Budixon Neb

Leaflet accompanying the packaging: patient information

BUDIXON NEB, 0.125 mg/ml, nebulizer suspension

BUDIXON NEB, 0.250 mg/ml, nebulizer suspension

BUDIXON NEB, 0.500 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 necessary.
• 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 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 glucocorticosteroids. Medicines in this group have local anti-inflammatory effects. Budixon Neb is used to treat:

• asthma, when the use of a pressure inhaler or powder inhaler is not suitable.
• 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.
• 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.

Budixon Neb is not indicated for relieving acute asthma attacks or asthmatic conditions and shortness of breath.

2. Important information before using Budixon Neb

When not to use Budixon Neb

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 case the use 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 a doctor. In such cases, the doctor may consider more effective anti-inflammatory treatment, for example, by increasing the dose of inhaled budesonide or starting treatment with an oral glucocorticosteroid. Particular caution is required when switching from oral glucocorticosteroids to inhaled products. During this period, transient adrenal insufficiency may occur. Patients who have required emergency treatment with high doses of oral glucocorticosteroids or long-term treatment with the maximum recommended doses of inhaled glucocorticosteroids 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 glucocorticosteroids. Note. If the treatment is switched from oral glucocorticosteroids 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 event of allergic reactions, such as runny nose or rash, the doctor may prescribe antihistamines and/or local-acting medicines. If any of the symptoms are severe or worrying, or if symptoms such as headache, fatigue, nausea, or vomiting occur, consult a doctor. The doctor may recommend a temporary increase in the dose of oral glucocorticosteroids. Regular monitoring of growth in children and adolescents taking glucocorticosteroids, 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 glucocorticosteroids. Before starting treatment, inform your doctor about other diseases or conditions, especially:

• active or recent infections,
• liver function disorders. You should also consult a doctor 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, stop using the medicine immediately and consult a doctor without delay. When using inhaled glucocorticosteroids, fungal infections in the mouth may occur. Such infections may require appropriate antifungal therapy and, in some patients, discontinuation of inhaled glucocorticosteroids. You should also consult a 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 consult a doctor.

Children

The medicine can be used to treat asthma in children from 6 months of age. The doctor will determine 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 available without a prescription, as well as any medicines you plan to take. Inform your doctor about any worrying reactions that have occurred after taking other medicines. In particular, inform your doctor about any antifungal medicines you 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 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. Some medicines may enhance the effect of Budixon Neb, and the doctor may want to closely monitor the patient's condition when taking such medicines (including some HIV medicines: ritonavir, cobicistat).

Pregnancy and breastfeeding

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

Always use this medicine exactly as your doctor has told you. If you are not sure, consult a doctor. The dose of Budixon Neb in the form of a nebulizer suspension is determined by the doctor individually for each patient. In case of doubts, consult a 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, 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 as well after each inhalation. 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

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

Maintenance dose

The smallest effective maintenance dose is recommended. Children from 6 months of age: the total daily dose is 0.25 mg to 2 mg. Adults, including the elderly: the total daily dose is 0.5 mg to 4 mg. 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 a 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 glucocorticosteroids Budixon Neb in the form of a nebulizer suspension may be prescribed to a patient who is taking oral glucocorticosteroids. Budixon Neb in the form of a nebulizer suspension can partially or completely replace oral glucocorticosteroids with the same or increased efficacy of treatment. The doctor should recommend a gradual reduction in the dose of the oral medicine. When switching from oral glucocorticosteroids 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 glucocorticosteroid at an unchanged dose for 10 days. Then, the dose of the oral glucocorticosteroid should be gradually reduced by about 2.5 mg of prednisolone or an equivalent dose of another glucocorticosteroid per month to the smallest dose that controls the symptoms of the disease. In many cases, the use of oral glucocorticosteroids can be completely discontinued. 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 when using the medicine.

Croup syndrome

The usual dose used in infants and children with croup syndrome is 2 mg of budesonide administered via nebulization. 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 a maximum of 36 hours or until the patient's condition improves.

POChP treatment

Patients with chronic obstructive pulmonary disease should be treated with doses of 1 to 2 mg of Budixon Neb per day. Treatment should be divided into 2 single doses every 12 hours.

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 important to use the medicine as directed in the leaflet or as recommended by the doctor. Do not increase or decrease the dose of the medicine without consulting a doctor. If a higher dose of the medicine is taken, consult a doctor or pharmacist without delay. If a higher dose of Budixon Neb is used accidentally, it is unlikely to cause harm. If doses higher than those recommended by the doctor are taken for a long time, symptoms such as those that occur with oral glucocorticosteroids, such as increased levels of adrenal hormones in the blood and suppression of adrenal function, may occur. In this case, the doctor should recommend continuing treatment with Budixon Neb in doses that keep the symptoms of asthma under control.

Missing a dose of Budixon Neb

If a dose of Budixon Neb in the form of a nebulizer suspension recommended by the doctor is missed, there is no need to make up for the missed dose. Take the next dose of the medicine as recommended by the 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 a 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 a doctor immediately:

Budixon Neb and consult a doctor immediately:

• swelling of the face, especially around the mouth, tongue, eyes, and ears, rash, itching, contact dermatitis, hives, and bronchospasm (constriction of the airway muscles, 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 and throat. 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 mucus color
• worsening cough or increased difficulty breathing.

Uncommon (occurring in less than 1 in 100 people)

Cataract (clouding of the lens of the eye). Muscle spasms. 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 excitement, aggression.

The use of inhaled glucocorticosteroids may affect the normal production of steroid hormones in the body, especially if they are used for a long time in high doses. The following symptoms may occur:

• 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 symptoms after using inhaled glucocorticosteroids is less likely than after taking oral glucocorticosteroids.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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. Al. Jerozolimskie 181C 02-222 Warsaw tel.: +48 22 49 21 301 fax: +48 22 49 21 309 e-mail: [email protected] 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. Store in the original packaging to protect from light. Shelf life after first opening: 3 months from the opening of the aluminum pouch. 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 Budixon Neb is budesonide. 1 ml of the nebulizer suspension contains: 0.125 mg, 0.250 mg, or 0.500 mg of micronized budesonide. 1 plastic container contains 0.25 mg, 0.5 mg, or 1 mg of budesonide in 2 ml of nebulizer suspension.
• The other ingredients are: disodium edetate, sodium chloride, polysorbate 80, anhydrous citric acid, sodium citrate, water for injections.

What Budixon Neb looks like and what the packaging contains

Budixon Neb is a white to almost white suspension in a 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

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 upright 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 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 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 upright.

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.