BUDEXAN 0.25 MG/ML Nebulizable suspension

Зміст інструкції

1. Budexan 0.25 mg/ml suspension for nebulizer, 0.5 mg/ml suspension for nebulizer
   1. What is Budexan and what is it used for
   2. What you need to know before taking Budexan
   3. How to take Budexan
   4. Possible side effects
   5. How to store Budexan
   6. Contents of the pack and other information

Budexan 0.25 mg/ml suspension for nebulizer, 0.5 mg/ml suspension for nebulizer

budesonide
equivalent medicine

Read this leaflet carefully before you start to take 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 may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Budexan and what is it used for

Budexan Budexan is an inhaled medicine for nebulization, containing the active ingredient
budesonide.
Budexan 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.
Budexan is indicated in the treatment of:

• Bronchial asthma,
• Very severe subglottic laryngitis (inflammation of the airways that makes breathing difficult) where hospitalisation is indicated.

2. What you need to know before taking Budexan

Do not take Budexan

• if you are allergic to the active ingredient 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 Budexan:

• if you have problems with the 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 or itraconazole (medicines used to treat fungal infections) (see also section “Other medicines and Budexan”
• if you are taking medicines used for the treatment of HIV infection;
• if you have lung infections (such as pulmonary tuberculosis) or respiratory tract infections;
• if you have infections including fungal or viral infections (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
a possible pituitary insufficiency and may provide false results (low values).
Budexan is not suitable for the rapid improvement of sudden asthma attacks, for which a short-acting bronchodilator is necessary.
The doctor will carefully evaluate the most appropriate therapy for you.

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

orally, intramuscularly or intravenously) to inhaled glucocorticoid therapy.
If you need to switch from systemic glucocorticoid treatment (for example, orally) to
treatment with inhaled glucocorticoids, your doctor will gradually reduce the dosage of
systemic glucocorticoid you are taking. In 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 occur. You may experience these symptoms
even if lung function is maintained or even improved. If you experience these symptoms, your doctor will continue the therapy with Budexan, and will ask you to
undergo blood tests to evaluate the function of the adrenal glands. Based on the
function of the adrenal glands, the doctor may temporarily increase the dose of
systemic glucocorticoid you are taking, and the switch to Budexan may proceed
more slowly.
If you are experiencing physical stress (for example, in the case of severe infections, trauma or surgery) or
have a severe asthma attack, you may experience problems with the adrenal glands. In these cases, the doctor
may prescribe you supplementary treatment with systemic glucocorticoids (for example, systemically).
In addition, switching from systemic glucocorticoid treatment to inhaled therapy may
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
happens, 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 happens, contact your doctor. The doctor will prescribe the appropriate therapy and, if necessary, will make you
interrupt the treatment (see also section 3 “How to take Budexan”)

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

for prolonged periods
Inhaled glucocorticoids can cause side effects, particularly if used at high doses
for prolonged periods. These effects are less likely to occur than with treatment with
glucocorticoids taken orally.
These side effects include: Cushing's syndrome and Cushingoid appearance (a condition characterized
by excessive production of the hormone cortisol, which manifests with a full moon face, increased
body weight, fluid retention, reduced sugar tolerance and increased risk of diabetes,
leg swelling, headache, etc.), adrenal suppression (severe impairment of adrenal gland activity), reduced bone mass, eye disorders (cataracts glaucoma).
Rarely, a number of psychological and behavioral effects may occur, including
psychomotor hyperactivity (a behavioral disorder characterized by excessive motor activity), sleep disturbances, anxiety, depression, aggression, behavioral disorders.
It is therefore important that you take the dose as prescribed by your doctor.

Paradoxical bronchospasm
As happens with other therapies administered by inhalation, paradoxical bronchospasm (unexpected narrowing of the bronchi) with an immediate increase in wheezing may occur after administration.
In this case, you should consult your doctor immediately, who may, if necessary,
interrupt treatment with budesonide for inhalation. The doctor will evaluate whether to start alternative therapy, if necessary.

Caution for those who play sports: the product contains substances prohibited for
doping. Taking it differently than the therapeutic indications, dosage scheme and route of administration is prohibited.
Children and adolescents
Budexan 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 side 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 evaluate the therapy in order to reduce the dose of glucocorticoids
by inhalation.
The doctor will carefully evaluate the benefits of therapy with glucocorticoids and the possible risk of growth block.
If necessary, the doctor will advise you to consult a pediatric pulmonologist (a pediatrician specializing in the treatment of respiratory diseases).

Other medicines and Budexan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained without a prescription.
No interactions of budesonide with any other medicines 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”). The doctor may also consider reducing the dose of Budexan.
• Some medicines containing cobicistat (used to treat HIV) as they may increase the risk of side effects of Budexan. medicines that contain hormones (estrogens) or oral contraceptives (the pill).

Pregnancy and breastfeeding
If 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 taking this medicine.
Pregnancy
Available data do not indicate an increased risk of adverse health effects on
the fetus/newborn with the use of budesonide for inhalation during pregnancy. It is important for
both the fetus and the mother to maintain adequate asthma treatment during pregnancy. As
happens with other medicines, consult your doctor for the administration of budesonide during
pregnancy, as the doctor needs to assess the expected benefits for the mother against the risks
for the fetus.
Breastfeeding
Budesonide passes into breast milk.
However, at the recommended doses of Budexan, no effects on the infant are expected.
Budesonide can be used during breastfeeding.

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

3. How to take Budexan

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts consult your doctor or pharmacist.

Asthmabronchiale
INITIAL DOSE
The dosage of Budexan is individual.

Adults and the elderly
The recommended initial dose is 0.5-1 mg twice a day.
Budexan If necessary, your doctor may increase the dose of Budexan (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: your doctor will gradually reduce the medicine until
reaching the minimum dose.
DOSAGE TABLE
* The product must be mixed with 0.9% saline solution (saline solution) to reach
a volume of 2 ml.

ONSET OF EFFECT
Improvement in asthma control following the administration of Budexan may occur
within 3 days of starting treatment, although the maximum benefit is obtained after 2-4 weeks.

Patients treated with oral glucocorticoids
With the use of Budexan it is possible to replace or significantly reduce the dose of glucocorticoids
taken orally, while maintaining asthma control.
The transition from therapy with oral glucocorticoids to that with Budexan will be evaluated by
your doctor based on your general condition. For about 10 days, your doctor will prescribe a high dose
of Budexan to be taken in association with the oral medicine you are already taking. After that,
your 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 Budexan. For further
information, see section “Warnings and precautions”.

DOSE DIVISION AND MIXING
Budexan can be mixed with 0.9% saline solution (saline solution) or with solutions that
contain other active ingredients that act on the respiratory system such as salbutamol, terbutaline,
sodium cromoglycate and ipratropium bromide. Follow your doctor's instructions carefully.
The mixture must be used within 30 minutes.
If an adjustment of the Budexan dose is necessary, the contents of the single-dose container can be divided.
In fact, a line is clearly visible on the Budexan containers. When the container is held upside down,
the line indicates a volume equal to 1 ml. If you only need to use 1 ml, you must pour the contents of the container
until the surface of the liquid reaches the indicated line. The opened single-dose container,
still containing some of the 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
rotary movement. Budexan Once the aluminum sachet is opened, the still-closed containers have
a validity of 3 months and must be kept in the sachet protected from light.

Use in children and adolescents
Asthmabronchiale
The recommended initial dose in children aged 6 months or older and up to 12 years is
0.25-0.5 mg per day. The doctor will assess the appropriate dose to use.

Subglottic laryngitis (for severe forms for which hospitalisation is indicated)

The usual recommended dose in newborns and children is 2 mg of Budexan, which can be given with
a single administration or with two administrations of 1 mg 30 minutes apart.
The dosage may be repeated every 12 hours for a maximum of 36 hours or until your doctor has
prescribed.
Budexan must be used with caution in children (see section “Children and adolescents”).

INSTRUCTIONS FOR THE CORRECT USE OF Budexan
The vapors produced by the nebulizer are inhaled through the mouth through a mouthpiece or an appropriate
facial mask.
The nebulizer must consist of: a compressor (a pump) capable of generating a flow
of air adequate (5-8 L/min) and a bulb (a reservoir), in which the solution of the medicine is placed,
having a volume of 2-4 ml.
The nebulization time and the amount of medicine delivered by a nebulizer depend on
the flow rate of the compressor and the filling volume.
Due to the small amount of budesonide delivered, ultrasonic nebulizers should not
be used to administer Budexan.
For children, it is recommended to use a perfectly sealed and well-fitting facial mask, capable of
optimizing the dose of budesonide delivered. Children should only use Budexan under
adult supervision.

INSTRUCTIONS FOR USE

• 1. Gently shake the single-dose container with a rotary movement.
• 2. Hold the single-dose container in a vertical position and open it by rotating the tab until the single-dose container is opened.

• 3. Place the open end of the single-dose container well into the reservoir of the nebulizer and squeeze slowly.

NOTES:

• 1. After inhalation, rinse your mouth with water to minimize the risk of oropharyngeal candidiasis (thrush, mouth and throat infection).
• 2. If you use a facial mask to inhale the vapor, make sure the mask adheres well during nebulization. After using the facial mask, wash your face with water to prevent irritation. CLEANING THE NEBULIZERThe nebulizer chamber must be cleaned after each administration. Wash the nebulizer chamber and the mouthpiece or facial mask in warm tap water using a mild detergent or follow the manufacturer's instructions. Rinse well and dry the chamber by reconnecting it to the compressor and the inhaler.

If you take more Budexan than you should
Taking an excessive dose of Budexan should not cause discomfort. In case of accidental taking
of an excessive dose of Budexan, immediately inform your doctor or go to the nearest
hospital.

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

If you stop taking Budexan
Do not stop treatment with Budexan without consulting your doctor,
If you have any doubts about the use of this medicine, ask 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, fungal infections of the mouth and throat);
• nausea;
• cough, hoarseness, throat irritation;
• pneumonia (lung infection) in patients with COPD. Tell your doctor if you have any of the following symptoms while taking budesonide, as they could be symptoms of a lung infection:
• Fever or chills.
• Increased mucus production, changes in mucus color.
• Increased cough or greater difficulty breathing.

Uncommon (may affect up to 1 in 100 people)

• cataract (clouding of the lens, the lens of the eye used to focus images)
• depression
• anxiety
• tremor
• muscle spasm (sudden and involuntary muscle contraction)
• blurred vision.

Rare (may affect up to 1 in 1000 people)

• immediate or delayed allergic reactions* including rash (skin eruption), contact dermatitis (skin inflammation usually manifested with redness, blisters, vesicles, abrasions and scabs), 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, behavioral changes, sleep disorders, psychomotor hyperactivity (behavioral disorder manifested by excessive motor activity), aggression;
• bronchospasm (narrowing of the bronchi causing difficulty breathing due to reduced airflow);
• ecchymosis (bruising), striae cutaneae (stretch mark-like stripes on the skin, reddish-purple in color).

*Skin irritation of the face, as an example of an allergic reaction, has occurred in some cases when a mask nebulizer has been 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 (eye disease caused by increased pressure of the fluid contained within the eye).

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 strident or low);
• behavioral disorders.

Given the risk of growth slowing 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 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 Budexan

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 the wording
“Exp.”.
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Store in the original package to protect the medicine from light.
After opening the aluminium sachet, unopened containers must be stored in the
sachet, protected from light and used within 3 months. After this time, any remaining product must
be discarded.
Once opened, the single-dose container must be stored in the sachet, protected from light and
used within 12 hours. After this time, any remaining product must be discarded.
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. Contents of the pack and other information

What Budexan contains

Budexan 0.25 mg/ml suspension for nebuliser

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

Budexan 0.5 mg/ml suspension for nebuliser

• The active substance is budesonide. One single-dose container of 2 ml 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 Budexan and contents of the pack
Budexan is presented as a homogeneous white nebulisation suspension with a pH
between 4.0-5.0.
Single-dose container in low-density polyethylene containing 2 ml of suspension. A line is visible on the surface
of the container indicating a volume of 1 ml.
Each pack contains 20 single-dose containers divided into strips of 5 units contained in a
sealed PET/Al/PE bag.

Marketing Authorisation Holder
Genetic S.p.A. – Via Della Monica, 26 – 84083 Castel San Giorgio (SA)

Manufacturer
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA)