Resbud
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Package leaflet: Information for the patient
Resbud, 0.25 mg/mL, suspension for nebulization
Resbud, 0.50 mg/mL, suspension for nebulization
Budesonide
Please read carefully the entire leaflet before use, as it contains important information for the patient.
- Keep this leaflet for future reference.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents
- What Resbud is and what it is used for
- Important information before using Resbud
- How to use Resbud
- Possible side effects
- How to store Resbud
- Contents of the pack and other information
1. What Resbud is and what it is used for
Budesonide, the active substance in Resbud, belongs to a group of medicines called glucocorticosteroids. Medicines in this group have local anti-inflammatory action. Resbud is used:
- in patients with bronchial asthma who require long-term glucocorticosteroid treatment to control the inflammatory process in the respiratory tract. Asthma is caused by inflammation of the airways. Nebulizers are recommended when pressurized 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 etiology, associated with significant narrowing of the upper airways, dyspnea, or "barking" cough, leading to breathing difficulties.
- in the treatment of exacerbations of chronic obstructive pulmonary disease (COPD), when the use of budesonide as a suspension for nebulization is justified. COPD is a chronic lung disease that causes breathlessness and cough.
2. Important information before using Resbud
When not to use Resbud
- if the patient is allergic (hypersensitive) to budesonide or any of the other components of Resbud (listed in section 6).
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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
Resbud is intended for long-term treatment, but does not provide rapid relief of symptoms during acute asthma attacks, which require the use of short-acting bronchodilators.
If there is no noticeable improvement after using short-acting bronchodilators, or if their use becomes more frequent than usual, you should consult your doctor.
In such cases, the doctor may consider intensifying 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 high-dose oral glucocorticosteroid treatment or long-term treatment with the highest recommended doses of inhaled glucocorticosteroids are also at increased risk of adrenal cortex insufficiency when exposed to severe stress situations. You should inform your doctor about anticipated stressful situations (e.g. exams) or planned surgical procedures. The doctor may consider increasing the dose of oral glucocorticosteroids.
WARNING: When switching from treatment with oral glucocorticosteroid-containing medicines to Resbud inhalation suspension, the following transient symptoms may occur: watery nasal discharge, rash, muscle and joint pain. In case of allergic reactions such as nasal discharge or rash, the doctor may recommend treatment with antihistamines and/or topical agents. If any of these symptoms are severe or bothersome, 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 conditions other than 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 Resbud. 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 the patient experiences blurred vision or other visual disturbances, medical advice should be sought.
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Children
Resbud may be used in the treatment of asthma in children from the age of 6 months. The treating physician determines the dose individually for each patient.
Resbud and other medicines
You should tell your doctor about all medicines currently used or recently used, including those obtained without a prescription, as well as any medicines the patient plans to use.
You should inform your doctor about any concerning reactions that occurred after taking other medicines.
Particular attention should be paid to 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 Resbud 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.
No interactions between budesonide and other medicines used in asthma treatment have been observed.
Pregnancy and breastfeeding
Pregnancy
If a woman is pregnant or planning pregnancy, 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 Resbud 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
Resbud does not affect the ability to drive or operate machinery.
3. How to use Resbud medicine
This medicine should always be used as directed by the physician.
The dosage of Resbud suspension for nebulization is individually determined.
In case of doubt, consult your doctor again.
Resbud suspension for nebulization may only be used with a jet nebulizer (PARI LC PLUS) equipped with a mouthpiece or a suitable face mask and a compressor (PARI BOY SX). The medicine is delivered into the lungs during breathing through the mouthpiece or face mask. Before starting treatment, carefully read the "Instructions for use of Resbud suspension for nebulization" provided below and follow the instructions given.
After each inhalation, rinse the mouth with water. If a face mask was used, wash the face after each inhalation as well.
WARNING: Do not use an ultrasonic nebulizer to administer budesonide suspension for nebulization.
Asthma
Initial dose
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Recommended initial dose for children from 6 months of age: total daily dose of 0.25 mg to 0.5 mg. If the child is taking an oral glucocorticosteroid, the doctor may increase the daily dose up to 1 mg if necessary.
Recommended initial dose for adults and elderly patients: 1 mg to 2 mg per day.
The treating physician may adjust the dosage after some time.
Maintenance dose
The lowest effective maintenance dose is recommended.
Children from 6 months of age: total daily dose of 0.25 mg to 2 mg.
Adults, including elderly patients: total daily dose of 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 in the morning or evening.
If the effect of the medicine seems too strong or too weak, consult your doctor.
If the patient's condition improves, the treating physician may decide to reduce the dose.
Improvement in the patient's condition after using Resbud may occur within a few hours of starting treatment. Full therapeutic effect is achieved after several weeks of treatment.
Resbud should be used even when there are no symptoms of the disease.
Patients treated with oral glucocorticosteroids
Resbud suspension for nebulization may be prescribed to patients who are taking oral glucocorticosteroid tablets.
Resbud suspension for nebulization may partially or completely replace oral glucocorticosteroids, maintaining or increasing treatment efficacy.
The physician should guide the gradual reduction of the oral medication dose.
The switch from oral glucocorticosteroids to inhaled therapy should occur when the patient is clinically stable.
For 10 days, high doses of Resbud are recommended 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 that maintains control of disease symptoms. Often, oral glucocorticosteroid treatment can be completely discontinued.
Budesonide administered as a nebulized suspension reaches the lungs during inhalation. It is very important that the patient inhales calmly and evenly through the nebulizer mouthpiece or face mask during treatment.
Croup syndrome
The usual dose for infants and children with croup syndrome is 2 mg of budesonide administered via nebulization. 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 the patient's condition improves.
Exacerbations of COPD
Based on limited clinical trial data, the recommended dose of Resbud suspension for nebulization is 4 to 8 mg per day, divided into 2 to 4 doses. Treatment should continue until clinical improvement is achieved, but treatment longer than 10 days is not recommended.
Instructions for use of Resbud suspension for nebulization
- Separate the required number of ampoules from the strip. Keep the remaining ampoules in the medicinal pouch.
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- Gently swirl the ampoule to mix the contents before use. Figure 2
- Holding the ampoule upright without pressing (see Figure 3), open the ampoule by twisting the top part – the "wings".
- Insert the open end of the ampoule into the nebulizer chamber and slowly squeeze the entire contents of the ampoule into the chamber, as shown in Figure 4.
- Discard the empty ampoule. Close the nebulizer cover.
- Attach the face mask or mouthpiece to the nebulizer, according to the device's instructions.
- Connect the nebulizer tubing to the compressor.
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- Turn on the compressor. Breathe calmly and deeply through the mist using the face mask or mouthpiece, while sitting or standing in an upright position. If the patient uses a face mask, ensure it fits properly.
- The patient will notice the end of the inhalation when no more mist appears in the mouthpiece or face mask.
- Nebulization time depends on the type of equipment used and the volume of suspension administered.
- After inhalation, a small amount of medicine will remain in the nebulizer.
- After inhalation, rinse the mouth with water and spit out the water. Do not swallow. If a face mask was used, wash the face with water as well.
- After each use, the nebulizer chamber, mouthpiece (or face mask) should be washed with warm running water using a mild detergent recommended by the nebulizer manufacturer. Then thoroughly rinse the nebulizer chamber and dry it by connecting the compressor to the outlet port.
Use of a higher than recommended dose of Resbud
It is important that the patient uses the medicine exactly as instructed in the leaflet or as prescribed by the doctor. Do not increase or decrease the dose without consulting a physician.
If an overdose is taken, contact a doctor or pharmacist immediately.
A single accidental overdose of Resbud is unlikely to cause harmful effects.
However, if higher than recommended doses have been used for a prolonged period, adverse effects similar to those of oral glucocorticosteroids may occur, such as increased blood levels of adrenal cortex hormones and suppression of adrenal function. In such cases, the doctor should recommend continuing Resbud treatment at a dose sufficient to maintain control of asthma symptoms.
Missed dose of Resbud
If a prescribed dose of Resbud 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 a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the symptoms listed below occur, stop using Resbud immediately
and contact your doctor without delay:
- swelling of the face, especially 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 reaction is rare (occurring in fewer than 1 in 1,000 people).
- sudden onset of wheezing after inhaling the medicine. This adverse reaction is rare (occurring in fewer than 1 in 1,000 people).
Other possible adverse reactions:
Common (occur in fewer than 1 in 10 people)
- Oral fungal infections (fungal infections of the mouth). To reduce the risk of these occurring, rinse your mouth with water after using Resbud;
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- Sore throat, cough and 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; these may be signs of lung infection:
- fever or chills,
- increased mucus production, change in mucus colour,
- worsening cough or increased difficulty breathing.
Uncommon (occur in fewer than 1 in 100 people)
- Cataract (clouding of the eye lens);
- Blurred vision;
- Muscle cramps;
- Muscle tremors;
- Depression;
- Anxiety.
Rare (occur in fewer than 1 in 1,000 people)
- 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 reactions for which frequency is unknown (frequency cannot be estimated from
available data)
- Sleep disorders, anxiety, excessive excitement, aggression.
Inhaled glucocorticosteroids may affect the normal production of steroid hormones in the body, especially when used long-term at high doses. Such symptoms may include:
- glaucoma (increased intraocular pressure), frequency unknown;
- growth retardation in children and adolescents (rare);
- effects on the adrenal glands (small glands near the kidneys) (rare). The occurrence of these symptoms with inhaled glucocorticosteroids is less likely than with oral glucocorticosteroid tablets.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store the medicine Resbud
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Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP:.
The expiry date refers to the last day of the stated month.
Do not store in a refrigerator or freeze. Store ampoules in the medicinal pouch to protect from light.
Shelf-life after opening the medicinal pouch: 3 months. WARNING: Record the date of opening on the foil of the pouch.
After opening an ampoule: if the contents are not used immediately, the remaining medicine must be discarded.
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 pack and other information
What Resbud contains
- The active substance is budesonide. 1 mL of nebuliser suspension contains 0.25 mg or 0.50 mg of budesonide. Each ampoule contains 0.5 mg or 1 mg of budesonide in 2 mL of nebuliser suspension.
- Other ingredients are: polysorbate 80, sodium chloride, disodium edetate, sodium citrate, citric acid monohydrate, water for injections.
What Resbud looks like and contents of the pack
Sterile suspension, white to almost white, in an LDPE ampoule.
Each ampoule contains 2 millilitres (mL) of sterile nebuliser suspension.
LDPE ampoule in a medicinal pouch made of PET/Aluminium/PE foil, packed in a cardboard box.
Each pouch contains 5 ampoules.
Pack sizes: 20, 40 or 60 ampoules.
Marketing Authorisation Holder:
LEK-AM Sp. z o.o. Pharmaceutical Company
ul. Ostrzykowizna 14A
05-170 Zakroczym
Tel.: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106
Importer:
LEK-AM Sp. z o.o. Pharmaceutical Company
ul. Ostrzykowizna 14A
05-170 Zakroczym
Tel.: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106
Cipla Europe NV
De Keyserlei 58-60 bus 19,
Antwerpen,
2018, Belgium
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07.2024
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