Nebbud

Patient Information Leaflet

Nebbud, 0,25 mg/ml, suspension for nebulization
Budesonidum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, 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:

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

1. What Nebbud is and what it is used for

Nebbud is a suspension for nebulization containing 0.25 mg of budesonide per 1 ml.
Budesonide belongs to a group of medicines called glucocorticosteroids, which are used to
reduce inflammation in the airways in asthma.
Nebbud is used:

• for the treatment of bronchial asthma in patients in whom pressurized metered dose inhalers or dry powder inhalers do not provide sufficient effect or are contraindicated,
• in infants and children with croup, i.e. acute laryngitis (laryngitis acuta),
• for the treatment of exacerbations of chronic obstructive pulmonary disease (COPD), when use of budesonide as a nebulized suspension is justified. COPD is a chronic lung disease causing breathlessness and cough.

2. Important information before using Nebbud

When not to use Nebbud:

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

Warnings and precautions
Nebbud is not suitable for treating sudden breathing difficulties, including acute asthma attacks, which require administration of short-acting bronchodilators.
If the patient experiences blurred vision or other visual disturbances, they should contact a doctor.
Before starting treatment with Nebbud, consult a doctor:

• if the patient has ever had tuberculosis;
• if the patient has liver disease;
• if the patient has a cold or chest infection;
• if the patient is taking other steroids in any form (tablets, injections, inhalations).

If the patient has been taking high doses of inhaled steroids for a prolonged period, the doctor may recommend additional systemic administration of glucocorticosteroids in tablet form during periods of increased stress or before surgery.
Children and adolescents
Regular monitoring of growth is recommended in children and adolescents receiving long-term glucocorticosteroid therapy. Increased aggressive behaviour may occur in children.
Nebbud and other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take, including medicines obtained without a prescription.
Inform the doctor about any adverse reactions that occurred after taking other medicines.
Particularly inform the doctor about currently used antifungal medicines such as ketoconazole, itraconazole, other strong inhibitors of the CYP3A4 isoenzyme such as erythromycin and clarithromycin, and HIV protease inhibitors such as ritonavir and atazanavir, which may increase budesonide plasma concentrations. If possible, concomitant use of these medicines with Nebbud should be avoided. If concomitant use of such medicines with Nebbud is necessary, the interval between doses of each medicine should be as long as possible, and the doctor may consider reducing the dose of budesonide.
Some medicines may enhance the effect of Nebbud. In such cases, the doctor may closely monitor the patient taking these medicines (including certain HIV medicines: ritonavir, cobicistat).
Other medicines that may interact with budesonide include: ethinylestradiol (used in hormonal therapy in women), troleandomycin (an antibiotic), and cimetidine (used in the treatment of gastric ulcers).
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
The doctor will decide whether Nebbud can be used during pregnancy.
Breastfeeding
If a woman is breastfeeding or planning to breastfeed, she should consult her doctor or pharmacist.
Budesonide passes into breast milk.
However, when therapeutic doses of budesonide are used, no effect of this treatment on the breastfed infant is expected. Nebbud may be used by women who are breastfeeding.
Driving and operating machinery
Nebbud has no influence on the ability to drive or operate machinery.

3. How to use Nebbud

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist.
Nebbud is administered by inhalation.
The medicine is taken as an inhalation from a nebulizer using a mouthpiece or a face mask.
The usual dose is:
Asthma
Adults (including elderly patients) and adolescents aged over 12 years:
The usual starting dose is 1 mg to 2 mg per day. In very severe cases, the dose may be increased.
Your doctor will determine the appropriate dose, which depends on the severity of asthma in the
patient. Once improvement is achieved, your doctor may reduce the dose to the lowest dose that
provides adequate asthma control. The total daily dose ranges from 0.5 mg to 4 mg.
Children aged 6 months to 12 years:
The usual starting dose is 0.25 mg to 0.5 mg per day. In children taking oral corticosteroids, the
daily dose may be increased if necessary up to 1 mg. Once improvement is achieved, your doctor
may reduce the dose to the lowest dose that provides adequate asthma control. The total daily dose
ranges from 0.25 mg to 2 mg per day.
In young children unable to inhale the medicine through a mouthpiece, the medicine should be
administered using a face mask.
Children should use the nebulizer under the supervision of an adult.
If the patient is taking steroid tablets for asthma treatment, after starting Nebbud, the doctor may
reduce their dose or frequency of administration.
Improvement in the patient's condition after using Nebbud may occur within a few hours of
starting treatment. Full therapeutic effect is achieved after several weeks of treatment.
The medicine should be used exactly as prescribed by the doctor, even if the patient feels better.
Croup
The usual dose for infants and children with croup is 2 mg of budesonide per day. This dose may be
administered as a single dose (4 ampoules) or divided into two doses of 1 mg each, given 30 minutes
apart. This dosing regimen may be repeated every 12 hours, for up to 36 hours or until the patient's
condition improves.
Exacerbations of COPD
Based on limited clinical trial data, the recommended dose of Nebbud, nebuliser suspension, 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
Prepare the nebulizer for use according to the manufacturer's instructions.
Separate the sterile plastic container (ampoule) from the marked strip by twisting and pulling (Fig. A).
Gently shake the ampoule.
Holding the ampoule upright, unscrew the closure (Fig. B).
The ampoule is marked with a dotted 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. The opened
plastic container should be stored in its laminated foil, within the original packaging.
The contents of a single-use plastic container remain suitable for use within 12 hours after opening.
Squeeze the appropriate amount of suspension from the ampoule into the nebulizer chamber (Fig. C).
Use the nebulizer according to the manufacturer's instructions.
After each completed inhalation, rinse the mouth with water, and if a face mask was used, also wash
the face.
After using the nebulizer, flush out any remaining solution from the nebulizer chamber.
Wash the nebulizer thoroughly. The nebulizer chamber, mouthpiece, or face mask should be washed
in hot water with a mild detergent. Rinse thoroughly and dry by connecting the nebulizer chamber to
the inlet of compressed air or a compressor.
Note: Ultrasonic nebulizers must not be used for administering Nebbud.
If only 1 ml of suspension from the ampoule has been used, the remaining volume of suspension is
no longer sterile.
A B C

The suspension must not be swallowed or used as an injection.
If there is a sudden worsening of wheezing after using the medicine, contact your doctor, who will
reassess the treatment and, if necessary, consider alternative therapy.
Dosing instructions
The total volume of suspension in the plastic container (ampoule) may be divided to achieve the
appropriate dose. Single-dose ampoules are marked with a horizontal dotted line. When the ampoule
is inverted, this line indicates a volume of 1 ml. If only 1 ml of suspension is to be used, remove the
liquid above the indicator line.
The opened plastic container should always be stored in laminated foil, within the original packaging.
The contents of an opened ampoule remain suitable for use within 12 hours.
Accidental overdose of Nebbud
If too much medicine has been used, contact a doctor immediately or go to the nearest hospital.
Bring this leaflet with you.
Never use more medicine than prescribed by your doctor. If asthma symptoms worsen or the medicine
does not work as before, inform your doctor.
It is important to use the prescribed doses exactly as directed by your doctor. Do not increase or
decrease the dose without consulting your doctor.
Missed dose of Nebbud
If the patient forgets to take a dose at the scheduled time, it should be taken as soon as remembered.
Do not take a double dose to make up for a missed dose.
Stopping Nebbud treatment
It is very important to continue taking Nebbud every day until your doctor advises otherwise. Do not
stop taking Nebbud suddenly, as symptoms of the disease may worsen.
If you have any further questions about 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.
You must stop taking the medicine immediately and consult a doctor if any of the following symptoms occur:

• swelling of the face, particularly around the lips, tongue, and eyes. Rash, itching, skin problems, and chest tightness with difficulty breathing. These symptoms indicate that the patient has developed an allergic reaction. This occurs rarely, in 1 to 10 patients per 10,000.
• sudden wheezing after taking the medicine. These symptoms occur rarely, in fewer than 1 in 1,000 patients.

