Budiair

Leaflet accompanying the packaging: information for the user

Budiair, 200 micrograms/dose, inhalation aerosol, solution

Budesonide

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for you.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Budiair and what is it used for

Budiair is available as an inhalation aerosol solution, intended for inhalation through the mouth, directly into the lungs. The active substance of the medicine is budesonide, which belongs to a group of medicines called corticosteroids, also known as steroids. Medicines in this group have anti-inflammatory effects, reduce swelling, and irritation of the mucous membranes of the airways.

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 carried with you.

Budiair is indicated for:

Treatment of mild, moderate, and severe chronic asthma.

2. Important information 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).

You should consult your doctor.

Warnings and precautions

Before starting treatment with Budiair, you should discuss it with your doctor:

• if you have severe liver disease,
• if you have a stomach ulcer,
• if you are being treated or have been treated for tuberculosis or other respiratory infections,
• if you are pregnant, plan to become pregnant, or are breastfeeding.

During therapy, if you develop oral thrush, you should tell your doctor, as antifungal treatment or discontinuation of therapy may be necessary. To reduce the risk of oral thrush, see section 3. How to use Budiair.

In the event of paradoxical bronchospasm with wheezing immediately after taking the medicine, treatment should be discontinued immediately.

If you experience blurred vision or other vision disturbances, you should contact your doctor.

Children and adolescents

It is essential to monitor the growth of children treated long-term and inform your doctor.

Budiair and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

It is particularly important to inform your doctor about taking medicines such as:

• corticosteroids,
• antifungal medicines, such as ketoconazole and itraconazole,
• medicines containing disulfiram or metronidazole (see "Budiair contains glycerol and ethanol"),
• HIV protease inhibitors or other potent CYP3A4 inhibitors,
• estrogens and contraceptive steroids.

Some medicines may enhance the effect of Budiair, and your doctor may want to monitor your condition closely when 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 changing the dose of Budiair or other concomitantly used medicines.

If an ACTH stimulation test is performed to diagnose adrenal insufficiency, the results may be false (reduced values).

Your doctor may recommend using other medicines to treat breathing problems. It is crucial to use them regularly and NOT TO STOP their use or change the dosage when starting treatment with Budiair.

Pregnancy, breastfeeding, and fertility

If you are pregnant, plan to become pregnant, or are breastfeeding, you should consult your doctor or pharmacist before using this medicine.

If you become pregnant while using Budiair, you should inform your doctor immediately.

Global experience with inhaled budesonide has not demonstrated an increased risk of adverse effects in the fetus and newborn associated with the use of budesonide during pregnancy.

Budesonide may be used during breastfeeding.

Driving and using machines

No effects on the ability to drive and use machines have been observed.

Budiair contains glycerol and ethanol

This medicine contains 8.4 mg of ethanol (alcohol) per actuation, which is equivalent to 0.12 mg/kg body weight per actuation in adults and 0.42 mg/kg body weight in children. The amount of alcohol in one actuation of this medicine is equivalent to less than 1 ml of beer or wine. The small amount of alcohol in this medicine is unlikely to have noticeable effects.

Ethanol may interact with disulfiram or metronidazole in particularly sensitive patients taking this medicine.

This medicine contains glycerol: it may cause headache, stomach upset, and diarrhea.

3. How to use Budiair

Budiair is intended for inhalation use.

This medicine should always be used as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.

Your doctor will recommend regular monitoring of your asthma symptoms to ensure that the dose of Budiair used is optimal.

Your doctor will adjust the dosage individually for each patient, depending on the severity of asthma symptoms. Your doctor will determine the lowest effective dose of the medicine (maintenance dose) that provides the best control of asthma symptoms. Under no circumstances should youchange the prescribed dosage without consulting your doctor first.

It is essential to use Budiair for as long as your doctor decides. The effect of Budiair usually occurs within a few days of starting treatment. Therefore, it is crucial to take the medicine regularly.

Adults and adolescents

The recommended dose is 200 micrograms (one actuation) 2 to 4 times a day. The maintenance dose usually is 200 micrograms (one actuation) per day.

The maximum daily dose of the medicine is 1600 micrograms.

Use in children

Children aged 6 to 12 years

The recommended dose is 200 micrograms (one actuation) per day. The maximum daily dose is 400 micrograms.

If Budiair is prescribed for a child, you should ensure that the child uses the medicine correctly. Inhalation in children should always be performed under adult supervision.

Corticosteroid use

If you have just started using Budiair instead of taking corticosteroid tablets or if you are taking high doses of inhaled corticosteroids for a long time, you may need to take higher doses of steroids in stressful situations. Such situations may include hospitalization after an accident, severe injury, or planned surgery. In these cases, your doctor may decide to use additional corticosteroids in tablets or injections.

How to use Budiair

See "Inhaler instruction" at the end of the leaflet.

Rinsing your mouth with water after each inhalation is recommended to reduce the risk of oral thrush.

Using more than the recommended dose of Budiair

It is essential to take the doses as indicated on the label or as directed by your doctor. Do not increase or decrease the dose without consulting your doctor. If you have used more than the recommended dose of Budiair, you should contact your doctor as soon as possible.

