Budixon neb

Patient Information Leaflet

BUDIXON NEB, 0.25 mg/mL, suspension for nebulisation
BUDIXON NEB, 0.5 mg/mL, suspension for nebulisation
Budesonide
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Budixon Neb is and what it is used for
2. What you need to know before you use Budixon Neb
3. How to use Budixon Neb
4. Possible side effects
5. How to store Budixon Neb
6. Contents of the pack and other information

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

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

• in patients with bronchial asthma who require long-term glucocorticosteroid therapy to control inflammation in the respiratory tract. Asthma is caused by inflammation of the airways. Nebulisers are recommended when pressurised metered dose inhalers (pMDIs) or dry powder inhalers (DPIs) are unsatisfactory or inappropriate.
• in patients with croup syndrome – acute laryngotracheobronchitis of any etiology, associated with significant narrowing of the upper airways, dyspnoea, or "barking" cough, leading to breathing difficulties.
• in the treatment of acute exacerbations of chronic obstructive pulmonary disease (COPD), when administration of budesonide as a nebulised suspension is indicated. COPD is a chronic lung disease causing breathlessness 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).

Inform your doctor about any concerning reactions that occurred after taking a medicine
containing budesonide or any ingredient of this medicine.
Warnings and precautions
Before starting treatment with Budixon Neb, discuss this with your doctor.
Budixon Neb is intended for long-term treatment, but does not provide rapid relief of symptoms during acute asthma attacks, which require administration of short-acting bronchodilators.
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 intensifying anti-inflammatory treatment, for example by increasing the inhaled dose of budesonide or initiating oral glucocorticosteroid therapy.
Extreme caution should be exercised when switching treatment from oral glucocorticosteroids to inhaled products. During this period, transient adrenal cortex insufficiency may occur.
Patients who have recently required emergency treatment with high doses of oral glucocorticosteroids or long-term treatment with the highest recommended doses of inhaled glucocorticosteroids also belong to the group at increased risk of adrenal cortex insufficiency during periods of severe stress. Inform your doctor about anticipated stressful situations (e.g. exams) or planned surgical procedures.
Your doctor may consider increasing the dose of oral glucocorticosteroids.
Note: When switching from oral glucocorticosteroid therapy to treatment with Budixon Neb as a nebulizer suspension, the following transient symptoms may occur: watery nasal discharge, rash, muscle and joint pain. In case of allergic reactions, such as rhinorrhea or rash, the doctor may recommend treatment with antihistamines and/or topical medications. If any of the symptoms are severe or concerning, or if symptoms such as headache, fatigue, nausea or vomiting occur, contact your doctor. The doctor may recommend temporary increase in the dose of oral glucocorticosteroids.
Regular monitoring of growth in children and adolescents receiving glucocorticosteroids, regardless of route of administration, is recommended due to the risk of growth suppression. If growth retardation occurs, the doctor may reassess the treatment regimen by reducing the dose of glucocorticosteroids.
Before starting treatment, inform your doctor about any medical conditions other than asthma, especially:

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

As with other inhaled medicines, paradoxical bronchospasm may occur immediately after administration of Budixon Neb. If a severe reaction occurs, discontinue use immediately and contact your doctor without delay.
Fungal infections of the oral cavity may occur during treatment with inhaled glucocorticosteroids. Such infections may require appropriate antifungal therapy, and in some patients, discontinuation of inhaled glucocorticosteroids.
You should also contact your doctor if symptoms do not improve despite regular use of the prescribed doses of the medicine.
If the patient experiences blurred vision or other visual disturbances, consult a doctor.

Children
This medicine may be used in the treatment of asthma in children from the age of 6 months. The treating physician determines the dosage individually for each patient.

Budixon Neb and other medicines
Inform your doctor about all medicines currently used or recently used, including those obtained without prescription, as well as any medicines the patient plans to take.
Inform your doctor about any concerning reactions that occurred after taking other medicines.
Especially inform your doctor about current treatment with antifungal agents such as ketoconazole or itraconazole (strong inhibitors of CYP3A4 isoenzyme) and HIV protease inhibitors such as ritonavir and atazanavir, which may increase budesonide plasma concentrations. If concomitant use of such medicines with Budixon Neb is necessary, the interval between doses of each medicine should be as long as possible, and the doctor may recommend reducing the dose of budesonide.
No interactions between budesonide and other medicines used in asthma treatment have been observed.

