BODINET

Package leaflet: Information for the patient

Bodinet 0.25 mg/ml suspension for nebuliser, 0.5 mg/ml suspension for nebuliser

budesonide
equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Bodinet is and what it is used for

Bodinet is an inhalation medicine for nebulization, containing the active substance budesonide.
Bodinet belongs to a group of medicines called "glucocorticoids" which work by reducing and
preventing swelling and inflammation in the lungs, thereby facilitating airflow.
Bodinet is indicated for the treatment of:

• Bronchial asthma,
• Severe subglottic laryngitis (inflammation of the airways that makes breathing difficult) requiring hospitalization.

2. What you need to know before taking Bodinet

Do not take Bodinet

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Bodinet:

• if you have problems with your adrenal glands (glands located above the kidneys that produce various types of hormones);
• if you have undergone treatment with high doses of glucocorticoids (anti-inflammatory medicines) or prolonged treatments with high-dose inhaled glucocorticoids;
• if you are experiencing a period of severe physical stress, such as surgery;
• if you have liver problems;
• if you are taking ketoconazole or itraconazole (medicines used to treat fungal infections) (see also section “Other medicines and Bodinet”);
• if you are taking medicines used to treat HIV infection;
• if you have lung infections (such as pulmonary tuberculosis) or respiratory tract infections;
• if you have infections, including fungal or viral infections (such as measles and chickenpox);
• if you have eye problems (blurred vision, glaucoma, cataracts). Contact your doctor if you experience visual disturbances.

Budexan may alter the result of an ACTH stimulation test used to diagnose possible pituitary insufficiency, potentially leading to misleading results (low values).
Bodinet is not suitable for the rapid relief of sudden asthma attacks, for which a short-acting bronchodilator must be used. Your doctor will carefully evaluate the most appropriate therapy for you.

Switching from systemic glucocorticoid therapy (i.e., taken orally, intramuscularly, or intravenously) to inhaled glucocorticoid therapy.
If you are switching from systemic glucocorticoid treatment (e.g., oral) to inhaled glucocorticoid therapy, your doctor will gradually reduce the dose of the systemic glucocorticoid you are currently taking. During this phase, you may experience general malaise, such as muscle and/or joint pain. Rarely, symptoms such as fatigue, depression, headache, nausea, and vomiting may occur. You may experience these symptoms even if your lung function remains stable or improves. If such symptoms occur, your doctor will advise you to continue treatment with Bodinet and may request blood tests to assess adrenal gland function. Depending on adrenal function, your doctor may temporarily increase the dose of the systemic glucocorticoid you are taking, and the switch to Bodinet can continue later, more gradually. If you are under physical stress (e.g., severe infections, trauma, or surgery) or experience a severe asthma attack, you may develop adrenal problems. In such cases, your doctor may prescribe additional systemic glucocorticoid treatment (e.g., systemic administration).

Furthermore, switching from systemic glucocorticoid treatment to inhaled therapy may lead to the emergence of allergic conditions such as rhinitis and eczema (irritation and inflammation of the nose or skin), which were previously controlled by the systemically administered drug. If this occurs, consult your doctor, who will prescribe appropriate treatment to manage these symptoms.

Oral candidiasis (thrush, a mouth infection)
Oral candidiasis may develop during treatment with inhaled glucocorticoids. If this occurs, consult your doctor. Your doctor will prescribe appropriate treatment and, if necessary, may advise you to discontinue the treatment (see also section 3 “How to take Bodinet”).

Potential side effects of inhaled glucocorticoids (anti-inflammatory medicines) when used at high doses for prolonged periods
Inhaled glucocorticoids may cause side effects, particularly when used at high doses for prolonged periods. These side effects are less likely than with oral glucocorticoid treatment.
Such side effects include: Cushing's syndrome and Cushingoid appearance (a condition characterized by excessive cortisol hormone production, manifesting as a rounded "moon face", weight gain, fluid retention, reduced glucose tolerance and increased risk of diabetes, leg swelling, headache, etc.), adrenal suppression (severe impairment of adrenal gland function), reduced bone mass, and eye disorders (cataract, glaucoma).
Rarely, a range of psychological and behavioral effects may occur, including psychomotor hyperactivity (a behavioral disorder characterized by excessive motor activity), sleep disturbances, anxiety, depression, aggression, and behavioral disorders.
It is therefore important that you take the dose exactly as prescribed by your doctor.

Paradoxical bronchospasm
As with other inhaled therapies, paradoxical bronchospasm (unexpected narrowing of the airways) may occur after administration, with an immediate increase in wheezing. In this case, you must consult your doctor immediately. Your doctor may, if necessary, discontinue treatment with inhaled budesonide and evaluate whether to start an alternative therapy.

Caution for athletes: the product contains substances prohibited for doping. Any use differing from the approved therapeutic indications, dosage regimen, or route of administration is prohibited.

Children and adolescents
Bodinet should be used with caution in children.

