PULMAXAN 100 MCG Inhalation powder

Зміст інструкції

1. Pulmaxan 100 micrograms/delivery, powder for inhalation
   1. What is Pulmaxan and what is it used for
   2. What you need to know before taking Pulmaxan
   3. How to take Pulmaxan
   4. Possible side effects
   5. How to store Pulmaxan
   6. Contents of the pack and other information
2. Pulmaxan 0.125 mg/ml suspension for nebulizer
   1. What is Pulmaxan and what is it used for
   2. What you need to know before you take Pulmaxan
   3. How to take Pulmaxan
   4. Possible side effects
   5. How to store Pulmaxan
   6. Contents of the pack and other information

Pulmaxan 100 micrograms/delivery, powder for inhalation

Pulmaxan200 micrograms/delivery, powder for inhalation
Pulmaxan400 micrograms/delivery, powder for inhalation
Budesonide
Read this leaflet carefully before you start to take 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 pass it on to others, even if their symptoms are the same as yours, 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 Pulmaxan is and what it is used for
• 2. What you need to know before you take Pulmaxan
• 3. How to take Pulmaxan
• 4. Possible side effects
• 5. How to store Pulmaxan
• 6. Contents of the pack and other information

1. What is Pulmaxan and what is it used for

Pulmaxan is an inhaled medicine for oral administration delivered through an
inhaler (Turbohaler device). Pulmaxan contains the active ingredient budesonide.
Budesonide belongs to a group of medicines called “glucocorticoids”, which
work by reducing and preventing swelling and inflammation of the lungs, promoting
airflow.
Pulmaxan is indicated in adults and children 6 years of age and older in the treatment of:

• asthma (inflammation of the airways, which makes breathing difficult).

2. What you need to 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 infections of the lungs (such as pulmonary tuberculosis) or of the airways.

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

• if you suffer from stomach or intestinal ulcers
• if you have problems with the adrenal glands (glands located above the kidneys that are able to produce different types of hormones)
• if you have undergone therapies with high doses of glucocorticoids (anti-inflammatory drugs) or prolonged treatments with high doses of glucocorticoids by inhalation
• if you are in a period of severe physical stress such as in the case of surgery
• if you have liver problems
• if you are taking ketoconazole and itraconazole (medicines used to treat fungal infections) (see also section “Other medicines and Pulmaxan”)
• if you are taking medicines used for the treatment of HIV infection
• if you have lung infections (such as pulmonary tuberculosis) or airway infections
• if you have infections including fungal or viral infections such as measles and chickenpox
• if you suffer from glaucoma (eye disease caused by an increase in the pressure of the fluid contained inside the eye)
• if you suffer from cataracts (clouding of the lens, the lens of the eye that is used to focus images).

Contact your doctor if you experience blurred vision or other visual disturbances.
Since the function of the adrenal glands can be inhibited, a stimulation test with ACTH to diagnose possible pituitary insufficiency may provide false results (low values).
Pulmaxan constitutes a basic treatment for asthma disease, so you must take this medicine regularly at the prescribed doses and as long as your doctor deems appropriate.
Pulmaxan is not suitable for the rapid improvement of sudden asthma attacks, for which it is necessary to use a short-acting bronchodilator for inhalation. The doctor will carefully evaluate the most suitable therapy for you.

Switching from systemic glucocorticoid (anti-inflammatory) therapy (i.e.

taken orally, intramuscularly or intravenously) to inhaled glucocorticoid therapy
If you need to switch from systemic glucocorticoid (anti-inflammatory) therapy (for example, orally) to inhaled glucocorticoid therapy, your doctor will gradually reduce the dosage of the systemic glucocorticoid you are taking. In this phase, you may experience general malaise, such as muscle and joint pain. In rare cases, symptoms such as fatigue, depression, headache, nausea and vomiting may appear.
You may experience these symptoms even if your lung function is maintained or even improved. If you experience these symptoms, your doctor will continue the therapy with Pulmaxan and ask you to undergo blood tests to evaluate the function of your adrenal glands (glands located above the kidneys that are able to produce different types of hormones). Based on the function of your adrenal glands, your doctor may temporarily increase the dose of the systemic glucocorticoid you are taking, and the switch to Pulmaxan may then proceed more slowly.
If you are subjected to physical stress (for example, in case of severe infections, trauma or surgery) or have a severe asthma attack during this transition phase, especially if associated with an increase in mucus, your doctor may prescribe you supplementary systemic glucocorticoid treatment (for example, systemically).
In addition, switching from systemic glucocorticoid therapy to inhaled therapy can cause allergies, such as rhinitis and eczema (irritation and inflammation of the nose or skin), which were previously controlled by the drug administered systemically.
If this occurs, consult your doctor who will prescribe you the appropriate therapy to control these symptoms.

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

Possible undesirable effects of inhaled glucocorticoids (anti-inflammatory drugs) if

used at high doses for prolonged periods
Inhaled glucocorticoids can cause undesirable effects. In particular, if used at high doses for prolonged periods, the following undesirable effects may occur: Cushing's syndrome and Cushingoid appearance (disease characterized by excessive production of a glucocorticoid hormone, cortisol, which manifests with a full moon face, weight gain, fluid retention, reduced sugar tolerance and increased risk of diabetes, swelling of the legs, headache, etc.), adrenal suppression (severe impairment of the activity of the adrenal glands), reduction of bone mass, cataracts (clouding of the lens, the lens of the eye that is used to focus images), glaucoma (eye disease caused by an increase in the pressure of the fluid contained inside the eye).
These effects are less likely to occur than with treatment with glucocorticoids taken orally.
Rarely, a number of psychological and behavioral effects may occur, including psychomotor hyperactivity (behavioral disorder manifested by excessive motor activity), sleep disturbances, anxiety, depression, aggression, behavioral disorders.
Therefore, based on the above, it is important that you take the dose as is, or increase or decrease the dose without first consulting your doctor (see section 3 “How to take Pulmaxan”).

Paradoxical bronchospasm
As happens with other therapies administered by inhalation, paradoxical bronchospasm (unexpected narrowing of the bronchi causing severe breathing difficulties due to reduced air passage) with immediate increase in wheezing (difficulty breathing accompanied by whistling, i.e. like a whistle) may occur after administration. In this case, you should consult your doctor immediately, who may, if necessary, interrupt the treatment with inhaled budesonide. The doctor will evaluate whether to start alternative therapy, if necessary.

For those who play sports
The use of the drug without therapeutic necessity constitutes doping and may in any case determine positivity to anti-doping tests.

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

Influence on growth
The use of inhaled glucocorticoids can affect the growth of children and adolescents (see section “Additional undesirable effects in children and adolescents”). Therefore, it is recommended that the height of children undergoing prolonged treatment with inhaled glucocorticoids be periodically checked by the doctor. If growth is slowed, the doctor will re-evaluate the therapy in order to reduce the dose of glucocorticoids by inhalation. The doctor will carefully evaluate the benefits of glucocorticoid therapy and the possible risk of growth arrest. If necessary, the doctor will advise you to consult a pediatric pulmonologist (pediatrician specializing in the treatment of respiratory diseases).

In addition, in rare cases, prolonged treatment with inhaled glucocorticoids can cause behavioral disorders 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 of budesonide with any other drug used in the treatment of asthma have been observed.
In particular, tell your doctor or pharmacist if you are taking:

• glucocorticoids (anti-inflammatory drugs) orally
• ketoconazole and itraconazole (medicines used to treat fungal infections) (see section “Warnings and precautions”)
• medicines containing hormones (estrogens) or oral contraceptives (the pill)

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.

• Studies have not shown an increased risk of adverse effects on the health of 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 for the administration of budesonide during pregnancy, as the doctor needs to assess the expected benefits for the mother versus the risks for the fetus
• Budesonide passes into breast milk. However, no adverse effects on the infant are expected at the recommended doses of Pulmaxan. Budesonide can be used during breastfeeding.

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

3. How to take Pulmaxan

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

INITIAL DOSE
The dosage of Pulmaxan is individual in relation to the severity of asthma and the stage of therapy.

Adults

• the recommended initial dose is 200 micrograms 2-4 times a day (in cases of severe asthma).

MAINTENANCE DOSE
The maintenance dose is individual.
The maintenance dose should be the minimum dose that allows the absence of symptoms: usually, one inhalation of 200 micrograms per day is sufficient.
If sudden asthma attacks recur, the doctor may increase the dose of Pulmaxan.

