AIRCORT 200 MICROGRAMS Pressurized inhalation suspension

Зміст інструкції

1. AIRCORT 0,25 mg/ml suspension for nebulisation, 0,5 mg/ml suspension for nebulisation
   1. What is AIRCORT and what is it used for
   2. What you need to know before you take AIRCORT
   3. How to take AIRCORT
   4. Possible side effects
   5. How to store AIRCORT
   6. Contents of the pack and other information
2. AIRCORT 200 micrograms/dose, Pressurized Suspension for inhalation, 400 micrograms/dose, Pressurized Suspension for inhalation
   1. What is AIRCORT and what is it used for?
   2. What you need to know before you use AIRCORT
   3. How to use AIRCORT
   4. Possible side effects
   5. How to store AIRCORT
   6. Contents of the pack and other information
3. AIRCORT 100 micrograms nasal spray, suspension, 50 micrograms nasal spray, suspension
   1. What is AIRCORT and what is it used for
   2. What you need to know before using AIRCORT
   3. How to use AIRCORT
   4. Possible side effects
   5. How to store AIRCORT
   6. Contents of the pack and other information

AIRCORT 0,25 mg/ml suspension for nebulisation, 0,5 mg/ml suspension for nebulisation

Budesonide
Equivalent Medicinal Product

Read this leaflet carefully before you start to take this medicine as it contains
important information for you.

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

Contents of this leaflet:

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

1. What is AIRCORT and what is it used for

Aircort contains the active ingredient budesonide.
Aircort belongs to a group of medicines called glucocorticosteroids, which are hormones that
perform numerous activities, with an important function in controlling inflammation.
AIRCORT is indicated for the treatment of the following diseases:

• an inflammatory disease characterized by an obstruction of the bronchi (bronchial asthma);
• a disease characterized by an obstruction of the throat (larynx) that makes it difficult for air to pass, for which hospital admission is indicated (very severe subglottic laryngitis (croup)).

2. What you need to know before you take AIRCORT

Do not take AIRCORT

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

Warnings and precautions
Talk to your doctor or pharmacist before taking AIRCORT if:

• you have reduced liver function;
• you are taking ketoconazole (a medicine to treat fungal infections) or HIV protease inhibitors (medicines for the treatment of AIDS) or other cytochrome CYP3A4 inhibitors (enzymes largely involved in the breakdown of medicines) at the same time;
• you have active or quiescent pulmonary tuberculosis or fungal or viral infections of the respiratory tract;
• you have fungal and viral infections (measles and chickenpox);
• you have glaucoma (characterised by chronic damage to the optic nerve) and cataracts (loss of transparency of a part of the eye called the lens).

AIRCORT does not provide rapid improvement for sudden (acute) asthma episodes, for which other types of medicines such as short-acting bronchodilators are necessary.
The doctor must carefully assess if you have not benefited from the use of short-acting bronchodilators, in which case they may decide to increase the number of inhalations of budesonide compared to usual or to start therapy with oral glucocorticosteroids.
The doctor, in these two cases, must assess the possible risks of impairment and/or insufficiency of a gland called the adrenal gland. The doctor must carefully assess the discontinuation of treatment with oral glucocorticosteroids as rare cases of general malaise such as muscle and joint pain, fatigue, headache, depression, nausea and vomiting may occur, even if there is an improvement in lung function.
Replacing treatment with systemic glucocorticosteroids (those that distribute throughout the body) with inhaled therapy can sometimes make allergies manifest, such as nasal inflammation (rhinitis) and skin inflammation (eczema).
During inhaled therapy, a fungal disease called oral candidiasis may develop. This infection may require treatment with appropriate antifungal therapy and in some cases it may be necessary to discontinue treatment (see section “How to take AIRCORT”).
In long-term treatment, with high doses of AIRCORT, local and systemic effects may occur (Cushing's syndrome, Cushingoid appearance, adrenal suppression, reduced bone mineral density, cataracts, glaucoma, rarely psychological and behavioural effects including psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioural disturbances).
Once asthma control is achieved, your doctor will prescribe the minimum effective maintenance dose.
Do not increase or decrease the dose without first consulting your doctor.
As with other inhaled therapies, bronchospasm (paradoxical bronchospasm) with an immediate increase in breathing difficulty (wheezing) may occur after administration. In such a case, you should immediately stop treatment with inhaled budesonide and the doctor will assess the situation and alternative therapy, if necessary.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
Aircort must be used with caution in children.

Effect on growth
Height should be periodically monitored if a child is undergoing prolonged treatment with inhaled glucocorticosteroids. If growth is slowed, the doctor will assess whether to reduce the dose of the medicine. The benefits of therapy and the possible risk of growth suppression must be carefully evaluated by the doctor who may refer the child to a pediatric pulmonologist specialist.
In long-term treatment, with high doses of AIRCORT, behavioural disturbances may occur.

Other medicines and AIRCORT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
No interactions of budesonide with any other medicines used in the treatment of asthma have been observed.
You should avoid taking or allow as long an interval as possible between treatments if you need to take:

• ketoconazole and itraconazole, medicines to treat fungal infections, as they can increase the amount of budesonide in the body (see section “Warnings and precautions”). The doctor may also consider reducing the dose of AIRCORT.

Some medicines can increase the effects of AIRCORT and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).
.
Tell your doctor if you are using other medicines, such as:

• cimetidine, a medicine used to treat heartburn
• oestrogens and hormones used in contraceptive pills as in these cases the amount of budesonide in the blood increases with the resulting effects on the body. No effect has been observed with the use of budesonide and the concomitant use of low-dose oral contraceptives.

AIRCORT can alter the result of some laboratory tests used to diagnose insufficient activity of a gland called the pituitary gland (ACTH stimulation test to diagnose possible pituitary insufficiency may provide false results for the detection of low values).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Inhaled budesonide has not shown any adverse effects on the health of the fetus/newborn during pregnancy.
The doctor will assess the expected benefits for you during pregnancy against the risks to the fetus.

Breastfeeding
Budesonide may pass into breast milk. No adverse effects on the infant are expected at therapeutic doses of AIRCORT. Budesonide can be used during breastfeeding.

Driving and using machines
AIRCORT does not affect the ability to drive and operate machinery.

3. How to take AIRCORT

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Bronchial Asthma
Adults and the elderly

Initial dose:the dosage of AIRCORT is individual.
The recommended initial dose is 0.5 -1 mg twice a day. In cases where a
greater therapeutic effect is required, you may be prescribed higher doses of AIRCORT.

Maintenance dose: the maintenance dose is individual. Once the desired clinical
results are obtained, your doctor will reduce the dose until the minimum amount necessary for
controlling the symptoms is reached.

Onset of effect:
Improvement in asthma control following the administration of AIRCORT may
occur within three days of starting treatment, although the maximum benefit is obtained after

• 2 – 4 weeks.

Patients treated with oral glucocorticosteroids (see section “Warnings and Precautions”)
AIRCORT may allow the replacement or significant reduction of the dosage of
oral glucocorticosteroids, while maintaining asthma control.
Your doctor will assess how to switch from oral glucocorticosteroid therapy to treatment with
AIRCORT suspension for nebulization.

Dose division and mixing
Your doctor may ask you to mix AIRCORT with 0.9% saline solution and with other
solutions containing medicines that act on the respiratory system such as terbutaline, salbutamol, fenoterol,
acetylcysteine, sodium cromoglycate or ipratropium bromide.
The mixture must be used within 30 minutes.
The contents of the single-dose container can be divided to allow dosage adjustment.
A clear line is visible on the AIRCORT single-dose containers. When the single-dose container is
held upside down, the line indicates a volume equal to 1 ml. If only 1 ml is to be used, empty the
contents of the single-dose container until the surface of the liquid reaches the indicated line.
Before using the remaining liquid, carefully shake the contents with a rotating motion.

DOSAGE TABLE

* The medicine must be mixed with 0.9% saline solution until a volume of
2 ml is reached.

Use in children and adolescents
Bronchial Asthma

Children aged 6 months and over up to 12 years
The recommended total daily dose is 0.25 - 0.5 mg.
If a child is undergoing therapy with oral glucocorticosteroids, the doctor may decide to start with a
higher initial total daily dose, for example 1 mg.
The doctor will consider the highest dose (2mg per day) only in children with severe asthma
and for limited periods.

Subglottic laryngitis (throat obstruction)
The recommended dose is 2 mg of AIRCORT, which can be given with a single administration
or with two administrations of 1 mg 30 minutes apart. The dosage may
be repeated every 12 hours for a maximum of 36 hours or until clinical improvement.
For children, it is recommended to use a tight-fitting and well-adhering facial mask, capable of
optimizing the dose of budesonide administered.

INSTRUCTIONS FOR CORRECT USE OF AIRCORT

Notes:
The nebulization time and the amount of medicine delivered by a nebulizer depend on the
flow rate of the compressor and the filling volume.
Due to the small amount of budesonide delivered, ultrasonic nebulizers should not
be used to administer AIRCORT.
Gently shake the vial with a rotating motion.
Hold the single-dose container in a vertical position and open by rotating the tab until the container opens.
Place the open end of the single-dose container well into the nebulizer reservoir and
press slowly.
Rinse your mouth with water after each administration to reduce the occurrence of
fungal infections (oral thrush).
If a facial mask is used, make sure the mask adheres well during
nebulization. After using the facial mask, wash your face with water to prevent
irritation.

Cleaning:
The nebulizer chamber should be cleaned after each administration. Wash the chamber
of the nebulizer and the mouthpiece or facial mask in warm tap water using a
mild detergent or follow the manufacturer's instructions. Rinse thoroughly and dry the chamber
by reconnecting it to the compressor and the inhaler.

If you take more AIRCORT than you should
An acute overdose with AIRCORT, even in high doses, should not cause clinical
problems.
If you accidentally take an excessive dose of AIRCORT, immediately inform your
doctor or go to the nearest hospital.

If you forget to take AIRCORT
Do not take a double dose to make up for a missed dose.

If you stop taking AIRCORT
If you have any doubts 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.
The following side effects have been observed:

Common(may affect less than 1 in 10 people)

• fungal infections in the mouth and throat (Candida in the oropharynx);
• nausea;
• cough, hoarseness, throat irritation.

Uncommon(may affect less than 1 in 100 people)

• blurred vision.

Rare(may affect less than 1 in 1,000 people)

• immediate or delayed hypersensitivity reactions including skin rashes with pustules, blisters and bubbles (rash), skin inflammation due to contact with certain substances (contact dermatitis), sudden appearance of itchy rash (urticaria), rapid swelling of the skin and mucous membranes (angioedema) and severe and sudden allergic reaction (anaphylactic reaction);
• suppression of the activity of a gland called the adrenal gland;
• restlessness, nervousness, depression, behavioral changes, sleep disorders, anxiety, psychomotor hyperactivity, aggression;
• bruising, skin striations.

Not known(frequency cannot be estimated based on available data)

• chronic damage to the optic nerve (glaucoma), loss of transparency of a part of the eye called the lens (cataract).

Rarely, through unknown mechanisms, medicines administered by inhalation can cause
bronchospasm.
To prevent irritation, the skin of the face should be washed with water after using the facial
mask.

Additional side effects in children and adolescents
Rare(may affect less than 1 in 1,000 people)

• growth retardation;
• psychomotor hyperactivity, aggression;
• bronchospasm with voice disorders (dysphonia and hoarseness).

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:
http://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 AIRCORT

Store at a temperature not exceeding 25°C in the original packaging to protect the
medicinal product from light.
After opening the aluminum sachet, the single-dose containers must be used within 3
months. After this time, any remaining product must be discarded.
After opening the aluminum sachet, unused single-dose containers must be
stored in the sachet, protected from light.
The opened single-dose container must be used within 12 hours. After this time, any remaining product
must be discarded.
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 pack after the words
“Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AIRCORT contains
AIRCORT0.25 mg/ml suspension for nebulisation

• The active ingredient is budesonide. 1 single-dose container contains 0.5 mg of budesonide.
• The other ingredients are: disodium edetate; sodium chloride; polysorbate 80; anhydrous citric acid; sodium citrate; water for injections.

AIRCORT0.5 mg/ml suspension for nebulisation

• The active ingredient is budesonide. 1 single-dose container contains 1 mg of budesonide.
• The other ingredients are: disodium edetate; sodium chloride; polysorbate 80; anhydrous citric acid; sodium citrate; water for injections.

Description of the appearance of AIRCORT and contents of the pack
Suspension for nebulisation.
Each pack contains 20 single-dose containers divided into strips of 5 units contained in an
aluminium pouch.

Marketing Authorisation Holder
Italchimici SpA - Via Pontina 5, km 29 - 00071 Pomezia (Rome)

Manufacturer:
Genetic SpA Contrada Canfora 84084 Fisciano (SA)

AIRCORT 200 micrograms/dose, Pressurized Suspension for inhalation, 400 micrograms/dose, Pressurized Suspension for inhalation

Budesonide

Read this leaflet carefully before you start using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is AIRCORT and what is it used for?

AIRCORT contains the active ingredient budesonide, which belongs to a group of medicines
called corticosteroids, used to relieve inflammation and allergies.
This medicine is indicated in adults and children from 6 years of age for the treatment of
bronchial asthma.

2. What you need to know before you use AIRCORT

Do not use AIRCORT

• if you are allergic to budesonide or to any of the other ingredients of this medicine (listed in section 6);
• if you have a type of respiratory infection called pulmonary tuberculosis;
• if you have a respiratory infection caused by bacteria, viruses or fungi.

Warnings and precautions
Talk to your doctor or pharmacist before using AIRCORT.
Use AIRCORT regularly at the doses prescribed by your doctor and for as long as your doctor considers necessary.
Do not use AIRCORT for the treatment of acute asthma episodes. In these cases your doctor will prescribe
a suitable medicine (short-acting inhaled bronchodilator). Also, if you do not experience
benefit from the use of short-acting bronchodilators or if you have to increase the number of
inhalations compared to normal, your doctor will assess the need to increase the doses of budesonide for
inhalation or establish a therapy with similar medicines (glucocorticosteroids) taken orally.
Use AIRCORT with particular caution:

• if you have lesions in the stomach or intestine (ulcer affecting the digestive tract). In this case, your doctor will monitor you closely during treatment;
• if you suffer from liver problems (reduced liver function), as this may increase the levels of budesonide in the blood;
• if you have a respiratory infection that is still evident, called quiescent pulmonary tuberculosis;
• if you suffer from respiratory infections caused by fungi or viruses;
• if you have an infection caused by a virus (chickenpox, measles);
• if you have eye problems (glaucoma, cataracts).

Pay particular attention if you need to switch from therapy with medicines similar to budesonide
used orally (systemic glucocorticosteroid therapy) to therapy with AIRCORT, as the
risk of adrenal gland problems (adrenal insufficiency) may persist for a long
time (See section “How to use AIRCORT”).
You may experience adrenal gland problems (adrenal insufficiency) even if you have
been treated with emergency doses of similar medicines orally
(systemic corticosteroids) or if you have taken high doses of similar medicines for
inhalation for a long time, especially if you are under severe stress.
Tell your doctor if you are in a stressful condition or if you are to undergo major
surgery, as they may prescribe you additional therapy with similar medicines
used orally (systemic corticosteroid) (See section “How to use AIRCORT”).
During the discontinuation of oral therapy (systemic glucocorticosteroid therapy),
general malaise such as muscle and joint pain may occur. If you experience
fatigue, headache, nausea and vomiting, tell your doctor as it may be
necessary to temporarily increase the medicine (corticosteroid) taken orally.
After switching to treatment with AIRCORT, symptoms that had
disappeared with the previous oral treatment (systemic steroid treatment) such as symptoms of
allergies, inflammation of the nasal mucosa (rhinitis), skin irritations (eczema) may reappear. In this case, consult your doctor who will prescribe you appropriate therapy (antihistamines and/or topical preparations) to control these symptoms.
Avoid using AIRCORT together with the following medicines:

• ketoconazole, itraconazole, medicines used to treat fungal infections;
• HIV protease inhibitors, medicines used to treat AIDS;
• other medicines that increase the amount of budesonide in the blood (potent CYP3A4 inhibitors). If the combination with these medicines is necessary, allow as much time as possible to pass between taking these medicines and using AIRCORT (See section “Other medicines and AIRCORT”).

If a fungal infection of the mouth (oral candidiasis) occurs during treatment with AIRCORT,
tell your doctor who will prescribe you appropriate therapy (antifungal) and, if
necessary, they may decide to interrupt the treatment (See section “How to use
AIRCORT”).
During treatment with this medicine, especially at high doses and for prolonged periods, both local and especially widespread effects throughout the body (systemic) can occur (See section “Possible side effects”), which include:

• typical symptoms of Cushing's syndrome, such as increased hair growth (hirsutism), hair loss, irregular menstrual cycles in women, loss of muscle tone, irritability, fatigue and difficulty concentrating;
• typical symptoms of Cushingoid appearance such as sudden weight gain, especially localized to the abdomen (trunk obesity), rounding and redness of the face, the appearance of a slight hump;
• decreased activity of a gland called the adrenal gland (adrenal suppression);
• delayed growth in children and adolescents (See section “Children and adolescents”);
• reduction of mineral substances in the bones (reduction of bone mineral density);
• eye problems (onset of increased intraocular pressure, cataracts or glaucoma);
• behavioral disorders, more rarely, such as increased mental activity and behaviors (psychomotor hyperactivity), sleep disturbances, anxiety, depression, aggression, especially in children.

Stop treatment immediately and tell your doctor if, after administering
AIRCORT, you experience constriction of the airways (paradoxical bronchospasm) and increased
difficulty breathing (wheezing dyspnea). In this case, the doctor will need to carefully assess
your condition and possibly start alternative therapy.
Tell your doctor if you are using this medicine before undergoing a test to diagnose
a possible hormonal problem (ACTH stimulation test for the diagnosis of hypopituitarism) because AIRCORT can falsify the results (low values).
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
Use this medicine with caution in children.
If you use AIRCORT or similar medicines (inhaled corticosteroids) for a long time in
children, the doctor will need to regularly monitor their height growth.
If the child's growth is slowed down, the doctor will need to reduce the dose of AIRCORT, carefully assess
the benefits of treatment and the possible risk of growth suppression and
advise you to consult a specialist doctor (pediatric pulmonologist).

Other medicines and AIRCORT
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained without a prescription.
Avoid using AIRCORT together with the following medicines as they may increase the systemic effects of budesonide and your doctor may want to monitor you closely:

• ketoconazole, itraconazole, medicines used to treat fungal infections;
• HIV protease inhibitors, medicines used to treat AIDS (ritonavir, cobicistat);
• other medicines that increase the amount of budesonide in the blood (potent CYP3A4 inhibitors). If the combination with these medicines is necessary, allow as much time as possible to pass between taking these medicines and using AIRCORT. Your doctor may eventually decide to reduce the dose of AIRCORT (See section “Warnings and precautions”).

Tell your doctor if you are using other medicines, such as:

• cimetidine, a medicine used to treat high stomach acidity
• estrogens and hormones used in birth control pills as in these cases the amount of budesonide in the blood increases with the resulting effects on the body.

No effects have been observed with the use of budesonide and the concomitant use of
low-dose oral contraceptives.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant, use AIRCORT only if absolutely necessary and under the direct supervision of
your doctor.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

AIRCORT contains ethanol
This medicine contains small amounts of ethanol (alcohol) less than 100 mg per dose.

3. How to use AIRCORT

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Read carefully the following instructions before using AIRCORT:

• shake the canister well and remove the protective cap (figure 1);
• exhale slowly from your lungs (breathe out). Bring the canister to your mouth and close your lips around the mouthpiece, keeping the canister between your fingers (figure 2);
• inhale slowly and deeply through the mouthpiece, firmly pressing the canister between your fingers until a dose of the product is released, continuing to inhale (figure 3);
• remove the canister from your mouth and hold your breath for a few seconds before exhaling from your lungs (figure 4);
• reapply the protective cap.

If you perform the maneuver correctly, the medicine will be effective.
Do not exhale from your lungs through the mouthpiece.
Remember to always reapply the protective cap.
Rinse your mouth with water after inhalation to reduce the risk of infections in the mouth or throat caused by fungi (oral candidiasis) (See the paragraph “Warnings and
precautions”).
The dose will be established by your doctor based on the severity of your condition and the stage of therapy.
The recommended initial dose is 200 micrograms (1 actuation), 2-4 times a day, if you suffer from severe asthma
or if you are in the phase of reducing or stopping treatment with similar medicines taken by mouth (oral corticosteroid therapy).
The maintenance dose is generally 200 micrograms (1 actuation) per day. However, the doctor will establish
the maintenance dose based on the individual case and will prescribe the minimum dose sufficient to eliminate the
symptoms to reduce the risk of widespread (systemic) side effects (See the paragraphs “Warnings and
precautions” and “Possible side effects”).
The medicine begins to be effective within 24 hours of starting treatment.
To obtain the maximum effect, 1-2 weeks or more of treatment are necessary.

Use in patients not treated with similar medicines (corticosteroids)
If you have not taken medicines similar to budesonide (corticosteroids) before starting treatment with
AIRCORT, the effect manifests within 10 days of starting therapy.
If you experience an increase in mucus production in the bronchi, which may hinder the penetration of the active
ingredient into the mucosa, your doctor may prescribe, in association with AIRCORT, a short treatment of
about 2 weeks with a medicine similar to budesonide taken by mouth (oral corticosteroid treatment). Subsequently, the doctor will gradually reduce the dose of medicine taken by mouth until
continuing therapy only with AIRCORT.
If a worsening (exacerbation) of asthma occurs following infections caused by bacteria, your doctor will prescribe a therapy with medicines for the treatment of infections (antibiotics) and increase the dose of
AIRCORT.

Use in patients treated with similar medicines taken by mouth (oral corticosteroids)
If you have to switch from therapy with medicines similar to budesonide taken by mouth (oral corticosteroid
therapy) to treatment with AIRCORT, you can start therapy with AIRCORT when your symptoms are under
control, as long-term treatment with corticosteroids taken by mouth can cause
problems at the level of the nervous and hormonal system that slowly return to normal (slow recovery
of hypothalamic functions) (See the paragraph “Warnings and precautions”).
In this case, the doctor must associate the treatment with AIRCORT with the therapy with
corticosteroids taken by mouth (oral therapy) for about 10 days and then reduce the dose until the minimum
dose necessary to control the symptoms or, if possible, suspend the treatment by mouth completely.
Sometimes, when switching from oral therapy to treatment with AIRCORT, a reduction may occur
of the effect of the medicine on the body (systemic steroid effect) and the following symptoms may appear:
inflammation of the nasal mucosa (rhinitis), skin irritation (eczema), headache,
muscle and/or joint pain, fatigue, depression, nausea and vomiting. Sometimes an
improvement in lung function may also occur. In these cases, the doctor will decide whether it is necessary or not
to maintain the therapy with AIRCORT.
Treatment with AIRCORT may be associated with a short-term therapy with similar medicines
(corticosteroids) taken by mouth (oral route) if you are in a state of stress due to severe infections,
trauma or surgery or if asthma worsens and is associated with increased mucus consistency.

Use in children over 6 years of age
The recommended dose is 200 micrograms (1 actuation) per day.
If necessary, the dose can be doubled.
If a worsening (exacerbation) occurs, the doctor will increase the dose.

If you use more AIRCORT than you should
The use of excessive amounts of AIRCORT is very unlikely and does not cause serious problems
to health.
In case of accidental ingestion/intake of AIRCORT, contact your doctor or go
immediately to the nearest hospital.

If you forget to use AIRCORT
Do not use a double dose to make up for the missed dose.

If you stop using AIRCORT
Discontinue treatment with AIRCORT gradually according to your doctor's prescription.
If you have any doubts about the use of 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.
The following side effects may occur:

Common(may affect less than 1 in 10 people)

• mouth and throat (oropharynx) infections caused by fungi ( Candida);
• nausea;
• cough, altered voice (hoarseness), throat irritation.

Uncommon(may affect less than 1 in 100 people)

• blurred vision.

Rare(may affect less than 1 in 1,000 people)

• allergic reactions, including delayed reactions (immediate or delayed hypersensitivity) including skin irritation (rash, contact dermatitis, urticaria), swelling of the face, lips, mouth, tongue or throat due to fluid retention which can cause difficulty swallowing and breathing (angioedema);
• severe allergic reactions (anaphylactic reactions);
• decreased activity of the adrenal gland (adrenal suppression) and growth delay (symptoms of systemic corticosteroid effects) (See section “Warnings and precautions”);
• restlessness, nervousness, depression, behavioral disorders (especially in children), sleep disorders, anxiety, increased mental activity and behaviors (psychomotor hyperactivity), aggression;
• difficulty breathing (bronchospasm);
• bruising (ecchymosis), reddish stretch marks on the skin (striae cutaneae).

Frequency not known(the frequency of which cannot be estimated based on available data)

• eye problems (cataract, glaucoma);
• lung inflammation (pneumonia), especially if you have lung problems (chronic obstructive pulmonary disease (COPD)).

Additional side effects in children and adolescents
Rare(may affect less than 1 in 1,000 people)

• altered voice (dysphonia, hoarseness).

In children and adolescents, the use of AIRCORT at high doses and/or for prolonged periods may
lead to widespread effects throughout the body (systemic) such as growth delay
(See section “Children and adolescents”).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly through the national reporting
system at
http://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 AIRCORT

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 pack after “Scad”. The
expiry date refers to the last day of that month.
Store at temperatures not exceeding 25°C.
Do not puncture the canister and do not expose it to sources of heat or direct light.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AIRCORT contains

• The active ingredient is budesonide. A pressurised container contains 40 mg of budesonide.
• The other ingredients are: oleic acid, anhydrous ethanol, 1,1,1,2-tetrafluoroethane (HFA 134a).

Description of the appearance of AIRCORT and contents of the pack
AIRCORT 200 micrograms/dose, Pressurised Suspension for inhalation
Pack of 1 pressurised container (canister) equipped with a 50 microlitre dosing valve and containing 200 doses of 200 micrograms.

AIRCORT 400 micrograms/dose, Pressurised Suspension for inhalation
Pack of 1 pressurised container (canister) equipped with a 100 microlitre dosing valve and containing 100 doses of 400 micrograms.

Marketing Authorisation Holder
ITALCHIMICI S.p.A. – Via Pontina 5, km 29 – 00071 Pomezia (RM) – Italy

Manufacturers
Laboratorio Aldo-Union, S.A. – Carrer de la Barobessa de Maldà, 73 – 08950 Esplugues de
Llobregat – Barcelona – Spain
ITC Farma srl – Via Pontina 5, km 29 – 00071 Pomezia (RM) – Italy

AIRCORT 100 micrograms nasal spray, suspension, 50 micrograms nasal spray, suspension

Budesonide

Read this leaflet carefully before you start using this medicine as it contains important information for you.

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

Contents of this leaflet:

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

1. What is AIRCORT and what is it used for

AIRCORT contains the active ingredient budesonide, which belongs to a group of medicines
called corticosteroids, used to relieve inflammation and allergies.
This medicine is indicated:

• in case of irritation and inflammation of the nasal mucosa, seasonal or persistent (seasonal rhinitis, perennial rhinitis) of both allergic and non-allergic type;
• for the treatment of a nasal disorder called nasal polyposis, characterized by the formation of growths (nasal polyps) or to prevent this disorder from recurring after undergoing a specific operation (polypectomy).

2. What you need to know before using AIRCORT

Do not use AIRCORT

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

Warnings and precautions
Talk to your doctor or pharmacist before using AIRCORT.
Use AIRCORT regularly at the doses prescribed by your doctor and for as long as your doctor considers necessary.
During treatment with this medicine, especially at high doses and for prolonged periods, local and especially widespread effects throughout the body (systemic) can occur (See the section “Possible side effects”), which include:

• symptoms typical of Cushing's syndrome, such as increased hair growth (hirsutism), hair loss, irregular menstrual cycles in women, loss of muscle tone, irritability, fatigue and difficulty concentrating;
• symptoms typical of Cushingoid appearance such as sudden weight gain, especially localized to the abdomen (trunk obesity), rounding and redness of the face, the appearance of a slight hump;
• decreased activity of a gland called the adrenal gland (adrenal suppression);
• delayed growth in children and adolescents (See the section “Children and adolescents”);
• reduction of mineral substances in the bones (reduction of bone mineral density);
• problems with the eyes (development of increased intraocular pressure, cataracts or glaucoma);
• behavioral disorders, more rarely, such as increased mental activity and behaviors (psychomotor hyperactivity), sleep disturbances, anxiety, depression, aggression, especially in children.

Use AIRCORT with particular caution:

• if you suffer from liver problems (reduced liver function), as they may increase the levels of budesonide in the blood;
• if you have a respiratory infection called tuberculosis;
• if you suffer from respiratory infections caused by fungi or viruses.

Pay particular attention if you need to switch from therapy with medicines similar to budesonide used orally (systemic glucocorticosteroid therapy) to therapy with AIRCORT, as the risk of adrenal gland problems (adrenal insufficiency) may persist for a long time (See the section “How to use AIRCORT”). The dose of the medicine taken by mouth must be reduced gradually.
Avoid using AIRCORT if you have lesions of the nasal septum (nasal septal ulcers), if you have undergone nasal surgery or if you have suffered nasal trauma.
Tell your doctor that you are using this medicine before undergoing a test to diagnose a possible hormonal problem (ACTH stimulation test for the diagnosis of pituitary insufficiency) because AIRCORT may falsify the results (low values).
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
Use this medicine with caution in children.
If you use AIRCORT or similar medicines (inhaled or other route corticosteroids) for a long time in children, the doctor will need to regularly monitor their height growth.
The doctor will carefully assess the benefits of treatment and the possible risk of growth suppression. Long-term treatments are not recommended in children.

Other medicines and AIRCORT
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Tell your doctor if you are using other medicines, such as:

• cimetidine, a medicine used to treat high stomach acidity
• estrogens and hormones used in contraceptive pills because in these cases the amount of budesonide in the blood increases with consequent effects on the body. No effect has been observed with the use of budesonide and the concomitant use of low-dose oral contraceptives.

Avoid using AIRCORT together with the following medicines as they may increase the widespread effects throughout the body (systemic) of budesonide and your doctor may want to keep you under close observation:

• ketoconazole, itraconazole, medicines used to treat fungal infections;
• other medicines that increase the amount of budesonide in the blood (potent CYP3A4 inhibitors);
• some medicines for the treatment of HIV: ritonavir, cobicistat. If the association with these medicines is necessary, allow as much time as possible to pass between taking these medicines and using AIRCORT. Eventually, the doctor may decide to reduce the dose of AIRCORT (See the section “Warnings and precautions”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant, use AIRCORT only if absolutely necessary and under the direct control of your doctor.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles or operate machinery.

3. How to use AIRCORT

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The doctor must establish the dose individually.

Treatment of inflammation of the nasal mucosa (rhinitis)
Use in adults and children over 6 years of age.
The recommended dose is 2 administrations of 50 micrograms per nostril (100 micrograms) 2
times a day, morning and evening, or 2 administrations of 100 micrograms per nostril (200
micrograms) 1 time a day, in the morning.

Treatment and prevention of nasal polyposis
The recommended dose is 200 micrograms 2 times a day (100 micrograms per nostril).

Instructions for use
Follow the instructions carefully before each administration of AIRCORT:

• shake the bottle well;
• remove the protective cap of the nasal applicator by gently rotating it;
• hold the bottle in a vertical position and away from your face, activate the metering valve by firmly squeezing the bottle between your fingers until a fine spray is obtained. Subsequently, the valve remains activated unless the bottle is disassembled or used very infrequently (Figure 1);
• gently blow your nose before administering AIRCORT to clear your nostrils;
• slightly tilt your head, close one nostril with a finger, gently insert the nasal applicator into the other nostril and press upwards on the bottom of the bottle until a fine spray is obtained (Figure 2);
• move the bottle away from your nose and keep your head tilted back to allow the medicine to spread. Repeat this operation for the other nostril;
• reapply the protective cap.

WARNING:
Use the medicine within 3 months of opening the bottle.
In case of blockage, remove the applicator from the bottle and rinse it in warm water for a few
minutes (Figure 3).Do not use sharp objects to remove the obstruction from the applicator.
The effect of the medicine is achieved only after a few days of treatment, in rare cases not
before two weeks. If you need to use this medicine for the treatment of rhinitis, start the
treatment before exposure to allergens. To control the symptoms of eye irritation
your doctor may advise you to take treatment with other medicines to be taken together with AIRCORT
(antihistamines).
If you experience a feeling of nasal congestion during the first 2-3 days of treatment, your doctor may advise you
to take a medicine to clear the nasal passages (nasal vasoconstrictors).

If you use more AIRCORTthan you should
The use of excessive amounts of AIRCORT is very unlikely and does not cause serious health
problems.
In case of ingestion/accidental intake of AIRCORT, contact your doctor or go
immediately to the nearest hospital.

If you forget to use AIRCORT
Do not use a double dose to make up for a missed dose.

If you stop using AIRCORT
Discontinue treatment with AIRCORT gradually as prescribed by your doctor.
If you have any doubts about 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.
The following side effects may occur, particularly with prolonged use:

Common(may affect less than 1 in 10 people)

• nosebleeds (epistaxis and/or haemorrhagic secretion) and nasal irritation.

Uncommon(may affect less than 1 in 100 people)

• allergic reactions, including delayed ones (immediate or delayed hypersensitivity) including skin irritation (rash, contact dermatitis, urticaria), swelling of the face, lips, mouth, tongue or throat due to fluid accumulation which can cause difficulty swallowing and breathing (angioedema).

Rare(may affect less than 1 in 1,000 people)

• decreased activity of the adrenal gland (adrenal suppression) and growth delay (symptoms of systemic corticosteroid effects) (See section “Warnings and precautions”);
• blurred vision.

Very rare(may affect less than 1 in 10,000 people)

• severe allergic reactions (anaphylactic reactions);
• formation of lesions in the nasal mucosa and perforation of the nasal septum.

Frequency not known(the frequency of which cannot be estimated based on available data)

• eye problems (cataract, glaucoma).

Additional side effects in children and adolescents
Frequency not known(the frequency of which cannot be estimated based on available data)

• growth delay (See section “Children and adolescents”).

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
http://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 AIRCORT

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Scad”. The
expiry date refers to the last day of that month.
Store in the original container at a temperature below 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What AIRCORT contains
AIRCORT 100 micrograms nasal spray, suspension

• The active ingredient is budesonide. One ml of suspension contains 2 mg of budesonide.
• The other ingredients are: microcrystalline cellulose/sodium carboxymethylcellulose, hydroxypropylmethylcellulose, sodium lauryl sulfate, polyethylene glycol 400, butylated hydroxyanisole, sodium citrate, citric acid monohydrate, potassium sorbate, disodium edetate, purified water.

AIRCORT 50 micrograms nasal spray, suspension

• The active ingredient is budesonide. One ml of suspension contains 1 mg of budesonide.
• The other ingredients are: microcrystalline cellulose/sodium carboxymethylcellulose, hydroxypropylmethylcellulose, sodium lauryl sulfate, polyethylene glycol 400, butylated hydroxyanisole, sodium citrate, citric acid monohydrate, potassium sorbate, disodium edetate, purified water.

Description of the appearance of AIRCORTand contents of the pack
Pack of 1 spray bottle equipped with a 50 microlitre metering valve containing 200
sprays.

Marketing Authorisation Holder
ITALCHIMICI S.p.A. – Via Pontina 5, km 29 – 00071 Pomezia (RM) – Italy

Manufacturer
ITC Farma srl – Via Pontina 5, km 29 – 00071 Pomezia (RM) – Italy