Missing a dose of Budiair

If you miss a dose, you should take the next dose at the usual planned time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Budiair

You should not stop using the medicine, even if you feel better, unless your doctor advises you to do so. Stopping treatment with Budiair abruptly may cause worsening of asthma symptoms.

If your asthma symptoms worsen

If your symptoms worsen or you experience difficulties in controlling them (e.g., more frequent use of inhaled bronchodilators) or if there is no improvement after using a fast-acting, inhaled bronchodilator, you should contact your doctor immediately. This may indicate worsening of asthma, and your doctor may decide to change the dosage of Budiair or use other treatments.

If you switch from oral steroids to Budiair, despite improvement in breathing, you may experience worsening of your overall condition. You should inform your doctor, but DO NOT STOPtreatment unless your doctor advises you to do so.

If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects that occur are usually mild and temporary. However, some of them may be severe and require medical attention.

Possible side effects are listed below:

Common(may affect up to 1 in 10 people):

Hoarseness, cough, throat irritation, oral thrush, difficulty swallowing.

Uncommon(may affect up to 1 in 100 people):

Anxiety, depression, tremors, cataracts, blurred vision, muscle spasms.

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

Easy bruising, thinning of the skin, rash or hives, skin inflammation, itching, redness of the skin, anaphylactic reaction, angioedema, excess or deficiency of cortisol in the blood, bronchospasm.

Anxiety, nervousness, irritability, psychiatric disorders, and behavioral changes. These effects are more likely to occur in children.

Very rare(may affect up to 1 in 10,000 people):

Abnormal or decreased taste, nausea, tongue pain, oral mucositis, dryness of the oral mucosa, back pain.

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

Sleep disturbances, aggressive reactions, increased motor activity (mainly in children). Increased intraocular pressure (glaucoma).

Rare but severe allergic reactions:

If you experience itching, an allergic reaction, with symptoms such as redness of the skin, facial swelling, very low blood pressure, and irregular heartbeat (anaphylactic reaction), facial swelling, eye swelling, lip swelling, tongue swelling, or throat swelling, or difficulty breathing (angioedema), early and late hypersensitivity reactions:

• you should stop using Budiair
• you should contact your doctor immediately.

Breathing difficulties immediately after using Budiair:

Rarely, in the case of inhaled medicines, immediately after their administration, worsening of wheezing and breathing difficulties (bronchospasm) may occur. In this case:

• you should stop using Budiair immediately
• you should use a fast-acting, inhaled bronchodilator to relieve shortness of breath and wheezing
• you should contact your doctor immediately.

Using inhaled corticosteroids in high doses for a long time may

cause systemic effects:in rare cases, growth retardation in children and adolescents, and adrenal gland disorders (adrenal insufficiency), very rarely, a decrease in bone mineral density (osteoporosis).

Sleep disturbances are more likely to occur in children, but their frequency is unknown.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Budiair

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the label and carton. The expiry date refers to the last day of the month stated.
• Store in a temperature below 25°C.
• The container contains a pressurized solution. Do not pierce the container, do not expose it to heat, even after it has been emptied, do not freeze it, or expose it to direct sunlight.
• Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Budiair contains:

The active substance of the medicine is budesonide. One dose contains 200 micrograms of budesonide.

The 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), which corresponds to 0.016 tons of CO2 equivalent (GWP = 1430).

What Budiair looks like and what the pack contains:

Budiair is available as an inhalation solution in a pressurized aluminum container with a Jet inhalation chamber.

Each pack contains one inhaler, which delivers 200 doses.

Marketing authorization holder and manufacturer

Marketing authorization 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

To obtain detailed information about the medicine and its names in the Member States of the European Economic Area, you should contact the local representative of the marketing authorization holder:

Chiesi Poland Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw

Tel.: (22) 620 14 21, Fax: (22) 652 37 79, Email: [email protected]

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Italy

Budiair

Greece

Budiair

Netherlands

Budesonide All-Gen

Poland

Budiair

Czech Republic

Budiair

Slovenia

Budiair

Date of leaflet approval:03/2025

INHALER INSTRUCTIONS:

Budiair is easy to use. To use the inhaler correctly, you should first read the following instructions.

The effectiveness of treatment depends on the correct use of the inhaler.

Test the inhaler before first use or if it has not been used for 3 days or more: remove the protective cap from the mouthpiece by gently squeezing the sides, then perform one actuation into the air to ensure the inhaler is working correctly.

Unpacking

After opening the carton, the mouthpiece of the inhaler should be covered with the protective cap.

Taking a dose of Budiair

Figure 1-2. Hold the inhaler between your thumb and index finger, with the mouthpiece facing downwards. Remove the protective cap from the mouthpiece.

Figure 3 a-b. Perform a slow exhalation (3a), then place the mouthpiece firmly between your lips (3b).

Figure 4 a-b-c. Perform a deep and slow inhalation through your mouth, simultaneously pressing the canister once (4a). After inhalation, hold your breath for as long as possible (4b). After taking the prescribed number of doses, replace the protective cap on the mouthpiece (4c).

When using the inhaler in children, it may be helpful to pinch the child's nostrils shut.

Cleaning the inhaler:

The mouthpiece should always be kept clean. To do this, remove the metal container from the plastic casing and rinse the mouthpiece with warm water. Let it dry in a warm place.