Nebulin

Package Leaflet: Information for the Patient

NEBULIN, 0.5 mg/2 mL, Nebulizer Suspension

NEBULIN, 1 mg/2 mL, Nebulizer Suspension

Budesonide

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

Keep this leaflet, you may need to read it again.
In case of any doubts, consult a doctor or pharmacist.
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.
If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist.
See section 4.

Table of Contents of the Leaflet

What is Nebulin and what is it used for
Important information before using Nebulin
How to use Nebulin
Possible side effects
How to store Nebulin
Contents of the pack and other information

What is Nebulin and what is it used for

Budesonide, the active substance of Nebulin, belongs to a group of medicines called corticosteroids. These medicines have local anti-inflammatory effects.
Nebulin is used to treat:

• bronchial asthma, in patients who require long-term administration of corticosteroids to control the inflammatory process in the respiratory system, when the use of pressurized inhalers (pMDI) or dry powder inhalers (DPI) is unsatisfactory or unjustified;
• croup syndrome - acute laryngitis, tracheitis, and bronchitis, regardless of etiology (cause of the disease), associated with significant narrowing of the upper airways, shortness of breath, or "barking" cough, leading to respiratory disorders;
• exacerbation of chronic obstructive pulmonary disease (COPD), when the use of budesonide in the form of a nebulizer suspension is justified. COPD is a chronic lung disease that causes shortness of breath and cough.

2. Important Information Before Using Nebulin

When Not to Use Nebulin

If the patient is hypersensitive (allergic) to budesonide or any of the other ingredients of this medicine (listed in section 6).
The patient should inform their doctor about any worrying reactions that have occurred after taking a medicine containing budesonide or any other ingredient of the medicine.

Warnings and Precautions

Before starting treatment with Nebulin, the patient should discuss it with their doctor.
Nebulin is intended for long-term treatment, but it does not provide quick relief of acute asthma attacks, for which short-acting bronchodilators are indicated.
If there is no noticeable improvement after using short-acting bronchodilators or if their use becomes more frequent than usual, the patient should consult their doctor.
In such cases, the doctor may consider using more effective anti-inflammatory treatment, for example, by increasing the dose of inhaled budesonide or starting oral corticosteroid treatment.
Particular caution is required when switching from oral corticosteroids to inhaled corticosteroids. During this period, transient adrenal insufficiency may occur.
Patients who have required emergency treatment with high doses of oral corticosteroids or long-term treatment with the maximum recommended doses of inhaled corticosteroids are also at increased risk of adrenal insufficiency when exposed to stressful situations.
The patient should inform their doctor about anticipated stressful situations (e.g., exams) or planned surgical procedures. The doctor may consider increasing the dose of oral corticosteroids.
Note.If the treatment is switched from oral corticosteroids to Nebulin in the form of a nebulizer suspension, the following symptoms may temporarily occur: runny nose, rash, muscle and joint pain. In the case of allergic reactions, such as runny nose or rash, the doctor may prescribe antihistamines and/or local-acting medicines. If any of the occurring symptoms are severe or worrying, or if symptoms such as headache, fatigue, nausea, or vomiting occur, the patient should contact their doctor. The doctor may recommend a temporary increase in the dose of oral corticosteroids.
Regular monitoring of growth in children and adolescents taking corticosteroids, regardless of the route of administration, is recommended due to the risk of growth retardation. If growth is slowed, the doctor may verify the treatment by reducing the dose of corticosteroids.
Before starting treatment, the patient should inform their doctor about other diseases or conditions, especially:
active or recently experienced infections;
liver function disorders.
The patient should also consult their doctor if the above warnings apply to past situations.
As with other inhaled medicines, paradoxical bronchospasm may occur immediately after using Nebulin. In case of a severe reaction, the patient should stop using the medicine and consult their doctor immediately.
During treatment with inhaled corticosteroids, fungal infections in the mouth may occur. Such infections may require appropriate antifungal therapy and, in some patients, discontinuation of inhaled corticosteroids.
The patient should also consult their doctor if the symptoms of the disease do not improve despite regular use of the recommended doses of the medicine.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Children

The medicine can be used to treat bronchial asthma in children from 6 months of age. The doctor will determine the dose of the medicine individually for each patient.

Nebulin and Other Medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, including those that are available without a prescription, as well as any medicines they plan to take.
The patient should inform their doctor about any worrying reactions that have occurred after taking other medicines.
Particularly, the patient should inform their doctor about any antifungal medicines they are currently taking, such as ketoconazole or itraconazole (which are potent inhibitors of the CYP 3A4 isoenzyme), and HIV protease inhibitors, such as ritonavir and atazanavir, which may increase the concentration of budesonide in the blood. If concomitant use of such medicines with Nebulin is necessary, the interval between doses of individual medicines should be as long as possible, and the doctor may recommend reducing the dose of budesonide. Some medicines may enhance the effect of Nebulin, and the doctor may want to monitor the patient's condition closely when taking such medicines (including some HIV medicines: ritonavir, cobicistat).
No interaction between budesonide and other medicines used to treat bronchial asthma has been observed.