Other adverse effects:
Common adverse effects (occurring in fewer than 1 in 10 and more than 1 in 100 people taking the medicine):

• oral and throat thrush (candidiasis) – the likelihood of this effect can be reduced if the patient rinses their mouth with water after each inhalation;
• throat irritation, cough;
• infection of the mouth and throat;
• pneumonia (lung infection) in patients with COPD.

You should inform your doctor if any of the following symptoms occur during treatment with budesonide, as they may be signs of a lung infection:

• fever or chills;
• increased mucus production, change in mucus color;
• worsening cough or increased difficulty breathing.

Uncommon adverse effects may occur in up to 1 in 100 people:

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

Rare adverse effects (occurring in fewer than 1 in 1,000 and more than 1 in 10,000 people taking the medicine):

• restlessness, nervousness, behavioral disturbances (particularly in children);
• immediate and delayed hypersensitivity reactions, including skin reactions, rash, itching and redness, urticaria, contact dermatitis, angioedema, and anaphylactic reaction;
• easy bruising;
• facial skin irritation;
• bronchospasm;
• hoarseness; loss of voice;
• chest tightness, breathing difficulties, wheezing. If such symptoms occur, you must immediately stop taking Nebbud and consult a doctor;
• swelling of the face, lips, and tongue;
• effects on the adrenal glands (a small gland next to the kidney) leading to reduced cortisol secretion (adrenal hormone); your doctor may recommend periodic blood tests;
• slowed growth in children and adolescents; regular growth monitoring is recommended.

Very rare adverse effects (occurring in fewer than 1 in 10,000 people taking the medicine), (particularly if the patient is taking high doses of the medicine for a prolonged period or is also taking (or has taken) oral steroids):

• changes in bone mineral density (thinning).

Frequency not known (frequency cannot be determined from available data):

• glaucoma (increased eye pressure);
• sleep disorders, psychomotor hyperactivity, irritability, aggression (these symptoms are more likely to occur in children).

If the patient is taking steroid tablets for asthma treatment, the doctor may reduce their dose or frequency after starting Nebbud. This may be accompanied by symptoms such as nasal congestion or runny nose, weakness, or muscle and joint pain, as well as rash. If any of these symptoms become bothersome or if symptoms such as headache, fatigue, nausea, or vomiting occur, the patient should consult a doctor immediately.
If any adverse effects concern the patient or persist, they should inform their doctor.
If the patient notices any other symptoms affecting their well-being, they should inform their doctor as soon as possible.
Reporting adverse effects
If any adverse effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
By reporting adverse effects, more information on the safety of this medicine can be collected.

5. How to store Nebbud

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule and outer packaging. The expiry date refers to the last day of the stated month.
After opening the laminated foil sachet, the medicine may be used within 3 months.
After opening the ampoule, the medicine is suitable for use within 12 hours.
If only 1 ml of the suspension from the ampoule has been used, the remaining volume of the suspension is no longer sterile.
Ampoules should be stored in the original packaging.
It is recommended to record the date of opening the laminated foil sachet in the designated space on the label. This will help you remember the date.
Do not store above 25°C. Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Nebbud contains

• The active substance is budesonide. 1 ml of nebuliser suspension contains 0.25 mg of budesonide. Each ampoule of Nebbud 0.5 mg/2 ml contains 0.5 mg of budesonide in 2 ml of aqueous suspension (0.25 mg/ml).
• The other ingredients are: disodium edetate dihydrate, sodium chloride, polysorbate 80, citric acid monohydrate, sodium citrate dihydrate, and water for injections.

What Nebbud looks like and contents of the pack
Nebbud is a white or almost white nebuliser suspension, contained in an ampoule.
Each pack contains plastic ampoules with 2 ml of suspension. Strips of 5 ampoules are packed in laminated foil sachets and cardboard boxes. Each box contains 10 or 20 ampoules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Tel: (22) 345 93 00

Manufacturer/Importer:
Merckle GmbH
Ludwig-Merckle-Str. 3,
89143 Blaubeuren
Germany