Effect on growth
The use of inhaled glucocorticoids may affect the growth of children and adolescents (see section “Additional side effects in children and adolescents”).
Therefore, it is recommended that the height of children undergoing long-term inhaled glucocorticoid therapy be periodically monitored by a doctor.
If growth is slowed, the doctor will evaluate the therapy with the aim of reducing the dose of inhaled glucocorticoid.
The doctor will carefully weigh the benefits of glucocorticoid therapy against the potential risk of growth suppression.
If necessary, the doctor may advise you to consult a pediatric pulmonologist (a pediatrician specialized in respiratory diseases).

Other medicines and Bodinet
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
No interactions between budesonide and other medicines used in asthma treatment have been observed.
In particular, inform your doctor or pharmacist if you are taking:

• ketoconazole and itraconazole (medicines used to treat fungal infections) (see section “Warnings and precautions”). Your doctor may consider reducing the dose of Bodinet.
• Certain medicines containing cobicistat (used in HIV treatment), as they may increase the risk of side effects from Bodinet.
• Medicines containing hormones (estrogens) or oral contraceptives (birth control pills).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Available data do not indicate an increased risk of adverse effects on the fetus/newborn with the use of inhaled budesonide during pregnancy. It is important for both the mother and the fetus to maintain adequate asthma treatment during pregnancy. As with other medicines, consult your doctor about using budesonide during pregnancy, as your doctor must evaluate the expected benefits for the mother against any potential risks for the fetus.

Breastfeeding
Budesonide passes into breast milk.
However, at the recommended doses of Bodinet, effects on the breastfed infant are not expected.
Budesonide may be used during breastfeeding.

Driving and using machines
Bodinet does not affect the ability to drive vehicles or operate machinery.

3. How to take Bodinet

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Bronchial asthma
INITIAL DOSE
The dosage of Bodinet is individual.
Adults and elderly
The recommended initial dose is 0.5–1 mg twice daily.
If necessary, your doctor may increase the dose of Bodinet (see dosing table).
MAINTENANCE DOSE:
The maintenance dose is individual.
Once asthma control is achieved, the maintenance dose should be the lowest dose that
maintains effective control of symptoms: your doctor will gradually reduce the medicine until
the lowest effective dose is reached.
DOSING TABLE

* The product must be mixed with 0.9% sodium chloride solution (physiological saline) up to a volume of 2 ml.
ONSET OF EFFECT
Improvement in asthma control following administration of Bodinet may occur within 3 days of starting treatment, although maximum benefit is achieved after 2–4 weeks.
Patients treated with oral glucocorticoids
With the use of Bodinet, it may be possible to replace or significantly reduce the dose of orally administered glucocorticoids while maintaining asthma control.
The switch from oral glucocorticoid therapy to therapy with Bodinet will be evaluated by your doctor based on your general condition. For approximately 10 days, your doctor will prescribe a higher dose of Bodinet to be taken in association with the oral medication you are already using. After this period, your doctor will gradually reduce the dose of the oral medication to the lowest possible level.
In many cases, oral therapy can be completely replaced by Bodinet. For further information, see section "Warnings and precautions".
MIXING AND DOSAGE SPLITTING
Bodinet can be mixed with 0.9% sodium chloride solution (physiological saline) or with solutions containing other active substances acting on the respiratory system, such as salbutamol, terbutaline, sodium cromoglicate, and ipratropium bromide. Always follow your doctor's instructions carefully.
The mixture must be used within 30 minutes.
If dose adjustment of Bodinet is required, the contents of the single-dose container may be divided.
Once the aluminum foil pouch has been opened, unused containers still sealed inside the pouch remain valid for 3 months and must be kept within the pouch, protected from light.
Use in children and adolescents
Bronchial asthma
The recommended initial dose in children aged 6 months and older up to 12 years is 0.25–0.5 mg daily. Your doctor will determine the appropriate dose for your child.
If needed, your doctor may increase the dose of Bodinet.
Subglottic laryngitis (for severe forms requiring hospitalization)
The usual recommended dose in neonates and children is 2 mg of Budexan, which may be administered as a single dose or as two 1 mg doses given 30 minutes apart.
The dosing may be repeated every 12 hours for up to 36 hours or as long as prescribed by your doctor.
Bodinet must be used with caution in children (see section "Children and adolescents").
INSTRUCTIONS FOR CORRECT USE OF Bodinet
The mist produced by the nebulizer is inhaled through the mouth using a mouthpiece or an appropriate facial mask.
The nebulizer must consist of: a compressor (a pump) capable of generating an adequate airflow (5–8 L/min), and a chamber (a reservoir) with a volume of 2–4 ml, into which the medicinal solution is placed.
The nebulization time and the amount of medication delivered by a nebulizer depend on the compressor's flow rate and the filling volume.
Due to the small amount of budesonide delivered, ultrasonic nebulizers should not be used for administering Bodinet.
For children, it is recommended to use a well-fitting, airtight facial mask to optimize the delivered dose of budesonide.
Children must use Bodinet only under adult supervision.
INSTRUCTIONS FOR USE

1. Gently shake the single-dose container with a rotational movement.
2. Hold the single-dose container in an upright position and open it by rotating the tab until the container is fully opened.