Pregnancy and Breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.
If a woman treated with Nebulin becomes pregnant, she should not stop treatment on her own but should inform her doctor as soon as possible.

Driving and Using Machines

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

3. How to Use Nebulin

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The dose of Nebulin in the form of a nebulizer suspension is determined individually by the doctor for each patient.
In case of doubts, the patient should consult their doctor again.
Nebulin in the form of a nebulizer suspension can only be used with a nebulizer (inhalation device). The medicine is introduced into the lungs during breathing through a mouthpiece or face mask.
Before using the medicine, the patient should carefully read the "Instructions for Use of Nebulin in the Form of a Nebulizer Suspension" at the end of the leaflet and follow the instructions.
The patient should remember to rinse their mouth with water after each inhalation. If a face mask was used, the patient should also wash their face after each inhalation.
Not all inhalation devices (nebulizers) are suitable for administering Nebulin in the form of a nebulizer suspension.
Ultrasonic nebulizers should not be used.

Asthma

Initial Dose

Recommended initial dose for children from 6 months of age: the total daily dose is from 0.25 mg to 0.5 mg. If the child is taking an oral corticosteroid, the doctor may increase the daily dose to 1 mg if necessary.
Recommended initial dose for adults and the elderly: from 1 mg to 2 mg per day.
The doctor may change the dose after some time.

Maintenance Dose

The smallest effective maintenance dose should be used.
Children from 6 months of age: the total daily dose is from 0.25 mg to 2 mg.
Adults, including the elderly: the total daily dose is from 0.5 mg to 4 mg.
If the symptoms are very severe, the doctor may increase the dose of the medicine.
If the daily dose is up to 1 mg, the medicine can be administered once a day in the morning or evening.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.
If the patient's condition improves, the doctor may decide to reduce the dose of the medicine.
Improvement in the patient's condition after using Nebulin may occur after a few hours from the start of treatment. The full therapeutic effect is achieved after a few weeks from the start of treatment.
Nebulin should be used even when symptoms of the disease are not present.
Patients treated with oral corticosteroids
Nebulin in the form of a nebulizer suspension may be prescribed to a patient who is taking oral corticosteroids.
Nebulin in the form of a nebulizer suspension can partially or completely replace oral corticosteroids while maintaining the same or increased efficacy of treatment. The gradual reduction of the oral corticosteroid dose should be recommended by the doctor.
During the transition from oral corticosteroids to inhaled corticosteroids, the patient should be in a stable condition.
For 10 days, it is recommended to use high doses of Nebulin in combination with the previously used oral corticosteroid at an unchanged dose. Then, the dose of the oral corticosteroid should be gradually reduced by about 2.5 mg of prednisolone or an equivalent dose of another corticosteroid per month to the smallest dose that controls the symptoms of the disease. Often, the use of oral corticosteroids can be completely stopped.
Budesonide administered to the patient in the form of a nebulizer suspension is delivered to the lungs during inhalation. It is very important that the patient performs calm, even inhalations through the nebulizer mouthpiece or face mask.

Croup Syndrome

The usual dose used in infants and children with croup syndrome is 2 mg of budesonide administered in the form of a nebulizer suspension. This dose can be administered in its entirety 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.

Exacerbations of COPD

Based on limited clinical trial data, the recommended dose of Nebulin, nebulizer suspension, is from 4 to 8 mg per day, divided into 2 to 4 doses. Treatment should be continued until clinical improvement is achieved, but it is not recommended to continue treatment for more than 10 days.
Administration Method
Nebulin can be mixed with a 9 mg/mL (0.9%) sodium chloride injection solution.
The prepared mixture should be used within 30 minutes.
The dose in the container can be divided to achieve the desired dose.
The containers are single-dose units and are marked with a horizontal line (Nebulin 0.5 mg/2 mL and 1 mg/2 mL). When the container is inverted, this line indicates a volume of 1 mL. If only 1 mL is to be used, the liquid above the indicator line should be removed. The opened container should be stored in a protective foil without light exposure. The contents of the opened container should be used within 24 hours.
*Dilute to 2 mL with 0.9% sodium chloride solution.

Read the instructions for cleaning and disinfecting the nebulizer.

Nebulin can be mixed with a 9 mg/mL (0.9%) sodium chloride injection solution.

Using a Higher Than Recommended Dose of Nebulin

It is important that the patient uses the medicine as directed in the leaflet or as recommended by the doctor. The patient should not increase or decrease the dose of the medicine without consulting their doctor.
In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.
If a higher dose of Nebulin than recommended has been used once, it is unlikely to have harmful effects.
If doses higher than those recommended by the doctor have been taken for a longer period, there is a possibility of side effects such as those that occur with oral corticosteroids, i.e., increased levels of adrenal hormones in the blood and suppression of adrenal function. In this case, the doctor should recommend continuing treatment with Nebulin in doses that keep the symptoms of asthma under control.

Missing a Dose of Nebulin

If a dose of Nebulin in the form of a nebulizer suspension recommended by the doctor is missed, there is no need to make up for the missed dose. The patient should take the next dose of the medicine as directed by the doctor. The patient should not take a double dose to make up for the missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

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

If any of the following symptoms occur, the patient should stop using Nebulin and consult their doctor immediately:

swelling of the face, especially around the mouth, tongue, eyes, and ears, rash, itching, contact dermatitis

skin inflammation, hives, and bronchospasm (bronchial muscle spasm that causes wheezing). This may indicate an allergic reaction. This side effect is rare (may occur in less than 1 in 1,000 people);
sudden onset of wheezing after inhaling the medicine. This side effect is rare (may occur in less than 1 in 1,000 people).

Other Possible Side Effects:

Common (may affect up to 1 in 10 people)

Oral thrush (fungal infections). To reduce the risk of their occurrence, the patient should rinse their mouth with water after using Nebulin.
Sore throat, cough, and hoarseness, loss of voice.
Pneumonia (lung infection) in patients with COPD.
The patient should tell their doctor if any of the following symptoms occur during treatment with budesonide; these may be symptoms of pneumonia:
fever or chills;
increased production of sputum, change in sputum color;
worsening cough or increased breathing difficulties.

Uncommon (may affect up to 1 in 100 people)

Cataract (clouding of the lens of the eye).
Blurred vision.
Muscle cramps.
Muscle tremors.
Depression.
Anxiety.

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

Rash on the face after using a face mask. This can be prevented by washing the face with water after using the face mask.
Nervousness, changes in behavior (mainly in children).
Easy bruising.
Hoarseness and loss of voice (in children).

Side Effects with Unknown Frequency (frequency cannot be estimated from available data)

Sleep disturbances, anxiety, excessive agitation, aggression.
The use of inhaled corticosteroids may affect the normal production of steroid hormones in the body, especially if used for a long time in high doses. The following symptoms may occur:
glaucoma (increased intraocular pressure), frequency unknown;
growth retardation in children and adolescents (rare);
adrenal gland problems (rare).
The occurrence of these symptoms after using inhaled corticosteroids is less likely than after taking oral corticosteroids.

Reporting Side Effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to Store Nebulin

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP:". The expiry date refers to the last day of the month.
Store in the original packaging to protect from light.
Shelf life after opening the sachet: 3 months
Shelf life after opening the container: 24 hours
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 Pack and Other Information

What Nebulin Contains

• The active substance of Nebulin is budesonide. 1 mL of the nebulizer suspension contains 0.25 mg or 0.5 mg of micronized budesonide. 1 single-dose container contains 0.5 mg or 1 mg of budesonide in 2 mL of nebulizer suspension.
• The other ingredients are: disodium edetate, sodium chloride, polysorbate 80, citric acid, sodium citrate, water for injections, hydrochloric acid 10% or sodium hydroxide 10% (to adjust pH).

What Nebulin Looks Like and Contents of the Pack

Nebulin is a white, homogeneous suspension with a pH of 4.0-5.0, in a single-dose container.
Pack size:
10 or 20 single-dose containers of 2 mL each.
The single-dose container is made of LDPE in a sachet of PET/Aluminum/PE in a cardboard box.
2 or 4 sachets containing 5 containers each.

Marketing Authorization Holder and Manufacturer

Polfarmex S.A.
Józefów 9
99-300 Kutno
Phone: +48 24 357 44 44
Fax: +48 24 357 45 45
Email: [email protected]

Manufacturer

GENETIC S.p.A.
Contrada Canfora
84084 Fisciano (SA)
Italy
Date of last revision of the leaflet:

Instructions for Use of Nebulin in the Form of a Nebulizer Suspension

Before use, the contents of the container should be gently shaken for 30 seconds.
Hold the container vertically and open it by twisting the "wing".
Attach the open end of the container to the nebulizer reservoir and slowly squeeze it out.
The single-dose containers containing 0.5 mg/2 mL and 1 mg/2 mL are marked with a horizontal line. When the container is inverted, this line indicates a volume of 1 mL. If only 1 mL is to be used, the liquid above the indicator line should be removed.
Before using the rest of the medicine, the contents of the container should be gently mixed.

• The patient should record the date of opening the sachet with aluminum foil. The patient should not use the single-dose containers after 3 months from the date of opening the aluminum foil.
• The prepared mixture should be used within 30 minutes.
• The medicine should be stored at a temperature below 30°C.
• The containers should always be stored in a sachet with aluminum foil to protect from light. If the entire contents of the container are not used at once, the remaining amount should be protected from light.
• The containers should be stored in a vertical position.

WARNING

• 1. The patient should rinse their mouth after each use of the medicine.
• 2. If the patient uses a face mask, they should check that the mask fits tightly to the face during inhalation. The patient should wash their face after using the medicine.

CLEANING

The nebulizer chamber, mouthpiece, or face mask should be washed after each use.
These parts should be washed with warm running water using a mild detergent recommended by the nebulizer manufacturer. The nebulizer chamber should then be rinsed well and dried by connecting the compressor to the outlet.