Budiair

Patient Information Leaflet

Budiair, 200 micrograms/dose, inhalation aerosol, solution
package with standard inhaler
Budesonidum
Please read all of this leaflet carefully before you start using the medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents:

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

1. What Budiair is and what it is used for

Budiair is available as a solution in an inhalation aerosol, intended for inhalation through the mouth directly into the lungs. The active substance in Budiair is budesonide, which belongs to a group of medicines called corticosteroids, commonly referred to simply as steroids. These medicines have anti-inflammatory effects, reducing swelling and irritation of the airway mucosa.
Budiair is a preventive medicine: it treats inflammation and is used to prevent asthma symptoms. Budiair does not relieve asthma attacks. In such cases, a fast-acting inhaled bronchodilator should be used, which should always be kept available.
Budiair is indicated for:
Treatment of mild, moderate, and severe chronic bronchial asthma.

2. Important information before using Budiair

When not to use Budiair

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

Consult your doctor.
Warnings and precautions
Before starting treatment with Budiair, discuss the following with your doctor:

• if the patient has severe liver disease,
• if the patient has peptic ulcer,
• if the patient is being treated or has ever been treated for pulmonary tuberculosis or other respiratory tract infections,
• if the patient is pregnant, planning to become pregnant, or breastfeeding.

During treatment, if oral candidiasis occurs, inform your doctor,
as antifungal treatment may be necessary or therapy may need to be discontinued. To
reduce the risk of oral candidiasis, see section 3. How to use Budiair.
In case of paradoxical bronchospasm with increased wheezing immediately after inhalation,
treatment must be stopped immediately.
If the patient experiences blurred vision or other visual disturbances, contact your doctor.
Children and adolescents
It is important to monitor growth in children receiving long-term treatment and to inform the doctor about it.
Budiair and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
It is especially important to inform your doctor about taking the following medicines:

• medicines containing corticosteroids,
• antifungal medicines such as ketoconazole and itraconazole,
• medicines containing disulfiram or metronidazole (see "Budiair contains glycerol and ethanol"),
• HIV protease inhibitors or other strong CYP3A4 inhibitors,
• Estrogens and steroid contraceptives.

Some medicines may increase the effect of Budiair, and your doctor may wish to closely monitor the patient's condition when taking such medicines (including certain HIV medicines: ritonavir, cobicistat).
If the patient is taking any of the above-mentioned medicines, the doctor may recommend
taking another medicine or adjusting the dose of Budiair or other concomitantly used medicines.
If an ACTH stimulation test is performed to diagnose pituitary insufficiency,
the results may be false (falsely low values).
Your doctor may recommend using other medicines to treat breathing problems. It is very
important to use them regularly and NOT DISCONTINUE their use or change the dosage when starting
treatment with Budiair.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
If the patient becomes pregnant while using Budiair, she should immediately inform
her doctor.
Worldwide experience with inhaled budesonide has not demonstrated an increased risk
of adverse effects in the fetus and newborn related to the use of budesonide during
pregnancy.
Budesonid may be used during breastfeeding.
Driving and operating machinery
It has not been established that Budiair may affect the ability to drive or operate machinery.
Budiair contains glycerol and ethanol.
This medicine contains 8.4 mg of alcohol (ethanol) per spray, equivalent to
0.12 mg/kg body weight per spray in adults and 0.42 mg/kg body weight in children. The amount of alcohol in one spray of this medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medicine will not cause noticeable effects.
Ethanol may interact with disulfiram or metronidazole in particularly sensitive patients taking this medicine.
This medicine contains glycerol: it may cause headache, gastrointestinal disturbances, and diarrhea.

3. How to use Budiair

Budiair is intended for inhalation use only.
This medicine should always be used as directed by the doctor. If in doubt, consult the doctor or pharmacist.
The doctor will recommend regular monitoring of asthma symptoms to ensure that the prescribed dose of Budiair is optimal.
The doctor will adjust the dosage individually for each patient depending on the severity of asthma symptoms. The doctor will determine the lowest possible dose (maintenance dose) that provides the best control of asthma symptoms. Under no circumstances should the prescribed dosage be changed without prior consultation with the doctor.
It is important to continue using Budiair for as long as the doctor advises. The effect of Budiair usually occurs within a few days of starting treatment. Therefore, it is very important to use the medicine regularly.

Adults and adolescents
The recommended dose is 200 micrograms (one spray) 2 to 4 times daily. The usual maintenance dose is 200 micrograms (one spray) per day.
The maximum daily dose of this medicine is 1600 micrograms.

Use in children
Children aged 6 to 12 years
The recommended dose is 200 micrograms (one spray) per day. The maximum daily dose is 400 micrograms.
If Budiair is prescribed for a child, ensure that the child uses the medicine correctly. Inhalation in children should always be supervised by an adult. Gently pinching the child's nostrils during inhalation may be helpful.

Use of corticosteroids
If the patient has recently started using Budiair instead of taking corticosteroid tablets, or if the patient has been using high doses of inhaled corticosteroids for a long time, higher steroid doses may be needed during periods of stress. Stress situations may include hospitalization after an accident, serious injury, or planned surgery. In such cases, the treating doctor may decide to prescribe additional corticosteroid doses in tablet form or by injection.

How to use Budiair
See “Instructions for use of the inhaler” at the end of this leaflet.
It is recommended to rinse the mouth with water after each inhalation to reduce the risk of developing a fungal infection of the mouth and throat.

Use of a higher than recommended dose of Budiair
It is important to use the medicine exactly as indicated on the label provided by the pharmacist or as directed by the doctor. Do not increase or decrease the dose without consulting the doctor. If a higher than recommended dose of Budiair is used, contact the doctor as soon as possible.

Missed dose of Budiair
If a dose is missed, take the next dose at the usual scheduled time. Do not use a double dose to make up for a missed dose.

Stopping Budiair treatment
Do not stop using Budiair, even if the patient feels better, unless advised otherwise by the doctor. Abruptly stopping treatment with Budiair may cause worsening of asthma symptoms.

In case of worsening asthma symptoms
If symptoms worsen or become difficult to control (e.g. more frequent use of a reliever inhaler), or if there is no improvement after using a fast-acting bronchodilator inhaler, contact the doctor immediately. This may indicate an asthma exacerbation, and the doctor may decide that a change in the Budiair dosage or alternative treatment is necessary.
When switching from oral steroid treatment to Budiair, despite improvement in breathing, a decline in general well-being may be observed. Inform the treating doctor about this, but DO NOT STOP treatment unless otherwise advised by the doctor.

If there are any further questions about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
The adverse reactions that occur are usually mild and temporary. However, some of them may be severe and require medical intervention.
Possible adverse reactions are listed below:
Common (may occur in 1 out of 10 patients):
Hoarseness, cough, sore throat, oral and pharyngeal fungal infection (candidiasis), difficulty swallowing.
Uncommon (may occur in 1 out of 100 patients):
Anxiety, depression, tremor, cataract, blurred vision, and muscle spasms.
Rare (may occur in 1 out of 1000 patients):
Easy bruising, skin thinning, rash or hives, skin inflammation, itching, skin redness (erythema), anaphylactic reaction, angioedema, excess or deficiency of blood cortisol (adrenal cortex hyperfunction or adrenal cortex insufficiency), narrowing of the airways (bronchospasm).
Restlessness, nervousness, irritability, psychiatric disorders (psychosis), and behavioral changes. These are more likely in children.
Very rare (may occur in 1 out of 10,000 patients):
Distorted or diminished taste sensation (taste disturbances), nausea, tongue pain, inflammation of the oral mucosa, dryness of the oral mucosa, back pain.
Frequency not known (frequency cannot be estimated from available data):
Sleep problems, aggressive reactions, increased motor activity (mainly in children). Increased intraocular pressure (glaucoma).
Rare severe allergic reactions:
If, immediately after taking the medicine, itching occurs or an allergic reaction with symptoms such as skin redness, facial swelling, very low blood pressure, and irregular heartbeat (anaphylactic reaction), swelling of the face, eyes, lips, tongue, and throat, or breathing difficulties (angioedema), or early- and late-type hypersensitivity reactions:

• discontinue use of Budiair immediately,
• contact your physician immediately.
  Breathing difficulties immediately after administration of Budiair:
  Rarely, with inhaled medicines, immediately after administration, worsening of wheezing and breathing difficulties (bronchospasm) may occur. In such a case:
• immediately discontinue administration of Budiair,
• use a fast-acting inhaled bronchodilator to relieve breathlessness and wheezing,
• contact your physician immediately.

Long-term use of inhaled corticosteroids at high doses may lead to systemic effects:
In rare cases, growth retardation in children and adolescents, adrenal function disorders (suppression of adrenal function), and very rarely decreased bone mineral density (osteoporosis) may occur.
Sleep disturbances are more likely in children, but their frequency is unknown.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Budiair

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and the outer carton. The expiry date refers to the last day of the specified month.
• Store below 25 °C.
• The container holds a pressurised solution. Do not pierce the container, do not expose it to heat, even after it has been emptied, and do not freeze or expose it directly to sunlight.
• Medicines should not be disposed of 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 Budiair contains:
The active substance is budesonide. Each metered dose contains 200 micrograms of budesonide.
Other ingredients are: norflurane (HFC 134a), anhydrous ethanol and glycerol.
This medicine contains fluorinated greenhouse gases. Each inhaler contains 11.200 g of norflurane (HFC 134a), equivalent to 0.016 tonnes of CO₂-equivalent (global warming potential GWP = 1430).

What Budiair looks like and contents of the pack:
Budiair is available as a solution for inhalation, contained in a pressurised aluminium container fitted with a plastic spray device.
Each pack contains one inhaler delivering 200 metered doses.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Chiesi Farmaceutici S.p.A, Via Palermo 26/A, 43122 Parma, Italy
Manufacturer
Chiesi Farmaceutici S.p.A, Via S. Leonardo 96, 43122 Parma, Italy
Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria
All-Gen Pharmaceuticals & Generics BV, Rouboslaan 32, 2252 TR Voorschoten, Netherlands

For detailed information about this medicine and its names in the European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
Chiesi Poland Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw
Tel.: (22) 620 14 21, Fax: (22) 652 37 79, e-mail: [email protected]

This medicinal product is authorised for sale in the following countries of the European Economic Area under the following names:
Italy Budiair
Greece Budiair
Netherlands Budesonide All-Gen
Poland Budiair
Czech Republic Budiair
Slovenia Budiair

INHALER INSTRUCTIONS FOR USE:
Budiair is easy to use. To ensure correct use of the inhaler, please read the instructions below carefully.
The effectiveness of treatment depends on correct use of the inhaler.

Test of proper inhaler function: Before first use, or if the inhaler has not been used for 3 days or longer, remove the protective cap from the mouthpiece by gently squeezing its sides, then spray once into the air to ensure the inhaler is working properly.

Unpacking
After opening the cardboard box, the inhaler mouthpiece should be protected by the cap.

Taking a dose of Budiair
Figure 1-2 Hold the inhaler between your thumb and index finger, with the mouthpiece pointing downwards. Remove the protective cap from the mouthpiece.
Figure 3 a-b Breathe out slowly (3a), then place the mouthpiece firmly between your lips (3b).
Figure 4 a-b-c Breathe in deeply and slowly through your mouth while pressing down once on the top of the canister (4a). After inhaling, hold your breath as long as possible (4b). After taking the number of doses prescribed by your doctor, replace the protective cap on the inhaler mouthpiece (4c).
When administering to a child, gently pinching the child's nostrils may be helpful.

