Pulmicort

Patient Information Leaflet

Pulmicort, 0.125 mg/ml, nebuliser suspension
Pulmicort, 0.250 mg/ml, nebuliser suspension
Pulmicort, 0.500 mg/ml, nebuliser suspension
Budesonide
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Pulmicort is and what it is used for

Budesonide, the active substance in Pulmicort, belongs to a group of medicines called glucocorticosteroids. Medicines in this group have local anti-inflammatory action. Pulmicort 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. Nebulisers are recommended when pressurised 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 its cause, associated with significant narrowing of the upper airways, breathing difficulty, or "barking" cough, leading to respiratory disturbances.
• in the treatment of exacerbations of chronic obstructive pulmonary disease (COPD), when budesonide in the form of nebuliser suspension is considered appropriate. COPD is a chronic lung disease causing breathlessness and cough.

2. Important information before using Pulmicort

When not to use Pulmicort

• if the patient is allergic (hypersensitive) to budesonide or any of the other ingredients of Pulmicort (listed in section 6). Inform your doctor of any concerning reactions that occurred after taking a medicine containing budesonide or any ingredient of this medicine.

Warnings and precautions
Pulmicort is intended for long-term treatment and does not provide rapid relief of symptoms during acute asthma attacks, which require administration of short-acting bronchodilators.
If there is no noticeable improvement after using short-acting bronchodilators, or if their use becomes more frequent than usual, contact your doctor.
In such cases, the doctor may consider intensifying anti-inflammatory treatment, for example by increasing the inhaled dose of budesonide or initiating treatment with oral glucocorticosteroids.
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 emergency treatment with high doses of oral glucocorticosteroids or long-term treatment with the highest recommended doses of inhaled glucocorticosteroids are also at increased risk of adrenal insufficiency during periods of severe stress. Inform your doctor about anticipated stressful situations (e.g. exams) or planned surgical procedures.
The doctor may consider increasing the dose of oral glucocorticosteroids.
Note: When switching from oral glucocorticosteroid therapy to Pulmicort suspension for nebulization, the following transient symptoms may occur: watery nasal discharge, rash, muscle and joint pain. In case of allergic reactions such as rhinorrhea or rash, the doctor may recommend treatment with antihistamines and/or topical medications. If any of these symptoms are severe or bothersome, or if symptoms such as headache, fatigue, nausea or vomiting occur, contact your doctor. The doctor may recommend temporary increase in the dose of oral glucocorticosteroids.
Regular monitoring of growth in children and adolescents receiving glucocorticosteroids, regardless of 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, inform your doctor about any medical conditions other than asthma, particularly:

• active or recent infections,
• liver function disorders. Consult your doctor also if the above warnings apply to past medical conditions.

As with other inhaled medications, paradoxical bronchospasm may occur immediately after using Pulmicort. If a severe reaction occurs, discontinue use immediately and contact your doctor without delay.
Fungal infections in 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 contact your doctor if symptoms do not improve despite regular use of the recommended doses of the medicine.
If the patient experiences blurred vision or other visual disturbances, contact your doctor.

Children
Pulmicort may be used in the treatment of asthma in children from the age of 6 months. The treating doctor determines the dose individually for each patient.

Pulmicort and other medicines
Inform 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.
Inform your doctor about any concerning reactions that occurred after taking other medicines.
Particularly inform your doctor about current treatment with 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 these medicines with Pulmicort is necessary, the interval between doses of each medicine should be as long as possible, and the doctor may additionally 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 Pulmicort 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
Pulmicort does not affect the ability to drive or operate machinery.

3. How to use Pulmicort

This medicine should always be used exactly as prescribed by your doctor.
The dosage of Pulmicort suspension for nebulization is individually determined.
If in doubt, please consult your doctor again.
Pulmicort suspension for nebulization must only be used with a nebulizer (inhalation device). The medicine is delivered to the lungs during breathing through a mouthpiece or a facial mask. Before starting treatment, carefully read the “Instructions for the use of Pulmicort suspension for nebulization” located at the end of this leaflet and follow the instructions provided.
After each inhalation, rinse your mouth with water. If a facial mask was used, wash your face after each inhalation.
Not all inhalation devices (nebulizers) are suitable for administering Pulmicort suspension for nebulization.
Do not use ultrasonic nebulizers.

