Budineb

Package leaflet: Information for the patient

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

Budesonide
Generic medicine
Please read this leaflet carefully before using 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including 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 using Budineb
3. How to use Budineb
4. Possible side effects
5. How to store Budineb
6. Contents of the pack and other information

1. What Budineb is and what it is used for

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

• bronchial asthma, an inflammatory disease characterized by obstruction of the bronchi;
• severe subglottic laryngitis (pseudocroup), a disease characterized by obstruction of the throat (larynx) that makes it difficult for air to pass through, requiring hospitalization.

2. What you need to know before taking Budineb

Do not take Budineb

• 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 Budineb if:

• you have reduced liver function;
• you are currently taking ketoconazole (a medicine used to treat fungal diseases) or HIV protease inhibitors (medicines for the treatment of AIDS) or other inhibitors of cytochrome CYP3A4 (an enzyme mainly involved in the breakdown of medicines);
• you have active or quiescent pulmonary tuberculosis or fungal or viral respiratory infections;
• you have fungal or viral infections (measles and chickenpox);
• you have glaucoma (characterized by chronic damage to the optic nerve) or cataracts (loss of transparency of a part of the eye called the lens).

Budineb does not provide rapid relief during sudden (acute) asthma attacks, for which other types of medicines such as short-acting bronchodilators are required.
Your doctor must carefully assess whether you have not benefited from the use of short-acting bronchodilators; in such a case, they may decide to increase the number of budesonide inhalations compared to the usual dose or initiate oral glucocorticosteroid therapy.
In these two cases, your doctor must carefully evaluate the potential risks of impairment and/or insufficiency of a gland called the adrenal gland.
Your doctor must carefully consider stopping treatment with oral glucocorticosteroids, as rare cases of general malaise may occur, such as muscle and joint pain, fatigue, headache (cephalalgia), depression, nausea, and vomiting, even though there may be improvement in lung function.
Switching from systemic glucocorticosteroid treatment (affecting the entire body) to inhaled therapy may sometimes unmask allergies, such as inflammation of the nose (rhinitis) and skin (eczema).
During inhaled therapy, a fungal disease called oral candidiasis may develop. This infection may require appropriate antifungal treatment and, in some cases, discontinuation of therapy may be necessary (see section "How to take Budineb").
During long-term treatment with high doses of Budineb, local and systemic effects may occur (Cushing's syndrome, Cushingoid appearance, adrenal suppression, reduced bone mineral density, cataracts, glaucoma, and rarely psychological and behavioral effects including psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, and behavioral disorders).
Once asthma control is achieved, your doctor will prescribe the lowest effective maintenance dose. Do not increase or decrease the dose without first consulting your doctor.
As with other inhaled therapies, you may experience bronchoconstriction (paradoxical bronchospasm), with an immediate increase in breathing difficulty (wheezing dyspnea) after administration. In this case, you must immediately stop inhaled budesonide treatment and your doctor will assess the situation and consider alternative therapy if necessary.
Contact your doctor if blurred vision or other visual disturbances occur.
Attention for athletes: The product contains substances prohibited in doping.
It is forbidden to use this medicine in a manner different from that indicated for therapeutic indications, dosage regimen, or route of administration as specified.

Children and adolescents
Budineb should be used with caution in children.
Effect on growth
Height should be monitored periodically in children undergoing prolonged treatment with inhaled glucocorticosteroids. If growth is slowed, your doctor will evaluate whether to reduce the dose of the medicine. The benefits of therapy and the potential risk of growth suppression must be carefully evaluated by the doctor, who may refer the child to a pediatric pulmonologist.
During long-term treatment with high doses of Budineb, behavioral disorders may occur.

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

• ketoconazole and itraconazole, medicines used to treat fungal diseases, as they may increase the amount of budesonide in the body (see section "Warnings and precautions"). Your doctor may consider reducing the dose of Budineb.
  Budineb interferes with:
• estrogens and hormones used in contraceptive pills, as they may increase the amount of budesonide in the blood, leading to systemic effects. No effect has been observed with the use of budesonide and concomitant low-dose oral contraceptives.
  Budineb may alter the results of certain laboratory tests used to diagnose insufficient activity of a gland called the pituitary gland (ACTH stimulation test to diagnose possible pituitary insufficiency may yield misleading results due to detection of low values).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Inhaled budesonide has not shown any negative effects on the fetus or newborn during pregnancy.
Your doctor will evaluate the expected benefits for you against the risks for the fetus during pregnancy.
Breastfeeding
Budesonide may pass into breast milk.
At therapeutic doses of Budineb, effects on the breastfed infant are not expected.
Budesonide may be used during breastfeeding.

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

3. How to take Budineb

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Bronchial asthma
Adults and elderly
Initial dose:
The dosage of Budineb is individual.
The recommended initial dose is 0.5–1 mg twice daily.
In cases where a greater therapeutic effect is required, higher doses of Budineb may be prescribed.
Maintenance dose:
The maintenance dose is individual.
Once the desired clinical response has been achieved, your doctor will reduce the dose to the lowest amount needed to control symptoms.
Onset of effect
Improvement in asthma control following administration of Budineb may occur within 3 days of starting treatment, although maximum benefit is usually achieved after 2–4 weeks.
Patients treated with oral glucocorticosteroids (see section “Warnings and precautions”)
Budineb may allow for replacement or significant reduction of oral glucocorticosteroid dosage while maintaining asthma control.
Your doctor will determine how to switch from oral glucocorticosteroid therapy to treatment with Budineb nebulizer suspension.
Dose division and mixing
Your doctor may instruct you to mix Budineb with 0.9% sodium chloride solution and with other solutions containing medicines acting on the respiratory system, such as terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglicate, or ipratropium bromide.
The mixture must be used within 30 minutes.
The contents of the single-dose container may be divided to allow dose adjustment.
On the single-dose containers of Budineb, a clearly visible line is present.
When the single-dose container is held upside down, the line indicates a volume of 1 ml.
If only 1 ml is to be used, empty the container until the liquid surface reaches the marked line.
Before using the remaining liquid, carefully mix the contents by rotating the container.
DOSAGE TABLE

* The medicine must be mixed with 0.9% sodium chloride solution up to a volume of 2 ml.
Use in children and adolescents
Bronchial asthma
Children aged 6 months and older up to 12 years
The recommended total daily dose is 0.25–0.5 mg.
If your child is being treated with oral glucocorticosteroids, the doctor may decide to start with a higher initial total daily dose, for example 1 mg.
The doctor will consider the higher 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 administered as a single dose or as two 1 mg doses given 30 minutes apart.
The dosing may be repeated every 12 hours for up to 36 hours or until clinical improvement.
For children, it is recommended to use a well-fitting, airtight facial mask capable of optimizing the delivered dose of budesonide.
INSTRUCTIONS FOR THE CORRECT USE OF BUDINEB
Notes:
The nebulization time and the amount of medicine 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 Budineb.
Gently shake the vial with a rotating motion.
Hold the single-dose container in an upright position and open it by twisting the tab until the container opens.
Insert the open end of the single-dose container well into the nebulizer reservoir and press slowly.
Rinse the mouth with water after each administration to reduce the occurrence of fungal infections (oropharyngeal candidiasis).
If a facial mask is used, ensure that the mask fits properly during nebulization. After using the facial mask, wash the face with water to prevent irritation.
Cleaning:
The nebulizer chamber should be cleaned after each administration. Wash the nebulizer chamber, mouthpiece, or facial 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 inhaler.
If you take more Budineb than you should
Acute overdose with Budineb, even in high doses, should not cause clinical problems.
In case of accidental ingestion of an excessive dose of Budineb, contact your doctor immediately or go to the nearest hospital.
If you forget to take Budineb
Do not take a double dose to make up for the forgotten dose.
If you stop treatment with Budineb
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 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 optic nerve (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 pustular, vesicular or bullous skin rashes, skin inflammation due to contact with certain substances (contact dermatitis), sudden onset of more or less itchy skin 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, behavioural changes, sleep disturbances, psychomotor hyperactivity, aggression;
• bruising, skin streaking.

Rarely, due to unknown mechanisms, medicines administered by inhalation may cause bronchospasm.
To prevent irritation, the skin of the face should be washed with water after using the face mask.
Following the instructions provided in this leaflet reduces the risk of 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 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 Budineb

Store below 25°C in the original packaging to protect the medicine from light.
After opening the aluminium foil pouch, the single-dose containers must be used within 3 months. Any remaining product must be discarded after this time.
After opening the aluminium foil pouch, unused single-dose containers must be stored inside the pouch, protected from light.
An opened single-dose container must be used within 12 hours. Any remaining product must be discarded after this time.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after the word “Expiry”.
The expiry date refers to the last day of that month.
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 Budineb contains
Budineb 0.25 mg/ml nebules suspension

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

Budineb 0.5 mg/ml nebules suspension

• The active substance is budesonide. Each single-dose container 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 Budineb and the contents of the pack
Nebuliser suspension.
Each pack contains 20 single-dose containers divided into strips of 5 units contained in an aluminium pouch.
Marketing Authorisation Holder
I.B.N. Savio S.r.l. – Via del Mare, 36 – Pomezia (RM)
Manufacturer
Genetic S.p.A. – Contrada Canfora – 84084 Fisciano (SA)