3. Insert the open end of the single-dose container well into the nebulizer chamber and slowly squeeze it out.

NOTES:

1. After inhalation, rinse your mouth with water to minimize the risk of developing oropharyngeal candidiasis (thrush, an infection of the mouth and throat).
2. If you use a facial mask to inhale the vapor, ensure that the mask fits properly during nebulization. After using the facial mask, wash your face with water to prevent skin irritation.

NEBULIZER CLEANING
The nebulizer chamber must be cleaned after each administration. Wash the nebulizer chamber, mouthpiece, or facial mask with warm tap water using a mild detergent, or follow the manufacturer's instructions. Rinse thoroughly and dry the chamber by reassembling it to the compressor and inhaler.
If you take more Bodinet than you should
Taking an excessive dose of Bodinet is unlikely to cause disturbances. However, if you accidentally take too much Bodinet, contact your doctor immediately or go to the nearest hospital.
If you forget to take Bodinet
Do not take a double dose to make up for the missed dose.
If you stop treatment with Budexan
Do not stop treatment with Budexan without consulting your doctor.
If you have any 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.
The side effects are listed below according to the following frequency:
Common (may affect up to 1 in 10 people)

• Candida infections in the oropharynx (thrush, mouth and throat fungal infections);
• nausea;
• cough, hoarseness, throat irritation;
• pneumonia (lung infection) in patients with COPD. Inform your doctor if you experience any of the following symptoms while taking budesonide, as they could be signs of a lung infection:
  • Fever or chills.
  • Increased mucus production, changes in mucus color.
  • Worsening cough or increased breathing difficulties.

Uncommon (may affect up to 1 in 100 people)

• cataract (clouding of the lens, the eye's structure responsible for focusing images);
• depression;
• anxiety;
• tremor;
• muscle spasm (sudden, involuntary muscle contraction);
• blurred vision.

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

• immediate or delayed allergic reactions* including rash (skin eruption), contact dermatitis (skin inflammation typically presenting with redness, blisters, vesicles, abrasions, and crusts), urticaria (red, itchy skin patches), angioedema (swelling), and anaphylactic reaction (severe allergic reaction);
• signs and symptoms of systemic glucocorticoid effects (i.e., when taken orally, intramuscularly, or intravenously), including adrenal suppression (severe impairment of adrenal gland function);
• restlessness, nervousness, behavioral changes, sleep disturbances, psychomotor hyperactivity (a behavioral disorder characterized by excessive motor activity), aggression;
• bronchospasm (narrowing of the airways causing breathing difficulties due to reduced airflow);
• bruising (ecchymosis), cutaneous striae (skin streaks resembling stretch marks, red-purple in color).

*Skin irritation of the face, as an example of an allergic reaction, has occurred in some cases when a nebulizer with a face mask was used. To prevent facial skin irritation, wash your face with water after using the face mask.
Not known (frequency cannot be estimated from the available data)

• glaucoma (an eye disease caused by increased pressure of the fluid inside the eye).

Additional side effects in children and adolescents
The side effects are listed below according to the following frequency:
Rare (may affect up to 1 in 10,000 people)

• slowed growth;
• dysphonia (difficulty producing voice), hoarseness (when the voice is harsh or low);
• behavioral disorders.

Due to the risk of growth retardation in the pediatric patient population, growth must be monitored as described in the section "Children and adolescents".
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bodinet

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the word
"Exp.".
The expiry date refers to the last day of that month.
Store below 25°C.
Keep in the original packaging to protect the medicine from light.
After opening the aluminium pouch, unopened containers must be stored inside the pouch, protected from light, and used within 3 months. After this period, any remaining product must be discarded.
The single-dose container, once opened, must be stored in the pouch, protected from light, and used within 12 hours. After this period, any remaining product must be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bodinet contains
Bodinet 0.25 mg/ml nebulizing suspension

• The active substance is budesonide. A single-dose container of 2 ml contains 0.5 mg of budesonide.
• The other components are disodium edetate, sodium chloride, polysorbate 80, anhydrous citric acid, sodium citrate, water for injections.

Bodinet 0.5 mg/ml nebulizing suspension

• The active substance is budesonide. A single-dose container of 2 ml contains 1 mg of budesonide.
• The other components are disodium edetate, sodium chloride, polysorbate 80, anhydrous citric acid, sodium citrate, water for injections.

Description of the appearance of Budexan and package contents
Bodinet is a homogeneous white nebulizing suspension with a pH between 4.0–5.0.
Single-dose container made of low-density polyethylene, containing 2 ml of suspension. A line indicating a volume of 1 ml is visible on the surface of the container.
Each package contains 20 single-dose containers divided into strips of 5 units, contained in a sealed pouch made of PET/Al/PE.
Marketing Authorization Holder
Genetic S.p.A. – Via Della Monica, 26 – 84083 Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA)