Pulmaxan

Patient Information Leaflet

Pulmaxan 100 micrograms/dose, powder for inhalation, 200 micrograms/dose, powder for inhalation, 400 micrograms/dose, powder for inhalation

Budesonide
Read this entire leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult 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 effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Pulmaxan is and what it is used for

Pulmaxan is an inhaled medicine administered by mouth using an inhaler (Turbohaler device). Pulmaxan contains the active substance budesonide.
Budesonide belongs to a group of medicines called "glucocorticoids", which work by reducing and preventing swelling and inflammation in the lungs, thereby improving airflow.
Pulmaxan is indicated in adults and children aged 6 years and older for the treatment of:

• asthma (an inflammation of the airways that makes breathing difficult).

2. What you should know before taking Pulmaxan

Do not take Pulmaxan

• if you are allergic to budesonide or to any of the other ingredients of this medicine (listed in section 6);
• if you have bacterial, viral, or fungal lung infections (such as pulmonary tuberculosis) or respiratory tract infections.

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

• if you suffer from stomach or intestinal ulcers
• if you have adrenal gland problems (glands located above the kidneys capable of producing various types of hormones)
• if you have undergone treatment with high doses of glucocorticoids (anti-inflammatory agents) or prolonged treatment with high inhaled doses of glucocorticoids
• if you are experiencing a period of severe physical stress, such as surgery
• if you have liver problems
• if you are taking ketoconazole or itraconazole (medicines used to treat fungal infections) (see also section “Other medicines and Pulmaxan”)
• if you are taking medicines used to treat HIV infection
• if you have lung infections (such as pulmonary tuberculosis) or respiratory tract infections
• if you have infections including fungal or viral infections such as measles or chickenpox
• if you have glaucoma (an eye disease caused by increased pressure of the fluid inside the eye)
• if you have cataracts (clouding of the lens, the eye structure responsible for focusing images).

Contact your doctor if you experience blurred vision or other visual disturbances.
Since adrenal gland function may be suppressed, an ACTH stimulation test to diagnose possible pituitary insufficiency might yield misleading results (low values).
Pulmaxan is a maintenance treatment for asthma and must therefore be taken regularly at the prescribed doses for as long as your doctor considers necessary.
Pulmaxan is not suitable for the rapid relief of sudden asthma attacks, for which a short-acting inhaled bronchodilator is required. Your doctor will carefully evaluate the most appropriate therapy for you.

Switching from systemic glucocorticoid therapy (anti-inflammatory agents administered orally, intramuscularly, or intravenously) to inhaled glucocorticoid therapy
If you are switching from systemic glucocorticoid therapy (e.g., oral) to inhaled glucocorticoid therapy, your doctor will gradually reduce the dose of systemic glucocorticoid you are currently taking. During this phase, you may experience general malaise such as muscle and joint pain. Rarely, symptoms such as fatigue, depression, headache, nausea, and vomiting may occur.
You may experience these symptoms despite maintained or even improved lung function. If this occurs, your doctor will continue your Pulmaxan treatment and may request blood tests to assess your adrenal function (glands located above the kidneys capable of producing various types of hormones). Depending on your adrenal function, your doctor may temporarily increase the dose of systemic glucocorticoid you are taking, and the transition to Pulmaxan may continue later, more gradually.
If during this transition phase you experience physical stress (e.g., severe infections, trauma, or surgery) or have a severe asthma attack, especially if associated with increased mucus production, your doctor may prescribe additional systemic glucocorticoid treatment (e.g., systemic administration).
Furthermore, switching from systemic glucocorticoid therapy to inhaled therapy may trigger allergic reactions such as rhinitis or eczema (inflammation of the nose or skin), which were previously controlled by the systemically administered medicine.
If this occurs, consult your doctor, who will prescribe appropriate treatment to manage these symptoms.

Oral candidiasis (thrush, a mouth infection)
Oral candidiasis may develop during treatment with inhaled glucocorticoids. If this occurs, consult your doctor. Your doctor will prescribe appropriate treatment and, if necessary, may advise you to stop the treatment (see also section 3 “How to take Pulmaxan”).

Potential adverse effects of inhaled glucocorticoids when used at high doses for prolonged periods
Inhaled glucocorticoids may cause adverse effects. In particular, when used at high doses for prolonged periods, the following adverse effects may occur: Cushing's syndrome and Cushingoid appearance (a condition characterized by excessive production of the glucocorticoid hormone cortisol, manifesting as moon face, weight gain, fluid retention, reduced glucose tolerance and increased risk of diabetes, leg swelling, headache, etc.), adrenal suppression (severe impairment of adrenal gland function), decreased bone mass, cataracts (clouding of the lens, the eye structure responsible for focusing images), and glaucoma (an eye disease caused by increased pressure of the fluid inside the eye).
These effects are less likely compared to treatment with orally administered glucocorticoids.
Rarely, a range of psychological and behavioral effects may occur, including psychomotor hyperactivity (a behavioral disorder characterized by excessive motor activity), sleep disturbances, anxiety, depression, aggression, and behavioral disorders.
Therefore, based on the above, it is important that you take the dose as indicated in the package leaflet or as prescribed by your doctor. You must not increase or decrease the dose without first consulting your doctor (see section 3 “How to take Pulmaxan”).

Paradoxical bronchospasm
As with other inhaled therapies, paradoxical bronchospasm (unexpected narrowing of the bronchi causing severe breathing difficulty due to reduced airflow) may occur after administration, with an immediate increase in wheezing (difficulty breathing accompanied by a whistling sound). In this case, you must consult your doctor immediately, who may, if necessary, discontinue treatment with inhaled budesonide. Your doctor will evaluate whether to start an alternative therapy, if needed.

For athletes
Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

Children and adolescents
Pulmaxan should be used with caution in children.

Effect on growth
The use of inhaled glucocorticoids may affect the growth of children and adolescents (see section “Additional adverse effects in children and adolescents”). Therefore, it is recommended that children undergoing long-term inhaled glucocorticoid therapy have their height monitored regularly by a doctor. If growth is slowed, the doctor will reassess the therapy with the aim of reducing the inhaled glucocorticoid dose. The doctor will carefully evaluate the benefits of glucocorticoid therapy against the potential risk of growth suppression. If necessary, the doctor may advise you to consult a pediatric pulmonologist (a pediatrician specialized in respiratory diseases).
Additionally, in rare cases, prolonged treatment with inhaled glucocorticoids may cause behavioral disturbances in children.

Other medicines and Pulmaxan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions have been observed between budesonide and any other drugs used in the treatment of asthma.
In particular, inform your doctor or pharmacist if you are taking:

• oral glucocorticoids (anti-inflammatory agents)
• ketoconazole and itraconazole (medicines used to treat fungal infections) (see section “Warnings and precautions”)
• medicines containing hormones (estrogens) or oral contraceptives (birth control pills)

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

• Studies conducted do not indicate an increased risk of adverse effects on the fetus/newborn with the use of inhaled budesonide during pregnancy. It is important for both the fetus and the mother to maintain adequate asthma treatment during pregnancy. As with other medicines, consult your doctor about the use of budesonide during pregnancy, as your doctor needs to evaluate the expected benefits for the mother against any potential risks for the fetus.
• Budesonide passes into breast milk. However, at the recommended doses of Pulmaxan, effects on the breastfed infant are not expected. Budesonide may be used during breastfeeding.

Driving and using machines
Pulmaxan does not affect the ability to drive or use machinery.

3. How to take Pulmaxan

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
INITIAL DOSE
The dosage of Pulmaxan is individual, depending on the severity of asthma and the stage
of therapy.
Adults

• The recommended starting dose is 200 micrograms 2–4 times daily (in cases of severe asthma).