Pregnancy and breastfeeding

Pregnancy
If the patient is pregnant or planning to become pregnant, she should consult her doctor before using this medicine – do not use the medicine unless advised by a doctor.
If a woman being treated with Budixon Neb becomes pregnant, she should not discontinue treatment on her own, but must inform her doctor as soon as possible.

Breastfeeding
If a woman is breastfeeding, she should consult her doctor before using this medicine.

Driving and operating machinery
Budixon Neb does not affect the ability to drive or operate machinery.

3. How to use Budixon Neb

This medicine should always be used as directed by the doctor.
The dosage of Budixon Neb suspension for nebulisation is determined individually by the doctor for each patient.
If in doubt, consult the doctor again.
Budixon Neb suspension for nebulisation may only be used with a mesh or pneumatic nebuliser (inhalation device). The medicine is delivered to the lungs during breathing through a mouthpiece or a face mask. Before starting to use the medicine, carefully read the “Instructions for use of Budixon Neb suspension for nebulisation” located at the end of this leaflet and follow the provided instructions.
After each inhalation, remember to rinse the mouth with water. If a face mask was used, wash the face as well after each inhalation.
Not every inhalation device (nebuliser) is suitable for administering Budixon Neb suspension for nebulisation.
Do not use ultrasonic nebulisers.

Asthma
Initial dose
Recommended initial dose for children from 6 months of age: total daily dose of 0.25 mg to 0.5 mg. If the child is taking an oral glucocorticosteroid, the doctor may, if necessary, increase the daily dose up to 1 mg.
Recommended initial dose for adults and elderly patients: 1 mg to 2 mg per day.
The treating physician may adjust the dosage after some time.

Maintenance dose
The lowest effective maintenance dose should be used.
Children from 6 months of age: total daily dose of 0.25 mg to 2 mg.
Adults, including elderly patients: total daily dose of 0.5 mg to 4 mg.
If symptoms are very severe, the doctor may increase the dose of the medicine.
If the daily dose is up to 1 mg, the medicine may be administered once daily, either in the morning or evening.
If the effect of the medicine seems too strong or too weak, consult the doctor.
If the patient's condition improves, the treating physician may decide to reduce the dose of the medicine.
Improvement in the patient's condition after using Budixon Neb may occur within a few hours of starting treatment. Full therapeutic effect is achieved after several weeks of treatment.
Budixon Neb should be used even when there are no symptoms of the disease.

Patients treated with oral glucocorticosteroids
Budixon Neb suspension for nebulisation may be prescribed to a patient who is taking glucocorticosteroids in the form of oral tablets.
Budixon Neb suspension for nebulisation may partially or completely replace oral glucocorticosteroids, maintaining the same or increased treatment efficacy.
The doctor should advise gradual reduction of the oral medicine dose.
When switching from oral glucocorticosteroids to inhaled therapy, the patient should be in a stable condition.
For 10 days, high doses of Budixon Neb are recommended in combination with the previously used oral glucocorticosteroid at the unchanged dose. Then, the dose of the oral glucocorticosteroid should be gradually reduced by approximately 2.5 mg of prednisolone or an equivalent dose of another glucocorticosteroid per month, down to the lowest dose ensuring symptom control. Often, treatment with oral glucocorticosteroids can be completely discontinued.
Budesonide administered as a nebulised suspension is delivered to the lungs during inhalation. It is very important that the patient performs calm, even inhalations through the nebuliser mouthpiece or face mask while using the medicine.

Croup syndrome
The usual dose in infants and children with croup syndrome is 2 mg of budesonide administered by nebulisation. This dose may be given as a single dose or divided into two doses of 1 mg each, administered 30 minutes apart. This dosing regimen may be repeated every 12 hours, up to a maximum of 36 hours or until improvement in the patient's condition.

Exacerbations of COPD
Based on limited clinical trial data, the recommended dose of Budixon Neb suspension for nebulisation is 4 to 8 mg per day, divided into 2 to 4 doses. Treatment should continue until clinical improvement is achieved, but treatment longer than 10 days is not recommended.

Method of administration
Budixon Neb may be mixed with 0.9% sodium chloride solution and with solutions of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglicate, or ipratropium. The prepared mixture should be used within 30 minutes.

The container with unused suspension should be immediately discarded.
Use of a higher than recommended dose of Budixon Neb
It is important that the patient uses the medicine according to the instructions in the leaflet or as directed by a physician. The dose should not be increased or decreased without consulting a doctor.
If a higher than recommended dose has been taken, medical advice should be sought immediately from a doctor or pharmacist.
If a single excessive dose of Budixon Neb has been administered, it is unlikely to cause harmful effects.
However, if doses higher than those recommended by the doctor have been used for a prolonged period, symptoms similar to those observed with oral glucocorticosteroids may occur, such as increased concentration of adrenal cortex hormones in the blood and suppression of adrenal function. In such cases, the doctor should recommend continuing treatment with Budixon Neb at a dose sufficient to maintain control of bronchial asthma symptoms.
Missed dose of Budixon Neb
If one prescribed dose of Budixon Neb suspension for nebulization has been missed, there is no need to make up for the missed dose. The next dose should be taken according to the doctor's instructions. A double dose must not be used to compensate for the missed dose.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the symptoms listed below occur, stop using the medicine
Budixon Neb and contact your doctor immediately:

• swelling of the face, especially around the mouth, tongue, eyes and ears, rash, itching, contact dermatitis, urticaria and bronchospasm (contraction of the muscles in the airways, causing wheezing). These may indicate an allergic reaction. This adverse reaction is rare (occurs in fewer than 1 in 1,000 people).
• sudden onset of wheezing after inhalation of the medicine. This adverse reaction is rare (occurs in fewer than 1 in 1,000 people).

Other possible adverse reactions:
Common (occur in fewer than 1 in 10 people)

• Oral candidiasis (fungal infections in the mouth). To reduce the likelihood of this occurring, rinse the mouth with water after using Budixon Neb.
• Sore throat, cough and hoarseness, loss of voice.
• Pneumonia (lung infection) in patients with COPD. Inform your doctor if any of the following symptoms occur during budesonide treatment; they may be signs of lung infection:
  • fever or chills
  • increased mucus production, change in mucus color
  • worsening cough or increased breathing difficulties.

Uncommon (occur in fewer than 1 in 100 people)
Cataract (clouding of the eye lens).
Muscle spasms.
Muscle tremors.
Depression.
Anxiety.
Blurred vision.
Rare (occur in fewer than 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, behavioral changes (mainly in children).
• Easy bruising.
• Hoarseness and loss of voice (in children).

Adverse reactions for which frequency is unknown (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 used long-term at high doses. Such symptoms may include:

• glaucoma (increased intraocular pressure), frequency unknown.
• slowed growth in children and adolescents (rare).
• effects on the adrenal glands (small glands near the kidneys) (rare). The occurrence of these symptoms after using inhaled glucocorticosteroids is less likely than after oral glucocorticosteroids.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Budixon Neb

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following: Expiry
date (EXP).
Store the medicine below 30°C. Do not freeze.
Keep in the original packaging to protect from light.
Shelf life after first opening: 3 months from opening the aluminium pouch.
Contents of a single-use plastic container should be used within 24 hours of opening.
After reconstitution or dilution: the mixture should be used within 30 minutes.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the package and other information

What Budixon Neb contains

• The active substance is budesonide. 1 mL of nebulising suspension contains 0.25 mg or 0.5 mg micronised budesonide. Each plastic container contains either 0.5 mg in 2 mL of nebulising suspension or 1 mg budesonide in 2 mL of nebulising 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 pack
Budixon Neb is a suspension, white to almost white in colour, in a single-dose plastic container.
Pack size:
10 or 20 containers of 2 mL (2 or 4 sealed aluminium foil pouches, each containing 5 containers)
in a cardboard box.
Marketing Authorisation 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
Instructions for use of Budixon Neb nebulising suspension

1. Before use, gently mix the contents of the plastic container by swirling in a circular motion.
2. Hold the plastic container upright and open it by twisting the "wings".
3. Attach the open end of the container firmly to the nebuliser chamber and slowly squeeze out the entire contents.

Before each use, gently mix the contents of the container.

• Record the date when the aluminium foil pouch was first opened. Do not use the single-dose plastic containers more than 3 months after opening the aluminium foil pouch.
• The prepared solution should be used within 30 minutes.
• Store the medicine below 30°C.
• The plastic containers should always be stored in the aluminium foil pouch to protect from light. If the entire contents of a plastic container are not used at once, the remainder should be protected from light.
• The plastic containers should be stored in an upright position.

WARNING

1. Rinse the mouth after each use of the medicine.
2. If the patient uses a face mask, ensure that the mask fits tightly against the face during inhalation. Wash the face after using the medicine.

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