Bds n

Package leaflet: Information for the patient

BDS N, 0.125 mg/ml, suspension for nebulization
BDS N, 0.25 mg/ml, suspension for nebulization
BDS N, 0.5 mg/ml, suspension for nebulization
Budesonide
Please read the entire leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What BDS N is and what it is 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 pack and other information

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

What BDS N is
BDS N is a suspension for nebulization containing the active substance budesonide. Budesonide
belongs to a group of medicines known as "glucocorticosteroids".

What BDS N is used for
BDS N is used in the treatment of:

• Asthma, when use of a pressurized or dry powder inhaler is inappropriate;
• Croup syndrome – acute laryngotracheobronchitis, regardless of etiology, associated with significant narrowing of the upper airways, dyspnea, or "barking" cough, leading to breathing difficulties;
• Exacerbations of chronic obstructive pulmonary disease (COPD), when nebulized budesonide is indicated. COPD is a chronic obstructive lung disease causing shortness of breath and cough.

BDS N, suspension for nebulization, is NOT indicated for the treatment of acute bronchospasm
(constriction of muscles in the airways causing wheezing and difficulty breathing) and dyspnea.

How BDS N works
When inhaled, BDS N reaches the lungs directly and reduces and prevents swelling and inflammation in the lungs.

2. Important information before using BDS N

When not to use BDS N

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

Warnings and precautions
Before starting to use BDS N, discuss this with your doctor or pharmacist.
Contact your doctor immediately:

• if breathing difficulties worsen or if the patient frequently wakes up 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 adequately controlled and that immediate additional or alternative treatment may be necessary.

Continue using BDS N, but contact your doctor as soon as possible:

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

Before using BDS N, inform your doctor or pharmacist:

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

Contact your doctor if blurred vision or other visual disturbances occur.

BDS N and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
In particular, inform your doctor or pharmacist if the patient is using 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, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
• If the patient becomes pregnant while using BDS N, do not stop using this medicine, but inform the doctor as soon as possible.

Driving and operating machinery
Budesonide has no influence on the ability to drive or operate machinery.

BDS N contains sodium:
This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, i.e. the medicine is considered "sodium-free".

3. How to use BDS N

BDS N is administered by inhalation.
This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Asthma treatment

When appropriate doses of BDS N cannot be achieved, medicines with different strengths are available.

• The doctor will determine the dose of the medicine appropriate for the patient and will advise how long treatment with BDS N should continue. This will depend on the severity of asthma. Improvement in health may occur as early as two days after starting the medicine; however, achieving full therapeutic effect may take up to four weeks. The doctor may reduce the dose of the medicine to the lowest effective dose that prevents asthma symptoms from occurring.
• It is important to use BDS N every day, even if asthma symptoms are not present at the time.
• The maximum daily dose (2 mg budesonide) for infants and children under 12 years of age should be used only in children with severe asthma and for a limited period of time.

Treatment of croup
The usual dose for infants and children with croup is 2 mg budesonide. This dose may be administered as a single dose or divided into two doses of 1 mg given 30 minutes apart. This dosing regimen may be repeated every 12 hours, up to a maximum of 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 renal or hepatic impairment
There is no evidence of differences in budesonide efficacy in patients with renal or hepatic impairment.
Method of administration
Inhalation use.
Preparation for inhalation
If the patient is being treated at home, prior to first use of the medicine, the patient should consult a doctor or pharmacist who will demonstrate how to inhale BDS N using a nebulizer. Children should use the nebulizer under adult supervision.
To inhale the nebulizer suspension of BDS N, an inhalation system must be used – the PARI LC PLUS nebulizer equipped with a mouthpiece or an appropriate face mask (PARI Baby mask with PARI Baby bend head strap) and the PARI Boy (SX) air compressor.
Note: ULTRASOUND NEBULIZERS MUST NOT BE USED for administration of BDS N.
Carefully read the instructions for using the nebulizer.
Using an alternative, untested nebulization system may alter the amount of active substance inhaled into the lungs, which in turn may affect the efficacy and safety of the medicine. Dose adjustment may then become necessary.
Instructions for use of BDS N

1. Separate the required number of ampoules from the strip. Keep the remaining ampoules in the sachet.
2. Gently shake the ampoule(s) for 30 seconds.
3. Holding the ampoule in an upright position, unscrew the top part of the ampoule(s).
4. Pour the prescribed amount of medicine into the nebulizer chamber.
5. Discard the empty ampoule(s). Close the nebulizer cap.
6. Attach the face mask or mouthpiece to the nebulizer chamber according to the nebulizer's instructions for use.
7. Connect the nebulizer tubing to the air compressor.
8. Turn on the air compressor. Using the face mask or mouthpiece, breathe calmly and deeply through the mist, sitting or standing in an upright position. If the patient uses a face mask, ensure that the mask fits properly.
9. The patient will notice when the inhalation is complete, as the "mist" will no longer be visible in the mouthpiece or face mask.
10. Nebulization time depends on the type of equipment used and will also depend on the nebulization solution volume used.
11. After inhalation, a few drops of medicine will remain in the nebulizer.
12. Rinse the mouth with water. Spit out the water. Do not swallow. If a face mask was used, wash the face as well.
13. After each use, wash the nebulizer medicine chamber, mouthpiece, and face mask (if applicable).

Unused nebulizer suspension should be discarded immediately.
It is important to always follow the manufacturer's instructions regarding cleaning
and disinfection of the nebulizer.
BDS N may be mixed with 9 mg/ml (0.9%) sodium chloride injection solution. The mixture should be used within 30 minutes.
Use of a dose higher than recommended of BDS N
It is important that the medicine is taken according to the package leaflet or the doctor's instructions. Do not increase or decrease the dose without consulting a doctor. If a single dose higher than recommended is taken, continue treatment as usual. If a dose higher than recommended is taken more than once, contact a doctor or pharmacist immediately.
Missed dose of BDS N
If the patient forgets to take a dose at the scheduled time, skip the missed dose and take the next dose as usual. Do not use a double dose to make up for a missed dose.
If there are any further doubts regarding the use of the medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
If any of the following adverse effects occur, stop using
BDS N and contact your doctor immediately:
Rare: occurs in fewer than 1 in 1,000 people
facial swelling, particularly around the mouth (with possible swelling of the lips, tongue, eyes, ears), itching,
skin rash or irritation (contact dermatitis), urticaria, bronchospasm
(constriction of the muscles in the airways causing wheezing). This may indicate that
the patient has experienced an allergic reaction.
Very rare: occurs in fewer than 1 in 10,000 people

• sudden wheezing after inhalation of the medicine.

Uncommon: occurs in fewer than 1 in 100 people

• blurred vision.

Other possible adverse effects:
Common: occurs in fewer than 1 in 10 people

• fungal infection (fungal infection) in the mouth. This is less likely if the patient rinses the mouth with water after using BDS N
• mild sore throat, cough, and hoarseness
• pneumonia (lung infection) in patients with COPD.

Patients using budesonide should inform their doctor if symptoms of
lung infection occur, such as:

• fever or cold-like symptoms
• increased production of sputum, change in sputum color
• worsening cough or increased difficulty breathing.

Rare: occurs in fewer than 1 in 1,000 people

• skin rash on the face after using a face mask. Washing the face after using the mask helps prevent these symptoms.
• sleep disorders, restlessness, anxiety, hyperactivity, and irritability. These symptoms are more likely to occur in children.
• bruising
• loss of voice
• slowed growth in children and adolescents
• effects on adrenal glands (small glands next to the kidneys).

Uncommon: occurs in fewer than 1 in 100 people

• depression or feelings of anxiety
• tremor
• cataract (clouding of the eye lens)
• muscle cramps.

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

• glaucoma (increased pressure in the eye).

Inhaled glucocorticosteroids may affect the physiological production of steroid hormones
in the body, especially when high doses are used over a prolonged period. Adverse effects include:

• changes in bone mineral density (reduced bone density)
• cataract (clouding of the eye lens)
• glaucoma (increased pressure in the eye)
• effects on adrenal glands (small glands next to the kidneys).

Budesonide suspension for nebulization should be used before meals to reduce
potential adverse effects on the throat.
Reporting adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store BDS N

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging,
sachet, and ampoule after EXP. The expiry date refers to the last day of the stated month.
Do not freeze.
Store in the original packaging to protect from light.
Shelf-life after first opening of the sachet: 3 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What BDS N contains
The active substance in BDS N is budesonide.
BDS N, 0.125 mg/ml, suspension for nebulisation
Each 2 ml ampoule contains 0.25 mg of budesonide.
BDS N, 0.25 mg/ml, suspension for nebulisation
Each 2 ml ampoule contains 0.5 mg of budesonide.
BDS N, 0.5 mg/ml, suspension for nebulisation
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 injections.

What BDS N looks like and contents of the pack

• Each ampoule contains a white to almost white suspension for nebulisation.
• Packs of 5 ampoules in a strip are enclosed in a foil sachet, which is then placed in a cardboard box.

Pack sizes:
10, 20 ampoules in a cardboard box.
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D lok.27
01-909 Warsaw
Poland
Manufacturer:
GENETIC S.P.A.
Nucleo Industriale,
Contrada Canfora, 84084 Fisciano (SA)
Italy