MAINTENANCE DOSE
The maintenance dose is individual.
The maintenance dose should be the lowest dose that keeps symptoms under control: usually one inhalation of 200 micrograms per day is sufficient.
If sudden asthma attacks recur, your doctor may increase the dose of Pulmaxan.
ONSET OF EFFECT
Improvement in asthma control following inhaled administration of Pulmaxan may occur within 24 hours of starting treatment, although maximum benefit is usually achieved after 1–2 weeks or more of treatment.
Patients not treated with glucocorticoids (anti-inflammatory agents)
The effect of Pulmaxan usually appears within 10 days of starting treatment. However, if you have excessive bronchial secretion (mucus in the airways) that may hinder the penetration of the medicine into the respiratory tract, your doctor may prescribe, for a short period (approximately 2 weeks), an oral glucocorticoid (anti-inflammatory) treatment.
If sudden asthma attacks recur or if difficulty arises in achieving asthma control, your doctor will prescribe the appropriate treatment.
Patients treated with inhaled glucocorticoids (anti-inflammatory agents)
If you are currently using inhaled glucocorticoids via an aerosol and are switching to Pulmaxan Turbohaler, your doctor may reduce your dose of the aerosol medicine.
Patients treated with oral glucocorticoids (anti-inflammatory agents)
Pulmaxan Turbohaler may allow replacement or significant reduction of the dose of orally administered glucocorticoids, while maintaining asthma control.
The switch from oral glucocorticoid therapy to Pulmaxan must be carried out under medical supervision.
For the first 10 days, your doctor will prescribe a high dose of Pulmaxan in combination with your current oral dose.
After this period, the oral dose will be gradually reduced. In many cases, oral therapy can be completely replaced by Pulmaxan. For further information, see section “Warnings and precautions”.
Use in children and adolescents
Children aged 6 years and older

• The dosage of Pulmaxan is individual, depending on the severity of asthma and the stage of therapy. The recommended dose is generally 200 micrograms per day, administered in two divided doses. If necessary, your doctor may increase the dose up to 400 micrograms per day.

Pulmaxan should be used with caution in children (see section “Children and adolescents”).
INSTRUCTIONS FOR CORRECT USE OF PULMAXAN
To take the medicine, you must activate the Turbohaler inhaler.

INSTRUCTIONS FOR THE CORRECT USE OF THE TURBOHALER INHALER

The Turbohaler is activated by inhalation through the mouth; this means that when you inhale through the mouthpiece, the medication enters the airways carried by the air you breathe in.
Please read carefully the following instructions for using the Turbohaler inhaler.
Instructions for use / handling
Read the complete instructions carefully before starting to take the medication.
The Turbohaler is an inhaler (inhalers are devices used to deliver medications to the bronchi and lungs through mouth inhalation) that is multidose (i.e. can be used for multiple administrations of the medication), delivering small

• amounts of powdered medication (Figure 1). When you inhale through the Turbohaler, the powder is delivered to the lungs. It is therefore important that you inhale strongly and deeply through the mouth via the mouthpiece to ensure that the optimal dose reaches the lungs.

How to prepare a new inhaler for use
Before using the Turbohaler for the first time, you must prepare the inhaler as follows:

• Unscrew and remove the cap.
• Hold the inhaler in an upright position with the wheel facing downwards (Figure 2). Do not grip the mouthpiece when turning the wheel.

Figure 2

• Turn the wheel fully in one direction, then turn it fully in the opposite direction. The initial direction in which you turn the wheel does not matter. During this procedure, you will hear a click.
• The inhaler is now ready for use, and this preparation procedure must not be repeated.
• To take a dose, continue with the instructions below.

HOW TO USE PULMAXAN TURBOHALER
To administer a dose, simply follow the instructions below.

1. Unscrew and remove the cap.

2. Hold the inhaler in an upright position with the wheel facing downwards (Figure 2). Do not grip the mouthpiece when turning the wheel. To load a dose into the inhaler, turn the wheel fully in one direction, then turn it fully in the opposite direction. The initial direction does not matter. During this procedure, you will hear a click.

3. Hold the inhaler away from your mouth. Breathe out (exhale). Do not exhale through the mouthpiece.

4. Gently place the mouthpiece between your teeth, close your lips around it, and inhale strongly and deeply through the mouth via the device (Figure 3). Do not chew or bite the mouthpiece.
   Figure 3

5. Remove the inhaler from your mouth before exhaling.

6. If more than one dose has been prescribed, repeat steps 2 to 5.

7. Replace the cap by screwing it back on securely.

8. Rinse your mouth with water after inhaling the prescribed dose to minimize the risk of oropharyngeal candidiasis (thrush, an infection of the mouth and throat).

NOTE!
Do not exhale through the mouthpiece.
Always replace the cap properly after use.
Because the amount of powdered medication delivered is very small, you may not taste or feel the medication after inhalation. However, if you have followed the instructions correctly, you can be sure that the dose has been delivered.

