Bds N

Leaflet attached to the packaging: patient information

BDS N, 0.125 mg/ml, nebulizer suspension

BDS N, 0.25 mg/ml, nebulizer suspension

BDS N, 0.5 mg/ml, nebulizer suspension

Budesonide

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is BDS N and what is it used for

What is BDS N

BDS N is a nebulizer suspension that contains the active substance budesonide. Budesonide belongs to a group of medicines called "glucocorticosteroids".

What is BDS N used for

BDS N is used to treat:

• asthma, when the use of a pressure inhaler or powder inhaler is not appropriate,
• croup syndrome - acute laryngitis, tracheitis, bronchitis - regardless of etiology, associated with significant narrowing of the upper airways, shortness of breath, or "barking" cough, leading to breathing difficulties,
• exacerbation of chronic obstructive pulmonary disease (COPD), when the use of nebulized budesonide is justified, and COPD is a chronic obstructive pulmonary disease that causes shortness of breath and cough.

BDS N, nebulizer suspension IS NOT indicated for the treatment of acute bronchospasm (constriction of the muscles in the airways, which causes wheezing) and shortness of breath.

How does BDS N work

When inhaled, BDS N directly enters the lungs, reducing and preventing swelling and inflammation of the lungs.

2. Important information before using BDS N

When not to use BDS N

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

Warnings and precautions

Before starting to use BDS N, the patient should discuss it with their doctor or pharmacist. The patient should contact their doctor immediately:

• if breathing difficulties worsen or if the patient wakes up frequently at night due to asthma
• if the patient experiences chest tightness in the morning or if chest tightness lasts longer than usual. These symptoms may indicate that the patient's condition is not properly controlled, and that it may be necessary to use another or additional treatment.

The patient should continue to use BDS N, but contact their doctor as soon as possible:

• if the patient experiences shortness of breath or wheezing, as additional treatment may be necessary.

Before using BDS N, the patient should inform their doctor or pharmacist:

• if the patient has pneumonia, is experiencing a cold, or has a chest infection
• if the patient has liver disease.

The patient should contact their doctor if they experience blurred vision or other vision disturbances.

BDS N and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, the patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• steroid medicines
• medicines used to treat fungal infections (such as itraconazole or ketoconazole)
• HIV protease inhibitors, such as ritonavir and nelfinavir (in patients with AIDS)

Pregnancy and breastfeeding

• If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
• If the patient becomes pregnant while using BDS N, they should not stop using the medicine, but should inform their doctor as soon as possible.

Driving and using machines

Budesonide does not affect the ability to drive or use machines.

BDS N contains sodium:

The medicine contains less than 1 mmol (23 mg) of sodium per ampoule, which means that the medicine is considered "sodium-free".

3. How to use BDS N

BDS N is used by inhalation. The patient should always use the medicine exactly as their doctor has told them. If they are unsure, they should consult their doctor or pharmacist. Asthma treatment

In case it is not possible to adjust the dose of BDS N, medicines with other strengths are available.

• The doctor will determine the dose of the medicine suitable for the patient and tell them how long the treatment with BDS N will last. This will depend on the severity of the asthma. Improvement in the patient's condition may occur after two days of starting to take the medicine, but it may take up to four weeks to achieve the full therapeutic effect. The doctor may reduce the dose of the medicine to the smallest effective dose that prevents the symptoms of asthma from occurring.
• It is essential to use BDS N every day, even if the symptoms of asthma do not occur at that time.
• The maximum daily dose (2 mg of budesonide) for infants and children under 12 years of age should only be used in children with severe asthma and for a limited period.

Treatment of croup syndrome

The usual dose used in infants and children with croup syndrome is 2 mg of budesonide. This dose can be given in one administration or divided into two doses of 1 mg each, administered at 30-minute intervals. This dosing regimen can be repeated every 12 hours, up to 36 hours or until the patient's condition improves.

Treatment of COPD

Patients with COPD should use 1 mg to 2 mg of BDS N per day. The medicine should be taken in two separate single doses every 12 hours.

Patients with kidney or liver function disorders

There is no evidence of a difference in the efficacy of budesonide in patients with kidney or liver function disorders.

Method of administration

Inhalation.

Preparation for inhalation

If the patient is being treated at home, before the first administration of the medicine, they should talk to their doctor or pharmacist, who will show them how to inhale BDS N using a nebulizer. Children should use a nebulizer under adult supervision.

To inhale the BDS N nebulizer suspension, the patient should use an inhalation system - a PARI LC PLUS nebulizer equipped with a mouthpiece or a suitable face mask (PARI Baby mask with a Pari Baby bend) with a PARI Boy (SX) air compressor.

Note:ULTRASONIC NEBULIZERS SHOULD NOT BE USED TO ADMINISTER BDS N.

The patient should carefully read the instructions for using the nebulizer.

Using an alternative, untested nebulization system may change the amount of active substance inhaled into the lungs, which may affect the efficacy and safety of the medicine. Dose adjustment may be necessary.

Instructions for using BDS N

• 1. Separate the required number of ampoules from the strip. The remaining ampoules should be left in the sachet.
• 2. Shake the ampoule(s) gently for 30 seconds.
• 3. Holding the ampoule vertically, unscrew the top part of the ampoule(s).
• 4. Pour the prescribed dose of the medicine into the nebulizer chamber.
• 5. Discard the empty ampoule(s). Close the nebulizer cap.
• 6. Connect the face mask or mouthpiece to the nebulizer chamber, following the nebulizer's instructions.
• 7. Connect the nebulizer tip to the air compressor.
• 8. Turn on the air compressor. Using the face mask or mouthpiece, breathe in the "mist" calmly and deeply, sitting or standing upright. If the patient is using a face mask, they should ensure that it fits well.
• 9. The patient will notice when the inhalation of the medicine is finished, as no more "mist" will appear in the mouthpiece or face mask.
• 10. The duration of the nebulization depends on the type of equipment used and the volume of the nebulizer solution used.
• 11. After inhalation, a few drops of the medicine will remain in the nebulizer.
• 12. Rinse the mouth with water. Spit out the water. Do not swallow. If a face mask is used, the patient should also wash their face.
• 13. After each use, the patient should wash the nebulizer tank and mouthpiece (or face mask).

Any unused nebulizer suspension should be discarded immediately.

It is essential to always follow the manufacturer's instructions regarding the cleaning and disinfection of the nebulizer.

BDS N can be mixed with a 9 mg/ml (0.9%) sodium chloride solution for injection. The mixture should be used within 30 minutes.

Using a higher dose of BDS N than recommended

It is essential to take the medicine as prescribed in the leaflet or by the doctor. The patient should not increase or decrease the dose without consulting their doctor. If the patient has taken a higher dose of BDS N than recommended once, they can continue the treatment as usual. If the patient has taken a higher dose of BDS N than recommended more than once, they should contact their doctor or pharmacist immediately.

Missing a dose of BDS N

If the patient forgets to take a dose of the medicine at the scheduled time, they should skip the missed dose and take the next dose as usual. The patient should not take a double dose to make up for the missed dose.

If the patient has any further doubts about using the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, BDS N can cause side effects, although not everybody gets them.

If any of the following side effects occur, the patient should stop using BDS N and contact their doctor immediately:

Rare: occurs in less than 1 in 1000 people

facial swelling, particularly in the mouth area (with possible swelling of the lips, tongue, eyes, ears), itching, skin rash or irritation (contact dermatitis), hives, bronchospasm (constriction of the muscles in the airways, which causes wheezing). This may indicate that the patient has had an allergic reaction.

Very rare: occurs in less than 1 in 10,000 people

• sudden wheezing after inhaling the medicine.

Uncommon: occurs in less than 1 in 100 people

• blurred vision.

Other possible side effects:

Common: occurs in less than 1 in 10 people

• thrush (fungal infection) in the mouth. This is less likely to happen if the patient rinses their mouth with water after taking BDS N
• mild sore throat, cough, and hoarse voice
• pneumonia (lung infection) in patients with COPD.

The patient should inform their doctor if they experience symptoms of a lung infection, such as:

• fever or cold
• increased production of sputum or change in sputum color
• worsening cough or increased breathing difficulties.

Rare: occurs in less than 1 in 1000 people

• facial rash after using a face mask. Washing the face after using the face mask helps prevent this symptom.
• sleep disturbances, restlessness, nervousness, overexcitement, and irritability. These symptoms are more likely to occur in children.
• bruising
• loss of voice
• growth retardation in children and adolescents
• effect on the adrenal glands (small gland near the kidney).

Uncommon: occurs in less than 1 in 100 people

• depression or feeling anxious
• tremors
• cataract (clouding of the lens in the eye)
• muscle cramps.

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

• glaucoma (increased pressure in the eye).

Inhaled glucocorticosteroids may affect the physiological production of steroid hormones in the body, especially when using high doses for a long time. Side effects include:

• changes in bone mineral density (decrease in bone density)
• cataract (clouding of the lens in the eye)
• glaucoma (increased pressure in the eye)
• effect on the adrenal glands (small gland near the kidney).

Budesonide in the form of a nebulizer suspension should be used before meals to minimize potential side effects on the throat.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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, it is possible to gather more information on the safety of the medicine.

5. How to store BDS N

The medicine should be stored out of sight and reach of children.

The medicine should not be used after the expiry date stated on the outer packaging, sachet, and ampoule after EXP. The expiry date refers to the last day of the specified month.

The medicine should not be frozen.

The medicine should be stored in its original packaging to protect it from light.

Shelf life after opening the sachet: 3 months.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 does BDS N contain

The active substance of the medicine is budesonide.

BDS N, 0.125 mg/ml, nebulizer suspension

Each 2 ml ampoule contains 0.25 mg of budesonide.

BDS N, 0.25 mg/ml, nebulizer suspension

Each 2 ml ampoule contains 0.5 mg of budesonide.

BDS N, 0.5 mg/ml, nebulizer suspension

Each 2 ml ampoule contains 1 mg of budesonide.

• Other ingredients are: disodium edetate, sodium chloride, polysorbate 80, anhydrous citric acid, sodium citrate, and water for injection.

What does BDS N look like and what does the packaging contain

• Each ampoule contains a white to almost white nebulizer suspension.
• Sets of 5 ampoules in a strip are packaged in a foil sachet, which is then packaged in a cardboard box.

Package sizes:

10, 20 ampoules in a cardboard box.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok.27

01-909 Warsaw

Poland

Manufacturer:

GENETIC S.P.A.

Nucleo Industriale,

Contrada Canfora, 84084 Fisciano (SA)

Italy

Date of last revision of the leaflet: 01.2025