Bodix

Package leaflet: Information for the patient

BODIX 0.25 mg/ml suspension, 0.5 mg/ml suspension

B ud e son i d e
Read this leaflet carefully before 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, consult 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, because it could be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Bodix is and what it is used for

Bodix is an inhalation medicine for nebulization, containing the active substance budesonide.
Budesonide belongs to a group of medicines called "glucocorticoids", which work by reducing and preventing swelling and inflammation in the lungs, thereby improving airflow.
Bodix is indicated in adults and children from 6 months of age onwards for the treatment of:

• asthma (an inflammation of the airways that makes breathing difficult), including in patients who are unable to use pressurized metered-dose inhalers or dry powder inhalers correctly;
• subglottic laryngitis or pseudocroup (a condition characterized by swelling of the tissues below the vocal cords, making breathing difficult), when the condition is severe and hospitalization is indicated.

2. What you need to know before using Bodix

Do not use Bodix

• if you are allergic to budesonide or to any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before using Bodix:
• if you have problems with your adrenal glands (glands located above the kidneys that produce various types of hormones)
• if you have been treated with high doses of glucocorticoids (anti-inflammatory agents) or have undergone prolonged treatment with high-dose glucocorticoids by inhalation
• if you are experiencing a period of severe physical stress, such as surgery
• if you have liver problems
• if you are taking ketoconazole and itraconazole (medicines used to treat fungal infections) (see also section “Other medicines and Bodix”)
• if you are taking medicines used to treat HIV infection
• if you have lung infections (such as pulmonary tuberculosis) or respiratory tract infections, including fungal or viral infections (such as measles and chickenpox)
• if you have glaucoma (an eye disease caused by increased pressure of the fluid inside the eye)
• if you have cataracts (clouding of the lens of the eye, which helps focus images)

Contact your doctor if you experience blurred vision or other visual disturbances.

Bodix is not suitable for the rapid relief of sudden asthma attacks, for which a short-acting bronchodilator is required. Your doctor will carefully assess the most appropriate treatment for you.

Switching from systemic glucocorticoid therapy (anti-inflammatory agents administered orally,
intramuscularly, or intravenously) to inhaled glucocorticoid therapy
If you are switching from systemic glucocorticoid therapy (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 though your lung function remains stable or even improves. If you develop such symptoms, your doctor will advise you to continue treatment with Bodix and may request blood tests to evaluate the function of your adrenal glands (glands located above the kidneys that produce various types of hormones). Depending on adrenal function, your doctor may temporarily increase the dose of systemic glucocorticoid you are taking, and the switch to Bodix can continue later, more gradually.
If during this transition phase you experience physical stress (e.g., severe infections, trauma, or surgery) or have a severe asthma attack, your doctor may prescribe additional systemic glucocorticoid treatment (e.g., systemic administration).
Furthermore, switching from systemic glucocorticoid therapy to inhaled therapy may unmask allergies previously controlled by the systemically administered drug, such as rhinitis or eczema (irritation and inflammation of the nose or skin).
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 stop the treatment (see also section 3 “How to take Bodix”).

Potential adverse effects of inhaled glucocorticoids when used at high doses for prolonged periods
Inhaled glucocorticoids may cause adverse effects. In particular, when used at high doses over prolonged periods, the following adverse effects may occur: Cushing's syndrome and Cushingoid appearance (a condition characterized by excessive production of the glucocorticoid hormone cortisol, 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), decreased bone mass, cataracts (clouding of the lens of the eye, which helps focus images), and glaucoma (an eye disease caused by increased pressure of the fluid inside the eye). These effects are less likely than with oral glucocorticoid therapy.
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.
Therefore, based on the above, it is important that you take the dose as indicated in the package leaflet or as prescribed by your doctor. Do not increase or decrease the dose without first consulting your doctor (see section 3 “How to take Bodix”).

Paradoxical bronchospasm
As with other inhaled therapies, paradoxical bronchospasm (unexpected narrowing of the airways causing severe breathing difficulty due to reduced airflow) may occur after administration, accompanied by an immediate increase in wheezing dyspnea (difficulty breathing with a whistling or wheezing sound). 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.

For athletes
Using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

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

Effect on growth
The use of inhaled glucocorticoids may affect growth in children and adolescents (see section “Additional adverse effects in children and adolescents”). Therefore, it is recommended that children undergoing long-term inhaled glucocorticoid therapy have their height monitored regularly by a doctor. If growth is slowed, the doctor will reassess the treatment 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 Bodix
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 drugs 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”)
• medicines containing hormones (estrogens) or oral contraceptives (the pill)

Some medicines may increase the effects of Bodix, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Fertility, pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine. Studies conducted do not indicate any adverse effects on fetal/neonatal health with the use of inhaled budesonide during pregnancy. As with other medicines, consult your doctor about the use of budesonide during pregnancy, as your doctor must evaluate the expected benefits for the mother against any potential risks for the fetus.
Budesonide passes into breast milk. However, at the recommended doses of Bodix, no effects on the breastfed infant are expected. Budesonide may be used during breastfeeding.

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

3. How to use Bodix

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 Bodix 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 Bodix (see dosing table).
Maintenance dose
The maintenance dose is individual.
Once asthma control is achieved, the maintenance dose should be the lowest dose that effectively controls symptoms: your doctor will gradually reduce the medicine until the minimum effective dose is reached.
Dosing table

*The product must be mixed with 0.9% physiological solution (saline solution) up to a
volume of 2 ml.
Onset of effect
Improvement in asthma control following administration of Bodix may occur within
3 days of starting treatment, although maximum benefit is achieved after 2–4 weeks.
Patients treated with oral glucocorticoids (anti-inflammatory agents)
With the use of Bodix, it may be possible to replace or significantly reduce the dose of oral glucocorticoids
while maintaining asthma control.
The transition from oral glucocorticoid therapy to therapy with Bodix will be evaluated by the
physician based on your individual condition.
For approximately 10 days, your doctor will prescribe a high dose of Bodix to be taken in combination
with the oral medication you are currently 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 with
Bodix. For further information, see section "Warnings and precautions".
Dose division and mixing
Bodix can be mixed with 0.9% physiological solution (saline solution) and with nebulizer solutions of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglicate, or ipratropium
(medications used for the treatment of respiratory disorders).
The mixture must be used within 30 minutes.
If dose adjustment of Bodix is required, the contents of the single-dose vial can be divided.
Indeed, on the 2 ml containers of Bodix 0.25 mg/ml suspension and Bodix 0.5 mg/ml
suspension, a clearly visible line is present. When the single-dose vial is held
upside down, the line indicates a volume of 1 ml.
If you use only 1 ml, pour the contents of the single-dose vial until the liquid surface reaches the marked line.
The opened single-dose container containing the remaining liquid must be stored
in the pouch, protected from light, and used within 12 hours.
Before using the remaining liquid, carefully shake the contents with a rotational motion.
Once the aluminum pouch has been opened, the unopened containers inside have a shelf life of 3 months and must be kept in the pouch, protected from light.
Use in children and adolescents
Bronchial asthma
Children from 6 months of age
The dosage of Bodix is individual.
The recommended initial dose is 0.25–0.5 mg per day. If symptoms recur, the
doctor may increase the dose of Bodix.
SUBGLOTTIC LARYNGITIS OR PSEUDOCROUP (for severe forms requiring hospitalization)
Newborns and children
The usual recommended dose is 2 mg of Bodix, which can be administered as a single dose or as two doses of 1 mg given 30 minutes apart. The dosing may be repeated every 12 hours for up to 36 hours or as long as prescribed by the doctor.
Bodix should be used with caution in children (see section “Children and adolescents”).
INSTRUCTIONS FOR CORRECT USE OF BODIX

1. Gently agitate the single-dose container with a rotational motion.
2. Hold the single-dose container in an upright position and open it by twisting the tab until the single-dose vial is opened.
3. Insert the open end of the single-dose container fully into the nebulizer reservoir and press slowly.
4. Before turning on the nebulizer, carefully read the instructions for use provided in the package leaflet included with each nebulizer. If you have any doubts about using the
   nebulizer, consult your doctor or pharmacist.
   Notes:
5. After inhalation, rinse your mouth with water to minimize the risk of developing oropharyngeal candidiasis (thrush, an infection of the
6. mouth and throat).
7. If you use a face mask to inhale the vapor, ensure that the mask fits properly during nebulization. After using the face mask, wash your face with water to prevent irritation.
8. Clean and maintain the nebulizer according to the manufacturer's instructions.
   Nebulizer cleaning
   The nebulizer reservoir must be cleaned after each administration. Wash the nebulizer chamber, mouthpiece, or face mask with warm tap water using a mild detergent, or follow the manufacturer's instructions. Rinse thoroughly and dry the chamber by reconnecting it to the compressor and inhaler.
   If you use more Bodix than you should
   Accidental ingestion of an excessive dose of Bodix is unlikely to cause adverse effects.
   In case of accidental overdose of Bodix, contact your doctor immediately or go to the nearest hospital.
   If you forget to use Bodix
   Do not use a double dose to make up for the missed dose.
   If you stop using Bodix
   If you have any questions about the use of 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 listed below are classified according to the following frequency:
Common (may affect up to 1 in 10 people)

• Candida infections of the oropharynx (thrush, mouth and throat infection)
• nausea
• cough, hoarseness (when the voice is harsh or low), throat irritation

Uncommon (may affect up to 1 in 100 people)

• blurred vision

Rare (may affect up to 1 in 10,000 people)

• immediate or delayed allergic reactions* including rash (skin eruption), contact dermatitis (inflammation of the skin usually 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. taken orally, intramuscularly or intravenously), including adrenal suppression (severe impairment of adrenal gland function)
• restlessness, nervousness, depression, behavioural changes, sleep disorders
• anxiety, psychomotor hyperactivity (behavioural disorder characterized by excessive motor activity), aggression
• bronchospasm (narrowing of the bronchi causing breathing difficulty due to reduced airflow)
• bruising, cutaneous striae (skin streaks similar to stretch marks, red-purple in colour)

*Facial skin irritation, as an example of allergic reaction, has occurred in some cases when a nebulizer with a face mask was used. To prevent irritation, wash the face with water after using the face mask.

Not known (frequency cannot be estimated from the available data)

• glaucoma (eye disease caused by increased pressure of the fluid inside the eye), cataract (clouding of the lens of the eye, the structure responsible for focusing images)

Additional side effects in children and adolescents

The side effects listed below are classified 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)
• behavioural disorders. Due to the risk of slowed growth in the paediatric patient population, growth must be monitored as described in section “Children and adolescents”.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bodix

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
Do not store above 25°C. The product must be stored in an upright position.
Keep the containers in the aluminium pouch to protect the medicine from light. Do not freeze.
After opening the aluminium pouch, unopened containers must be stored within the pouch, protected from light, and used within 3 months.
The single-dose container, once opened, must be used within 12 hours.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Bodix contains
Bodix 0.25 mg/ml suspension
The active substance is: budesonide (each 2 ml container contains 0.5 mg of budesonide).
The other components are: disodium edetate, sodium chloride, polysorbate 80, anhydrous citric acid, sodium citrate, water for injections.

Bodix 0.5 mg/ml suspension
The active substance is: budesonide (each 2 ml container 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 Bodix and contents of the pack
Bodix is a white or almost white suspension.
Each pack contains 20 single-dose containers divided into strips of 5 units, contained in an aluminium pouch.

Marketing Authorization Holder
Manufacturer
Genetic S.p.A. – Contrada Canfora – Fisciano (SA)