Budipulmi

Patient Information Leaflet

Budipulmi, 0.25 mg/mL, suspension for nebulisation
Budipulmi, 0.5 mg/mL, suspension for nebulisation
Budesonide
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if needed.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Budipulmi is and what it is used for
2. Important information before using Budipulmi
3. How to use Budipulmi
4. Possible side effects
5. How to store Budipulmi
6. Contents of the pack and other information

1. What Budipulmi is and what it is used for

Budesonide, the active substance in Budipulmi, belongs to a group of medicines called glucocorticosteroids. Medicines in this group have local anti-inflammatory action. Budipulmi is used:

• in patients with bronchial asthma who require long-term glucocorticosteroid therapy to control the inflammatory process in the respiratory tract. Asthma is caused by inflammation in the respiratory system. Nebulisers are recommended when pressurised metered-dose inhalers (pMDI) or dry powder inhalers (DPI) are unsatisfactory or inappropriate.
• in patients with croup syndrome – acute inflammation of the larynx, trachea and bronchi – regardless of the underlying cause (established etiology), associated with significant narrowing of the upper airways, breathing difficulty, or "barking" cough leading to respiratory disturbances.
• in the treatment of exacerbations of chronic obstructive pulmonary disease (COPD), when budesonide administered as a nebulised suspension is indicated. COPD is a chronic lung disease that causes breathlessness and cough.

2. Important information before using Budipulmi

When not to use Budipulmi

• if the patient is allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).

You should inform your doctor about any concerning reactions that occurred after taking a medicine containing budesonide or any other ingredient of this medicine.

Warnings and precautions

Budipulmi is intended for long-term treatment, but does not provide rapid relief of acute asthma attacks, for which short-acting bronchodilators are indicated.

If there is no noticeable improvement after using short-acting bronchodilators, or if there is a need to use them more frequently than usual, you should consult your doctor. In such cases, the doctor may consider more effective anti-inflammatory treatment, for example by increasing the inhaled dose of budesonide or initiating oral glucocorticosteroid therapy.

Special caution is required when switching treatment from oral glucocorticosteroids to inhaled products. During this period, transient adrenal cortex insufficiency may occur.

Patients who have recently required emergency treatment with high doses of oral glucocorticosteroids or long-term treatment with the highest recommended doses of inhaled glucocorticosteroids also belong to the group at increased risk of adrenal cortex insufficiency when exposed to severe stress situations. You should inform your doctor about anticipated stressful situations (e.g. examinations) or planned surgical procedures. The doctor may consider increasing the dose of oral glucocorticosteroids.

Note: When switching from treatment with oral glucocorticosteroid-containing medicines to treatment with Budipulmi suspension for nebulization, the following symptoms may transiently occur: watery nasal discharge, rash, muscle and joint pain. In the event of allergic reactions, such as nasal discharge or rash, the doctor may recommend treatment with antihistamines and/or topical medicines. If any of these symptoms are severe or concerning, or if symptoms such as headache, fatigue, nausea or vomiting occur, you should contact your doctor. The doctor may recommend a temporary increase in the dose of oral glucocorticosteroids.

Regular monitoring of growth in children and adolescents receiving glucocorticosteroids, regardless of the route of administration, is recommended due to the risk of growth retardation. If growth is slowed, the doctor may reassess the treatment regimen by reducing the dose of glucocorticosteroids.

Before starting treatment, you should inform your doctor about any other diseases or conditions besides asthma, particularly:

• active or recent infections,
• liver function disorders.

You should also consult your doctor if the above warnings apply to past medical history.

As with other inhaled medicines, paradoxical bronchospasm may occur immediately after using Budipulmi. If a severe reaction occurs, the medicine should be discontinued immediately and medical advice sought without delay.

Fungal infections of the oral cavity may occur during treatment with inhaled glucocorticosteroids. Such infections may require appropriate antifungal therapy, and in some patients, discontinuation of inhaled glucocorticosteroids.

You should also consult your doctor if symptoms of the disease do not improve despite regular use of the recommended doses of the medicine.

If a patient experiences blurred vision or other visual disturbances, they should contact their doctor.

Children

Budipulmi may be used in the treatment of asthma in children from 6 months of age. The treating doctor determines the dose individually for each patient.

Budipulmi and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, including those obtained without a prescription, as well as any medicines you plan to take. You should inform your doctor about any concerning reactions that occurred after taking other medicines.

You should especially inform your doctor about currently used antifungal medicines such as ketoconazole or itraconazole (strong inhibitors of CYP3A4 isoenzyme) and HIV protease inhibitors such as ritonavir and atazanavir, which may increase budesonide plasma concentrations. If concomitant use of such medicines with Budipulmi is necessary, the interval between doses of each medicine should be as long as possible, and the doctor may recommend reducing the dose of budesonide.

Some medicines may enhance the effect of Budipulmi; the doctor may wish to closely monitor the patient taking such medicines (including certain HIV medicines: ritonavir, cobicistat).

No interactions between budesonide and other medicines used in the treatment of asthma have been observed.

Pregnancy and breastfeeding

Pregnancy

If a woman is pregnant or planning to become pregnant, she should consult her doctor before using this medicine – do not use the medicine unless advised by a doctor.

If a woman being treated with Budipulmi becomes pregnant, she should not discontinue treatment on her own, but must inform her doctor as soon as possible.

Breastfeeding

If a woman is breastfeeding, she should consult her doctor before using this medicine.

Driving and operating machinery

Budipulmi does not affect the ability to drive or operate machinery.

3. How to use Budipulmi

This medicine should always be used exactly as directed by the doctor.
The dosage of Budipulmi suspension for nebulisation is individually determined. In case of
any doubt, consult your doctor again.
Budipulmi suspension for nebulisation may only be used with a nebuliser (inhalation device).
The medicine is delivered into the lungs during breathing through a mouthpiece or a face mask.
Before starting to use the medicine, carefully read the "Instructions for the use of Budipulmi
suspension for nebulisation" provided at the end of this leaflet and follow the instructions given.
Remember to rinse your mouth with water after each inhalation. If a face mask was used, wash
your face after each inhalation as well.
Not every inhalation device (nebuliser) is suitable for administering Budipulmi suspension
for nebulisation.
Do not use ultrasonic nebulisers.

Asthma
Initial dose
Recommended initial dose for children from 6 months of age: total daily dose ranges from
0.25 mg to 0.5 mg. If the child is taking an oral glucocorticosteroid, the doctor may, if necessary,
increase the daily dose up to 1 mg.
Recommended initial dose for adults and elderly patients: 1 mg to 2 mg per day.
The treating doctor may adjust the dosage after some time.

Maintenance dose
The lowest effective maintenance dose should be used.
Children from 6 months of age: total daily dose ranges from 0.25 mg to 2 mg.
Adults, including elderly patients: total daily dose ranges from 0.5 mg to 4 mg.
If symptoms are very severe, the doctor may increase the dose.
If the daily dose is up to 1 mg, the medicine may be administered once daily, either in the morning
or in the evening.
If you feel that the medicine's effect is too strong or too weak, consult your doctor.
If the patient's condition improves, the treating doctor may decide to reduce the dose.
Improvement in the patient's condition after using Budipulmi may occur within a few hours
after starting treatment. Full therapeutic effect is achieved after several weeks of treatment.
Budipulmi should be used even when there are no symptoms of the disease.

Patients treated with oral glucocorticosteroids
Budipulmi suspension for nebulisation may be prescribed to a patient who is taking
glucocorticosteroids in oral tablet form.
Budipulmi suspension for nebulisation can partially or completely replace oral glucocorticosteroids,
maintaining the same or increased treatment efficacy.
The gradual reduction of the oral medicine dose should be advised by the doctor.
When switching from oral glucocorticosteroids to inhaled therapy, the patient should be in a stable
condition.
For 10 days, high doses of Budipulmi are recommended, used in combination with the previously
used oral glucocorticosteroid at the unchanged dose. Then, the dose of the oral glucocorticosteroid
should be gradually reduced by approximately 2.5 mg of prednisolone or an equivalent dose
of another glucocorticosteroid per month, down to the lowest dose maintaining control of disease
symptoms. Often, oral glucocorticosteroid treatment can be completely discontinued.

Budesonide administered as a suspension for nebulisation is delivered to the lungs during
inhalation. It is very important that during administration the patient performs calm, even breaths
through the nebuliser mouthpiece or face mask.

Croup syndrome
The usual dose in infants and children with croup syndrome is 2 mg of budesonide administered
by nebulisation. This dose may be given as a single dose or divided into two doses of 1 mg each,
administered 30 minutes apart. This dosing regimen may be repeated every 12 hours, up to a maximum
of 36 hours or until improvement in the patient's condition is achieved.

Exacerbations of COPD
Based on limited clinical trial data, the recommended dose of Budipulmi suspension for nebulisation
is 4 to 8 mg per day, divided into 2 to 4 doses. Treatment should continue until clinical improvement
is achieved; however, treatment longer than 10 days is not recommended.

Dosage instructions
Budipulmi may be mixed with 0.9% sodium chloride solution. The prepared mixture should be used
within 30 minutes.
The contents of a single-dose container may be divided to achieve the appropriate dose.
Single-dose containers, which are unit packs, are marked with a horizontal line (Budipulmi 0.25 mg/mL and 0.5 mg/mL). When the single-dose container is inverted, this line indicates a volume of 1 mL. If only 1 mL is to be used, the liquid above the indicator line should be removed. An opened single-dose container should be stored in its protective foil, protected from light. The contents of an opened container should be used within 24 hours.

*Dilute to 2 mL with 0.9% sodium chloride solution.
Use of a higher than recommended dose of Budipulmi
It is important that the patient uses the medicine according to the instructions in the leaflet or as directed by a physician. Do not increase or decrease the dose of the medicine without consulting a doctor. If a higher than recommended dose has been taken, seek immediate advice from a doctor or pharmacist.
If an excessively large dose of Budipulmi has been used on a single occasion, it should not cause harmful effects.
However, if doses higher than those recommended by the doctor have been taken for a prolonged period, symptoms similar to those observed with oral glucocorticosteroids may occur, such as increased blood concentration of adrenal cortex hormones and suppression of adrenal function. In such a case, the doctor should recommend continuing treatment with Budipulmi at doses sufficient to maintain control of bronchial asthma symptoms.
Missed dose of Budipulmi
If one prescribed dose of Budipulmi suspension for nebulization has been missed, there is no need to make up for the missed dose. Take the next dose as directed by the doctor.
Do not use a double dose to compensate for the missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the symptoms listed below occur, stop using Budipulmi immediately
and contact your doctor without delay:

• Swelling of the face, particularly around the mouth, tongue, eyes and ears, rash, itching, contact dermatitis, urticaria and bronchospasm (constriction of the muscles in the airways causing wheezing). These may indicate an allergic reaction. This adverse effect is rare (occurring in fewer than 1 in 1,000 people).
• Sudden onset of wheezing after inhaling the medicine. This adverse effect is rare (occurring in fewer than 1 in 1,000 people).

Other possible adverse effects:
Frequent (occurring in fewer than 1 in 10 people)

• Oral candidiasis (fungal infections in the mouth). To reduce the risk of occurrence, rinse the mouth with water after using Budipulmi.
• Sore throat, cough, hoarseness, loss of voice.
• Pneumonia (lung infection) in patients with COPD. Inform your doctor if any of the following symptoms occur during treatment with budesonide; they may be signs of a lung infection:
  • fever or chills,
  • increased mucus production, change in mucus colour,
  • worsening cough or increased difficulty in breathing.

Uncommon (occurring in fewer than 1 in 100 people)

• Cataract (clouding of the eye lens).
• Blurred vision.
• Muscle spasms.
• Muscle tremors.
• Depression.
• Anxiety.

Rare (occurring in fewer than 1 in 1,000 people)

• Skin rash on the face after using a face mask. This can be prevented by washing the face with water after using the face mask.
• Nervousness, behavioural changes (mainly in children).
• Easy bruising.
• Hoarseness and loss of voice (in children).

Adverse effects for which frequency is not known (frequency cannot be estimated from available data):

• Sleep disorders, anxiety, excessive excitability, aggression.

Inhaled glucocorticosteroids may affect the normal production of steroid hormones in the body, particularly if used long-term at high doses. Such symptoms may include:

• Glaucoma (increased intraocular pressure), frequency not known.
• Slowed growth in children and adolescents (rare).
• Effects on the adrenal glands (small glands near the kidneys) (rare). The occurrence of these symptoms following inhaled glucocorticosteroids is less likely than with oral glucocorticosteroid tablets.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Budipulmi

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Single-dose unit containers must be stored in aluminium foil sachets
to protect from light.
Shelf-life after first opening of the aluminium foil sachet, when the medicine is protected from light:
3 months.
Shelf-life after first opening of the container, when the medicine is protected from light: 24 hours.
If only 1 mL of the suspension has been used from a single-dose container, the remaining volume
of suspension is not sterile.
There are no special requirements for storage temperature.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect
the environment.

6. Contents of the package and other information

What the medicine Budipulmi contains

• The active substance is budesonide. 1 mL of nebulising suspension contains: 0.25 mg or 0.5 mg budesonide. One single-dose container contains 0.5 mg or 1 mg budesonide in 2 mL of nebulising suspension.
• Other ingredients are: sodium chloride, sodium citrate, citric acid, polysorbate 80, disodium edetate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.

What Budipulmi looks like and contents of the pack
A white, homogeneous suspension with a pH between 4.0 and 5.0.
0.25 mg/mL: 20 single-dose containers of 2 mL nebulising suspension. One sachet contains 5 single-dose containers. Single-dose container made of LDPE in a sachet of PET/Aluminium/PE foil, in a cardboard box.
0.5 mg/mL: 20 single-dose containers of 2 mL nebulising suspension. One sachet contains 5 single-dose containers. Single-dose container made of LDPE in a sachet of PET/Aluminium/PE foil, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: [email protected]

Manufacturer
GENETIC S.P.A.
Contrada Canfora
84084 Fisciano
Italy

Instructions for use of Budipulmi nebulising suspension

1. Open the aluminium foil pouch and remove one single-dose container. Record the date on the cardboard box.
2. Before use, gently shake the contents of the single-dose container for 30 seconds.
3. Hold the single-dose container upright and twist off the top part.
4. Attach the open end of the container securely to the nebuliser chamber and slowly squeeze the entire contents into the chamber. Close the nebuliser.
5. Switch on the nebuliser. Follow the manufacturer's instructions.

Single-dose containers containing 0.25 mg/mL and 0.5 mg/mL are marked with a line indicating a volume of 1 mL when the container is inverted. If only 1 mL is to be used, empty the container down to the level of the indicator line. If only 1 mL of suspension from a single-dose container has been used, the remaining suspension is no longer sterile. Before using the remainder, gently mix the contents of the container.

• Record the date of opening the aluminium foil sachet. Do not use single-dose containers after 3 months from the date of opening the aluminium foil pouch.
• The contents of a single-dose container must be used within 24 hours of opening.
• Single-dose containers should always be stored in the aluminium foil sachet to protect from light. If the entire contents of a single-dose container are not used at once, the remainder must be protected from light.
• Single-dose containers should be stored in an upright position.

WARNING

1. Rinse the mouth after each use of the medicine.
2. If the patient uses a face mask, ensure that the mask fits tightly against the face during inhalation. Wash the face after using the medicine.

CLEANING
The nebuliser chamber, mouthpiece, or face mask should be cleaned after each use. These parts should be washed with warm running water using a mild detergent recommended by the nebuliser manufacturer. The nebuliser chamber should then be thoroughly rinsed and dried by connecting the compressor to the outlet.