Budexan

Package leaflet: Information for the patient

Budexan 0.25 mg/ml nebuliser suspension, 0.5 mg/ml nebuliser suspension

budesonide
equivalent medicine
Please read all of 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 taking 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 Budexan is and what it is used for

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

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

2. What you need to know before taking Budexan

Do not take Budexan

• 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 Budexan:

• 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 drugs) or prolonged treatment with high inhaled doses of 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 Budexan”);
• 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 (measles and chickenpox);
• if you have eye problems (blurred vision, glaucoma, cataract). 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).
Budexan is not suitable for the rapid relief of sudden asthma attacks, for which a short-acting bronchodilator should be used. Your doctor will carefully evaluate the most appropriate treatment 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. In rare cases, 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 you develop such symptoms, your doctor will advise continuing treatment with Budexan 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 Budexan may proceed 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 gland problems. In such cases, your doctor may prescribe additional systemic glucocorticoid treatment (e.g., systemic administration).

Additionally, switching from systemic glucocorticoid treatment to inhaled therapy may trigger allergic reactions, such as rhinitis or 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 therapy to manage these symptoms.

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

Potential side effects of inhaled glucocorticoids (anti-inflammatory drugs) 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 therapy.
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 sugar 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.
Therefore, it is important that you take the dose prescribed by your doctor.

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

Caution for athletes: the product contains substances prohibited for doping.
It is forbidden to take the product in a manner different from that indicated for therapeutic use, dosage regimen, and route of administration as specified.

Children and adolescents
Budexan 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 prolonged inhaled glucocorticoid therapy be monitored regularly by a doctor.
If growth is slowed, your doctor will evaluate the treatment with the aim of reducing the inhaled glucocorticoid dose.
Your doctor will carefully weigh the benefits of glucocorticoid therapy against the potential risk of growth suppression.
If necessary, your doctor may advise you to consult a pediatric pulmonologist (a pediatrician specialized in respiratory diseases).

Other medicines and Budexan
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 have been observed between budesonide and any other medicines used in the treatment of asthma.
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 Budexan.
• Certain medicines containing cobicistat (used in HIV treatment), as they may increase the risk of Budexan side effects.
• Medicines containing hormones (estrogens) or oral contraceptives (the pill).

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 fetal/neonatal health with the use of inhaled budesonide during pregnancy. It is important for both the fetus and the mother to maintain adequate asthma treatment during pregnancy. As with other medicines, consult your doctor regarding the use of budesonide during pregnancy, as your doctor needs to 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 Budexan, effects on the breastfed infant are not expected.
Budesonide may be used during breastfeeding.

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

3. How to take Budexan

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Bronchial asthma
INITIAL DOSE
The dosage of Budexan is individual.
Adults and elderly
The recommended initial dose is 0.5–1 mg twice daily.
Budexan If necessary, your doctor may increase the dose of Budexan (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% physiological saline solution (saline solution) up to a volume of 2 ml.
ONSET OF EFFECT
Improvement in asthma control following administration of Budexan 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 Budexan, it may be possible to replace or significantly reduce the dose of oral glucocorticoids while maintaining asthma control.
The switch from oral glucocorticoid therapy to Budexan will be evaluated by your doctor based on your general condition. For approximately 10 days, your doctor will prescribe a high dose of Budexan 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 Budexan. For further information, see section “Warnings and precautions”.
MIXING AND DOSAGE SPLITTING
Budexan can be mixed with 0.9% physiological saline solution or with solutions containing other active substances acting on the respiratory system, such as salbutamol, terbutaline, sodium cromoglicate, and ipratropium bromide. Follow your doctor’s instructions carefully.
The mixture must be used within 30 minutes.
If dose adjustment of Budexan is required, the contents of the single-dose container can be divided.
Indeed, a clearly visible line is marked on Budexan containers. When the container is held upside down, the line indicates a volume of 1 ml. If you need to use only 1 ml, pour the container contents until the liquid surface reaches the marked line. The opened single-dose container, containing part of the liquid, must be stored in the pouch, protected from light, and used within 12 hours. Before using the remaining liquid, carefully swirl the container gently to mix the contents. Once the aluminum pouch has been opened, unused containers must be kept in the pouch, protected from light, and are valid for 3 months.
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 per day. Your doctor will determine the appropriate dose to use.
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 dosage may be repeated every 12 hours for up to 36 hours or as long as prescribed by your doctor.
Budexan should be used with caution in children (see section “Children and adolescents”).
INSTRUCTIONS FOR CORRECT USE OF Budexan
The mist produced by the nebulizer is inhaled through the mouth using a mouthpiece or an appropriate face mask.
The nebulizer must consist of: a compressor (a pump) capable of generating an adequate airflow (5–8 L/min), and a nebulizer chamber (a reservoir) with a volume of 2–4 ml, where the medication 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 Budexan.
For children, it is recommended to use a well-fitting, airtight face mask to optimize the delivered dose of budesonide. Children must use Budexan only under adult supervision.
INSTRUCTIONS FOR USE

1. Gently swirl the single-dose container with a rotating motion.
2. Hold the single-dose container in an upright position and open it by twisting the tab until the container opens.

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

NOTES:

1. After inhalation, rinse your mouth with water to minimize the risk of developing oropharyngeal candidiasis (thrush, infection of the mouth and throat).
2. If you use a face mask to inhale the mist, ensure the mask fits properly during nebulization. After using the face 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 face mask in warm tap water using a mild detergent, or follow the manufacturer’s instructions. Rinse thoroughly and dry the chamber by reassembling it with the compressor and inhaler.

If you take more Budexan than you should
Taking an excessive dose of Budexan is unlikely to cause problems. However, if you accidentally take too much Budexan, contact your doctor immediately 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 using 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 will experience them.
The side effects are listed below according to the following frequency:
Common (may affect up to 1 in 10 people)

• Candida infection in the oropharynx (thrush, fungal infection of the mouth and throat);
• 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 may be signs of a lung infection:
  • Fever or chills.
  • Increased mucus production, changes in mucus colour.
  • Worsening cough or increased breathing difficulty.

Uncommon (may affect up to 1 in 100 people)

• cataract (clouding of the lens of the eye, which focuses 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, behavioural changes, sleep disturbances, psychomotor hyperactivity (behavioural disorder characterised by excessive motor activity), aggression;
• bronchospasm (narrowing of the bronchi causing breathing difficulty due to reduced airflow);
• bruising (ecchymosis), skin striae (stretch mark-like skin lesions, red-purple in colour).

*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 (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 sounds harsh or low);
• behavioural disorders.

Due to the risk of growth retardation in the paediatric 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, talk to 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 Budexan

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.
Once opened, the single-dose container 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What Budexan contains
Budexan 0.25 mg/ml suspension for nebuliser

• The active substance is budesonide. Each 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.

Budexan 0.5 mg/ml suspension for nebuliser

• The active substance is budesonide. Each 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 contents of the pack
Budexan is a homogeneous white suspension for nebulisation with a pH between 4.0 and 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 pack contains 20 single-dose containers divided into strips of 5 units, enclosed in a sealed pouch made of PET/Al/PE.
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)