Cleaning the inhaler:
The mouthpiece should always be kept clean. To do this, remove the metal canister from the plastic housing and rinse the mouthpiece with lukewarm water. Leave to dry in a warm place.

Package leaflet: information for the user

Budiair, 200 micrograms/dose, inhalation aerosol, solution
pack with Jet spacer chamber
Budesonidum
Please read all of this leaflet carefully before you start using this medicine,
.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Leaflet contents:

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

1. What Budiair is and what it is used for

Budiair is available as a solution in an inhalation aerosol, intended for oral inhalation directly into the lungs. The active substance is budesonide, which belongs to a group of medicines called corticosteroids, commonly referred to as steroids. These medicines have anti-inflammatory effects, reducing swelling and irritation of the airway lining.
Budiair is a preventive medicine: it treats inflammation and is used to prevent asthma symptoms. Budiair does not relieve asthma attacks. In such cases, a fast-acting inhaled bronchodilator should be used, which you should always carry with you.
Budiair is indicated for:
Treatment of mild, moderate and severe chronic bronchial asthma.

2. What you need to know before using Budiair

When not to use Budiair

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

Consult your doctor.
Warnings and precautions
Before starting treatment with Budiair, discuss with your doctor:

• if you have severe liver disease,
• if you have peptic ulcer,
• if you are being treated or have ever been treated for tuberculosis or other respiratory tract infections,
• if you are pregnant, planning to become pregnant or breastfeeding.

During treatment, if you develop oral candidiasis, inform your doctor, as antifungal treatment or discontinuation of therapy may be necessary. To reduce the risk of oral candidiasis, see section 3. How to use Budiair.
If paradoxical bronchospasm with increased wheezing occurs immediately after taking the medicine, treatment must be stopped immediately.
If you experience blurred vision or other visual disturbances, contact your doctor.

Children and adolescents
It is important to monitor the growth of children undergoing long-term treatment and to inform the doctor about it.

Budiair with other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, including those obtained without a prescription, and any medicines you plan to take.
It is especially important to inform your doctor about taking:

• medicines containing corticosteroids,
• antifungal medicines such as ketoconazole and itraconazole,
• medicines containing disulfiram or metronidazole (see “Budiair contains glycerol and ethanol”),
• HIV protease inhibitors or other strong CYP3A4 inhibitors,
• Estrogens and steroid contraceptives.

Some medicines may increase the effect of Budiair, and your doctor may wish to monitor you closely if you are taking such medicines (including some HIV medicines: ritonavir, cobicistat).
If you are taking any of the above medicines, your doctor may recommend taking a different medicine or adjusting the dose of Budiair or other concomitant medicines.
If an ACTH stimulation test is performed to diagnose pituitary insufficiency, the results may be falsely low.
Your doctor may recommend other medicines to treat breathing problems. It is very important to take them regularly and NOT to stop or change the dose when starting Budiair.

Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant or plan to have a baby, consult your doctor or pharmacist before using this medicine.
If you become pregnant while taking Budiair, inform your doctor immediately.
Worldwide experience with inhaled budesonide has not demonstrated an increased risk of adverse effects on the foetus and newborn associated with budesonide use during pregnancy.
Budesonide may be used during breastfeeding.

Driving and using machines
Budiair has not been shown to affect the ability to drive or operate machinery.

Budiair contains glycerol and ethanol
This medicine contains 8.4 mg of alcohol (ethanol) per spray, equivalent to 0.12 mg/kg body weight per spray in adults and 0.42 mg/kg body weight in children. The amount of alcohol in each spray is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medicine will not cause noticeable effects.
Ethanol may interact with disulfiram or metronidazole in particularly sensitive patients taking this medicine.
This medicine contains glycerol: may cause headache, stomach disturbances and diarrhoea.

3. How to use Budiair

Budiair is intended for inhalation use.
Always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Your doctor will recommend regular monitoring of asthma symptoms to ensure the dose of Budiair is optimal.
Your doctor will adjust the dose individually depending on the severity of asthma symptoms. Your doctor will determine the lowest possible dose (maintenance dose) that provides the best asthma symptom control. Under no circumstances should you change the prescribed dose without consulting your doctor first.
It is important to continue using Budiair for as long as your doctor recommends. The effect of Budiair usually occurs within a few days of starting treatment. Therefore, it is very important to take the medicine regularly.

Adults and adolescents
Recommended dose: 200 micrograms (one spray) 2 to 4 times daily. The usual maintenance dose is 200 micrograms (one spray) daily.
Maximum daily dose is 1600 micrograms.

Use in children
Children aged 6 to 12 years
Recommended dose: 200 micrograms (one spray) daily. Maximum daily dose is 400 micrograms.
If Budiair is prescribed for a child, ensure the child uses the medicine correctly. Inhalation in children should always be supervised by an adult.

Taking corticosteroids
If you have just started using Budiair instead of oral corticosteroid tablets, or if you have been taking high doses of inhaled corticosteroids for a long time, you may need higher steroid doses during periods of stress. Stress situations include hospitalisation after an accident, serious injury or planned surgery. In such cases, your doctor may decide to prescribe additional corticosteroid tablets or injections.

How to use Budiair
See “Instructions for use of the inhaler” at the end of this leaflet.
Rinsing the mouth with water after each inhalation is recommended to reduce the risk of fungal infection of the mouth and throat.

Taking more than the recommended dose of Budiair
It is important to take doses as indicated on the label from the pharmacist or as prescribed by your doctor. Do not increase or decrease the dose without consulting your doctor. If you take more than the recommended dose of Budiair, contact your doctor as soon as possible.

Missing a dose of Budiair
If you miss a dose, take the next dose at the usual scheduled time. Do not take a double dose to make up for a missed dose.

Stopping Budiair treatment
Do not stop using Budiair, even if you feel better, unless your doctor advises otherwise. Stopping Budiair suddenly may worsen asthma symptoms.

Worsening asthma symptoms
If your symptoms worsen or become difficult to control (e.g. more frequent use of a reliever inhaler), or if you do not improve after using a fast-acting inhaled bronchodilator, contact your doctor immediately. This may indicate worsening asthma, and your doctor may decide to adjust the dose of Budiair or change treatment.
When switching from oral steroids to Budiair, despite improved breathing, you may experience worsening well-being. Inform your doctor but DO NOT stop treatment unless advised otherwise.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are usually mild and temporary. However, some may be serious and require medical intervention.
Possible side effects are listed below:

Common (may affect up to 1 in 10 people):
Hoarseness, cough, sore throat, oral candidiasis (fungal infection of the mouth and throat), difficulty swallowing.

Uncommon (may affect up to 1 in 100 people):
Anxiety, depression, tremor, cataract, blurred vision, muscle cramps.

Rare (may affect up to 1 in 1,000 people):
Easy bruising, skin thinning, rash or urticaria, skin inflammation, itching, skin redness (flushing), anaphylactic reaction, angioedema, excess or deficiency of cortisol in the blood (adrenal cortex hyperfunction or hypofunction), narrowing of the airways (bronchospasm).
Restlessness, nervousness, irritability, psychiatric disorders (psychosis) and behavioural changes. These are more likely in children.

Very rare (may affect up to 1 in 10,000 people):
Impaired or reduced taste sensation (taste disturbances), nausea, tongue pain, inflammation of the oral mucosa, dryness of the oral mucosa, back pain.

Frequency not known (cannot be estimated from available data):
Sleep problems, aggressive reactions, increased motor activity (mainly in children). Increased intraocular pressure (glaucoma).

