BUFANET 0.25 MG/ML Suspension for nebulization

Зміст інструкції

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

BUFANET 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 they have the same symptoms as you, 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 BUFANET is and what it is used for
• 2. What you need to know before you take BUFANET
• 3. How to take 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 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 of the lungs, promoting the passage of air.
BUFANET is indicated in adults and children from 6 months of age and older in 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;
• Subglottic laryngitis or pseudocroup (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 taking BUFANET

Do not take BUFANET

• 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 BUFANET:

• 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 by 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 BUFANET”
• 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 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 is used to focus images). Contact your doctor if you experience blurred vision or other visual disturbances.

Since the function of the adrenal glands may be inhibited, a stimulation test with
ACTH to diagnose possible pituitary insufficiency may provide false results
(low values).
BUFANET 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 orally,

orally, intramuscularly or intravenously) to inhaled glucocorticoid therapy.
If you need to switch from glucocorticoid (anti-inflammatory) treatment by systemic route (for example orally)
to treatment with glucocorticoids by inhalation, your doctor will gradually reduce the
dosage of the 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 appear. You may
experience these symptoms even if lung function is maintained or even improved. If you experience these symptoms, your doctor will continue therapy
with BUFANET, and will 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, the doctor may temporarily increase the dose of
systemic glucocorticoid you are taking, and the switch to BUFANET may proceed
more slowly. If, during this transition phase, you are subjected to physical stress (for
example in case of severe infections, trauma or surgery) or have a severe asthma attack, the
doctor may prescribe you supplementary treatment with systemic glucocorticoids (for example
systemically).
In addition, switching from systemic glucocorticoid treatment to inhalation 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 happens,
consult your doctor who will prescribe you 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 you the appropriate therapy and, if necessary, will make you
interrupt the treatment (see also section 3 “How to take BUFANET”)

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 can 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, fluid retention,
reduced sugar tolerance and increased risk of diabetes, swelling of the legs, headache, etc.),
adrenal suppression (severe impairment of adrenal gland activity), reduction
of bone mass, cataracts (clouding of the lens, the lens of the eye that is used to
focus 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 can occur, including
psychomotor hyperactivity (behavioral disorder manifested by 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 leaflet
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 BUFANET”).

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

Children and adolescents
BUFANET 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
be periodically checked by the doctor.
If growth is slowed down, the doctor will assess the therapy in order to reduce the dose of glucocorticoids
by inhalation.
The doctor will carefully assess the benefits of glucocorticoid therapy and the possible risk of
growth arrest.
If necessary, the doctor will advise you to consult a pediatric pulmonologist (pediatrician
specializing in the treatment of respiratory diseases).

Other medicines and BUFANET
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”).
• 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
Studies have not shown an increased risk of adverse effects on the health of the
fetus/newborn with the use of budesonide by 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, no adverse effects on the infant are expected at the recommended doses of BUFANET.
Budesonide can be used during breastfeeding.

Driving and operating machinery
BUFANET does not affect the ability to drive vehicles and operate machinery.

3. How to take BUFANET

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

ASTHMA
INITIAL DOSE
The dosage of BUFANET is individual.

Adults and the elderly
The recommended initial dose is 0.5-1 mg twice a day.
If necessary, your doctor may increase the dose of BUFANET (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
the minimum dose is reached.
DOSAGE TABLE

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

ONSET OF EFFECT
Improvement in asthma control following the administration of BUFANET 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 BUFANET, 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 BUFANET will be evaluated by
your doctor based on your general condition. For about 10 days, your doctor will prescribe a
high dose of BUFANET 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
BUFANET. For further information, see section “Warnings and precautions”.

DOSE DIVISION AND MIXING
BUFANET can be mixed with 0.9% sodium chloride solution (saline solution).
The mixture must be used within 30 minutes.
If an adjustment of the BUFANET dose is necessary, the contents of the
single-dose container can be divided.
In fact, 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, 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, shake
the contents carefully with a rotating movement. Once the aluminum sachet is opened, the containers
still closed have a validity of 3 months and must be kept in the sachet protected from light.

Use in children and adolescents
ASTHMA
Children from 6 months of life
The dosage of BUFANET is individual.
The recommended initial dose is 0.25-0.5 mg per day.
If a need recurs, your doctor may increase the dose of BUFANET.

SUBGLOTTIC LARYNGITIS OR PSEUDO-CROUP (for severe forms requiring
hospitalization)
Infants and children
The usual recommended dose is 2 mg of BUFANET, 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 your doctor has
prescribed it.
BUFANET should 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 vapors produced by the nebulizer are
inhaled through the mouth via 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 chamber (a reservoir), in which the solution of
the medicine is placed, having a volume of 2-4 ml.
Ultrasonic nebulizers are not suitable for the administration of BUFANET.
The nebulization time and the amount of medicine delivered by a nebulizer depend on
the flow rate of the compressor and the filling volume.
There may be variability in performance (dose administered) between different nebulizers, even of the
same brand and model.
For children, it is recommended to use a tightly fitting and well-adhering facial mask, capable of
optimizing the dose of budesonide administered.
Children must use BUFANET only under the supervision of an adult.

INSTRUCTIONS FOR USE

• 1. Gently shake the single-dose container with a rotating movement for at least 30 seconds.
• 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.
• 4. Before turning on the nebulizer, read carefully the instructions for use reported in the

If you have any doubts about using the nebulizer, contact your doctor or pharmacist.
NOTES:

• 1. After inhalation, rinse your mouth with water to minimize the risk of oral 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.
• 3. Clean and maintain the nebulizer according to the instructions provided by the manufacturer.

CLEANING THE NEBULIZER
The 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
reconnecting it to the compressor and the inhaler.

If you take more BUFANET than you should
Accidental ingestion of an excessive dose of BUFANET should not cause discomfort. In case of
accidental ingestion of an excessive dose of BUFANET, immediately inform your doctor 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 taking BUFANET
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 everyone will experience 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 (when the voice is strident or low), sore throat irritation;
• pneumonia (lung infection) in patients with COPD. Inform your doctor if you have any of the following symptoms while taking budesonide, as they may 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, 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 glucocorticoid effects systemically (i.e. taken orally, intramuscularly or intravenously), including adrenal suppression (severe impairment of adrenal gland activity);
• restlessness, nervousness, behavioral changes, sleep disturbances, 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 streaks 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 skin irritation of the face, wash your face with water after using the face mask.

Not known (frequency cannot be estimated based on 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 retardation in the pediatric patient population, growth should be monitored as described in the “Children and adolescents” section.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. 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 BUFANET

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.
Do not store at a temperature above 25°C.
Store in the original packaging to protect the medicine from light. Do not freeze.
After opening the aluminium sachet, the containers not yet opened 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 used within 12 hours. After this time, any remaining
product must be discarded.
Do not dispose of any medicine in waste water 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 BUFANET contains

BUFANET 0.25 mg/ml suspension for nebulizer

• The active ingredient 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.

BUFANET 0.5 mg/ml suspension for nebulizer

• The active ingredient 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 BUFANET and contents of the pack
BUFANET is presented as a homogeneous white suspension for nebulization with a pH
between 4.0-5.0 and an osmolarity between 260 and 320 mosmol/kg.
Single-dose container in low-density polyethylene containing 2 ml of suspension. On the surface
of the container, a line is visible 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
Eberlife farmaceutici S.p.A. - Via G. Porzio snc, 80143 CDN Isola E1, Napoli

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