ONSET OF EFFECT
Improvement in asthma control following administration of Pulmaxan for inhalation may occur within 24 hours of starting treatment, although the maximum benefit is obtained after 1-2 weeks or more of treatment.
Patients not treated with glucocorticoids (anti-inflammatory drugs)
The effect of Pulmaxan usually manifests within 10 days of starting treatment, however, if you have abundant bronchial secretion (mucus in the bronchi), so as to hinder the penetration of the medicine into the airways, the doctor may for a short period (about 2 weeks) prescribe a treatment with glucocorticoids (anti-inflammatory drugs) orally.
In case of recurrence of sudden asthma attacks or difficulty in achieving asthma control, the doctor will prescribe the appropriate treatment.
Patients treated with glucocorticoids (anti-inflammatory drugs) for inhalation
If you are taking glucocorticoids for inhalation through an aerosol and need to switch to treatment with Pulmaxan Turbohaler, the doctor may reduce the dose of the medicine to be taken through the aerosol.
Patients treated with glucocorticoids (anti-inflammatory drugs) orally
Pulmaxan Turbohaler may allow the replacement or significant reduction of the dose of glucocorticoids taken orally, allowing you to maintain asthma control.
The switch from therapy with oral glucocorticoids to that with Pulmaxan must occur under medical supervision.
For the first 10 days, the doctor will prescribe a high dose of Pulmaxan in association with the oral dose you are taking.
After that, the oral dose will be gradually reduced. In many cases, it is possible to completely replace oral therapy with Pulmaxan. For further information, see section "Warnings and precautions".

Use in children and adolescents
Children 6 years and over

• The dosage of Pulmaxan is individual in relation to the severity of asthma and the stage of therapy. The recommended dose is generally 200 micrograms per day, in two administrations. If necessary, the 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 need to activate the Turbohaler dispenser.

INSTRUCTIONS FOR CORRECT USE OF THE TURBOHALER DISPENSER
The Turbohaler is operated by suction through the mouth; this means that when you inhale through the mouthpiece, the medicine enters the airways following the air you inhale.
Read the following instructions for using the Turbohaler dispenser carefully.

Instructions for use / handling
Read the complete instructions carefully before starting to take the medicine
Turbohaler is a multi-dose inhaler (i.e. that can be used for multiple administrations of the medicine) through which small amounts of powder of the medicine are administered (Figure 1).
When you inhale from your mouth through Turbohaler, the powder is distributed to the lungs. It is therefore important that you inhale strongly and deeply through the mouthpieceto ensure that the optimal dose reaches the lungs.

Figure 1
How to prepare a new inhaler for use
Before using Turbohaler for the first time, you need to prepare the inhaler for use as follows:

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

Figure 2

• Turn the wheel in one direction to the end of its travel, and then turn it in the other direction again to the end of its travel.It does not matter in which direction you turn the wheel the first time. You will hear a click during this procedure.
• The inhaler is now ready for use, and you must not repeat the procedure again.
• To take a dose, continue according to 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 a vertical positionwith the wheel facing down (Figure 2). Do not grip the mouthpiece when turning the wheel. To load the inhaler with a dose turn the wheel in one direction to the end of its travel, and then turn it in the other direction again to the end of its travel.It does not matter in which direction you turn the wheel the first time. You will hear a click during this procedure.
• 3. Hold the inhaler away from your mouth. Exhale (blow out the air). Do not exhale throughthe mouthpiece.

• 4. Gently grip the mouthpiece between your teeth, close your lips and inhale through the device forcefully and deeply through the mouthpiece(Figure 3). Do not chew or bite the mouthpiece.

Figure 3

• 5. Remove the inhaler from your mouth before exhaling.
• 6. If you have been prescribed more than one dose, repeat operations 2 to 5.
• 7. Replace the capby screwing it back on tightly. 8 Rinse your mouth with water after inhaling the dose prescribed by your doctorto minimize the risk of oropharyngeal candidiasis (thrush, infection of the mouth and throat).

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

Cleaning
Clean the outside of the mouthpiece regularly (weekly) with a dry cloth.

Do not use water to clean the mouthpiece.
Dose indicator
Figure 4
When a red mark first appears in the indicator window, it means that approximately 20 doses remain (Figure 4)
When the red mark reaches the bottom edge of the window, the inhaler will no longer deliver the correct amount of medicine and must be discarded (Figure 5). The sound you hear when shaking the inhaler is not produced by the medicine but by a desiccant.

Figure 5
Disposal
Always make sure to dispose of the used Turbohaler responsibly and as recommended, as some of the medicine will remain inside.

If you take more Pulmaxan than you should
Accidental intake of an excessive dose of Pulmaxan should not cause discomfort.
In case of accidental intake of an excessive dose of Pulmaxan, immediately inform your doctor or go to the nearest hospital.

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

If you stop the treatment with Pulmaxan
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 everyone will experience them.
The side effects are listed below according to the following frequency:

Common (may affect up to 1 in 10 people)

• candidiasis infections of 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 have any of the following symptoms while taking budesonide, as they may be symptoms of a lung infection:
• Fever or chills.
• Increased mucus production, changes in mucus color.
• Increased cough or greater difficulty breathing.

Uncommon (may affect up to 1 in 100 people)

• cataract (clouding of the lens, the lens of the eye used to focus images)
• depression
• anxiety
• tremor
• muscle spasm (sudden and 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 that usually manifests with

redness, blisters, bubbles, abrasions and crusts), urticaria (skin redness
accompanied by itching), angioedema (swelling) and anaphylactic reaction (severe
allergic reaction)

• signs and symptoms of systemic glucocorticoids effects (i.e. taken orally, intramuscularly or intravenously), including adrenal suppression (severe impairment of adrenal gland activity)
• restlessness, nervousness, behavioral changes, sleep disorders, psychomotor hyperactivity (behavioral disorder characterized by excessive motor activity), aggression
• bronchospasm (narrowing of the bronchi causing difficulty breathing due to reduced airflow)
• ecchymosis (bruises), striae cutaneae (stretch mark-like stripes on the skin, reddish-purple in color)

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

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

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

Given the risk of growth slowing in the pediatric patient population,
growth should be monitored as described in the “Children and
adolescents” section.

Reporting of side effects
If you experience any side effects, including those not listed in this
leaflet, please inform your doctor or pharmacist. You can also report side effects directly through 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 that is reported on the pack after Scad.
• Do not store at a temperature above 30°C. Store with the cap tightly closed.
• 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

Pulmaxan 100 micrograms/delivery, powder for inhalation

• the active ingredient is: budesonide (one Turbohaler delivers 20 mg of budesonide). Pulmaxan 200 micrograms/delivery, powder for inhalation
• the active ingredient is: budesonide (one Turbohaler delivers 20 mg of budesonide). Pulmaxan 400 micrograms/delivery, powder for inhalation
• the active ingredient is: budesonide (one Turbohaler delivers 20 mg of budesonide).

This medicine does not contain excipients.

Description of the appearance of Pulmaxan and contents of the pack
Pulmaxan presents as powder for inhalation by mouth, contained in a
powder inhaler (Turbohaler) multidose device (i.e. that can be used
for multiple administrations of the medicine).
The device is made of plastic material and can contain 50, 100 or 200 doses

Pulmaxan 100 micrograms/delivery, powder for inhalation: pack of one
Turbohaler device with 200 doses.

Pulmaxan 200 micrograms/delivery, powder for inhalation: pack of one
Turbohaler device with 100 doses.

Pulmaxan 400 micrograms/delivery, powder for inhalation: pack of one
Turbohaler device with 50 doses.

Marketing Authorisation 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).

Pulmaxan 0.125 mg/ml suspension for nebulizer

Pulmaxan 0.25 mg/ml suspension for nebulizer

Pulmaxan 0.5 mg/ml suspension for nebulizer
Budesonide
Read this leaflet carefully before you start to take 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 pass it on to others, even if their symptoms are the same as yours, 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 Pulmaxan is and what it is used for
• 2. What you need to know before you take Pulmaxan
• 3. How to take Pulmaxan
• 4. Possible side effects
• 5. How to store Pulmaxan
• 6. Contents of the pack and other information

1. What is Pulmaxan and what is it used for

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

• asthma (inflammation of the airways, which makes breathing difficult), even for those who are unable to use spray inhalers or dry powder inhalers correctly
• laryngotracheobronchitis or pseudocroup (a disease characterized by swelling of the tissues below the vocal cords that makes breathing difficult) when it is very severe and hospital admission is indicated.

2. What you need to know before you take 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 the adrenal glands (glands located above the kidneys that are able to produce different types of hormones)
• if you have undergone therapies with high doses of glucocorticoids (anti-inflammatory drugs) or prolonged treatments with high doses of glucocorticoids for inhalation
• if you are in a period of severe physical stress such as in the case of surgery
• if you have liver problems
• if you are taking ketoconazole and itraconazole (medicines used to treat fungal infections) (see also section “Other medicines and Pulmaxan”)
• if you are taking medicines used for the treatment of 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 suffer from glaucoma (eye disease caused by an increase in the pressure of the fluid contained inside the eye)
• if you suffer from cataracts (clouding of the lens, the lens of the eye that is used to focus images).

Contact your doctor if you experience blurred vision or other visual disturbances.
Since the function of the adrenal glands may be inhibited, a stimulation test with ACTH to diagnose possible pituitary insufficiency may provide false results (low values).
Pulmaxan is not suitable for the rapid improvement of sudden asthma attacks, for which a short-acting bronchodilator is necessary. The doctor will carefully assess the most appropriate therapy for you.

Switching from systemic glucocorticoid (anti-inflammatory) therapy (i.e.

taken orally, intramuscularly or intravenously) to inhaled glucocorticoid therapy
If you need to switch from glucocorticoid (anti-inflammatory) treatment by systemic route (for example orally) to treatment with glucocorticoids by inhalation, your doctor will gradually reduce the dosage of the systemic glucocorticoid you are taking. In this phase you may experience general malaise such as muscle and/or joint pain. In rare cases, symptoms such as fatigue, depression, headache, nausea and vomiting may appear.
You may experience these symptoms even if lung function is maintained or even improved. If you experience these symptoms, your doctor will continue the therapy with Pulmaxan, and will ask you to undergo blood tests to evaluate the functionality of your adrenal glands (glands located above the kidneys that are able to produce different types of hormones). Based on the functionality of your adrenal glands, your doctor may temporarily increase the dose of the systemic glucocorticoid you are taking, and the switch to Pulmaxan will be able to proceed subsequently, more slowly.
If you are subjected to physical stress (for example in case of severe infections, trauma or surgery) or have a severe asthma attack during this transition phase, your doctor may prescribe you supplementary treatment with systemic glucocorticoids (for example by systemic route).
Furthermore, switching from systemic glucocorticoid treatment to inhalation therapy can cause allergies, such as rhinitis and eczema (irritation and inflammation of the nose or skin), which were previously controlled by the drug administered by systemic route.
If this happens, consult your doctor who will prescribe you the appropriate therapy to control these symptoms.

Oral candidiasis (thrush, a mouth infection
Oral candidiasis may occur during therapy with inhaled glucocorticoids. If this happens, contact your doctor. The doctor will prescribe you the appropriate therapy and, if necessary, will interrupt the treatment (see also section 3 “How to take Pulmaxan”).

Possible undesirable effects of inhaled glucocorticoids (anti-inflammatory drugs) if

used at high doses for prolonged periods
Inhaled glucocorticoids can cause undesirable effects. In particular, if used at high doses for prolonged periods, the following undesirable effects can occur: Cushing's syndrome and Cushingoid appearance (disease characterized by excessive production of a glucocorticoid hormone, cortisol, which manifests with a full moon face, weight gain, fluid retention, reduced sugar tolerance and increased risk of diabetes, swelling of the legs, headache, etc.), adrenal suppression (severe impairment of the activity of the adrenal glands), reduction of bone mass, cataracts (clouding of the lens, the lens of the eye that is used to focus images), glaucoma (eye disease caused by an increase in the pressure of the fluid contained inside the eye).
These effects are less likely to occur than with treatment with glucocorticoids taken orally.
Rarely, a series of psychological and behavioral effects can occur, including psychomotor hyperactivity (behavioral disorder manifested by excessive motor activity), sleep disturbances, anxiety, depression, aggression, behavioral disorders.
Therefore, based on the above, it is important that you take the dose as prescribed and do not increase or decrease the dose without first consulting your doctor (see section 3 “How to take Pulmaxan”).

Paradoxical bronchospasm
As happens with other therapies administered by inhalation, paradoxical bronchospasm (unexpected narrowing of the bronchi that causes severe breathing difficulties due to reduced air passage) with an immediate increase in wheezing (difficulty breathing accompanied by a whistling sound) can occur after administration. In this case, you should consult your doctor immediately, who may, if necessary, interrupt the treatment with inhaled budesonide. The doctor will assess whether to start alternative therapy, if necessary.

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

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

Influence on growth
The use of inhaled glucocorticoids can affect the growth of children and adolescents (see section “Additional undesirable effects in children and adolescents”). Therefore, it is recommended that the height of children undergoing prolonged treatment with inhaled glucocorticoids be periodically checked by the doctor. If growth is slowed, the doctor will re-evaluate the therapy in order to reduce the dose of glucocorticoids by inhalation. The doctor will carefully assess the benefits of glucocorticoid therapy and the possible risk of growth arrest. If necessary, the doctor will advise you to consult a pediatric pulmonologist (pediatrician specializing in the treatment of respiratory diseases).

In addition, in rare cases, prolonged treatment with inhaled glucocorticoids can 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 of budesonide with any other drug used in the treatment of asthma have been observed.
In particular, tell your doctor or pharmacist if you are taking:

• ketoconazole and itraconazole (medicines used to treat fungal infections) (see section “Warnings and precautions”)
• medicines that contain hormones (estrogens) or oral contraceptives (the pill)

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.

• Studies conducted do not indicate an increased risk of adverse effects on the health of the fetus/newborn with the use of budesonide for inhalation 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 for the administration of budesonide during pregnancy, as the doctor needs to assess the expected benefits for the mother against the risks for the fetus
• Budesonide passes into breast milk. However, at the recommended doses of Pulmaxan, no effects on the infant are expected. Budesonide can be used during breastfeeding.

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

3. How to take Pulmaxan

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask 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 a day. If necessary, your doctor may increase the dose of Pulmaxan (see the dosage table).

MAINTENANCE DOSE
The maintenance dose is individual.
Once asthma control is achieved, the maintenance dose should be the minimum dose that allows effective control of symptoms: your doctor will gradually reduce the medicine until the minimum dose is reached.

DOSAGE TABLE

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

ONSET OF EFFECT
Improvement in asthma control following the administration of Pulmaxan may occur within 3 days of starting treatment, although the maximum benefit is obtained after 2-4 weeks.

Patients treated with oral glucocorticoids (anti-inflammatory drugs)
With the use of Pulmaxan, it is possible to replace or significantly reduce the dose of glucocorticoids taken orally, while maintaining asthma control.
The transition from oral glucocorticoid therapy to Pulmaxan will be evaluated by the doctor based on your general condition.
For about 10 days, your doctor will prescribe a high dose of Pulmaxan to be taken in association with the oral medicine you are already taking.
After that, your doctor will gradually reduce the dose of the oral medicine to the lowest possible level. In many cases, it is possible to completely replace oral therapy with Pulmaxan. For further information, see paragraph “Warnings and precautions”.

DOSE DIVISION AND MIXING
Pulmaxan can be mixed with 0.9% saline solution (saline) and with nebulization solutions of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate or ipratropium (medicines used for the treatment of respiratory disorders).
The mixture must be used within 30 minutes.
If it is necessary to adjust the dose of Pulmaxan, the contents of the single-dose vial can be divided.
In fact, on the 2 ml containers of Pulmaxan 0.25 mg/ml suspension for nebulizer and Pulmaxan 0.5 mg/ml suspension for nebulizer, a 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, you must pour the contents of the single-dose vial until the surface of the liquid reaches the indicated line.
The opened single-dose container, still containing some liquid, must be stored in the sachet, away from light, and must be used within 12 hours.
Before using the remaining liquid, carefully shake the contents with a rotating movement.
Once the aluminum sachet is opened, the still-closed containers have a validity of 3 months and must be kept in the sachet protected from light.

Use in children and adolescents
ASTHMA

Children from 6 months of life

• The dosage of Pulmaxan is individual.

The recommended initial dose is 0.25-0.5 mg per day. If necessity recurs, your doctor may increase the dose of Pulmaxan.
SUBGLOTTIC LARYNGITIS OR PSEUDOCROUP (for severe forms requiring hospital admission)

Infants and children

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

Pulmaxan must be used with caution in children (see paragraph “Children and adolescents”).

INSTRUCTIONS FOR CORRECT USE OF PULMAXAN
Pulmaxan must be used with a jet nebulizer. The vapors produced by the nebulizer are inhaled through the mouth through a mouthpiece or suitable facial mask.
The nebulizer must consist of: a compressor (a pump) capable of generating an adequate air flow (5-8 L/min) and a chamber (a reservoir), in which the solution of the medicine is placed, with a volume of 2-4 ml.
Ultrasonic nebulizers are not suitable for the administration of Pulmaxan.

INSTRUCTIONS FOR USE

• 1) Gently shake the single-dose container with a rotating movement.
• 2) Hold the single-dose container in a vertical position (see the figure) and open by rotating the tab until the single-dose vial is opened.

• 3) Place the open end of the single-dose container well into the nebulizer reservoir and press slowly.
• 4) Before turning on the nebulizer, read the instructions for use carefully.

If you have any doubts about using the nebulizer, contact your doctor or pharmacist.

NOTES:

• 1) After inhalation, rinse your mouth with water to minimize the risk of oropharyngeal candidiasis (thrush, mouth and throat infection).

• 2) If you use a facial mask to inhale the vapor, make sure the mask fits well during nebulization. After using the facial mask, wash your face with water to prevent irritation.
• 3) Clean and maintain the nebulizer according to the instructions provided by the manufacturer.

CLEANING THE NEBULIZER
The nebulizer reservoir must be cleaned after each administration. Wash the nebulizer chamber 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 inhaler.

If you take more Pulmaxan than you should
Accidental administration of an excessive dose of Pulmaxan should not cause discomfort.
In case of accidental administration of an excessive dose of Pulmaxan, immediately inform your doctor or go to the nearest hospital.

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

If you stop taking 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)

• candidiasis of the oropharynx (thrush, infection of the mouth and throat)
• nausea
• cough, hoarseness (when the voice is strident or low), throat irritation
• pneumonia (lung infection), in patients with COPD (common side effect). Tell your doctor if you have any of the following symptoms while taking budesonide, they may be symptoms of a lung infection:
• Fever or chills.
• Increased mucus production, changes in mucus color.
• Increased cough or greater difficulty breathing.

Uncommon (may affect up to 1 in 100 people)

• cataract (clouding of the lens, the eye lens used to focus images)
• depression
• anxiety
• tremor
• muscle spasm (sudden and 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 that usually manifests with redness, blisters, bubbles, abrasions and scabs), urticaria (skin redness accompanied by itching), angioedema (swelling) and anaphylactic reaction (severe allergic reaction)
• signs and symptoms of glucocorticoid effects systemically (i.e. taken orally, intramuscularly or intravenously), including adrenal suppression (severe impairment of the activity of the adrenal glands)
• restlessness, nervousness, behavioral changes, sleep disorders, psychomotor hyperactivity (behavioral disorder manifested by excessive motor activity), aggression
• bronchospasm (narrowing of the bronchi causing difficulty breathing due to reduced airflow)
• ecchymosis (bruises), striae cutaneae (stretch marks on the skin, reddish-purple in color)

*Skin irritation of the face, as an example of an allergic reaction, has occurred in
some cases when a nebulizer with a mask has been used. To prevent
facial skin irritation, wash your face with water after using the face
mask.

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

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

• slowing of growth
• dysphonia (difficulty producing voice), hoarseness (when the voice is strident or low)
• behavioral disorders.

Given the risk of growth retardation in the pediatric patient population,
growth should be monitored as described in the “Children and
Adolescents” section.

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
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 which is reported on the pack after Scad.
• Do not store at a temperature above 30°C. The product must be stored in an upright position.
• Keep the containers in the aluminum pouch to protect the medicine from light. Do not freeze.
• After opening the aluminum pouch, the unopened containers must be stored in the pouch, protected from light and used within 3 months. The single-dose container, once opened, must be used within 12 hours.
• 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

Pulmaxan 0,125 mg/ml suspension for nebuliser

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

Pulmaxan 0,25 mg/ml suspension for nebuliser

• the active ingredient is: budesonide (each 2 ml 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.

Pulmaxan 0,5 mg/ml suspension for nebuliser

• the active ingredient is :budesonide (each 2 ml 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 Pulmaxan and contents of the pack
Pulmaxan is presented as a white or almost
white nebulisation suspension.
Each pack: Pulmaxan 0,125 mg/ml suspension for nebuliser,
Pulmaxan 0,25 mg/ml suspension for nebuliser
Pulmaxan 0,5 mg/ml suspension for nebuliser
contains 4 aluminium pouches.
Each aluminium pouch contains 5 containers.
Each single-dose container contains 2 ml of nebulisation suspension.
Overall, each pack of Pulmaxan contains 20 containers.
On each single-dose container of Pulmaxan 0,25 mg/ml suspension for nebuliser
and Pulmaxan 0,5 mg/ml suspension for nebuliser a line is clearly visible. When
the single-dose container is held upside down, the line indicates a volume equal to 1 ml.
Not all pack sizes may be marketed.

Marketing Authorisation 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)