Asthma
Initial dose
Recommended initial dose for children from 6 months of age: total daily dose from 0.25 mg to 0.5 mg. If the child is taking another glucocorticosteroid orally, 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.
Your doctor may adjust the dosage after some time.

Maintenance dose
The lowest effective maintenance dose should be used.
Children from 6 months of age: total daily dose from 0.25 mg to 2 mg.
Adults, including elderly patients: total daily dose from 0.5 mg to 4 mg.
If symptoms are very severe, your 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 you feel the medicine's effect is too strong or too weak, consult your doctor.
If the patient's condition improves, your doctor may decide to reduce the dose.
Improvement in the patient's condition after using Pulmicort may occur within a few hours of starting treatment. Full therapeutic effect is achieved after several weeks of treatment.
Pulmicort should be used even when no symptoms are present.

Patients treated with oral glucocorticosteroids
Pulmicort suspension for nebulization may be prescribed to patients who are taking oral glucocorticosteroids.
Pulmicort suspension for nebulization can partially or completely replace oral glucocorticosteroids while maintaining the same or increased treatment efficacy.
The gradual reduction of the oral medication should be directed by your doctor.
When switching from oral glucocorticosteroids to inhaled therapy, the patient should be clinically stable.
For the first 10 days, it is recommended to use high doses of Pulmicort in combination with the previously used oral glucocorticosteroid at the same 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 is delivered to the lungs during inhalation. It is very important that the patient takes calm, even breaths through the nebulizer mouthpiece or facial mask during administration.

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 Pulmicort 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.

Dosage instructions
Pulmicort may be mixed with 0.9% sodium chloride solution and with solutions of terbutaline, salbutamol, fenoterol, acetylcysteine, sodium cromoglicate, or ipratropium. The prepared mixture should be used within 30 minutes.
The dose contained in a plastic container may be divided to achieve the appropriate dose.
The plastic unit-dose containers 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, remove the liquid above the indicator line. Store the opened plastic container in its protective foil, protected from light. The contents of an opened container should be used within 12 hours.

| Dose (mg) | Volume of Pulmicort suspension for nebulization |
|-----------|--------------------------------------------------|
| | 0.125 mg/ml | 0.25 mg/ml | 0.5 mg/ml |
| 0.25 | 2 ml | 1 ml* | - |
| 0.5 | 4 ml | 2 ml | - |
| 0.75 | - | 3 ml | - |
| 1.0 | - | 4 ml | 2 ml |
| 1.5 | - | - | 3 ml |
| 2.0 | - | - | 4 ml |
*Dilute to 2 ml with 0.9% sodium chloride solution or another prescribed liquid.

Use of a higher than recommended dose of Pulmicort
It is important that the patient uses the medicine exactly as described in this leaflet or as directed by the doctor. Do not increase or decrease the dose without consulting your doctor.
If a higher than recommended dose is taken, contact your doctor or pharmacist immediately.
If a single excessive dose of Pulmicort is administered, it should not cause harmful effects.
However, if doses higher than recommended have been taken for a prolonged period, symptoms similar to those seen with oral glucocorticosteroids may occur, such as increased blood levels of adrenal cortex hormones and suppression of adrenal function. In such cases, your doctor should recommend continuing treatment with Pulmicort at doses sufficient to maintain control of asthma symptoms.

Missed dose of Pulmicort
If a prescribed dose of Pulmicort suspension for nebulization is missed, there is no need to make up the missed dose. Take the next dose as prescribed by your doctor. Do not take 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the symptoms listed below occur, stop using the medicine
Pulmicort immediately and contact your doctor without delay:

• Swelling of the face, particularly 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 effect is rare (occurring in fewer than 1 in 1,000 people).
• Sudden onset of wheezing after inhaling the medicine. This adverse effect is rare (occurring in fewer than 1 in 1,000 people).

Other possible adverse effects:
Common (occurring in fewer than 1 in 10 people)

• Oral candidiasis (fungal infections in the mouth). To reduce the risk, rinse the mouth with water after using Pulmicort.
• Sore throat, cough, 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 a lung infection:

• Fever or chills,
• Increased mucus production, change in mucus colour,
• Worsening cough or increased breathing difficulties.

Uncommon (occurring in fewer than 1 in 100 people)

• Cataracts (clouding of the eye lens).
• Blurred vision.
• Muscle spasms.
• Muscle tremors.
• Depression.
• Anxiety.

Rare (occurring in fewer than 1 in 1,000 people)

• Skin 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 effects for which frequency is not known (frequency cannot be estimated from
available data):

• Sleep disorders, anxiety, excessive excitement, aggression.

The use of inhaled glucocorticosteroids may affect the normal production of steroid hormones
in the body, particularly if used long-term at high doses. Such symptoms may include:

• Glaucoma (increased intraocular pressure), frequency not known.
• Slowed growth 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 effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to collect more information on the safety of the medicine.

5. How to store Pulmicort

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date (EXP)".
Store the packaging below 30°C, keep closed and protect from light.
The plastic unit containers must be stored in aluminium foil sachets to protect them from light.
After opening the aluminium foil sachet, the medicine in the plastic unit containers, protected from light, remains stable for up to 3 months.
The contents of a plastic unit container should be used within 12 hours of opening.
If only 1 ml of the suspension has been used from the unit container, the remaining volume of suspension is no longer sterile.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Pulmicort contains

• The active substance is budesonide. 1 ml of nebuliser suspension contains: 0.125 mg, 0.250 mg or 0.500 mg micronised budesonide. Each plastic container contains 0.25 mg, 0.5 mg or 1 mg budesonide in 2 ml of nebuliser suspension.
• Other ingredients are: disodium edetate, sodium chloride, polysorbate 80, anhydrous citric acid, sodium citrate, purified water.

What Pulmicort looks like and contents of the pack
A liquid, white to almost white, in a single-dose plastic container.
0.125 mg/ml, 0.250 mg/ml, 0.500 mg/ml: 20 plastic containers of 2 ml (4 aluminium foil pouches containing 5 plastic containers each) in a cardboard box.
0.250 mg/ml, 0.500 mg/ml: 5 plastic containers of 2 ml (1 aluminium foil pouch containing 5 plastic containers) in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
AstraZeneca AB
S-151 85 Södertälje
Sweden
Manufacturer:
AstraZeneca AB
Forskargatan 18
SE-151 36 Södertälje
Sweden
For further information, contact the representative of the Marketing Authorisation Holder:
AstraZeneca Pharma Poland Sp. z o.o.
ul. Postępu 14
02-676 Warszawa
tel.: +48 22 245 73 00
fax: +48 22 485 30 07

Instructions for use of Pulmicort nebuliser suspension

1. Before use, gently mix the contents of the plastic container by rotating it.
2. Hold the plastic container in an upright position (see figure) and open it by twisting the "wing".
3. Attach the open end of the container securely to the nebuliser reservoir and slowly squeeze out the contents. The plastic containers containing 0.25 mg/ml and 0.5 mg/ml are marked with a line indicating the 1 ml volume when the container is inverted. If only 1 ml is to be used, empty the container down to the level of the marking line. Before using the remaining medicine, gently mix the contents of the container.
   • Record the date when the aluminium foil pouch is opened. Do not use the single-dose plastic containers after 3 months from the date of opening the aluminium foil pouch.
   • The contents of a single plastic container must be used within 12 hours of opening.
   • The medicine should be stored below 30 °C.
   • Plastic containers should always be stored in the aluminium foil pouch to protect from light. If the entire contents of a plastic container are not used at once, the remainder should be protected from light.
   • Plastic containers should be stored in an upright position.

WARNING

1. Rinse the mouth after each use of the medicine.
2. If a face mask is used, ensure that the mask fits tightly against the face during inhalation. Wash the face after using the medicine.

CLEANING
The nebuliser chamber, mouthpiece or face mask should be cleaned after each use.
These parts should be washed with warm running water, using a mild detergent recommended by the nebuliser manufacturer. The nebuliser chamber should then be thoroughly rinsed and dried by connecting the compressor to the outlet.