BUDINEB 0.25 mg/ml Небулизируемая суспензия

Содержание инструкции

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

Budineb 0.25 mg/ml suspension for nebulisation, 0.5 mg/ml suspension for nebulisation

budesonide

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

1. What is Budineb and what is it used for

Budineb contains the active substance budesonide.
Budineb belongs to a group of medicines called glucocorticosteroids, which are hormones
that perform numerous activities, with an important function in controlling
inflammation.
Budineb is indicated in the treatment of the following diseases:

• bronchial asthma, an inflammatory disease characterized by an obstruction of the bronchi;
• very severe subglottic laryngitis (pseudocroup), a disease characterized by an obstruction of the throat (larynx) that makes it difficult for air to pass, for which hospital admission is indicated.

2. What you need to know before you take Budineb

Do not take Budineb

• 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 Budineb if:

• you have reduced liver function;
• you are taking ketoconazole (a medicine to treat fungal infections) or HIV protease inhibitors (medicines for the

treatment of AIDS) or other cytochrome CYP3A4 inhibitors (enzymes largely
involved in the breakdown of medicines);

• you have active or inactive pulmonary tuberculosis or fungal or viral infections of the respiratory tract;
• you have fungal and viral infections (measles and chickenpox);
• you have glaucoma (characterized by chronic damage to the optic nerve) and cataracts (loss of transparency of a part of the eye called the lens).

Budineb does not provide rapid improvement of sudden (acute) asthma episodes, for which
other types of medicines such as short-acting bronchodilators are necessary.
The doctor must carefully evaluate if you have not benefited from the use of
short-acting bronchodilators, in which case they may decide to increase the number
of inhalations of budesonide compared to usual or start therapy with
oral corticosteroids.
The doctor, in these two cases, must evaluate the possible risks of impairment and/or
insufficiency of a gland called the adrenal gland.
The doctor must carefully evaluate the discontinuation of treatment with
oral corticosteroids as rare cases of general malaise such as muscle and joint pain, fatigue, headache,
depression, nausea and vomiting may occur despite possible improvement in
lung function.
Replacing treatment with systemic corticosteroids (those that distribute throughout
the body) with inhaled therapy can sometimes make allergies manifest, such as nasal inflammation (rhinitis) and skin inflammation (eczema).
During inhaled therapy, a fungal disease called oral candidiasis may occur. This infection may require treatment with appropriate antifungal therapy and, in some cases, it may be necessary to discontinue treatment (see
section “How to take Budineb”).
With long-term treatment, with high doses of Budineb, local and
systemic effects (Cushing's syndrome, Cushingoid appearance, adrenal suppression,
decreased bone mineral density, cataracts, glaucoma, rarely psychological and
behavioral effects including psychomotor hyperactivity, sleep disturbances, anxiety,
depression, aggression, behavioral disorders) can occur.
Once asthma control is achieved, your doctor will prescribe the minimum effective maintenance dose. Do not increase or decrease the dose without first consulting your doctor.
As with other inhaled therapies, bronchospasm (paradoxical bronchospasm) with immediate increase in
breathing difficulty (wheezing) may occur after administration. In such a case, you should
immediately discontinue treatment with inhaled budesonide and the doctor
will assess the situation and alternative therapy, if necessary.
Contact your doctor if you experience blurred vision or other visual disturbances.

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

Influence on growth
Height should be periodically monitored if a child is undergoing prolonged treatment
with inhaled corticosteroids. If growth is slowed, the doctor
will evaluate whether to reduce the dose of the medicine. The benefits of therapy and the possible risk of
growth suppression must be carefully evaluated by the doctor who may
refer the child to a pediatric pulmonologist specialist.
With long-term treatment, with high doses of Budineb, behavioral disturbances may occur.

Other medicines and Budineb
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
No interactions of budesonide with any other medicines used in
the treatment of asthma have been observed.
You should avoid taking them at the same time or allow as long an interval as possible if you need to take:

• ketoconazole and itraconazole, medicines to treat fungal infections, as they can increase the amount of budesonide in the body (see section “Warnings and precautions”). The doctor may also consider reducing the dose of Budineb. Budineb interferes with:
• estrogens and hormones used in contraceptive pills as in these cases it increases the amount of budesonide in the blood with the resulting effects on the body. No effect has been observed with the use of budesonide and the concomitant use of low-dose oral contraceptives. Budineb can alter the result of some laboratory tests used to diagnose insufficient activity of a gland called the pituitary gland (ACTH stimulation test to diagnose possible pituitary insufficiency may provide false results for the detection of low values).

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
Inhaled budesonide has not shown any adverse effects on the health of the
fetus/newborn during pregnancy.
The doctor will assess the expected benefits for you during pregnancy against the risks to the fetus.
Breastfeeding
Budesonide may pass into breast milk.
No effects on the infant are expected at therapeutic doses of Budineb.
Budesonide can be used during breastfeeding.

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

3. How to take Budineb

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

Bronchial Asthma

Adults and the elderly

Initial dose:
The dosage of Budineb is individual.
The recommended initial dose is 0.5-1 mg twice a day.
In cases where a greater therapeutic effect is required, you may be prescribed higher doses of Budineb.

Maintenance dose:
The maintenance dose is individual.
Once the desired clinical results are obtained, the doctor will reduce the dose until the minimum amount necessary to control the symptoms is reached.

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

Patients treated with oral glucocorticosteroids (see section “Warnings and precautions”)
Budineb may allow the replacement or significant reduction of the dosage of oral glucocorticosteroids, while maintaining asthma control.
The doctor will assess how to switch from oral glucocorticosteroid therapy to treatment with Budineb suspension for nebulization.

Dose division and mixing
Your doctor may ask you to mix Budineb with 0.9% saline solution and with other solutions containing medicines that act on the respiratory system such as terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglycate or ipratropium bromide.
The mixture must be used within 30 minutes.
The contents of the single-dose container can be divided to allow for dosage adjustment.
There is a clear line on the single-dose containers of Budineb.
When the single-dose container is held upside down, the line indicates a volume equal to 1 ml.
If only 1 ml is to be used, empty the contents of the single-dose container until the surface of the liquid reaches the indicated line.
Before using the remaining liquid, carefully shake the contents with a rotating movement.
DOSAGE TABLE
* The medicine must be mixed with 0.9% saline solution to reach a volume of 2 ml.

Use in children and adolescents
Bronchial Asthma

Children aged 6 months or older up to 12 years
The recommended total daily dose is 0.25-0.5 mg.
If a child is undergoing therapy with oral glucocorticosteroids, the doctor may decide to start with a higher total daily initial dose, for example 1 mg.
The doctor will consider the highest dose (2 mg per day) only in children with severe asthma and for limited periods.

Subglottic laryngitis (throat obstruction)
The recommended dose is 2 mg of Budineb, 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 clinical improvement.
For children, it is recommended to use a face mask with a perfect seal and good adherence, capable of optimizing the dose of budesonide administered.
INSTRUCTIONS FOR THE CORRECT USE OF BUDINEB

Notes:
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 Budineb.
Gently shake the vial with a rotating movement.
Hold the single-dose container in an upright position and open it by rotating the tab until the container opens.
Place the open end of the single-dose container well into the reservoir of the nebulizer and press slowly.
Rinse your mouth with water after each administration to reduce the occurrence of fungal infections (oral thrush).
If a face mask is used, make sure the mask adheres well during nebulization. After using the face mask, wash your face with water to prevent irritation.

Cleaning:
The nebulizer chamber should be cleaned after each administration. Wash the nebulizer chamber and the 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 the inhaler.

If you take more Budineb than you should
An acute overdose with Budineb, even in high doses, should not cause clinical problems.
If you accidentally take an excessive dose of Budineb, immediately inform your doctor or go to the nearest hospital.

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

If you stop taking Budineb
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.
The following side effects have been observed:
Common (may affect more than 1 in 10 people)

• fungal infections in the mouth and throat (Candida in the oropharynx);
• nausea;
• cough, hoarseness, throat irritation.

Uncommon (may affect up to 1 in 100 people)

• blurred vision
• chronic damage to the nerve of the eye (glaucoma), loss of transparency of a part of the eye called the lens (cataract).
• anxiety
• depression
• tremor
• muscle spasms

Rare (may affect up to 1 in 1000 people)

• immediate or delayed hypersensitivity reactions including skin rashes with pustules, blisters and bubbles (rash), skin inflammation due to contact with certain substances (contact dermatitis), sudden appearance of itchy or less itchy rash (urticaria), rapid swelling of the skin and mucous membranes (angioedema) and severe and sudden allergic reaction (anaphylactic reaction);
• suppression of the activity of a gland called the adrenal gland;
• restlessness, nervousness, behavioral changes, sleep disorders, psychomotor hyperactivity, aggression;
• bruising, skin striations.

Rarely, through unknown mechanisms, medicines administered by inhalation can
cause bronchospasm.
To prevent irritation, the skin of the face should be washed with water after use of the
face mask.

side effects.

Additional side effects in children and adolescents
Rare (may affect up to 1 in 1000 people)

• growth retardation;
• psychomotor hyperactivity, aggression;
• bronchospasm with voice disorders (dysphonia and hoarseness).

Reporting of side effects
If you get any side effects, talk to 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 Budineb

Store at a temperature not exceeding 25°C in the original packaging to protect the
medicinal product from light.
After opening the aluminum sachet, the single-dose containers must be used
within 3 months. After this time, any remaining product must be discarded.
After opening the aluminum sachet, unused single-dose containers must be
stored in the sachet, protected from light.
The opened single-dose container must be used within 12 hours. After this time, any
remaining product must be discarded.
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
words “Expiry date”.
The expiry date refers to the last day of that month.
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 Budineb contains

Budineb 0.25 mg/mlnebulizer suspension

• The active ingredient is budesonide. 1 single-dose 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.

Budineb 0.5 mg/mlnebulizer suspension

• The active ingredient is budesonide. 1 single-dose 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 Budineb and contents of the pack
Nebulizer suspension.
Each pack contains 20 single-dose containers divided into strips of 5 units contained
in an aluminum pouch.

Marketing authorization holder
I.B.N. Savio S.r.l. – Via del Mare, 36 – Pomezia (RM)

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