BODIX 0.25 MG/ML Nebulizable suspension

Зміст інструкції

1. BODIX 0.25 mg/ml suspension
   1. What is Bodix and what is it used for
   2. What you need to know before using Bodix
   3. How to use Bodix
   4. Possible side effects
   5. How to store Bodix
   6. Package contents and other information

BODIX 0.25 mg/ml suspension

BODIX 0.5 mg/ml suspension
Budesonide
Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including any not listed in this leaflet, tell 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 you take 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 is Bodix and what is it used for

Bodix is a medicinal product for inhalation to be nebulized, containing the active substance budesonide.
Budesonide belongs to a group of medicines called “glucocorticoids”, which work by reducing
and preventing swelling and inflammation of the lungs, promoting the passage of air.
Bodix is indicated in adults and children from 6 months of age for the treatment of:

• asthma (inflammation of the airways, which makes breathing difficult), even for those who are unable to use spray inhalers or dry powder inhalers correctly
• laryngotracheobronchitis or croup (a disease characterized by swelling of the tissues below the vocal cords that makes breathing difficult) when it is very severe and hospitalisation 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 precautionsTalk to your doctor or pharmacist before using Bodix:
• if you have problems with your adrenal glands (glands located above the kidneys that are able to produce different types of hormones)
• if you have undergone therapies with high doses of glucocorticoids (anti-inflammatory drugs) or prolonged treatments with high doses of glucocorticoids for inhalation
• if you are in a period of severe physical stress such as in the case of 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 for the treatment of HIV infection
• if you have lung infections (such as pulmonary tuberculosis) or respiratory infections if you have infections

including fungal or viral infections (measles and chickenpox)

• if you suffer from glaucoma (eye disease caused by an increase in the pressure of the fluid contained inside the eye)
• if you suffer from cataracts (clouding of the lens, the lens of the eye that serves to
• focus images). Contact your doctor if you experience blurred vision or other visual disturbances.

Bodix is not suitable for the rapid improvement of sudden asthma attacks, for which a
short-acting bronchodilator is necessary. The doctor will carefully assess the
most appropriate therapy for you.

Switching from systemic glucocorticoid (anti-inflammatory) therapy (i.e. taken by

oral, intramuscular or intravenous route) to inhaled glucocorticoid therapy
If you need to switch from glucocorticoid (anti-inflammatory) treatment by the systemic route (for example, orally)
to treatment with inhaled glucocorticoids, your doctor will gradually reduce the
dose of systemic glucocorticoid you are taking. During this phase you may
experience general malaise such as muscle and/or joint pain. In rare cases
symptoms such as fatigue, depression, headache, nausea and vomiting may appear.
You may experience these symptoms even if your lung function is maintained or even improved.
If you experience these symptoms, your doctor will continue the
therapy with Bodix and ask you to undergo blood tests to assess the function of your
adrenal glands (glands located above the kidneys that are able to produce different types of hormones). Based on the
function of your adrenal glands, your doctor may temporarily increase the dose of
systemic glucocorticoid you are taking, and the switch to Bodix may proceed
more slowly afterwards.
If you are subjected to physical stress (for example in case of severe infections,
trauma or surgery) or have a severe asthma attack during this transition phase, your doctor may prescribe a
supplemental treatment with systemic glucocorticoids (for example by the systemic route).
In addition, switching from systemic glucocorticoid treatment to inhaled therapy can
cause allergies, such as rhinitis and eczema (irritation and inflammation of the nose or
skin), which were previously controlled by the drug administered systemically.
If this occurs, consult your doctor who will prescribe the appropriate therapy to control these
symptoms.

Oral candidiasis (thrush, a mouth infection)
Oral candidiasis may occur during therapy with inhaled glucocorticoids. If this occurs
contact your doctor. The doctor will prescribe the appropriate therapy and if necessary
will interrupt the treatment (see also section 3 “How to use Bodix”).

Possible undesirable effects of inhaled glucocorticoids (anti-inflammatory drugs) if used at high doses

for prolonged periods
Inhaled glucocorticoids can cause undesirable effects. In particular, if used at high doses
for prolonged periods, the following undesirable effects may occur: Cushing's syndrome and Cushingoid appearance (disease characterized by excessive production of a glucocorticoid hormone, cortisol, which manifests with a full moon face, weight gain
body weight, fluid retention, reduced sugar tolerance and increased risk of diabetes, swelling
in the legs, headache, etc.), adrenal suppression (severe impairment
of the activity of the adrenal glands), reduction of bone mass, cataracts (clouding of the
lens, the lens of the eye that serves to focus the images), glaucoma
(eye disease caused by an increase in the pressure of the fluid contained inside
the eye). These effects are less likely to occur than with treatment with
glucocorticoids taken orally.
Rarely, a series of psychological and behavioral effects may occur
including psychomotor hyperactivity (behavioral disorder manifested by a
excessive motor activity), sleep disturbances, anxiety, depression, aggression, behavioral disorders.
Therefore, based on the above, it is important that you take the dose as indicated in the package
insert or as prescribed by your doctor. You should therefore not increase or
decrease the dose without first consulting your doctor (see section 3 “How to take
Bodix”).

Paradoxical bronchospasm
As happens with other therapies administered by inhalation, paradoxical bronchospasm (unexpected narrowing of the bronchi that
causes severe breathing difficulties due to reduced air passage) with an immediate increase in wheezing (difficulty breathing accompanied by a whistling breath, i.e.
similar to a whistle) may occur after administration. In this case, you should immediately consult your doctor, who may, if
necessary, discontinue treatment with inhaled budesonide. The doctor will assess whether to start
an alternative therapy, if necessary.

For those who play sports
The use of the drug without therapeutic need constitutes doping and may still
result in a positive doping test.

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

Influence on growth
The use of inhaled glucocorticoids can affect the growth of children and adolescents
(see section “Additional undesirable effects in children and adolescents”). Therefore, it is
recommended that the height of children undergoing prolonged treatment with inhaled glucocorticoids
is periodically monitored by the doctor. If growth is slowed, the doctor will re-evaluate the
therapy in order to reduce the dose of inhaled glucocorticoids. The doctor will carefully evaluate
the benefits of glucocorticoid therapy and the possible risk of growth arrest. If necessary
your doctor may advise you to consult a pediatric pulmonologist (pediatrician
specialized in the care of respiratory diseases).

Other medicines and Bodix
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including over-the-counter medicines.
No interactions of budesonide with any other drug used in
the treatment of asthma have been observed.
In particular, tell 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 want to keep you under close observation if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat) Fertility, pregnancy and breastfeedingIf you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine. Studies have not shown any adverse effects on the health of the fetus/newborn with the use of inhaled budesonide during pregnancy. As with other medicines, consult your doctor for the administration of budesonide during pregnancy, as it is necessary for the doctor to assess the expected benefits for the mother compared to the risks for the fetus. Budesonide passes into breast milk. However, no adverse effects on the infant are expected at the recommended doses of Bodix. Budesonide can be used during breastfeeding. Driving and using machinesBodix does not affect the ability to drive vehicles and operate machinery.

3. How to use Bodix

Take this medicine following exactly the instructions of the 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 the elderly
The recommended initial dose is 0.5-1 mg twice a day. If necessary, the doctor may increase the dose of Bodix (see the dosage table).

Maintenance dose
The maintenance dose is individual.
Once asthma control is achieved, the maintenance dose should be the minimum dose that allows effective control of symptoms: the doctor will gradually reduce the medicine until the minimum dose is reached.

Dosage table

*The product must be mixed with 0.9% saline solution (sodium chloride solution) until the volume of 2 ml is reached.

Onset of effect
Improvement in asthma control following the administration of Bodix may occur within 3 days of starting treatment, although the maximum benefit is obtained after 2-4 weeks.

Patients treated with oral glucocorticoids (anti-inflammatory drugs)
With the use of Bodix it is possible to replace or significantly reduce the dose of glucocorticoids taken orally, while maintaining asthma control.
The transition from oral glucocorticoid therapy to Bodix will be evaluated by the doctor based on your general condition.
For about 10 days, the doctor will prescribe a high dose of Bodix to be taken in association with the oral medicine you are already taking.
After that, the doctor will gradually reduce the dose of the oral medicine to the lowest possible level. In many cases, it is possible to completely replace oral therapy with Bodix. For further information, see paragraph “Warnings and precautions”.

Dose division and mixing
Bodix can be mixed with 0.9% saline solution (sodium chloride solution) and with nebulizer solutions of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate or ipratropium (medicines used for the treatment of respiratory disorders).
The mixture must be used within 30 minutes.
If an adjustment of the Bodix dose is necessary, the contents of the single-dose vial can be divided.
In fact, on the 2 ml containers of Bodix 0.25 mg/ml suspension and Bodix 0.5 mg/ml suspension, a line is clearly visible. When the single-dose vial is held upside down, the line indicates a volume of 1 ml.
If you use only 1 ml, you must pour the contents of the single-dose vial until the surface of the liquid reaches the indicated line.
The opened single-dose container, still containing some liquid, must be stored in the sachet, away from light and must be used within 12 hours.
Before using the remaining liquid, carefully shake the contents with a rotating movement.
Once the aluminum sachet is opened, the still-closed containers are valid for 3 months and must be kept in the sachet 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 for which hospital admission is indicated)
Infants and children
The usual recommended dose is 2 mg of Bodix, which can be given with a single administration or with two administrations of 1 mg 30 minutes apart. The dosage can be repeated every 12 hours for a maximum of 36 hours or until the doctor has prescribed.
Bodix must be used with caution in children (see paragraph “Children and adolescents”).

INSTRUCTIONS FOR THE CORRECT USE OF BODIX

• 1) Gently shake the single-dose container with a rotating movement.
• 2) Hold the single-dose container in a vertical position and open it by rotating the tab until the single-dose vial is opened.
• 3) Place the open end of the single-dose container well into the reservoir of the nebulizer and press slowly.
• 4) Before turning on the nebulizer, carefully read the instructions for use contained in the package leaflet that is found in the package of each nebulizer. If you have any doubts about using the nebulizer, contact your doctor or pharmacist. Note:
• 1) After inhalation, rinse your mouth with water to minimize the risk of oropharyngeal candidiasis (thrush, infection of the
• 2) mouth and throat).
• 3) If you use a face mask to inhale the steam, you must make sure that the mask adheres well during nebulization. After using the face mask, wash your face with water to prevent irritation.
• 4) Clean and maintain the nebulizer according to the instructions provided by the manufacturer.

Nebulizer cleaning
The nebulizer reservoir must be cleaned after each administration. Wash the nebulizer chamber and mouthpiece or face mask in 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 intake of an excessive dose of Bodix should not cause any disturbances.
In case of accidental intake of an excessive dose of Bodix, immediately inform your doctor or go to the nearest hospital.

If you forget to use Bodix
Do not take a double dose to make up for the missed dose.

If you stop the treatment with Bodix
If you have any doubts 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.
Side effects are listed below according to the following frequency:

Common (may affect up to 1 in 10 people)

• candidiasis of the oropharynx (thrush, infection of the mouth and throat)
• nausea
• cough, hoarseness (when the voice is raspy 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), dermatitis
• from contact (skin inflammation that usually manifests with redness, blisters, vesicles, abrasions and crusts), urticaria (skin redness accompanied by itching), 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 activity)
• restlessness, nervousness, depression, behavioral changes, sleep disorders,
• anxiety, psychomotor hyperactivity (behavioral disorder manifested by excessive motor activity), aggression
• bronchospasm (narrowing of the bronchi causing difficulty breathing due to a
• reduced passage of air)
• bruising (bruises), striae cutaneae (streaks on the skin similar to stretch marks, reddish-
• purple in color) *Skin irritation of the face, as an example of an allergic reaction, has occurred in some cases when using a nebulizer with a mask. To prevent irritation, the face should be washed with water after using the face mask. Frequency not known (cannot be estimated from available data)
• glaucoma (eye disease caused by increased pressure of the fluid contained within the eye), cataract (clouding of the lens, the lens of the eye used to focus images) Additional side effects in children and adolescents

Side effects are listed below according to the following frequency:

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

• slowing of growth
• dysphonia (difficulty producing voice), hoarseness (when the voice is raspy or low)
• behavioral disorders. Given the risk of growth retardation in the pediatric patient population, growth should be monitored as described in the “Children and adolescents” section.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the pack after
EXP.
Do not store at a temperature 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, the unopened containers must be stored
in 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 in 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 Bodix contains

Bodix0.25 mg/ml suspension
the active ingredient is: budesonide (each 2 ml container contains 0.5 mg of budesonide).
the other ingredients are:disodium edetate, sodium chloride, polysorbate 80, anhydrous citric acid, sodium citrate,
water for injections.

Bodix0.5 mg/ml suspension
the active ingredient is:budesonide (each 2 ml container contains 1 mg of budesonide).
the other ingredients are:disodium edetate, sodium chloride, polysorbate 80, anhydrous citric acid, sodium citrate,
water for injections.

Description of the appearance of Bodix and package contents
Bodix presents as 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 Authorisation Holder
Manufacturer
Genetic S.p.A. – Contrada Canfora – Fisciano (SA)