need to know before using AIRVEN

Do not use AIRVEN

• if you are allergic to ciclesonide or to 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 starting treatment with this medicine, speak with your doctor if:

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

If you are unsure, please check with your doctor. It is important to ensure that AIRVEN is the right medicine for you.
During treatment with AIRVEN, contact your doctor immediately if:

• your breathing becomes labored and your symptoms—cough, shortness of breath, wheezing, chest tightness, increased noises (rattles), or other symptoms of bronchial obstruction—worsen. You should use your usual inhaler, which normally provides rapid relief.
• you wake up at night due to the above-mentioned symptoms.
• you do not get relief from using your usual inhaled therapy for acute attacks. Your doctor will decide on an alternative treatment.

For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

Specific patient groups
Patients with severe asthma are at risk of acute attacks. For these patients, the doctor will carry out thorough and regular monitoring of the asthma condition, including lung function testing.
Patients already taking oral corticosteroid tablets:
AIRVEN may be used to replace tablets or to reduce the number of tablets you need. Follow your doctor's instructions carefully.

• This process will begin approximately one week after you start using AIRVEN inhalations.
• The number of tablets you take will be cautiously reduced over a period of time.
• During this period, you may experience a general feeling of unwellness.
• Nevertheless, it is important to continue both with AIRVEN inhalations and with gradually reducing the number of tablets.
• If you experience severe symptoms such as nausea, vomiting, diarrhea, or high temperature, contact your doctor.
• This process may sometimes reveal minor allergies such as rhinitis (inflammation inside the nose) or eczema (itching, red skin).
• If you have switched from tablets, you will remain at risk for a period of time of reduced adrenal function, which is related to the oral corticosteroids you previously took. Symptoms of reduced adrenal function (e.g., dizziness, weakness, nausea, loss of appetite, mood changes, reduced body hair, inability to cope with stress, fatigue, headache, memory problems, allergies, strong food cravings, blood sugar abnormalities) may also persist for some time.
• You may also need to consult a specialist to determine the extent of adrenal function reduction.
• Your doctor should also arrange for regular monitoring of adrenal function.
• During periods of stress—for example, if you need surgery or experience worsening asthma attacks—you may need additional oral corticosteroid tablets. In this case, you must carry a steroid user identification card specifying the need for additional administration.

Patients with liver or kidney problems
No dose adjustment of ciclesonide is necessary if you have liver or kidney problems.
If you have severe liver problems, your doctor will monitor you more closely for possible adverse effects resulting from altered normal steroid production.
Children:
This medicine is not indicated for children under 12 years of age due to lack of information on potential effects.
Other medicines and AIRVEN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Before using AIRVEN, inform your doctor if you are being treated for fungal or viral infections with medicines containing:

• ketoconazole,
• itraconazole,
• cobicistat,
• ritonavir,
• nelfinavir. These may enhance the effect of AIRVEN, so the possibility of adverse effects cannot be completely ruled out.

AIRVEN with food and drink
There are no interactions between AIRVEN and food or drink.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

• Since there is insufficient information on the effects of AIRVEN in pregnant women, your doctor will discuss with you the risks and benefits of using AIRVEN.
• Ciclesonide (the active substance in AIRVEN) may be used during pregnancy only if the potential benefits to the mother outweigh the potential risks to fetal development. If your doctor decides that you can continue using AIRVEN, the lowest effective dose of ciclesonide needed to maintain adequate asthma control will be used.
• Adrenal function should be carefully monitored in infants born to mothers who received corticosteroid therapy during pregnancy.
• Talk to your doctor if you wish to use AIRVEN while breastfeeding.
• It is not known whether inhaled ciclesonide passes into human breast milk.
• The prescription of AIRVEN to breastfeeding women should be considered only if the expected benefit to the mother outweighs the potential risk to the infant.

Driving and using machines
AIRVEN and its components have no effects or have negligible effects on the ability to drive vehicles or operate machinery.
AIRVEN contains ethanol
This medicine contains 4.7 mg of alcohol (ethanol) per dose. The amount in one 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 instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.

• If you have just started using this medicine instead of corticosteroid tablets, or in addition to them, see section 2, Patients who are already taking corticosteroid 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 daily, which controls asthma in the majority of patients.
• In some patients, a reduction of the dose to 80 micrograms once daily may be sufficient to maintain effective asthma control.
• A temporary increase in the dose of AIRVEN may be necessary in patients experiencing a severe worsening of their asthma symptoms. This may reach up to 640 micrograms per day, taken as 320 micrograms twice daily, but there are no data confirming additional therapeutic benefit beyond 3 months with these higher doses.

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

• Your doctor will adjust the dose to the lowest necessary to control your asthma.
• You should begin 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 daily. Follow your doctor’s
instructions exactly. It is important that you take AIRVEN regularly every day, even if you feel better.
If you find that you need your usual inhaled therapy for acute attacks more than 2–3 times a week, consult your doctor to review your treatment.

How should I use AIRVEN?
It is important that a doctor, nurse or pharmacist initially shows you how to correctly use the
AIRVEN inhaler. Proper technique ensures that the right amount of medicine reaches your lungs. Use the instructions in this leaflet as a reminder.
For the first few times, you may practise in front of a mirror until you are confident you can use the
AIRVEN inhaler correctly. 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, check that it is working
before use. Remove the mouthpiece cap and press down three times on the canister inside the inhaler to release three test sprays into the air, away from the person.
Do not shake the AIRVEN inhaler before use. The medicine is already in a fine solution,
mixed so that you receive the correct dose with each spray.
You may remain seated or standing during inhalation.
Follow these instructions carefully and use the illustrations as a guide.

1. Remove the mouthpiece cap and check inside and outside to ensure the mouthpiece is clean and dry.

2. Hold the inhaler upright (base of the canister uppermost), with your index finger on the top of the canister and your thumb on the base, below the mouthpiece.
3. Breathe out as much air as possible. Do not breathe out into the inhaler.

4. Place the mouthpiece in your mouth and close your lips tightly around it.
5. Immediately after starting to inhale through your mouth, press down on the top of the inhaler to release one spray of medicine, continuing to breathe in 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. Breathe out slowly through your mouth. Avoid breathing out into the inhaler.
It is important not to rush steps 3 to 6.

6. If you have been instructed to take another puff, wait about half a minute and repeat steps 3 to 6.
7. After use, always replace the mouthpiece cap to protect it from dust. Press until you hear a click.

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

1. Remove the mouthpiece cap, but do not remove the inhaler from the plastic actuator;
2. Using a folded dry cloth, dry the area around the small hole from which the medicine is released.
3. Do not use water or other liquids.

Correct technique will ensure that the right amount of AIRVEN reaches your lungs each time you
use the inhaler. Your doctor will regularly check your inhalation technique to ensure the treatment
is as effective as possible.
When the canister is completely empty, you will no longer feel or hear the propellant being released.
If your breathing becomes wheezy or you feel chest tightness after using AIRVEN:

• Do not take further puffs.
• Use your usual inhaled therapy for acute attacks to improve breathing.
• Contact your doctor immediately.

If you have difficulty using the inhaler, your doctor may recommend using 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 can advise you on this device.

If you use more AIRVEN than you should
It is important that you take your dose as advised by your doctor. You must not increase or reduce the
dose without medical advice.
If you have used too much AIRVEN, no specific treatment is required, but you should inform your
doctor. If high doses are used for prolonged periods, some degree of adrenal suppression cannot be ruled out, and monitoring of adrenal function may be necessary.

If you forget to use AIRVEN
If you forget to use AIRVEN, take the next dose at the usual scheduled time.
Do not take a double dose to make up for a forgotten dose.

If you stop using AIRVEN
Even if you feel better, do not stop treatment with AIRVEN.
If you stop treatment with this medicine, contact your doctor immediately.
If you have any questions about using this medicine, consult 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:

• severe allergic reactions such as swelling of the lips, tongue, and throat (may affect up to 1 in 1,000 treated patients)
• allergic reactions: skin rash, redness, itching, or skin inflammation such as eczema and urticaria (may affect up to 1 in 100 treated patients)
• cough or wheezing that worsens immediately after inhalation (may affect up to 1 in 100 treated patients)

Other side effects reported with AIRVEN are generally mild. In most cases, treatment can be continued. The possible side effects are:
Uncommon side effects (may affect up to 1 in 100 treated patients):

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

Rare side effects (may affect up to 1 in 1,000 treated patients):

• awareness of heartbeat (palpitations)
• malaise or abdominal discomfort or pain
• high blood pressure

Side effects with unknown frequency (but may also occur):

• sleep disorders, depression, malaise, restlessness, nervousness, hyperexcitability, or irritability. These effects may occur more easily in children
• blurred vision and eye disorders causing visual disturbances (central serous chorioretinopathy)

AIRVEN may interfere with the body's normal production of corticosteroids. This effect usually occurs in patients taking high doses for prolonged periods of time.
These effects may include:

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

Oral corticosteroid tablets may cause more side effects than inhaled corticosteroids such as AIRVEN. If you have taken oral steroids before or concurrently with AIRVEN, the risk of side effects from tablets may persist for some time. Regular visits to your doctor will ensure that the dose of AIRVEN you are taking is appropriate. Regular check-ups also allow early detection of any side effects and reduce the likelihood of them worsening.
Remember:
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the carton after EXP. The expiry date refers to the last day of the stated month.
The dispenser contains a pressurised solution. Do not expose to temperatures above 50°C.
The container must not be pierced, broken or burnt, even if it appears to be empty.
As with most medicines in pressurised 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 its plastic case and warm it in the 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 no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What AIRVEN contains

• The active substance is ciclesonide. Each actuation releases one spray (dose delivered 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, colourless liquid in an aluminium pressurised 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 housing incorporating a mouthpiece and fitted with a green dust cap (AIRVEN 80 micrograms), or purple dust cap (AIRVEN 160 micrograms), or red dust cap (AIRVEN 320 micrograms).
Pack sizes:
1 inhaler with 120 metered actuations
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 European Economic Area countries under the
following names:
Austria Ciclesonid Genetic
Netherlands Ciclesonide ACE
Italy AIRVEN
Greece CICLAIR