Nebbud

Patient Information Leaflet: Information for the Patient

Nebbud, 0.5 mg/ml, Nebuliser Suspension

Budesonide

Before taking the medicine, carefully read the contents of this leaflet, 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 taking Nebbud
• 3. How to take Nebbud
• 4. Possible side effects
• 5. How to store Nebbud
• 6. Contents of the pack and other information

1. What is Nebbud and what is it used for

Nebbud is a nebuliser suspension containing 0.5 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, acute laryngitis, chronic obstructive pulmonary disease (COPD), and chronic sinusitis with nasal polyps. Nebbud is used:

• in the treatment of bronchial asthma in patients for whom the use of pressurised inhalers or dry powder inhalers does not provide sufficient effect or is contraindicated,
• in infants and children with pseudocroup, i.e. acute laryngitis,
• in the treatment of exacerbations of chronic obstructive pulmonary disease (COPD), when 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 cough,
• in adult patients with chronic sinusitis with nasal polyps.

2. Important information before taking Nebbud

When not to take Nebbud:

• if the patient is hypersensitive (allergic) 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 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 long time, the doctor may recommend additional systemic intake of glucocorticosteroids in tablet form during periods of increased stress or before surgery.

Patients with chronic sinusitis with nasal polyps

In case of persistent unpleasant feeling of nasal congestion, ear pain, the treatment should be discontinued and the doctor consulted. Nebulisation of the sinuses with a pulsating aerosol should not be performed during an acute viral infection (see section 3).

Children and adolescents

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

Nebbud and other medicines

Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription. Inform the doctor about any worrying reactions that have occurred after taking other medicines. In particular, inform the doctor about any antifungal medicines being taken, such as ketoconazole, itraconazole, other potent inhibitors of the CYP 3A4 isoenzyme, 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 concurrent use of these medicines with Nebbud is necessary, 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 condition of the patient taking such medicines (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 in the treatment of stomach ulcers).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medicine. PregnancyThe doctor will decide whether Nebbud can be used during pregnancy. BreastfeedingIf a woman is breastfeeding or plans to breastfeed, she should consult a doctor or pharmacist. Budesonide passes into breast milk. However, during the use of therapeutic doses 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 take Nebbud

This medicine should always be taken according to the doctor's recommendations. In case of doubts, consult a doctor or pharmacist. Nebbud is for inhalation use only. The medicine is taken in the form of inhalation from a nebuliser through a mouthpiece or face mask or nasal nozzle (pulsating sinus nebulisation). The usual dose is:

Asthma

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

The usual initial 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 initial 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 nebuliser under adult supervision. If the patient is taking steroids in tablet form for asthma, after starting Nebbud, the doctor may reduce their dose or frequency of administration. Improvement in the patient's condition after taking Nebbud may occur after a few hours of starting treatment. The full therapeutic effect is achieved after a few weeks of starting treatment. The medicine should be taken according to the doctor's recommendations, even if the patient feels better.

Pseudocroup

The usual dose for infants and children with pseudocroup is 2 mg of budesonide administered in the form of nebulisation. This dose can be given in one go or divided into two doses of 1 mg at 30-minute intervals. 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 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 be continued until clinical improvement is achieved, but not for more than 10 days.

Chronic sinusitis with nasal polyps

The usual dose in adults is 1 mg of Nebbud administered every 12 hours for 14 days. Nebbud in the form of a nebuliser suspension should be administered using an appropriate nebuliser adapted for pulsating sinus nebulisation, e.g. PARI SINUS2, in accordance with the instructions for use of the nebuliser. Pulsating sinus nebulisation with an aerosol is different from regular inhalation nebulisation with a standard pneumatic or mesh nebuliser. Before use, the patient should ensure that they are using the correct device. The aerosol generated during nebulisation should only be delivered to the paranasal sinuses. Therefore, a device that generates a pulsating aerosol adapted for sinus nebulisation is required. In case of persistent unpleasant feeling of nasal congestion, ear pain, the treatment should be discontinued. Nebulisation of the sinuses with a pulsating aerosol should not be performed during an acute viral infection (common cold, usually with symptoms such as cough, sneezing, fever).

General instructions for taking the medicine in all indications - stage 1

Prepare the nebuliser 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 only 1 ml of the suspension is to be used, the liquid above the mark should be discarded. The opened plastic container should always be stored in a laminated foil, in the original packaging. The contents of the ampoule are suitable for use within 12 hours of opening. Squeeze the appropriate amount of suspension from the ampoule into the nebuliser chamber (Fig. C). If only 1 ml of the suspension is used from the ampoule, the remaining volume of the suspension is not sterile.

A B C

The suspension should not be swallowed or administered as an injection. In case of sudden worsening of wheezing after taking the medicine, the patient should contact their doctor or go to the nearest hospital. They should take this leaflet with them. Never take more of the medicine than recommended by the doctor. If the symptoms of asthma worsen or the medicine does not work as before, the patient should inform their doctor. It is essential to take the doses of the medicine as recommended by the doctor. Do not increase or decrease the dose without consulting the doctor.

Dosing instructions

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 horizontal broken line. When the ampoule is turned 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 mark should be discarded. The opened plastic container should always be stored in a laminated foil, in the original packaging. The contents of the opened ampoule are suitable for use within 12 hours.

Instructions for taking the medicine in patients with asthma, pseudocroup, exacerbations of COPD - stage 2

Use the nebuliser according to the manufacturer's instructions. After each completed inhalation, rinse the mouth with water, and if a face mask is used, wash the face as well. After using the nebuliser, rinse any remaining solution from the nebuliser chamber. Clean the nebuliser carefully. The nebuliser chamber and mouthpiece or face mask should be washed in warm water with a mild detergent. Rinse thoroughly and dry by connecting the nebuliser chamber to the air inlet or compressor. Warning:Do not use ultrasonic nebulisers for the administration of Nebbud. Nebbud in the form of a nebuliser suspension can also be administered using an appropriate mesh nebuliser.

Instructions for taking the medicine in patients with chronic sinusitis with nasal polyps using the PARI SINUS2 nebuliser - stage 2

A B C

• A. Put the nasal nozzle on the angled mouthpiece and then both parts on the nebuliser.
• B. The PARI SINUS2 tube system includes two identical tubes. One tube is needed to supply compressed air, the other to generate vibrations.
• C. To fully connect the tube system, perform the following steps:

insert the unused tube with the plug into the vibration adapter, insert the adapter into the upper part of the nebuliser, insert the free ends of both tubes into the corresponding connectors on the compressor. The above instructions do not contain all the information on preparing, assembling, filling, and cleaning the nebuliser. Before use, carefully read the instructions for use of the PARI SINUS2 nebuliser. Detailed and up-to-date information on the use of the medicine in patients with chronic sinusitis with nasal polyps is available at the following URL: www.tevamed.pl/em/nebbud.pl

Taking a higher dose of Nebbud than recommended

In case of taking too much of the medicine, the patient should immediately contact their doctor or go to the nearest hospital. They should take this leaflet with them. Never take more of the medicine than recommended by the doctor. If the symptoms of asthma worsen or the medicine does not work as before, the patient should inform their doctor. It is essential to take 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.

Stopping treatment with Nebbud

It is very important to take Nebbud every day as long as the doctor does not recommend stopping the treatment. Do not suddenly stop taking Nebbud, as the symptoms of the disease may worsen. In case of any further doubts related to the use of 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 breathing difficulties. These symptoms indicate that the patient has had 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 treatment with budesonide, as they may be symptoms of a lung infection:

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

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

• restlessness, nervousness, behavioural disturbances (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, the patient should stop taking Nebbud and consult a doctor;
• swelling of the face, lips, and tongue;
• effect on the adrenal glands (a small gland near the kidney) causing a decrease in cortisol secretion (adrenal hormone); the doctor may recommend occasional blood tests;
• growth retardation in children and adolescents; regular monitoring of growth is recommended.

Very rareside effects (may occur in no more than 1 in 10,000 people, 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 disturbances, psychomotor agitation, irritability, aggression (more likely to occur in children).

If the patient is taking steroids in tablet form for asthma, after starting Nebbud, the doctor may reduce their dose or frequency of administration. This may be accompanied by symptoms such as a feeling of nasal congestion or cold, weakness or muscle and joint pain, and rash. If any of these symptoms become troublesome or occur, such as headache, fatigue, nausea, or vomiting, the patient should consult their 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, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Nebbud

Keep the medicine out of the 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 month stated. After opening the laminated 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 is used from the ampoule, the remaining volume of the suspension is not sterile. The ampoules should be stored in the original packaging. It is recommended to write the date of opening the laminated 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 medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Nebbud contains

• The active substance of Nebbud is budesonide. 1 ml of the nebuliser suspension contains 0.5 mg of budesonide. Each Nebbud ampoule contains 1 mg of budesonide in 2 ml of aqueous suspension (0.5 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 off-white nebuliser suspension, packaged in an ampoule. Each pack contains plastic ampoules containing 2 ml of the suspension. Strips of 5 ampoules are packaged in laminated foil bags 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

Date of last revision of the leaflet: