Pulmicort

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Pulmicort, 0.250 mg/ml, nebulizer suspension

Budesonide

Before using the medicine, carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• 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 Pulmicort and what is it used for
• 2. Important information before using Pulmicort
• 3. How to use Pulmicort
• 4. Possible side effects
• 5. How to store Pulmicort
• 6. Contents of the packaging and other information

1. What is Pulmicort and what is it used for

Budesonide, the active substance of Pulmicort, belongs to a group of medicines called corticosteroids. Medicines in this group have local anti-inflammatory effects. Pulmicort 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. Nebulizers are recommended when the use of pressurized inhalers (pMDI) or powder inhalers (DPI) is unsatisfactory or unjustified;
• in patients with croup syndrome - acute laryngitis, tracheitis, and bronchitis - regardless of etiology, associated with significant narrowing of the upper airways, shortness of breath, or "barking" cough, leading to respiratory disorders;
• in the treatment of 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 cough.

2. Important information before using Pulmicort

When not to use Pulmicort:

Warnings and precautions

Pulmicort 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, the doctor should be consulted. In such cases, the doctor may consider using more effective anti-inflammatory treatment, for example, by increasing the dose of budesonide administered via inhalation or starting treatment with an oral corticosteroid. Particular caution should be exercised when changing treatment 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 highest recommended doses of inhaled corticosteroids are also at increased risk of adrenal insufficiency when exposed to stressful situations. The doctor should be informed about anticipated stressful situations (e.g., exams) or planned surgical procedures. The doctor may consider increasing the dose of oral corticosteroids. Warning. If the treatment is changed from oral corticosteroids to Pulmicort in the form of a nebulizer 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, the doctor may prescribe treatment with antihistamines and (or) local-acting medicines. If any of the symptoms are severe and worrying or if symptoms such as headache, fatigue, nausea, or vomiting occur, the doctor should be contacted. The doctor may recommend periodic 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, the doctor may verify the treatment method by reducing the dose of corticosteroids. Before starting treatment, the patient should inform their doctor about other diseases or conditions, especially:

• active or recently experienced infections,
• liver function disorders. The doctor should also be consulted if the above warnings apply to past situations.

Like other inhaled medicines, paradoxical bronchospasm may occur immediately after using Pulmicort. If a severe reaction occurs, the use of the medicine should be stopped immediately and the doctor should be consulted without delay. During the use of inhaled corticosteroids, fungal infections in the mouth may occur. Such infections may require the use of appropriate antifungal therapy and, in some patients, discontinuation of inhaled corticosteroids. The doctor should also be consulted 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 contact their doctor.

Children

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

Pulmicort and other medicines

The doctor should be told about all medicines currently being used or recently used, including those that are available without a prescription, as well as about medicines that the patient plans to use. The doctor should be informed about worrying reactions that occurred after taking other medicines. In particular, the doctor should be informed about currently used antifungal medicines, such as ketoconazole or itraconazole (which are strong 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 Pulmicort is necessary, the interval between the administration of individual doses of the medicines should be as long as possible, and the doctor may also recommend reducing the dose of budesonide. No interaction between budesonide and other medicines used to treat bronchial asthma has been observed.

Pregnancy and breastfeeding

Pregnancy If a woman is pregnant or plans to become pregnant, she should consult her doctor before using the medicine - she should not use the medicine unless the doctor recommends it. If a woman being treated with Pulmicort becomes pregnant, she should not stop the treatment on her own but should inform her doctor as soon as possible. Breastfeeding If a woman is breastfeeding, she should consult her doctor before using this medicine.

Driving and using machines

Pulmicort does not affect the ability to drive and use machines.

3. How to use Pulmicort

This medicine should always be used in accordance with the doctor's recommendations. The dosage of Pulmicort in the form of a nebulizer suspension is determined individually. In case of doubts, the doctor should be consulted again. Pulmicort in the form of a nebulizer suspension can only be used with a nebulizer (inhalation device). The medicine is introduced into the lungs during breathing through a mouthpiece or face mask. Before using the medicine, the patient should carefully read the "Instructions for using Pulmicort in the form of a nebulizer suspension" at the end of the leaflet and follow the instructions. It is recommended to rinse the mouth with water after each inhalation. If a face mask was used, the face should also be rinsed with water after each inhalation. Not all inhalation devices (nebulizers) are suitable for administering Pulmicort in the form of a nebulizer suspension. Ultrasonic nebulizers should not be used. Pulmicort is available in the following doses: 0.125 mg/ml, 0.250 mg/ml, 0.500 mg/ml.

Asthma

Initial dose

The recommended initial dose for children from 6 months of age is a total daily dose of 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. The recommended initial dose for adults and the elderly is 1 mg to 2 mg per day. The doctor may change the dosage after some time.

Maintenance dose

The smallest effective maintenance dose is recommended. Children from 6 months of age: the total daily dose is 0.25 mg to 2 mg. Adults, including the elderly: the total daily dose is 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 the effect of the medicine is too strong or too weak, the doctor should be consulted. 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 Pulmicort may occur after a few hours of starting treatment. The full therapeutic effect is achieved after a few weeks of starting treatment. Pulmicort should be used even when there are no symptoms of the disease. Patients treated with oral corticosteroids Pulmicort in the form of a nebulizer suspension may be prescribed to a patient who is taking oral corticosteroids. Pulmicort in the form of a nebulizer suspension can partially or completely replace oral corticosteroids while maintaining the same or increased efficacy of treatment. The gradual reduction of the dose of the oral medicine should be recommended by the doctor. During the change of treatment from oral corticosteroids to inhaled products, the patient should be in a stable condition. It is recommended to use high doses of Pulmicort in combination with the previously used oral corticosteroid in 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. Often, the use of oral corticosteroids can be completely stopped. Budesonide administered to the patient in the form of a nebulizer suspension is delivered to the lungs during inhalation. It is very important that the patient performs calm, even inhalations through the nebulizer mouthpiece or face mask during treatment.

Croup syndrome

The usual dose used in infants and children with croup syndrome is 2 mg of budesonide administered via nebulization. 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 Pulmicort, nebulizer 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. Administration method Pulmicort can be mixed with 0.9% sodium chloride solution and solutions of terbutaline, salbutamol, fenoterol, acetylcysteine, cromoglycate sodium, or ipratropium. The prepared mixture should be used within 30 minutes. The dose in the container can be divided to achieve the desired dose. The containers, which are single-dose packaging, are marked with a horizontal line (Pulmicort 0.25 mg/ml and 0.5 mg/ml). When the 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 container should be stored in a protective foil without light access. The contents of the opened container should be used within 12 hours.

*Should be diluted to 2 ml with 0.9% sodium chloride solution or another recommended liquid.

Using a higher dose of Pulmicort than recommended

It is important that the patient uses the medicine in accordance with the instructions in the leaflet or the doctor's recommendations. The dose of the medicine should not be increased or decreased without consulting a doctor. If a higher dose of the medicine than recommended is taken, the doctor or pharmacist should be consulted immediately. If a much higher dose of Pulmicort than recommended is used once, it should not have harmful effects. If doses higher than those recommended by the doctor are taken for a longer period, there is a possibility of side effects, such as those that occur after taking oral corticosteroids, i.e., increased levels of adrenal hormones in the blood and suppression of adrenal function. In this case, the doctor should recommend continuing treatment with Pulmicort in doses that keep the symptoms of asthma under control.

Missing a dose of Pulmicort

If a recommended dose of Pulmicort in the form of a nebulizer suspension is not taken, there is no need to make up for the missed dose. The next dose of the medicine should be taken in accordance with the doctor's recommendations. A double dose should not be taken to make up for the missed dose. If there are any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

If any of the following symptoms occur, the use of Pulmicort should be stopped and the doctor should be consulted immediately:

Pulmicort:

• 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, which causes wheezing). This may indicate an allergic reaction. This side effect is rare (less than 1 in 1000 people);
• sudden onset of wheezing after inhaling the medicine. This side effect is rare (less than 1 in 1000 people).

Other possible side effects:

Frequent (occurring in less than 1 in 10 people)

• thrush (fungal infections) in the mouth. To reduce the possibility of their occurrence, the mouth should be rinsed with water after using Pulmicort.
• sore throat, cough, and hoarseness, loss of voice.
• pneumonia (lung infection) in patients with COPD.

The doctor should be told if any of the following symptoms occur while taking budesonide; these may be symptoms of a lung infection:

• fever or chills,
• increased production of mucus, change in the color of mucus,
• 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 1000 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 behavior (mainly in children).
• easy bruising.
• hoarseness and loss of voice (in children).

Side effects whose frequency is not known (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 they are used for a long time in high doses. Side effects such as:

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

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be told. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Pulmicort

The medicine should be stored out of sight and reach of children. This medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. The medicine should not be stored at temperatures above 25°C. The packaging should be kept closed. Protect from light. Do not freeze. Single-dose containers must be stored in aluminum foil bags to protect them from light. After opening the aluminum foil bag, the medicine in single-dose containers, protected from light, is stable for 3 months. The contents of the single-dose container should be used within 12 hours of opening. If only 1 ml of the suspension is used from the single-dose container, the remaining volume of the suspension is not sterile. Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked 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 Pulmicort contains

• The active substance of Pulmicort is budesonide. 1 ml of nebulizer suspension contains: 0.250 mg of micronized budesonide. 1 container contains 0.5 mg of budesonide in 2 ml of nebulizer suspension.
• The other ingredients are: disodium edetate, sodium chloride, polysorbate 80, citric acid, sodium citrate, purified water.

What Pulmicort looks like and contents of the packaging

White or almost white liquid in a single-dose container. 20 containers of 2 ml (4 aluminum foil bags of 5 containers each) in a cardboard box. For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Greece, the country of export:

AstraZeneca A.E. Agisilaou 6-8 151 23 Marousi Greece

Manufacturer:

AstraZeneca AB Forskargatan 18 151 85 Södertälje Sweden

Parallel importer:

InPharm Sp. z o.o. ul. Strumykowa 28/11 03-138 Warszawa

Repackaged by:

InPharm Sp. z o.o. Services sp. k. ul. Chełmżyńska 249 04-458 Warszawa Marketing authorization number in Greece, the country of export:93165/10.12.2013

Parallel import authorization number: 139/22 Date of leaflet approval: 21.03.2022

[Information about the trademark]

Instructions for using Pulmicort in the form of a nebulizer suspension

• 1. Before use, the contents of the container with the medicine should be gently mixed by rotating it.
• 2. Hold the container with the medicine upright (see diagram), and then open the container by twisting the "wing".
• 3. The open end of the container should be attached precisely to the nebulizer reservoir and slowly squeezed out.

The containers are marked with a line indicating a volume of 1 ml when the container is inverted. If only 1 ml is to be used, the liquid above the indicator line should be removed. Before using the rest of the medicine, the contents of the container should be gently mixed.

• The date of opening the aluminum foil bag should be recorded. Single-dose containers should not be used after 3 months from the date of opening the aluminum foil bag.
• The contents of the single-dose container must be used within 12 hours of opening.
• Do not store above 25°C. Keep the packaging closed. Protect from light. Do not freeze.
• The containers with the medicine should always be stored in an aluminum foil bag to protect them from light. If the entire contents of the container are not used at once, the remaining amount should be protected from light.
• The containers with the medicine should be stored upright.

WARNING

• 1. The mouth should be rinsed after each use of the medicine.
• 2. If the patient uses a face mask, they should check that the mask fits tightly to the face during inhalation. The face should be rinsed with water after using the medicine.

CLEANING

The nebulizer 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 nebulizer manufacturer. The nebulizer chamber should then be rinsed well and dried by connecting the compressor to the outlet.