Budipulmi

Leaflet accompanying the packaging: patient information

Budipulmi, 0.25 mg/mL, nebuliser suspension

Budipulmi, 0.5 mg/mL, nebuliser suspension

Budesonide

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Budipulmi and what is it 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 packaging and other information

1. What is Budipulmi and what is it used for

Budesonide, the active substance of Budipulmi, belongs to a group of medicines called corticosteroids. These medicines have local anti-inflammatory effects. Budipulmi is used:

• in patients with bronchial asthma who require long-term administration of corticosteroids to control the inflammatory process in the respiratory system. The cause of asthma is inflammation of the respiratory system. Nebulisers are recommended when the use of pressurised inhalers (pMDI) or dry powder inhalers (DPI) is unsatisfactory or unjustified.
• in patients with croup - acute laryngitis, tracheitis, and bronchitis - regardless of aetiology (identified cause) associated with significant narrowing of the upper airways, shortness of breath, or a "barking" cough leading to respiratory disorders.
• to treat exacerbations of chronic obstructive pulmonary disease (COPD), in cases where the use of budesonide in the form of a nebuliser suspension is justified. COPD is a chronic lung disease that causes shortness of breath and coughing.

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).

Tell your doctor about any worrying reactions that have occurred after taking a medicine containing budesonide or any ingredient of the medicine.

Warnings and precautions

Budipulmi is intended for long-term treatment, but it does not provide quick relief from acute asthma attacks, in which the administration of short-acting bronchodilators is indicated. If there is no noticeable improvement after using short-acting bronchodilators or if they need to be used more frequently than usual, consult your doctor. In such cases, your doctor may consider using more effective anti-inflammatory treatment, for example, by increasing the dose of inhaled budesonide or starting oral corticosteroid treatment. Be careful when switching from oral corticosteroids to inhaled products. During this period, transient adrenal insufficiency may occur. Patients who have required emergency treatment with high doses of oral corticosteroids or long-term treatment with the maximum recommended doses of inhaled corticosteroids are also at increased risk of adrenal insufficiency when exposed to stressful situations. Inform your doctor about anticipated stressful situations (e.g., exams) or planned surgical procedures. Your doctor may consider increasing the dose of oral corticosteroids. Warning.If the treatment is switched from oral corticosteroids to Budipulmi in the form of a nebuliser suspension, the following symptoms may temporarily occur: runny nose, rash, muscle and joint pain. In the case of allergic reactions, such as runny nose or rash, your doctor may prescribe antihistamines and/or local-acting medicines. If any of the symptoms are severe or worrying, or if symptoms such as headache, fatigue, nausea, or vomiting occur, consult your doctor. Your doctor may recommend temporary increases in the dose of oral corticosteroids. Regular monitoring of growth in children and adolescents taking corticosteroids, regardless of the route of administration, is recommended due to the risk of growth retardation. If growth is slowed, your doctor may verify the treatment by reducing the dose of corticosteroids. Before starting treatment, inform your doctor about other diseases or conditions, especially:

• active or recent infections,
• liver function disorders. Consult your doctor also if the above warnings apply to past situations.

Like other inhaled medicines, paradoxical bronchospasm may occur immediately after using Budipulmi. If a severe reaction occurs, stop using the medicine immediately and consult your doctor without delay. During the use of inhaled corticosteroids, fungal infections in the mouth may occur. Such infections may require appropriate antifungal therapy and, in some patients, discontinuation of inhaled corticosteroids. Also, consult your doctor if the symptoms of the disease do not improve despite systematic use of the recommended doses of the medicine. If the patient experiences blurred vision or other vision disturbances, they should consult their doctor.

Children

The medicine can be used to treat bronchial asthma in children from 6 months of age. The doctor will determine the dose of the medicine individually for each patient.

Budipulmi and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, including those available without a prescription, as well as any medicines you plan to take. Inform your doctor about any worrying reactions that have occurred after taking other medicines. Especially, inform your doctor about any antifungal medicines you are currently taking, such as ketoconazole or itraconazole (these are potent inhibitors of the CYP 3A4 isoenzyme), and HIV protease inhibitors, such as ritonavir and atazanavir, which may increase the concentration of budesonide in the blood. If concomitant use of such medicines with Budipulmi is necessary, the interval between administrations of individual medicines should be as long as possible, and your doctor may also recommend reducing the dose of budesonide. Some medicines may enhance the effect of Budipulmi; your doctor may want to monitor the patient's condition closely when taking such medicines (including some HIV medicines: ritonavir, cobicistat). No interaction between budesonide and other medicines used to treat bronchial asthma has been observed.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant or plan to become pregnant, consult your doctor before using the medicine - do not use the medicine unless your doctor recommends it.
If you become pregnant while taking Budipulmi, do not stop treatment on your own, but inform your doctor as soon as possible.
Breastfeeding
If you are breastfeeding, consult your doctor before using this medicine.

Driving and using machines

Budipulmi does not affect the ability to drive or use machines.

3. How to use Budipulmi

Always use this medicine exactly as your doctor has told you.
The dose of Budipulmi in the form of a nebuliser suspension is determined individually. If in doubt, consult your doctor again.
Budipulmi in the form of a nebuliser suspension can only be used with a nebuliser (inhalation device). The medicine is introduced into the lungs during breathing through a mouthpiece or face mask. Before using the medicine, read the "Instructions for using Budipulmi in the form of a nebuliser suspension" at the end of the leaflet and follow the instructions.
Remember to rinse your mouth with water after each inhalation. If a face mask was used, rinse your face as well after each inhalation.
Not all inhalation devices (nebulisers) are suitable for administering Budipulmi in the form of a nebuliser suspension.
Do not use ultrasonic nebulisers.

Asthma

Initial dose
Recommended initial dose for children from 6 months of age: the total daily dose is from 0.25 mg to 0.5 mg. If the child is taking another oral corticosteroid, the doctor may increase the daily dose to 1 mg if necessary.
Recommended initial dose for adults and the elderly: from 1 mg to 2 mg per day.
Your doctor may change the dose later.
Maintenance dose
It is recommended to use the smallest effective maintenance dose.
Children from 6 months of age: the total daily dose is from 0.25 mg to 2 mg.
Adults, including the elderly: the total daily dose is from 0.5 mg to 4 mg.
If the symptoms are very severe, the doctor may increase the dose of the medicine.
If the daily dose is up to 1 mg, the medicine can be administered once a day in the morning or evening.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
If the patient's condition improves, the doctor may decide to reduce the dose of the medicine.
Improvement in the patient's condition after using Budipulmi may occur after a few hours of starting treatment. The full therapeutic effect is achieved after a few weeks of starting treatment.
Budipulmi should be used even when symptoms of the disease are not present.
Patients treated with oral corticosteroids
Budipulmi in the form of a nebuliser suspension may be prescribed to a patient who is taking oral corticosteroids in tablet form.
Budipulmi in the form of a nebuliser suspension can partially or completely replace oral corticosteroids while maintaining the same or increased efficacy of treatment.
The gradual reduction of the oral corticosteroid dose should be recommended by the doctor.
When switching from oral corticosteroids to inhaled medicines, the patient should be in a stable condition.
It is recommended to use high doses of Budipulmi in combination with the previously used oral corticosteroid at an unchanged dose for 10 days. Then, the dose of the oral corticosteroid should be gradually reduced by about 2.5 mg of prednisolone or an equivalent dose of another corticosteroid per month to the smallest dose that controls the symptoms of the disease. The use of oral corticosteroids can often be stopped completely.
Budesonide administered to the patient in the form of a nebuliser suspension is delivered to the lungs during inhalation. It is very important that the patient performs calm, even inhalations through the mouthpiece of the nebuliser or face mask when using the medicine.
Croup
The usual dose for infants and children with croup is 2 mg of budesonide administered by nebulisation. This dose can be administered in its entirety or divided into two doses of 1 mg each, administered at 30-minute intervals. This dosing regimen can be repeated every 12 hours, up to 36 hours, or until the patient's condition improves.
COPD exacerbations
Based on limited clinical trial data, the recommended dose of Budipulmi, nebuliser suspension, is from 4 to 8 mg per day, divided into 2 to 4 administrations. Treatment should be continued until clinical improvement is achieved, but it is not recommended to continue treatment for more than 10 days.

Dosing method

Budipulmi can be mixed with a 0.9% sodium chloride solution. The prepared mixture should be used within 30 minutes.
The dose in a single-dose container can be divided to achieve the desired dose.
Single-dose containers, which are individual packaging units, 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. The opened single-dose container should be stored in a protective foil without light exposure. The contents of the opened container should be used within 24 hours.
*Dilute to 2 mL with 0.9% sodium chloride solution.

Using a higher dose of Budipulmi than recommended

It is important to use the medicine as directed in the leaflet or as recommended by the doctor. Do not increase or decrease the dose of the medicine without consulting your doctor. If a higher dose of the medicine than recommended is taken, consult your doctor or pharmacist immediately.
If a much higher dose of Budipulmi than recommended is used once, it should not have harmful effects.
If doses higher than those recommended by the doctor have been taken for a longer period, there is a possibility of side effects such as those that occur with oral corticosteroids, i.e., increased levels of adrenal hormones in the blood and adrenal insufficiency. In this case, the doctor should recommend continuing treatment with Budipulmi in doses that keep the symptoms of asthma under control.

Missing a dose of Budipulmi

If a dose of Budipulmi in the form of a nebuliser suspension recommended by the doctor is missed, there is no need to make up for the missed dose. Take the next dose of the medicine as recommended by the doctor.
Do not take a double dose to make up for the missed dose.
If you have any further 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 gets them.
If any of the following symptoms occur, stop using Budipulmi and consult your doctor immediately:

• swelling of the face, especially around the mouth, tongue, eyes, and ears, rash, itching, contact dermatitis, urticaria, and bronchospasm (muscle spasm in the airways, which causes wheezing). This may indicate an allergic reaction. This side effect is rare (less than 1 in 1,000 people).
• sudden onset of wheezing after inhaling the medicine. This side effect is rare (less than 1 in 1,000 people).

Other possible side effects:
Common (occurring in less than 1 in 10 people)

• thrush (fungal infections) in the mouth. To reduce the possibility of their occurrence, rinse your mouth with water after using Budipulmi.

• sore throat, cough, and hoarseness, loss of voice.
• pneumonia (lung infection) in patients with COPD. Tell your doctor if any of the following symptoms occur while using budesonide; these may be symptoms of a lung infection:
• fever or chills,
• increased production of mucus, change in mucus colour,
• worsening cough or increased breathing difficulties.

Uncommon (occurring in less than 1 in 100 people)

• cataract (clouding of the lens of the eye).
• blurred vision.
• muscle cramps.
• muscle tremors.
• depression.
• anxiety.

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

• rash on the face after using a face mask. This can be prevented by rinsing the face with water after using the face mask.
• nervousness, changes in behaviour (mainly in children).
• easy bruising.
• hoarseness and loss of voice (in children).

Side effects with unknown frequency (frequency cannot be estimated from available data):

• sleep disturbances, anxiety, excessive excitement, aggression.

The use of inhaled corticosteroids may affect the normal production of steroid hormones in the body, especially if used for a long time in high doses. The following symptoms may occur:

• glaucoma (increased intraocular pressure), frequency not known.
• growth retardation in children and adolescents (rare).
• effect on the adrenal glands (a small gland near the kidneys) (rare). The occurrence of these symptoms after using inhaled corticosteroids is less likely than after taking oral corticosteroids.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
phone: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Budipulmi

Keep the medicine out of the 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 month stated.
Single-dose containers must be stored in aluminium foil bags to protect them from light.
Shelf life after opening the aluminium foil bag, when the medicine is protected from light: 3 months.
Shelf life after opening the container, when the medicine is protected from light: 24 hours.
If only 1 mL of the suspension is used from the single-dose container, the remaining volume of the suspension is not sterile.
There are no special recommendations for the storage temperature of the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Budipulmi contains

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

What Budipulmi looks like and contents of the packaging

White, homogeneous suspension, with a pH ranging from 4.0 to 5.0.
0.25 mg/mL: 20 single-dose containers of 2 mL of nebuliser suspension. One bag contains 5 single-dose containers. Single-dose container made of LDPE in a PET/Aluminium/PE bag, in a cardboard box.
0.5 mg/mL: 20 single-dose containers of 2 mL of nebuliser suspension. One bag contains 5 single-dose containers. Single-dose container made of LDPE in a PET/Aluminium/PE bag, in a cardboard box.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
phone: +48 61 66 51 500
fax: +48 61 66 51 505
email: biofarm@biofarm.pl

Manufacturer

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

Date of last revision of the leaflet:

Instructions for using Budipulmi in the form of a nebuliser suspension

• 1. Tear the aluminium foil packaging and break off a single container with the medicine. Note the date on the cardboard box.
• 2. Before using the contents of the single-dose container, shake it gently for 30 seconds.
• 3. Hold the single-dose container with the medicine upright and twist off the top part of the container.
• 4. Attach the opened top part of the container to the nebuliser reservoir and slowly squeeze the contents of the container into the nebuliser reservoir. Close the nebuliser.
• 5. Turn 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 contents of the container to the level of the indicator line. If only 1 mL of the suspension is used from the single-dose container, the remaining volume of the suspension is not sterile. Before using the rest of the medicine, gently mix the contents of the container.

• Note the date of opening the aluminium foil bag. Do not use single-dose containers after 3 months from the date of opening the aluminium foil bag.
• The contents of the single-dose container must be used within 24 hours of opening.
• Single-dose containers with the medicine should always be stored in an aluminium foil bag to protect them from light. If the entire contents of the single-dose container are not used at once, the remaining amount should be protected from light.
• Single-dose containers with the medicine should be stored upright.

WARNING

• 1. Rinse your mouth after each use of the medicine.
• 2. If you use a face mask, check that it fits tightly to your face during inhalation. Rinse your face after using the medicine.

CLEANING

The nebuliser chamber, mouthpiece, or face mask should be washed 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 rinsed thoroughly and dried by connecting the compressor to the outlet.