Bufanet

Patient Information Leaflet

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

budesonide
equivalent medicine
Please read this entire leaflet carefully before using 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 give it to others, even if they have the same symptoms as you, because it could 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 BUFANET is and what it is used for
2. What you need to know before using BUFANET
3. How to use BUFANET
4. Possible side effects
5. How to store BUFANET
6. Contents of the pack and other information

1. What BUFANET is and what it is used for

BUFANET is an inhalation medicine intended for nebulization, containing the active substance budesonide.
BUFANET belongs to a group of medicines called "glucocorticoids" which work by reducing and preventing swelling and inflammation in the lungs, thereby facilitating airflow.
BUFANET 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 should know before taking BUFANET

Do not take BUFANET

• 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 BUFANET:

• 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 treatments with high inhaled doses of glucocorticoids;
• if you are experiencing a period of severe physical stress, such as during 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 BUFANET”);
• 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 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 focuses images). Contact your doctor if you experience blurred vision or other visual disturbances.

Since adrenal gland function may be suppressed, an ACTH stimulation test to diagnose potential pituitary insufficiency may yield misleading results (low values).
BUFANET 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 therapy (e.g., oral administration) to inhaled glucocorticoid therapy, your doctor will gradually reduce the dose of 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 despite maintained or even improved lung function. If such symptoms occur, your doctor will have you continue treatment with BUFANET and may request blood tests to assess your adrenal function (glands located above the kidneys that produce various types of hormones). Depending on your adrenal function, your doctor may temporarily increase the dose of systemic glucocorticoid you are taking, and the transition to BUFANET may proceed later, more gradually. If during this transition phase you experience physical stress (e.g., severe infections, trauma, or surgery) or a severe asthma attack, your doctor may prescribe additional systemic glucocorticoid treatment (e.g., systemic administration).

Furthermore, switching from systemic glucocorticoid treatment to inhaled therapy may trigger allergic reactions 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 therapy 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 treatment (see also section 3 “How to take BUFANET”).

Potential side effects of inhaled glucocorticoids (anti-inflammatory drugs) when used at high doses for prolonged periods
Inhaled glucocorticoids may cause side effects. In particular, when used at high doses for 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), reduced bone mass, cataracts (clouding of the lens of the eye), and glaucoma (an eye disease caused by increased pressure of the fluid inside the eye).

These effects are less likely to occur compared to treatment with orally administered glucocorticoids.
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. You must not increase or decrease the dose without first consulting your doctor (see section 3 “How to take BUFANET”).

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, with an immediate increase in wheezing dyspnea (difficulty breathing accompanied by a whistling sound). In this case, you must consult your doctor immediately, who may, if necessary, discontinue treatment with inhaled budesonide. Your doctor will assess whether to start an alternative therapy, if needed.

Children and adolescents
BUFANET 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 treatment with inhaled glucocorticoids be monitored periodically by a doctor.
If growth is slowed, your doctor will evaluate the therapy with the aim of reducing the dose of inhaled glucocorticoids.
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).
In addition, in rare cases, prolonged treatment with inhaled glucocorticoids may cause behavioral disturbances in children.

Other medicines and BUFANET
Tell 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 the treatment of asthma 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).

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

Pregnancy
Studies conducted 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 about using 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 BUFANET, effects on the breastfed infant are not expected.
Budesonide may be used during breastfeeding.

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

3. How to take BUFANET

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
ASTHMA
INITIAL DOSE
The dosage of BUFANET 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 BUFANET (see dosing table).
MAINTENANCE DOSE:
The maintenance dose is individual.
Once asthma is under control, the maintenance dose should be the lowest dose that maintains effective symptom control: your doctor will gradually reduce the medicine until the minimum 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 BUFANET 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 BUFANET, 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 treatment with BUFANET will be evaluated by the doctor based on your general condition. For approximately 10 days, the doctor will prescribe a high dose of BUFANET to be taken in combination with the oral medication you are already using. After this period, the 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 BUFANET. For further information, see section “Warnings and precautions”.
DIVISION OF DOSE AND MIXING
BUFANET can be mixed with 0.9% physiological solution (saline solution).
The mixture must be used within 30 minutes.
If an adjustment of the BUFANET dose is required, the contents of the single-dose container may be divided.
Indeed, on the 2 ml containers of BUFANET 0.25 mg/ml suspension for nebulizer and BUFANET 0.5 mg/ml suspension for nebulizer, a line is clearly visible. When the single-dose vial is held upside down, this line indicates a volume of 1 ml. If only 1 ml is to be used, pour the contents of the single-dose vial until the surface of the liquid reaches the indicated 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 rotating motion. Once the aluminum pouch has been opened, the unopened containers have a shelf life of 3 months and must be kept in the pouch, protected from light.
Use in children and adolescents
ASTHMA
Children from 6 months of age
The dosage of BUFANET is individual.
The recommended initial dose is 0.25–0.5 mg per day.
If symptoms recur, your doctor may increase the dose of BUFANET.
SUBGLOTTIC LARYNGITIS OR CROUP (for severe forms requiring hospitalization)
Infants and children
The usual recommended dose is 2 mg of BUFANET, which may be administered as a single dose or as two doses of 1 mg given 30 minutes apart.
The dosage may be repeated every 12 hours for up to 36 hours or as prescribed by your doctor.
BUFANET must be used with caution in children (see section “Children and adolescents”).
INSTRUCTIONS FOR THE CORRECT USE OF BUFANET
BUFANET must be used with a jet nebulizer. The vapor 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 chamber (a reservoir) where the medication solution is placed, with a volume of 2–4 ml.
Ultrasonic nebulizers are not suitable for the administration of BUFANET.
The nebulization time and the amount of medication delivered by a nebulizer depend on the compressor flow rate and the filling volume.
There may be variability in performance (delivered dose) between different nebulizers, even of the same brand and model.
For children, it is recommended to use a well-fitting, airtight face mask to optimize the delivered dose of budesonide.
Children must use BUFANET only under adult supervision.
INSTRUCTIONS FOR USE

1. Gently shake the single-dose container with a rotating motion for at least 30 seconds.
2. Hold the single-dose container in an upright position and open it by twisting the tab until the single-dose container opens.

3. Insert the open end of the single-dose container well into the nebulizer chamber and squeeze slowly.
4. Before turning on the nebulizer, carefully read the instructions for use provided in the leaflet included in the packaging of each nebulizer. If you have any doubts about the use of the nebulizer, consult your doctor or pharmacist.

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 vapor, ensure that the mask fits properly during nebulization. After using the face mask, wash your face with water to prevent irritation.
3. Clean and maintain the nebulizer according to the manufacturer's instructions.

CLEANING THE NEBULIZER
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 BUFANET than you should
Accidental ingestion of an excessive dose of BUFANET is unlikely to cause problems. In case of accidental overdose of BUFANET, contact your doctor immediately or go to the nearest hospital.
If you forget to take BUFANET
Do not take a double dose to make up for the missed dose.
If you stop treatment with BUFANET
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 everyone experiences them.
The side effects are listed below according to the following frequency:

Common (may affect up to 1 in 10 people)

• Candida infections of the oropharynx (oral thrush, fungal infection of the mouth and throat);
• nausea;
• cough, hoarseness (when the voice is harsh or low), 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.
  • Increased cough or worsening 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 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. 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 airways causing breathing difficulty due to reduced airflow);
• bruising (ecchymoses), cutaneous striae (skin streaks resembling stretch marks, red-purple in colour).

*Skin irritation of the face, as an example of an allergic reaction, has occurred in some cases when using a nebulizer with a face mask. 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 is 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: 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 BUFANET

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.
Do not store above 25°C.
Store in the original packaging to protect the medicine from light. Do not freeze.
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 should be discarded.
The single-dose container, once opened, must be used within 12 hours. After this period, any remaining product should be discarded.
Do not dispose of any medicine 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 BUFANET contains
BUFANET 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.

BUFANET 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 BUFANET and contents of the pack
BUFANET is a homogeneous white suspension for nebulisation, with a pH between 4.0–5.0 and an osmolarity between 260 and 320 mosmol/kg.
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 contained in a sealed pouch made of PET/Al/PE.
Marketing Authorisation Holder
Eberlife farmaceutici S.p.A. - Via G. Porzio snc, 80143 CDN Isola E1, Napoli
Manufacturer
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA)