Aircort

Package leaflet: Information for the patient

AIRCORT 0.25 mg/ml nebulising suspension, 0.5 mg/ml nebulising suspension

Budesonide
Generic medicine
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
• 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, consult 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 using 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 AIRCORT is and what it is used for

AIRCORT contains the active substance budesonide.
AIRCORT belongs to a group of medicines called glucocorticosteroids, which are hormones that perform numerous functions, with an important role in controlling inflammation.
AIRCORT is indicated for the treatment of the following conditions:

• an inflammatory disease characterized by obstruction of the bronchi (bronchial asthma);
• a disease characterized by obstruction of the throat (larynx) that makes it difficult for air to pass through, for which hospitalization is indicated (severe laryngitis with supraglottic involvement (pseudocroup)).

2. What you should know before taking AIRCORT

Do not take AIRCORT

• if you are allergic to the active substance 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 concurrently taking ketoconazole (a medicine used to treat fungal diseases) or HIV protease inhibitors (medicines for the treatment of AIDS) or other inhibitors of cytochrome CYP3A4 (an enzyme mainly involved in drug metabolism);
• you have active or quiescent pulmonary tuberculosis or fungal or viral respiratory tract infections;
• you have fungal or viral infections (such as measles and chickenpox);
• you have glaucoma (characterized by chronic damage to the optic nerve) and cataract (loss of transparency of a part of the eye called the lens).

AIRCORT does not provide rapid relief of sudden (acute) asthma attacks, for which other types of medicines such as short-acting bronchodilators are required.
Your doctor must carefully evaluate whether you have not benefited from the use of short-acting bronchodilators; in such a case, your doctor may decide to increase the number of budesonide inhalations compared to the usual dose or initiate oral glucocorticosteroid therapy.
In these two cases, your doctor must carefully evaluate the possible risks of impairment and/or insufficiency of a gland called the adrenal gland. Your doctor must carefully evaluate stopping oral glucocorticosteroid treatment, as rare cases of general malaise may occur, such as muscle and joint pain, fatigue, headache (cephalalgia), depression, nausea and vomiting, even though there may be improvement in lung function.
Switching from systemic glucocorticosteroid treatment (affecting the whole body) to inhaled therapy may sometimes unmask allergies, such as inflammation of the nose (rhinitis) and skin (eczema).
During inhaled therapy, a fungal disease called oral candidiasis may occur. 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”).
With long-term treatment using high doses of AIRCORT, local and systemic effects may occur (Cushing's syndrome, Cushingoid appearance, adrenal suppression, reduced bone mineral density, cataract, glaucoma, and rarely psychological and behavioral effects including psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioral disturbances).
Once asthma control has been achieved, your doctor will prescribe the lowest effective maintenance dose.
Do not increase or decrease the dose without first consulting your doctor.
As with other inhaled therapies, you may experience bronchoconstriction (paradoxical bronchospasm), with immediate worsening of breathing difficulty (wheezing dyspnea) after administration. In this case, you must immediately stop inhaled budesonide treatment and your doctor will assess the situation and consider alternative therapy if necessary.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
AIRCORT should be used with caution in children.
Effect on growth
Height should be monitored periodically if your child is undergoing prolonged treatment with inhaled glucocorticosteroids. If growth is slowed, your doctor will evaluate whether to reduce the dose of the medicine. The benefits of therapy and the potential risk of growth suppression must be carefully evaluated by the doctor, who may refer the child to a pediatric pulmonologist.
With long-term treatment using high doses of AIRCORT, behavioral 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 those obtained without a prescription.
No interactions between budesonide and any other medicines used in asthma treatment have been observed.
You should avoid taking the following medicines at the same time or leave as long an interval as possible between treatments:

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

Some medicines may increase the effects of AIRCORT, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
.
Inform your doctor if you are using other medicines, such as:

• cimetidine, a medicine used to treat high stomach acidity;
• estrogens and hormones used in oral contraceptives, as these may increase the amount of budesonide in the blood and consequently its systemic effects. No effect has been observed with the use of budesonide and concomitant intake of low-dose oral contraceptives.

AIRCORT may alter the results of certain laboratory tests used to diagnose insufficient activity of a gland called the pituitary gland (ACTH stimulation test to diagnose possible pituitary insufficiency may yield falsely low values).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Inhaled budesonide has not shown any negative effects on fetal/neonatal health during pregnancy.
Your doctor will evaluate the expected benefits for you against the potential risks for the fetus.

Breastfeeding
Budesonide may pass into breast milk. At therapeutic doses of AIRCORT, effects on the breastfed infant are not expected. Budesonide may be used during breastfeeding.

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

3. How to take AIRCORT

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Bronchial asthma
Adults and elderly
Initial dose: The dosage of AIRCORT is individual.
The recommended initial dose is 0.5–1 mg twice daily. In cases where a greater therapeutic effect is required, higher doses of AIRCORT may be prescribed.
Maintenance dose: The maintenance dose is individual. Once the desired clinical results have been achieved, your doctor will reduce the dose to the lowest amount necessary to control symptoms.
Onset of effect:
Improvement in asthma control following administration of AIRCORT may occur within three days of starting treatment, although maximum benefit is usually achieved after 2–4 weeks.
Patients treated with oral glucocorticosteroids (see section “Warnings and Precautions”)
AIRCORT may allow replacement or significant reduction of orally administered glucocorticosteroid dosage while maintaining asthma control.
Your doctor will determine how to switch from oral glucocorticosteroid therapy to treatment with AIRCORT nebulizer suspension.
Dose division and mixing
Your doctor may instruct you to mix AIRCORT with 0.9% sodium chloride solution and with other solutions containing medicines acting on the respiratory system, such as terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglicate, or ipratropium bromide.
The mixture must be used within 30 minutes.
The content of the single-dose container may be divided to allow dose adjustment.
On the single-dose containers of AIRCORT, a clearly visible line is present. When the single-dose container is held upside down, the line indicates a volume of 1 ml. If only 1 ml is to be used, empty the container until the liquid surface reaches the marked line.
Before using the remaining liquid, carefully mix the contents with a rotating motion.
DOSAGE TABLE

* The medicinal product must be mixed with 0.9% sodium chloride solution to reach a volume of 2 ml.
Use in children and adolescents
Bronchial asthma
Children aged 6 months and older up to 12 years
The recommended total daily dose is 0.25 - 0.5 mg.
If your child is being treated 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 higher dose (2 mg 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 administered as a single dose or as two 1 mg doses given 30 minutes apart. The dosing may be repeated every 12 hours for up to 36 hours or until clinical improvement occurs.
For children, it is recommended to use a well-fitting, airtight facial mask capable of optimizing the delivered dose of budesonide.
INSTRUCTIONS FOR THE CORRECT USE OF AIRCORT
Notes:
The nebulization time and the amount of medicinal product delivered by a nebulizer depend on the compressor flow rate and the filling volume.
Due to the small amount of budesonide delivered, ultrasonic nebulizers should not be used for administering AIRCORT.
Gently shake the vial with a rotational movement.
Hold the single-dose container in an upright position and open it by twisting the tab until the container opens.
Place the open end of the single-dose container well into the nebulizer reservoir and press slowly.
Rinse the mouth with water after each administration to reduce the occurrence of fungal infections (oropharyngeal candidiasis).
If a facial mask is used, ensure that the mask fits properly during nebulization. After using the facial mask, wash the face with water to prevent irritation.
Cleaning:
The nebulizer chamber should be cleaned after each administration. Wash the nebulizer chamber and mouthpiece or facial mask with 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 inhaler.
If you take more AIRCORT than you should
Acute overdosage with AIRCORT, even at high doses, should not cause clinical problems.
In case of accidental ingestion of an excessive dose of AIRCORT, contact your doctor immediately or go to the nearest hospital.
If you forget to take AIRCORT
Do not take a double dose to make up for the forgotten dose.
If you stop treatment with AIRCORT
If you have any doubts about the use of this medicinal product, 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 up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• blurred vision.

Rare (may affect up to 1 in 1,000 people)

• immediate or delayed hypersensitivity reactions including pustular, vesicular or bullous skin rashes (rash), skin inflammation due to contact with certain substances (contact dermatitis), sudden onset of more or less itchy skin 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, behavioural changes, sleep disturbances, anxiety, psychomotor hyperactivity, aggression;
• bruising, skin streaking.

Not known (frequency cannot be estimated from the available data)

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

Rarely, due to unknown mechanisms, medicines administered by inhalation may cause bronchospasm.
To prevent irritation, the facial skin should be washed with water after using the face mask.
Following the instructions provided in the package leaflet reduces the risk of side effects.
Additional side effects in children and adolescents
Rare (may affect up to 1 in 1,000 people)

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

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:
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 medicine from light.
After opening the aluminium foil pouch, the single-dose containers must be used within 3 months. Any remaining product should be discarded after this period.
After opening the aluminium foil pouch, unused single-dose containers must be stored inside the pouch, protected from light.
An opened single-dose container must be used within 12 hours. Any remaining product should be discarded after this time.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after the word “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What AIRCORT contains
AIRCORT 0.25 mg/ml nebulizing suspension

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

AIRCORT 0.5 mg/ml nebulizing suspension

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

Description of the appearance of AIRCORT and the contents of the pack
Nebulizing suspension.
Each pack contains 20 single-dose containers divided into strips of 5 units contained in an aluminum foil pouch.
Marketing Authorization Holder
Italchimici SpA - Via Pontina 5, km 29 - 00071 Pomezia (Rome)
Manufacturer:
Genetic SpA Contrada Canfora 84084 Fisciano (SA)

PACKAGE LEAFLET

Package leaflet: Information for the user

AIRCORT 200 micrograms/dose, Pressurized Inhalation Suspension, 400 micrograms/dose, Pressurized Inhalation Suspension

Budesonide
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
• 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 effect, including those not listed in this leaflet, consult 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 using 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 AIRCORT is and what it is used for

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

2. What you need to know before using 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 tract infection called pulmonary tuberculosis;
• if you have a respiratory tract 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 attacks. In such cases, your doctor will prescribe a suitable medicine (a short-acting inhaled bronchodilator). Furthermore, if you do not experience relief with short-acting bronchodilators or if you need to increase the number of inhalations beyond the usual amount, your doctor will assess whether it is necessary to increase the inhaled budesonide dose or initiate treatment with oral glucocorticosteroids.
Use AIRCORT with particular caution:

• if you have stomach or intestinal lesions (gastrointestinal ulcers). In this case, your doctor will closely monitor you during treatment;
• if you have liver problems (reduced liver function), as this may increase budesonide levels in the blood;
• if you have a latent respiratory infection known as quiescent pulmonary tuberculosis;
• if you suffer from respiratory tract infections caused by fungi or viruses;
• if you have a viral infection (such as chickenpox, measles);
• if you have eye problems (glaucoma, cataract).

Exercise particular caution if switching from treatment with systemic corticosteroid-like medicines taken orally (systemic glucocorticosteroid therapy) to treatment with AIRCORT, as the risk of adrenal gland problems (adrenal suppression) may persist for a long time (See section “How to use AIRCORT”).
You may experience adrenal gland problems (adrenal insufficiency) even if you have previously received emergency treatment with high doses of systemic corticosteroids taken orally or if you have used high doses of inhaled corticosteroids for a prolonged period, especially if you are under severe stress.
Inform your doctor if you are under stress or are about to undergo major surgery, as your doctor may prescribe additional systemic corticosteroid therapy (See section “How to use AIRCORT”).
During the withdrawal phase of oral therapy (systemic steroid therapy), general malaise such as muscle and joint pain may occur. If you experience fatigue, headache (cephalalgia), nausea, and vomiting, inform your doctor, as a temporary increase in the dose of oral corticosteroid medicine may be necessary.
After switching to treatment with AIRCORT, symptoms previously suppressed by prior oral therapy (systemic steroid treatment) may reappear, such as allergy symptoms, inflammation of the nasal mucosa (rhinitis), or skin irritations (eczema). In such cases, consult your doctor, who will prescribe 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 (strong CYP3A4 inhibitors). If co-administration with these medicines is necessary, leave as much time as possible between taking these medicines and using AIRCORT (See section “Other medicines and AIRCORT”).

If, during treatment with AIRCORT, you develop a fungal infection of the mouth (oral candidiasis), inform your doctor, who will prescribe appropriate antifungal treatment and, if necessary, may decide to discontinue treatment (See section “How to use AIRCORT”).
During treatment with this medicine, especially at high doses and for prolonged periods, local effects and especially systemic effects may occur (See section “Possible side effects”), including:

• 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, particularly around the abdomen (truncal obesity), facial rounding and redness, and development of a slight hump;
• reduced activity of the adrenal glands (adrenal suppression);
• growth retardation in children and adolescents (See section “Children and adolescents”);
• reduced mineral content in bones (reduced bone mineral density);
• eye problems (onset of increased intraocular pressure, cataract, or glaucoma);
• behavioral disturbances, more rarely, such as increased mental and motor activity (psychomotor hyperactivity), sleep disturbances, anxiety, depression, aggression, especially in children.

Stop treatment immediately and inform your doctor if, after administration of AIRCORT, you experience airway constriction (paradoxical bronchospasm) and worsening breathing difficulties (wheezing dyspnea). In such cases, your doctor must carefully evaluate your condition and possibly initiate an alternative therapy.
Inform your doctor that you are using this medicine before undergoing a test for diagnosing possible hormonal disorders (ACTH stimulation test for diagnosing pituitary insufficiency), as AIRCORT may interfere with test results (low values).
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
Use this medicine cautiously in children.
If AIRCORT or similar medicines (inhaled corticosteroids) are used long-term in children, the doctor should regularly monitor the child’s height growth.
If a child’s growth is slowed, the doctor should reduce the dose of AIRCORT, carefully evaluate the benefits of treatment versus the potential risk of growth suppression, and advise you to consult a specialist (pediatric pulmonologist).
Other medicines and AIRCORT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Avoid using AIRCORT together with the following medicines, as they may increase systemic effects of budesonide, and your doctor may wish 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 budesonide blood levels (strong CYP3A4 inhibitors). If co-administration is necessary, leave as much time as possible between taking these medicines and using AIRCORT. Your doctor may consider reducing the dose of AIRCORT (See section “Warnings and precautions”).

Inform your doctor if you are taking other medicines, such as:

• cimetidine, a medicine used to treat high stomach acidity;
• estrogens and hormones used in oral contraceptives, as these may increase budesonide blood levels and thus its systemic effects.

No interaction has been observed between budesonide and concomitant use of low-dose oral contraceptives.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, use AIRCORT only when strictly necessary and under direct medical supervision.
Driving and using machines
This medicine does not affect the ability to drive vehicles 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 exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Read the following instructions carefully before using AIRCORT:

• shake the inhaler well and remove the protective cap (Figure 1);
• slowly breathe out (exhale) the air from your lungs. Place the inhaler in your mouth and close your lips around the mouthpiece, holding the inhaler between your fingers (Figure 2);
• inhale slowly and deeply through the mouthpiece, while pressing down firmly on the canister with your fingers to release a dose of the medicine, continuing to inhale (Figure 3);
• remove the inhaler from your mouth and hold your breath for a few seconds before breathing out (Figure 4);
• replace the protective cap.

If you perform the procedure correctly, the medicine will be effective.
Do not breathe out through the mouthpiece.
Remember to always replace the protective cap.
Rinse your mouth with water after inhalation to reduce the risk of fungal infections in the mouth or throat (oral oropharyngeal candidiasis) (See section “Warnings and precautions”).
The dose will be determined by your doctor according to the severity of your condition and the stage of treatment.
The recommended starting dose is 200 micrograms (1 puff), 2–4 times daily, if you have severe asthma
or are in the phase of tapering or stopping treatment with similar oral medications (oral corticosteroid therapy).
The usual maintenance dose is 200 micrograms (1 puff) per day. However, your doctor will determine the maintenance dose according to your individual needs and will prescribe the lowest effective dose required to control symptoms, in order to reduce the risk of widespread (systemic) side effects (See sections “Warnings and precautions” and “Possible side effects”).
The medicine begins to be effective within 24 hours of starting treatment.
Maximum benefit may require 1–2 weeks or more of treatment.
Use in patients not previously treated with similar medicines (corticosteroids)
If you have not previously taken medicines similar to budesonide (corticosteroids) before starting treatment with
AIRCORT, the effect will become apparent within 10 days of starting therapy.
If you have increased mucus production in the bronchi, which may hinder the penetration of the active substance into the mucosa, your doctor may prescribe, in addition to AIRCORT, a short-term treatment of about 2 weeks with an oral corticosteroid similar to budesonide. Subsequently, your doctor will gradually reduce the dose of the oral corticosteroid until continuing therapy with AIRCORT alone.
If your asthma worsens (exacerbation) due to bacterial infections, your doctor will prescribe treatment with antibiotics and may increase your dose of AIRCORT.
Use in patients previously treated with oral corticosteroids
If you are switching from oral corticosteroid therapy (e.g. corticosteroids similar to budesonide) to treatment with AIRCORT, you may start AIRCORT when your symptoms are under control, as long-term treatment with oral corticosteroids may affect the nervous and hormonal systems, which recover slowly (slow restoration of hypothalamic function) (See section “Warnings and precautions”).
In this case, your doctor should continue oral corticosteroid therapy alongside AIRCORT for approximately 10 days, then gradually reduce the oral dose to the lowest level needed to control symptoms or, if possible, discontinue oral therapy completely.
Occasionally, during the transition from oral therapy to AIRCORT, a reduction in the systemic steroid effect may occur, and the following symptoms may appear: inflammation of the nasal mucosa (rhinitis), skin irritation (eczema), headache (cephalalgia), muscle and/or joint pain, fatigue, depression, nausea, and vomiting. Sometimes, lung function may improve. In such cases, your doctor will decide whether continued treatment with AIRCORT is necessary.
Treatment with AIRCORT may be combined with a short course of oral corticosteroids if you are under stress due to severe infections, trauma, or surgery, or if your asthma worsens and is associated with increased mucus thickness.
Use in children over 6 years of age
The recommended dose is 200 micrograms (1 puff) per day.
If necessary, the dose may be doubled.
If your asthma worsens (exacerbation), your doctor will increase the dose.
If you use more AIRCORT than you should
It is very unlikely that excessive use of AIRCORT will cause serious health problems.
In case of accidental ingestion/overdose, contact your doctor or go immediately to the nearest hospital.
If you forget to use AIRCORT
Do not take a double dose to make up for the missed dose.
If you stop using AIRCORT
Stop treatment with AIRCORT gradually, as directed by your doctor.
If you have any doubts about how to use 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)

• fungal infections of the mouth and throat (oropharynx) ( Candida );
• nausea;
• cough, voice changes (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 accumulation which may cause difficulty in swallowing and breathing (angioedema);
• severe allergic reactions (anaphylactic reactions);
• decreased activity of the adrenal gland (adrenal suppression) and growth retardation (symptoms of systemic corticosteroid effects) (See section “Warnings and precautions”);
• restlessness, nervousness, depression, behavioural disorders (especially in children), sleep disorders, anxiety, increased mental and physical activity (psychomotor hyperactivity), aggression;
• difficulty in breathing (bronchospasm);
• bruising (ecchymosis), red-coloured skin stretch marks (cutaneous striae).

Frequency not known (cannot be estimated from the available data)

• eye problems (cataract, glaucoma);
• lung inflammation (pneumonia), particularly 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)

• voice changes (dysphonia, hoarseness).

In children and adolescents, the use of AIRCORT at high doses and/or for prolonged periods may lead to widespread systemic effects, such as growth retardation (See section “Children and adolescents”).
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
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 stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Store below 25°C.
Do not pierce the canister and do not expose it to heat sources or direct light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What AIRCORT contains

• The active substance is budesonide. A pressurized container contains 40 mg of budesonide.
• The other components 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, Pressurized Suspension for Inhalation
Pack containing 1 pressurized container (canister) equipped with a metering valve delivering 50
microliters and containing 200 doses of 200 micrograms.
AIRCORT 400 micrograms/dose, Pressurized Suspension for Inhalation
Pack containing 1 pressurized container (canister) equipped with a metering valve delivering 100
microliters and containing 100 doses of 400 micrograms.
Marketing Authorization 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

Package leaflet: Information for the user

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

Budesonide
Please read this leaflet carefully before 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 using 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 AIRCORT is and what it is used for

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

• for seasonal or persistent irritation and inflammation of the nasal mucosa (seasonal rhinitis, perennial rhinitis), both of allergic and non-allergic type;
• for the treatment of a nasal condition called nasal polyposis, characterized by the formation of growths (nasal polyps), or to prevent the recurrence of this condition after specific surgery (polypectomy).

2. What you should know before using 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).

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 it necessary.
During treatment with this medicine, especially at high doses and for prolonged periods, local effects and particularly systemic effects (affecting the whole body) may occur (see section "Possible side effects"), including:

• 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 around the abdomen (truncal obesity), rounding and reddening of the face, development of a slight hump;
• decreased activity of a gland called the adrenal gland (adrenal suppression);
• growth retardation in children and adolescents (see section "Children and adolescents");
• reduction of mineral content in the bones (reduced bone mineral density);
• eye problems (onset of increased intraocular pressure, cataract, or glaucoma);
• behavioral disturbances, more rarely, such as increased mental and motor activity (psychomotor hyperactivity), sleep disturbances, anxiety, depression, aggression, especially in children.

Use AIRCORT with particular caution:

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

Pay special attention if you are switching from treatment with oral medicines similar to budesonide (systemic glucocorticosteroid therapy) to treatment with AIRCORT, as the risk of adrenal gland problems (adrenal insufficiency) may persist for a long time (see section "How to use AIRCORT"). The dose of the oral medicine must be reduced gradually.
Avoid using AIRCORT if you have nasal septum lesions (nasal septum ulcers), if you have undergone nasal surgery, or if you have experienced nasal trauma.
Inform your doctor that you are using this medicine before undergoing a test for diagnosing a possible hormonal disorder (ACTH stimulation test for diagnosing pituitary insufficiency), as AIRCORT may interfere with test 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 AIRCORT or similar medicines (inhaled or other route corticosteroids) are used long-term in children, the doctor should regularly monitor their height growth.
The doctor must carefully evaluate the benefits of treatment against the potential risk of growth suppression. Long-term treatments are not recommended in children.
Other medicines and AIRCORT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Inform your doctor if you are taking other medicines such as:

• cimetidine, a medicine used to treat high stomach acidity;
• estrogens and hormones used in oral contraceptives, as these may increase the amount of budesonide in the blood and consequently its systemic effects. No interaction has been observed with the use of budesonide and concomitant use of low-dose oral contraceptives.

Avoid using AIRCORT together with the following medicines, as they may increase the systemic effects of budesonide and your doctor may wish to monitor you closely:

• ketoconazole, itraconazole, medicines used to treat fungal infections;
• other medicines that increase budesonide levels in the blood (strong CYP3A4 inhibitors);
• some medicines used to treat HIV: ritonavir, cobicistat. If co-administration with these medicines is necessary, leave as much time as possible between taking these medicines and using AIRCORT. Your doctor may decide to reduce the dose of AIRCORT (see section "Warnings and precautions").

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant, use AIRCORT only if absolutely necessary and under direct medical supervision.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.

3. How to use AIRCORT

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose for you individually.

Treatment of nasal mucosal inflammation (rhinitis)
Use in adults and children over 6 years of age.
The recommended dose is 2 sprays of 50 micrograms per nostril (100 micrograms total) twice daily, in the morning and evening, or 2 sprays of 100 micrograms per nostril (200 micrograms total) once daily in the morning.

Treatment and prevention of nasal polyposis
The recommended dose is 200 micrograms twice daily (100 micrograms per nostril).

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

• Shake the bottle well;
• Remove the protective cap from the nasal applicator by gently twisting it off;
• Hold the bottle upright and away from the face, prime the metering valve by firmly pressing the bottle with your fingers until a fine mist is produced. The valve remains primed unless the bottle is disassembled or used very infrequently (Figure 1);
• Gently blow your nose before administering AIRCORT to clear the nostrils;
• Tilt your head slightly forward, close one nostril with a finger, gently insert the nasal applicator into the other nostril, and press upward on the bottom of the bottle until a fine mist is released (Figure 2);
• Remove the bottle from the nose and keep your head tilted back slightly to allow the medicine to spread. Repeat this procedure for the other nostril;
• Replace the protective cap.

WARNING:
Use the medicine within 3 months after opening the bottle.
If the nozzle becomes blocked, remove the applicator from the bottle and rinse it under warm water for several minutes (Figure 3). Do not use sharp objects to clear the blockage from the applicator.
The effect of the medicine is achieved only after several days of treatment, and in rare cases not before two weeks. If you are using this medicine for the treatment of rhinitis, begin treatment before exposure to allergens. To control eye irritation symptoms, your doctor may prescribe additional medicines to be used together with AIRCORT (antihistamines).
If during the first 2–3 days of treatment you experience a sensation of nasal congestion, your doctor may recommend using a medicine to clear the nasal passages (nasal decongestants).

If you use more AIRCORT than you should
Excessive use of AIRCORT is highly unlikely and does not usually cause serious health problems.
In case of accidental ingestion or swallowing, 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 directed by your doctor.
If you have any doubts about how to use 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, particularly with prolonged use:

Common (may affect less than 1 in 10 people)

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

Uncommon (may affect less than 1 in 100 people)

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

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

• reduced activity of the adrenal gland (adrenal suppression) and growth retardation (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);
• development of lesions in the nasal mucosa and perforation of the nasal septum.

Frequency not known (frequency cannot be estimated from the available data)

• eye problems (cataract, glaucoma).

Additional side effects in children and adolescents
Frequency not known (frequency cannot be estimated from the available data)

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

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
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 carton after “Exp”. 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What AIRCORT contains
AIRCORT 100 microgram nasal spray, suspension

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

AIRCORT 50 microgram nasal spray, suspension

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

Description of the appearance of AIRCORT and contents of the pack
Pack containing 1 spray pump bottle equipped with a metering valve delivering 50 microliters and containing 200 sprays.
Marketing Authorization 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