Budixon Neb

Leaflet attached to the packaging: patient information

BUDIXON NEB, 0.25 mg/mL, nebulizer suspension

BUDIXON NEB, 0.5 mg/mL, nebulizer suspension

Budesonide

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 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 Budixon Neb and what is it used for
• 2. Important information before using Budixon Neb
• 3. How to use Budixon Neb
• 4. Possible side effects
• 5. How to store Budixon Neb
• 6. Contents of the packaging and other information

1. What is Budixon Neb and what is it used for

Budesonide, the active substance of Budixon Neb, belongs to a group of medicines called corticosteroids. Medicines in this group have local anti-inflammatory effects. Budixon Neb is used:

• in patients with bronchial asthma who require long-term administration of corticosteroids to control the inflammatory process in the respiratory system. The cause of asthma is inflammation of the respiratory system. Nebulizers are recommended when the use of pressurized inhalers (pMDI) or powder inhalers (DPI) is unsatisfactory or unjustified.
• in patients with croup syndrome - acute laryngitis, tracheitis, and bronchitis, regardless of etiology, associated with significant narrowing of the upper airways, shortness of breath, or "barking" cough, leading to respiratory disorders.
• in patients for the treatment of exacerbation of chronic obstructive pulmonary disease (COPD), in cases where 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 Budixon Neb

When not to use Budixon Neb

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

Tell your 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 Budixon Neb, discuss it with your doctor. Budixon Neb is intended for long-term treatment, but it does not provide quick relief from acute asthma attacks, in which the administration of short-acting bronchodilators is indicated. If there is no noticeable improvement after using short-acting bronchodilators or if they need to be used more frequently than usual, consult your doctor. In such cases, the doctor may consider 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 products. 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. Inform your doctor about anticipated stressful situations (e.g., exams) or planned surgical procedures. The doctor may consider increasing the dose of oral corticosteroids. Warning. If the treatment is changed from oral corticosteroids to Budixon Neb 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 antihistamine medications and/or local-acting medications. If any of the symptoms are severe or worrying, or if symptoms such as headache, fatigue, nausea, or vomiting occur, consult your doctor. The doctor may recommend temporary increases 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 method by reducing the dose of corticosteroids. Before starting treatment, inform your doctor about other diseases or conditions, especially:

• active or recent infections,
• liver function disorders. Consult your doctor also if the above warnings apply to past situations.

Like other inhaled medicines, paradoxical bronchospasm may occur immediately after using Budixon Neb. If a severe reaction occurs, discontinue the medicine and consult your doctor immediately. During the use of inhaled corticosteroids, fungal infections in the mouth may occur. Such infections may require appropriate antifungal therapy and, in some patients, discontinuation of inhaled corticosteroids. Also, consult your 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, consult your doctor.

Children

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

Budixon Neb and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, including those that are available without a prescription, as well as any medicines you plan to take. Inform your doctor about worrying reactions that have occurred after taking other medicines. Especially, inform your doctor about currently taken antifungal medicines, such as ketoconazole or itraconazole (these 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 Budixon Neb is necessary, the interval between doses of individual medicines should be as long as possible, and the doctor may also recommend reducing the dose of budesonide. No interaction of budesonide with other medicines used to treat bronchial asthma has been observed.

Pregnancy and breastfeeding

Pregnancy If you are pregnant or plan to have a child, consult your doctor before using this medicine – do not use the medicine unless your doctor recommends it. If a woman treated with Budixon Neb becomes pregnant, she should not stop treatment on her own but should consult her doctor as soon as possible. Breastfeeding If you are breastfeeding, consult your doctor before using this medicine.

Driving and using machines

Budixon Neb does not affect the ability to drive or use machines.

3. How to use Budixon Neb

This medicine should always be used as recommended by your doctor. The dose of Budixon Neb in the form of a nebulizer suspension is determined by the doctor individually for each patient. If you have any doubts, consult your doctor again. Budixon Neb 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, carefully read the "Instructions for using Budixon Neb in the form of a nebulizer suspension" at the end of the leaflet and follow the instructions. Remember to rinse your mouth with water after each inhalation. If a face mask was used, rinse your face after each inhalation as well. Not all inhalation devices (nebulizers) are suitable for administering Budixon Neb in the form of a nebulizer suspension. Do not use ultrasonic nebulizers.

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 another 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 dosage after some time.

Maintenance dose

It is recommended to use the smallest effective maintenance dose. 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 you feel that the effect of the medicine is too strong or too weak, consult your 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 Budixon Neb may occur after a few hours of starting treatment. The full therapeutic effect is achieved after a few weeks of starting treatment. Budixon Neb should be used even when symptoms of the disease are not present. Patients treated with oral corticosteroids Budixon Neb in the form of a nebulizer suspension may be prescribed to a patient who is taking oral corticosteroids. Budixon Neb in the form of a nebulizer suspension can partially or completely replace oral corticosteroids with the same or increased efficacy of treatment. The doctor should recommend a gradual reduction in the dose of the oral medicine. During the change from oral corticosteroids to inhaled products, the patient should be in a stable condition. It is recommended to use high doses of Budixon Neb in combination with the previously used oral corticosteroid in an unchanged dose for 10 days. 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 ensures control of the disease symptoms. 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 during treatment.

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. 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, for a maximum of 36 hours or until the patient's condition improves.

Exacerbations of COPD

Based on limited data from clinical trials, the recommended dose of Budixon Neb, 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.

Dosing method

Budixon Neb can be mixed with 0.9% sodium chloride solution and solutions of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate, or ipratropium. The prepared mixture should be used within 30 minutes. The container with the unused suspension should be discarded immediately.

Using a higher than recommended dose of Budixon Neb

It is essential to use the medicine as directed in the leaflet or as recommended by your doctor. Do not increase or decrease the dose of the medicine without consulting your doctor. If a higher dose of the medicine is taken than recommended, consult your doctor or pharmacist immediately. If a dose of Budixon Neb higher than recommended is used once, it should not have harmful effects. If doses higher than those recommended by the doctor are 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 Budixon Neb in doses that keep the symptoms of bronchial asthma under control.

Missing a dose of Budixon Neb

If a dose of Budixon Neb recommended by the doctor is not taken, it is not necessary to make up for the missed dose. Take the next dose of the medicine as recommended by your doctor. Do not take a double dose to make up for the missed dose. If you have any further doubts about using 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.

If you experience any of the following symptoms, stop using Budixon Neb and consult your doctor immediately:

Budixon Neb and consult your doctor immediately:

• swelling of the face, especially around the mouth, tongue, eyes, and ears, rash, itching, contact dermatitis, urticaria, and bronchospasm (constriction of the muscles in the airways, which causes wheezing). This may indicate an allergic reaction. This side effect is rare (less than 1 in 1,000 people).
• sudden onset of wheezing after inhaling the medicine. This side effect is rare (less than 1 in 1,000 people).

Other possible side effects:

Common (occurring in less than 1 in 10 people)

• thrush (fungal infections) in the mouth. To reduce the risk of their occurrence, rinse your mouth with water after using Budixon Neb.
• sore throat, cough, and hoarseness, loss of voice.

• pneumonia (lung infection) in patients with COPD. Tell your doctor if you experience any of the following symptoms while using budesonide; these may be symptoms of a lung infection:
• fever or chills
• increased production of mucus, change in the color of mucus
• worsening cough or increased breathing difficulties.

Uncommon (occurring in less than 1 in 100 people)

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

Rare (occurring in less than 1 in 1,000 people)

• rash on the face after using a face mask. This can be prevented by rinsing 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 disorders, anxiety, excessive agitation, aggression.

The use of inhaled corticosteroids may affect the normal production of steroid hormones in the body, especially if they are used for a long time in high doses. Side effects such as:

• glaucoma (increased intraocular pressure), frequency not known.
• growth retardation in children and adolescents (rare).
• effect on the adrenal glands (a small gland near the kidneys) (rare). The occurrence of these side effects after using inhaled corticosteroids is less likely than after taking oral corticosteroids.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring 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 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 Budixon Neb

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after: Expiry date (EXP). Store the medicine at a temperature below 30°C. Do not freeze. Keep the medicine in its original packaging to protect it from light. Shelf life after first opening: 3 months from the opening of the aluminum pouch. The contents of the single-dose plastic container should be used within 24 hours of opening. After reconstitution or dilution: the mixture should be used within 30 minutes. Medicines should not be disposed of via wastewater or household waste. 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 Budixon Neb contains

• The active substance of the medicine is budesonide. 1 mL of the nebulizer suspension contains: 0.25 mg or 0.5 mg of micronized budesonide. 1 plastic container contains 0.5 mg in 2 mL of the nebulizer suspension or 1 mg of budesonide in 2 mL of the nebulizer suspension.
• Other ingredients are: disodium edetate, sodium chloride, polysorbate 80, anhydrous citric acid, sodium citrate, water for injections.

What Budixon Neb looks like and contents of the packaging

Budixon Neb is a suspension with a color from white to almost white in a single-dose plastic container. Packaging size: 10 or 20 containers of 2 mL (2 or 4 sealed pouches containing 5 containers each) in a cardboard box.

Marketing authorization holder:

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów tel. +48 22 732 77 00

Manufacturer:

Adamed Pharma S.A. Pieńków, ul. M. Adamkiewicza 6A 05-152 Czosnów GENETIC S.p.A. Nucleo Industriale, Contrada Canfora, 84084 Fisciano (SA) Italy

Date of last revision of the leaflet:

Instructions for using Budixon Neb in the form of a nebulizer suspension

• 1. Before using the contents of the plastic container, gently mix it by rotating the container.
• 2. Hold the plastic container with the medicine vertically and open it by twisting the "wing".
• 3. Attach the open end of the container to the nebulizer reservoir and slowly squeeze it out.

Before using the rest of the medicine, gently mix the contents of the container.

• Write down the date of opening the aluminum pouch. Do not use the plastic single-dose containers after 3 months from the date of opening the aluminum pouch.
• The prepared mixture should be used within 30 minutes.
• Store the medicine at a temperature below 30°C.
• Always store the plastic containers with the medicine in the aluminum pouch to protect them from light. If the entire contents of the plastic container are not used at once, protect the remaining amount from light.
• Store the plastic containers with the medicine in a vertical position.

WARNING

• 1. Rinse your mouth after each use of the medicine.
• 2. If you use a face mask, make sure it fits tightly to your face during inhalation. Rinse your face after using the medicine.

CLEANING

Wash the nebulizer chamber, mouthpiece, or face mask after each use. These parts should be washed with warm running water using a mild detergent recommended by the nebulizer manufacturer. Then, rinse the nebulizer chamber thoroughly and dry it by connecting the compressor to the outlet.