Cleaning
Clean the outside of the mouthpiece regularly (weekly) with a dry cloth.
Do not use water to clean the mouthpiece.

Dose indicator
When the red mark first appears in the dose indicator window, approximately 20 doses remain (Figure 4).
Figure 4
When the red mark reaches the bottom edge of the window, the inhaler will no longer deliver the correct amount of medication and must be discarded (Figure 5). The sound heard when shaking the inhaler is not caused by the medication but by a drying agent.
Figure 5

Disposal
Always dispose of the used Turbohaler responsibly and as recommended, since some medication will remain inside.

If you take more Pulmaxan than you should
Accidental overdose of Pulmaxan is unlikely to cause problems.
However, if you accidentally take too much Pulmaxan, contact your doctor immediately or go to the nearest hospital.

If you forget to use Pulmaxan
Do not take a double dose to make up for a forgotten dose.

If you stop using Pulmaxan
If you have any doubts about using this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone experiences them.
The side effects are listed below according to the following frequency:
Common (may affect up to 1 in 10 people)

• Candida infections in the oropharynx (thrush, infection of the mouth and throat)
• nausea
• cough, hoarseness (when the voice is harsh or low), throat irritation
• pneumonia (lung infection) in patients with COPD (common side effect). Inform your doctor if you experience any of the following symptoms while taking budesonide, as they could be signs of a lung infection:
  • Fever or chills.
  • Increased mucus production, changes in mucus color.
  • Worsening cough or increased breathing difficulties.

Uncommon (may affect up to 1 in 100 people)

• cataract (clouding of the lens, the eye's structure responsible for focusing images)
• depression
• anxiety
• tremor
• muscle spasm (sudden, involuntary muscle contraction)
• blurred vision

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

• immediate or delayed allergic reactions including rash (skin eruption), contact dermatitis (inflammation of the skin usually presenting with
  redness, blisters, vesicles, abrasions, and crusts), urticaria (red, itchy skin patches),
  angioedema (swelling), and anaphylactic reaction (severe allergic reaction)

• signs and symptoms of systemic glucocorticoid effects (i.e., taken orally, intramuscularly, or intravenously), including adrenal suppression (severe impairment of adrenal gland function)

• restlessness, nervousness, behavioral changes, sleep disturbances, psychomotor hyperactivity (behavioral disorder characterized by excessive motor activity), aggression

• bronchospasm (narrowing of the bronchi causing breathing difficulty due to reduced airflow)

• bruising (ecchymosis), cutaneous striae (skin streaks similar to stretch marks, red-purple in color)

Not known (frequency cannot be estimated from available data)

• glaucoma (eye disease caused by increased pressure of the fluid inside the eye)

Additional side effects in children and adolescents
The side effects are listed below according to the following frequency:
Rare (may affect up to 1 in 1,000 people)

• slowed growth
• dysphonia (difficulty producing voice), hoarseness (when the voice is harsh or low)
• behavioral disorders.

Due to the risk of growth retardation in the pediatric patient population, growth must be monitored as described in the section “Children and adolescents”.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at 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 Pulmaxan

• 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.".
• Do not store above 30°C. Store with the cap tightly closed.
• 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

Pulmaxan 100 micrograms/dose, powder for inhalation

• The active substance is: budesonide (one Turbohaler inhaler contains 20 mg of budesonide).
  Pulmaxan 200 micrograms/dose, powder for inhalation
• The active substance is: budesonide (one Turbohaler inhaler contains 20 mg of budesonide).
  Pulmaxan 400 micrograms/dose, powder for inhalation
• The active substance is: budesonide (one Turbohaler inhaler contains 20 mg of budesonide).

This medicinal product does not contain excipients.
Description of the appearance of Pulmaxan and contents of the pack
Pulmaxan is a powder for oral inhalation, contained in a dry powder inhaler (Turbohaler device), which is multidose (i.e. it can be used for multiple administrations of the medicine).
The inhaler is made of plastic and may contain 50, 100 or 200 doses.
Pulmaxan 100 micrograms/dose, powder for inhalation: pack containing one 200-dose Turbohaler inhaler.
Pulmaxan 200 micrograms/dose, powder for inhalation: pack containing one 100-dose Turbohaler inhaler.
Pulmaxan 400 micrograms/dose, powder for inhalation: pack containing one 50-dose Turbohaler inhaler.
Marketing Authorization Holder
AstraZeneca S.p.A.
Palazzo Ferraris
Via Ludovico il Moro 6/C
Basiglio (MI)
Manufacturer
ASTRAZENECA AB - Södertälje (Sweden).
or
ASTRAZENECA Dunkerque Production – Dunkerque (France).

Package leaflet: information for the patient

Pulmaxan 0.125 mg/ml suspension for nebulizer, 0.25 mg/ml suspension for nebulizer, 0.5 mg/ml suspension for nebulizer

Budesonide
Please read this leaflet carefully before 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, consult 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 could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Pulmaxan is and what it is used for

Pulmaxan is an inhalation medicine for nebulization, containing the active substance
budesonide.
Budesonide belongs to a group of medicines called “glucocorticoids”, which work by reducing and preventing swelling and inflammation in the lungs, thereby improving airflow.
Pulmaxan is indicated in adults and children from 6 months of age onwards for the treatment of:

• asthma (an inflammation of the airways that makes breathing difficult), including in patients who are unable to use pressurized metered-dose inhalers or dry powder inhalers correctly
• subglottic laryngitis or pseudocroup (a condition characterized by swelling of the tissues below the vocal cords, making breathing difficult), when the condition is severe and hospitalization is indicated.

2. What you should know before taking Pulmaxan

Do not take Pulmaxan

• 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 taking Pulmaxan:

• if you have problems with your adrenal glands (glands located above the kidneys that produce various types of hormones)
• if you have undergone treatment with high doses of glucocorticoids (anti-inflammatory agents) or prolonged treatment with high-dose inhaled glucocorticoids
• if you are experiencing a period of severe physical stress, such as surgery
• if you have liver problems
• if you are taking ketoconazole or itraconazole (medicines used to treat fungal infections) (see also section “Other medicines and Pulmaxan”)
• if you are taking medicines used to treat HIV infection
• if you have lung infections (such as pulmonary tuberculosis) or respiratory tract infections
• if you have infections including fungal or viral infections (measles and chickenpox)
• if you have glaucoma (an eye disease caused by increased pressure of the fluid inside the eye)
• if you have cataracts (clouding of the lens of the eye, which focuses images).

Contact your doctor if you experience blurred vision or other visual disturbances.
Since adrenal gland function may be suppressed, an ACTH stimulation test to diagnose possible pituitary insufficiency may yield falsely low results.
Pulmaxan is not suitable for rapid relief of sudden asthma attacks, for which a short-acting bronchodilator must be used. Your doctor will carefully assess the most appropriate treatment for you.

Switching from systemic glucocorticoid therapy (anti-inflammatory agents taken orally, intramuscularly, or intravenously) to inhaled glucocorticoid therapy
If you are switching from systemic glucocorticoid therapy (e.g., oral) to inhaled glucocorticoid therapy, your doctor will gradually reduce the dose of systemic glucocorticoid you are currently taking. During this phase, you may experience general malaise such as muscle and/or joint pain. Rarely, symptoms such as fatigue, depression, headache, nausea, and vomiting may occur.
You may experience these symptoms even if your lung function remains stable or even improves. If this occurs, your doctor will continue your treatment with Pulmaxan and may request blood tests to evaluate your adrenal function (glands located above the kidneys that produce various types of hormones). Depending on your adrenal function, your doctor may temporarily increase the dose of systemic glucocorticoid you are taking, and the switch to Pulmaxan may continue later, more gradually.
If during this transition phase you experience physical stress (e.g., severe infections, trauma, or surgery) or a severe asthma attack, your doctor may prescribe additional systemic glucocorticoid therapy (e.g., systemic administration).
Additionally, switching from systemic glucocorticoid treatment to inhaled therapy may cause allergic reactions such as rhinitis or eczema (irritation and inflammation of the nose or skin), which were previously controlled by the systemically administered drug.
If this occurs, consult your doctor, who will prescribe appropriate treatment to manage these symptoms.

Oral candidiasis (thrush, a mouth infection)
Oral candidiasis may occur during treatment with inhaled glucocorticoids. If this occurs, consult your doctor. Your doctor will prescribe appropriate treatment and, if necessary, may advise you to stop treatment (see also section 3 “How to take Pulmaxan”).

Possible side effects of inhaled glucocorticoids (anti-inflammatory agents) when used at high doses for prolonged periods
Inhaled glucocorticoids may cause side effects. In particular, when used at high doses for prolonged periods, the following side effects may occur: Cushing's syndrome and Cushingoid appearance (a condition characterized by excessive production of the glucocorticoid hormone cortisol, manifesting as moon-shaped face, weight gain, fluid retention, reduced glucose tolerance and increased risk of diabetes, leg swelling, headache, etc.), adrenal suppression (severe impairment of adrenal gland function), reduced bone mass, cataracts (clouding of the lens of the eye), glaucoma (an eye disease caused by increased pressure of the fluid inside the eye).
These effects are less likely than with oral glucocorticoid therapy.
Rarely, a range of psychological and behavioral effects may occur, including psychomotor hyperactivity (a behavioral disorder characterized by excessive motor activity), sleep disturbances, anxiety, depression, aggression, and behavioral disorders.
Therefore, based on the above, it is important that you take the dose as indicated in the package leaflet or as prescribed by your doctor. You must not increase or decrease the dose without first consulting your doctor (see section 3 “How to take Pulmaxan”).

Paradoxical bronchospasm
As with other inhaled therapies, paradoxical bronchospasm (unexpected narrowing of the airways causing severe breathing difficulty due to reduced airflow) may occur after administration, accompanied by an immediate increase in wheezing (difficulty breathing with a whistling sound). In this case, you must consult your doctor immediately. Your doctor may, if necessary, discontinue treatment with inhaled budesonide. Your doctor will assess whether alternative therapy should be started, if needed.

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

Children and adolescents
Pulmaxan should be used with caution in children.

Effect on growth
The use of inhaled glucocorticoids may affect growth in children and adolescents (see section “Additional side effects in children and adolescents”). Therefore, it is recommended that the height of children undergoing long-term inhaled glucocorticoid therapy be monitored regularly by a doctor. If growth is slowed, the doctor will reassess the treatment with the aim of reducing the inhaled glucocorticoid dose. The doctor will carefully evaluate the benefits of glucocorticoid therapy against the potential risk of growth suppression. If necessary, the doctor may advise you to consult a pediatric pulmonologist (a pediatrician specialized in respiratory diseases).
Additionally, in rare cases, prolonged treatment with inhaled glucocorticoids may cause behavioral disturbances in children.

Other medicines and Pulmaxan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between budesonide and other drugs used in asthma treatment have been observed.
In particular, inform your doctor or pharmacist if you are taking:

• ketoconazole and itraconazole (medicines used to treat fungal infections) (see section “Warnings and precautions”)
• medicines containing hormones (estrogens) or oral contraceptives (birth control pills)

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

• Studies conducted do not indicate an increased risk of adverse effects on the fetus/newborn with the use of inhaled budesonide during pregnancy. It is important for both the mother and the fetus to maintain adequate asthma control during pregnancy. As with other medicines, consult your doctor about using budesonide during pregnancy, as your doctor needs to evaluate the expected benefits for the mother against any potential risks for the fetus.
• Budesonide passes into breast milk. However, at the recommended doses of Pulmaxan, effects on the breastfed infant are not expected. Budesonide may be used during breastfeeding.

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

3. How to take Pulmaxan

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
ASTHMA
INITIAL DOSE
The dosage of Pulmaxan is individual.
Adults and elderly
The recommended initial dose is 0.5–1 mg twice daily. If necessary, your doctor may increase the dose of Pulmaxan (see dosing table).
MAINTENANCE DOSE
The maintenance dose is individual.
Once asthma is under control, the maintenance dose should be the lowest dose that maintains effective symptom control. Your doctor will gradually reduce the medicine until the minimum effective dose is reached.
DOSING TABLE

*The product must be mixed with 0.9% physiological saline solution (saline solution)
up to a volume of 2 ml.
ONSET OF EFFECT
Improvement in asthma control following administration of Pulmaxan
may occur within 3 days of starting treatment, although maximum benefit
is achieved after 2–4 weeks.
Patients treated with oral glucocorticoids (anti-inflammatory agents)
With the use of Pulmaxan, it may be possible to replace or significantly reduce the dose of
oral glucocorticoids, while maintaining asthma control.
The transition from oral glucocorticoid therapy to Pulmaxan will be evaluated by the physician based on your overall condition.
For approximately 10 days, your doctor will prescribe a high dose of Pulmaxan to be taken
in combination with the oral medication you are currently using.
Thereafter, your doctor will gradually reduce the dose of the oral medication to the lowest possible level. In many cases, oral therapy can be completely replaced with Pulmaxan. For further information, see section "Warnings and precautions".
DOSAGE SPLITTING AND MIXING
Pulmaxan can be mixed with 0.9% physiological saline solution (saline solution) and with nebulizing solutions of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium
cromoglycate, or ipratropium (medications used for the treatment of respiratory disorders).
The mixture must be used within 30 minutes.
If an adjustment of the Pulmaxan dose is required, the contents of the single-dose vial can be divided.
Indeed, on the 2 ml containers of Pulmaxan 0.25 mg/ml suspension for nebulizer
and Pulmaxan 0.5 mg/ml suspension for nebulizer, a marking line is clearly visible. When the single-dose vial is held upside down, the line indicates a volume of 1 ml.
If you use only 1 ml, pour the contents of the single-dose vial until the liquid surface reaches the indicated line.
The opened single-dose container containing the remaining liquid must be stored in the pouch, protected from light, and used within 12 hours.
Before using the remaining liquid, carefully shake the container with a rotational movement.
Once the aluminum pouch has been opened, the unopened containers inside have a shelf life of 3 months and must be kept in the pouch, protected from light.
Use in children and adolescents
ASTHMA
Children from 6 months of age

• The dosage of Pulmaxan is individual.

The recommended initial dose is 0.25–0.5 mg per day. If necessary, your doctor may increase the dose of Pulmaxan.
SUBGLOTTIC LARYNGITIS OR CROUP (for severe forms requiring hospitalization)
Infants and children

• The usual recommended dose is 2 mg of Pulmaxan, 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 as prescribed by your doctor.

Pulmaxan should be used with caution in children (see section “Children and adolescents”).
INSTRUCTIONS FOR CORRECT USE OF PULMAXAN
Pulmaxan must be used with a jet nebulizer. The vapor produced by the
nebulizer is inhaled through the mouth via a mouthpiece or an appropriate
facial mask.
The nebulizer must consist of: a compressor (a pump) capable of generating an adequate airflow (5–8 L/min), and a nebulizer chamber (a reservoir) where the medication solution is placed, with a volume of 2–4 ml.
Ultrasonic nebulizers are not suitable for the administration of Pulmaxan.
INSTRUCTIONS FOR USE

1. Gently agitate the single-dose container with a rotational movement.
2. Hold the single-dose container in an upright position (see figure) and open it by twisting the tab until the single-dose vial opens.

3. Insert the open end of the single-dose container well into the nebulizer chamber and slowly press.
4. Before turning on the nebulizer, carefully read the instructions for use provided in the leaflet included in the packaging of each nebulizer.
   If you have any doubts about using the nebulizer, consult your doctor or pharmacist.
   NOTES:
5. After inhalation, rinse your mouth with water to minimize the risk of developing oropharyngeal candidiasis (thrush, an infection of the mouth and throat).
6. If you use a facial mask to inhale the vapor, ensure that the mask fits properly during nebulization. After using the facial mask, wash your face with water to prevent irritation.
7. Clean and maintain the nebulizer according to the manufacturer's instructions.
   CLEANING THE NEBULIZER
   The nebulizer chamber must be cleaned after each administration. Wash the nebulizer chamber, 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 reassembling it with the compressor and inhaler.
   If you take more Pulmaxan than you should
   Accidental ingestion of an excessive dose of Pulmaxan is unlikely to cause adverse effects.
   In case of accidental overdose of Pulmaxan, contact your doctor immediately or go to the nearest hospital.
   If you forget to take Pulmaxan
   Do not take a double dose to make up for the missed dose.
   If you stop treatment with Pulmaxan
   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 everyone gets them.
The side effects are listed below according to the following frequency:
Common (may affect up to 1 in 10 people)

• Candida infections in the oropharynx (thrush, infection of the mouth and throat)
• nausea
• cough, hoarseness (when the voice sounds harsh or low), throat irritation
• pneumonia (lung infection), in patients with COPD (common side effect). Inform your doctor if you experience any of the following symptoms while taking budesonide, as they could be signs of a lung infection:
  • Fever or chills.
  • Increased mucus production, changes in the colour of mucus.
• Worsening cough or increased breathing difficulties.

Uncommon (may affect up to 1 in 100 people)

• cataract (clouding of the lens, the eye's structure responsible for focusing images)
• depression
• anxiety
• tremor
• muscle spasm (sudden, involuntary muscle contraction)
• blurred vision

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

• immediate or delayed allergic reactions* including rash (skin eruption), contact dermatitis (skin inflammation usually presenting with redness, blisters, vesicles, abrasions, and crusts), urticaria (red, itchy skin patches), angioedema (swelling), and anaphylactic reaction (severe allergic reaction)
• signs and symptoms of systemic glucocorticoid effects (i.e. when taken orally, intramuscularly, or intravenously), including adrenal suppression (severe impairment of adrenal gland function)
• restlessness, nervousness, behavioural changes, sleep disorders, psychomotor hyperactivity (a behavioural disorder characterised by excessive motor activity), aggression
• bronchospasm (narrowing of the bronchi causing breathing difficulty due to reduced airflow)
• bruising, skin striae (skin streaks similar to stretch marks, red-purple in colour)

*Skin irritation of the face, as an example of an allergic reaction, has occurred in some cases when using a nebulizer with a face mask. To prevent facial skin irritation, wash your face with water after using the face mask.
Not known (frequency cannot be estimated from the available data)

• glaucoma (an eye disease caused by increased pressure of the fluid inside the eye)

Additional side effects in children and adolescents
The side effects are listed below according to the following frequency:
Rare (may affect up to 1 in 10,000 people)

• slowed growth
• dysphonia (difficulty producing voice), hoarseness (when the voice sounds harsh or low)
• behavioural disorders.

Due to the risk of slowed growth in the paediatric patient population, growth must be monitored as described in the 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 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 Pulmaxan

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the pack after "Exp".
• Do not store above 30°C. The product must be kept in an upright position.
• Keep the containers in the aluminium pouch to protect the medicine from light. Do not freeze.
• After opening the aluminium pouch, unopened containers must be stored inside the pouch, protected from light, and used within 3 months. Once opened, the single-dose container must be used within 12 hours.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

Pulmaxan 0.125 mg/ml suspension for nebulizer

• The active substance is: budesonide (each single-dose container of 2 ml contains 0.25 mg of budesonide).
• The other components are: disodium edetate, sodium chloride, polysorbate 80, anhydrous citric acid, sodium citrate, water for injections.

Pulmaxan 0.25 mg/ml suspension for nebulizer

• The active substance is: budesonide (each 2 ml 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.

Pulmaxan 0.5 mg/ml suspension for nebulizer

• The active substance is: budesonide (each 2 ml 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 Pulmaxan and contents of the pack
Pulmaxan is a white or almost white suspension for nebulization.
Each pack: Pulmaxan 0.125 mg/ml suspension for nebulizer,
Pulmaxan 0.25 mg/ml suspension for nebulizer,
Pulmaxan 0.5 mg/ml suspension for nebulizer
contains 4 aluminium pouches.
Each aluminium pouch contains 5 containers.
Each single-dose container holds 2 ml of suspension for nebulization.
Thus, each pack of Pulmaxan contains a total of 20 containers.
On each single-dose container of Pulmaxan 0.25 mg/ml suspension for nebulizer
and Pulmaxan 0.5 mg/ml suspension for nebulizer, a clearly visible line is marked. When
the single-dose container is held upside down, the line indicates a volume of 1 ml.
Please note that not all pack sizes may be marketed.

Marketing Authorization Holder
AstraZeneca S.p.A.
Palazzo Ferraris
Via Ludovico il Moro 6/C, Basiglio (MI)
Manufacturer
AstraZeneca AB – Kvarnbergagatan 12 – SE-151 85 Södertälje (Sweden)