Nebbud

Leaflet accompanying the packaging: patient information

Nebbud, 0.25 mg/ml, nebulizer suspension

Budesonide

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Nebbud and what is it used for

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

• to treat asthma in patients for whom the use of pressurized inhalers with a metered dose or dry powder inhalers does not provide sufficient effect or is contraindicated,
• in infants and children with croup, i.e. acute laryngitis (laryngitis acuta),
• to treat exacerbations of chronic obstructive pulmonary disease (COPD), when the use of budesonide in the form of a nebulizer suspension is justified. COPD is a chronic lung disease that causes shortness of breath and coughing.

2. Important information before using Nebbud

When not to use Nebbud:

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

Warnings and precautions

Nebbud is not suitable for the treatment of suddenly occurring breathing difficulties, including acute asthma attacks, in which the administration of short-acting bronchodilators is indicated.
If the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

Before starting Nebbud, consult your 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 long time, the doctor may recommend additional systemic use of glucocorticosteroids in tablets during periods of increased stress or before surgery.

Children and adolescents

Regular monitoring of growth in children and adolescents taking glucocorticosteroids for a long time is recommended. Aggressive behavior may occur in children.

Nebbud and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
Inform your doctor about any worrying reactions that have occurred after taking other medicines.
Particularly, inform your doctor about any antifungal medicines you are taking, such as ketoconazole, itraconazole, other potent CYP 3A4 inhibitors, such as erythromycin and clarithromycin, and HIV protease inhibitors, such as ritonavir and atazanavir, which may increase the concentration of budesonide in the blood. If possible, avoid taking these medicines at the same time. If it is necessary to take these medicines with Nebbud, the interval between doses of individual medicines should be as long as possible, and the doctor may also recommend reducing the dose of budesonide.
Some medicines may enhance the effect of Nebbud. The doctor may then carefully monitor the patient's condition (including some HIV medicines: ritonavir, cobicistat).
Other medicines that may interact with budesonide include: ethinyl estradiol (used in hormone therapy in women), troleandomycin (an antibiotic), and cimetidine (used to treat stomach ulcers).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 plans to breastfeed, she should consult her doctor or pharmacist.
Budesonide passes into breast milk in women who are breastfeeding.
However, during therapeutic use of budesonide, no effect on the breastfed child is expected. Nebbud can be used by breastfeeding women.

Driving and using machines

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

3. How to use Nebbud

This medicine should always be used as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
Nebbud is used by inhalation.
The medicine is taken in the form of an inhalation from a nebulizer through a mouthpiece or face mask.
Usually, the dose used is:

Asthma

Adults (including elderly patients) and adolescents over 12 years of age:

The usual starting dose is 1 mg to 2 mg per day. In very severe cases, the dose can be increased. The appropriate dose is determined by the doctor. The dose depends on the severity of asthma in the patient. After improvement, the doctor may reduce the dose to the smallest dose that provides adequate control of asthma. The total daily dose is from 0.5 mg to 4 mg.

Children from 6 months to 12 years of age:

The usual starting dose is 0.25 mg to 0.5 mg per day. In children who take oral glucocorticosteroids, the daily dose can be increased to 1 mg if necessary.
After improvement, the doctor may reduce the dose to the smallest dose that provides adequate control of asthma. The total daily dose is 0.25 mg to 2 mg per day.
In small children who cannot inhale the medicine through a mouthpiece, the medicine should be administered through a face mask.
Children should use the nebulizer under adult supervision.
If the patient is taking steroids in tablets for asthma, after starting Nebbud, the doctor may reduce their dose or frequency of use.
Improvement in the patient's condition after using Nebbud may occur after a few hours from the start of treatment. The full therapeutic effect is achieved after a few weeks from the start of treatment.
The medicine should be taken as directed by the doctor, even if the patient feels better.

Croup

The usual dose used in infants and children with croup is 2 mg of budesonide per day. This dose can be given in whole (4 ampoules) or divided into two doses of 1 mg each, given 30 minutes apart. This dosing regimen can be repeated every 12 hours, up to 36 hours, or until the patient's condition improves.

Exacerbations of COPD

Based on limited data from clinical trials, the recommended dose of Nebbud, nebulizer suspension, is from 4 to 8 mg per day, divided into 2 to 4 doses. Treatment should be continued until clinical improvement is achieved, but not for more than 10 days.

Instructions for using the medicine

Prepare the nebulizer for use according to the manufacturer's instructions.
Separate the sterile plastic container (ampoule) from the designated strip by twisting and pulling (Fig. A).
Gently shake the ampoule.
Holding the ampoule upright, unscrew the cap (Fig. B).
The ampoule is marked with a broken line indicating a volume of 1 ml, if the container is turned upside down. If only 1 ml of the suspension is to be used, the contents should be emptied to the level of the indicator line. The opened plastic container should be stored in foil, in the original packaging.
The contents of the plastic container are suitable for use within 12 hours of 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 using a face mask, also wash the face.
After using the nebulizer, rinse any remaining solution from the nebulizer chamber.
Wash the nebulizer carefully. The nebulizer chamber and 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 air inlet or compressor.
Warning:Do notuse ultrasonic nebulizers to administer Nebbud.
If only 1 ml of the suspension has been used from the ampoule, the remaining volume of the suspension is not sterile.
ABC

The suspension should not be swallowed or used as an injection.
In case of sudden worsening of wheezing after using the medicine, consult a doctor, who will reassess the treatment and, if necessary, consider using another treatment.

Dosing

The total volume of the suspension in the plastic container (ampoule) can be divided to achieve the desired dose. The ampoules are marked with a broken line. After turning the ampoule upside down, this line indicates a volume of 1 ml. If only 1 ml of the suspension is to be used, the liquid above the indicator line should be removed.
The opened plastic container should always be stored in foil, in the original packaging.
The contents of the opened ampoule are suitable for use within 12 hours.

Using a higher than recommended dose of Nebbud

In case of using too high a dose of the medicine, consult a doctor or go to the nearest hospital immediately. Bring this leaflet with you.
Never use a higher dose of the medicine than recommended by the doctor. If asthma symptoms worsen or the medicine does not work as before, inform the doctor.
It is important to use the doses of the medicine as recommended by the doctor. Do not increase or decrease the dose without consulting the doctor.

Missing a dose of Nebbud

If the patient forgets to take a dose of the medicine at the specified time, they should take it as soon as they remember. Do not take a double dose to make up for the missed dose of the medicine.

Stopping Nebbud

It is very important to take Nebbud every day as long as the doctor does not recommend stopping it. Do not stop taking Nebbud suddenly, as the symptoms of the disease may worsen.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Nebbud can cause side effects, although not everybody gets them.

Stop taking the medicine and consult a doctor immediately if any of the following symptoms occur:

• swelling of the face, especially 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 out of 10,000.
• sudden wheezing after taking the medicine. These symptoms occur rarely, in less than 1 in 1000 patients.

Other side effects:
Common side effects(in less than 1 in 10 and more than 1 in 100 patients taking the medicine):

• thrush (candidiasis) of the mouth and throat - the occurrence of this side effect will be less likely if the patient rinses their mouth with water after each inhalation;
• irritation of the throat, cough;
• infection in the mouth and throat;
• pneumonia (lung infection) in patients with COPD.

Tell the doctor if any of the following symptoms occur during budesonide treatment, as they may be signs of a lung infection:

• fever or chills;
• increased production of sputum, change in sputum color;
• worsening cough or increased breathing difficulties.

Uncommon side effectsmay occur in no more than 1 in 100 people:

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

Rare side effects(in less than 1 in 1000 and more than 1 in 10,000 people taking the medicine):

• restlessness, nervousness, behavioral disorders (especially in children);
• immediate and delayed hypersensitivity reactions, including skin reactions, rash, itching, and redness, hives, contact dermatitis, and anaphylactic reaction;
• easy bruising;
• skin irritation of the face;
• bronchospasm;
• hoarseness; loss of voice;
• chest tightness, breathing difficulties, wheezing. If such symptoms occur, stop taking Nebbud and consult a doctor immediately;
• swelling of the face, lips, and tongue;
• effect on the adrenal glands (a small gland near the kidney) causing reduced production of cortisol (an adrenal hormone); the doctor may recommend occasional blood tests;
• growth retardation in children and adolescents; regular monitoring of growth is recommended.

Very rare side effects(in less than 1 in 10,000 people taking the medicine), (especially if the patient is taking high doses of the medicine for a long time or if they are also taking (or have taken) oral steroids):

• changes in bone mineral density (thinning of bones).

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

• glaucoma (increased pressure in the eye);
• sleep disorders, psychomotor agitation, irritability, aggression (more likely to occur in children).

If the patient is taking steroids in tablets for asthma, after starting Nebbud, the doctor may reduce their dose or frequency of use. This may be accompanied by symptoms such as a stuffy nose or runny nose, weakness, or muscle and joint pain, as well as rash. If any of these symptoms become troublesome or occur along with symptoms such as headache, fatigue, nausea, or vomiting, consult a doctor immediately.
If any side effect worries the patient or persists, they should inform their doctor.
If the patient notices any other symptoms that affect their well-being, they should inform their doctor as soon as possible.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, inform a 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: Al. Jerozolimskie 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 authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Nebbud

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the ampoule and carton. The expiry date refers to the last day of the specified month.
After opening the foil bag, the medicine can be used for 3 months.
After opening the ampoule, the medicine is suitable for use within 12 hours.
If only 1 ml of the suspension has been used from the ampoule, the remaining volume of the suspension is not sterile.
Ampoules should be stored in the original packaging.
It is recommended to write the date of opening the foil bag in the space provided on the label. This will help remember the date.
Do not store above 25°C. Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Nebbud contains

• The active substance of the medicine is budesonide. 1 ml of the nebulizer suspension contains 0.25 mg of budesonide. Each Nebbud 0.5 mg/2 ml ampoule 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 what the packaging contains

Nebbud is a white or off-white nebulizer suspension, contained in an ampoule.
Each pack contains plastic ampoules containing 2 ml of suspension. Strips of 5 ampoules are packaged in foil bags and a cardboard box. Each box contains 10 or 20 ampoules.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Phone: (22) 345 93 00

Manufacturer/Importer:

Merckle GmbH
Ludwig-Merckle-Str. 3,
89143 Blaubeuren
Germany

Date of last revision of the leaflet: January 2021