Rare but serious allergic reactions:
If, immediately after taking the medicine, you experience itching or an allergic reaction with symptoms such as: skin redness, facial swelling, very low blood pressure and irregular heartbeat (anaphylactic reaction), facial, eye, lip, tongue or throat swelling or breathing difficulties (angioedema), or early or late hypersensitivity reactions:

• stop taking Budiair immediately,
• contact your doctor immediately.

Breathing difficulties immediately after using Budiair:
Rarely, with inhaled medicines, shortly after administration, worsening wheezing and breathing difficulties (bronchospasm) may occur. In such cases:

• stop using Budiair immediately,
• use a fast-acting inhaled bronchodilator to relieve breathlessness and wheezing,
• contact your doctor immediately.

Long-term use of high-dose inhaled corticosteroids may lead to systemic effects: in rare cases, growth retardation in children and adolescents and adrenal dysfunction (suppression of adrenal function), very rarely reduced bone mineral density (osteoporosis).
Sleep disturbances are more likely in children, but frequency is unknown.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the Marketing Authorisation Holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Budiair

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and cardboard box. The expiry date refers to the last day of the stated month.
• Store below 25°C.
• The container holds contents under pressure. Do not pierce, expose to heat (even after emptying), freeze or expose to direct sunlight.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This helps protect the environment.

6. Contents of the pack and other information

What Budiair contains:
The active substance is budesonide. Each metered dose contains 200 micrograms of budesonide.
Other ingredients are: norflurane (HFC-134a), anhydrous ethanol and glycerol.
This medicine contains fluorinated greenhouse gases. Each inhaler contains 11.200 g of norflurane (HFC 134a), equivalent to 0.016 tonnes of CO₂-equivalent (global warming potential GWP = 1430).

What Budiair looks like and contents of the pack:
Budiair is available as a solution for inhalation, contained in a pressurised aluminium container fitted with a Jet spacer chamber.
Each pack contains one inhaler delivering 200 metered doses.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Chiesi Farmaceutici S.p.A, Via Palermo 26/A, 43122 Parma, Italy
Manufacturer
Chiesi Farmaceutici S.p.A, Via S. Leonardo 96, 43122 Parma, Italy
Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, 1010 Vienna, Austria
All-Gen Pharmaceuticals & Generics BV, Rouboslaan 32, 2252 TR Voorschoten, Netherlands

For detailed information about this medicine and its names in the European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
Chiesi Poland Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw
Tel.: (22) 620 14 21, Fax: (22) 652 37 79, e-mail: [email protected]

This medicinal product is authorised for sale in the following countries of the European Economic Area under the following names:
Italy Budiair
Greece Budiair
Netherlands Budesonide All-Gen
Poland Budiair
Czech Republic Budiair
Slovenia Budiair

INHALER INSTRUCTIONS FOR USE:
Budiair is easy to use. To ensure correct use of the inhaler, please read the instructions below carefully.

Unpacking
Figure 1. After opening the cardboard box, the Jet spacer chamber should have its mouthpiece protected by the cap.

Taking a dose of Budiair
Figure 2. Remove the protective cap from the mouthpiece of the Jet spacer chamber, holding the device as shown in the illustration.
Figure 3 a-b Breathe out slowly (3a), then place the mouthpiece firmly between your lips (3b).
Figure 4 Press down on the top of the canister with your index finger and inhale deeply, even after a few seconds have passed (you may take more than one breath through the inhaler with Jet spacer chamber).
Figure 5 a-b After inhaling, hold your breath as long as possible (5a), then replace the protective cap on the mouthpiece of the Jet spacer chamber (5b).

Cleaning the inhaler:
Figure 6. The Jet spacer chamber should be kept clean. To do this, remove the metal canister from the plastic housing and rinse the device with lukewarm water. Leave to dry in a warm place. Avoid excessive heating.
1 2 3a 3b
4 5a 5b 6