Pulmicort turbuhaler

Package leaflet: Information for the patient

Pulmicort Turbuhaler, 100 g/inhalation dose, powder for inhalation
Pulmicort Turbuhaler, 200 g/inhalation dose, powder for inhalation
Budesonidum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Pulmicort Turbuhaler is and what it is used for

Budesonide, the active substance in Pulmicort Turbuhaler, belongs to a group of medicines called glucocorticosteroids. Medicines in this group have strong local anti-inflammatory effects. Pulmicort Turbuhaler is used in:

• bronchial asthma,
• chronic obstructive pulmonary disease (COPD).

2. Important information before using Pulmicort Turbuhaler

When not to use Pulmicort Turbuhaler

• if the patient is allergic (hypersensitive) to budesonide.

Warnings and precautions
Before starting to use Pulmicort Turbuhaler, inform the doctor if:

• the patient has pneumonia,
• the patient has a cold or chest infection, or has any breathing problems,
• the patient has ever had tuberculosis of the lungs,
• the patient has liver problems,
• the patient has any other diseases or conditions apart from asthma.

Inform the doctor about any anticipated stressful situations (e.g. exams) or planned surgical procedures. The doctor may then consider increasing the dose of oral glucocorticosteroids.
If the patient experiences blurred vision or any other visual disturbances, contact the doctor.

Children and adolescents
The medicine is intended for the treatment of bronchial asthma in children aged 6 years and older.
Regular monitoring of growth in children and adolescents receiving glucocorticosteroids, regardless of the route of administration, is recommended.

Use of Pulmicort Turbuhaler in patients with renal and/or hepatic impairment
Inform the doctor about any past or current liver function disorders.

Pulmicort Turbuhaler and other medicines
Inform the doctor about any disturbing reactions that occurred after taking other medicines. Tell the doctor about all medicines currently used or used recently, as well as any medicines the patient plans to take, including those available without a prescription, and herbal preparations.

Pulmicort Turbuhaler may affect the way some medicines work, and some medicines may affect the action of Pulmicort Turbuhaler.

Especially inform the doctor about taking the following medicines:

• steroid medicines, including estrogens or steroid contraceptives,
• medicines used to treat fungal infections (such as ketoconazole and itraconazole),
• HIV protease inhibitors (such as ritonavir and nelfinavir).

Pregnancy and breastfeeding
Pregnancy
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
If a woman being treated with Pulmicort Turbuhaler becomes pregnant, she should inform the doctor as soon as possible.

Breastfeeding
Consult a doctor before using the medicine.

Driving and operating machinery
Pulmicort Turbuhaler has no influence on the ability to drive or operate machinery.

3. How to use Pulmicort Turbuhaler

• This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor. Bronchial asthma The dosage of Pulmicort Turbuhaler is individual. Below are general recommendations for determining the total starting dose and maximum total dose of Pulmicort Turbuhaler, depending on prior asthma treatment and patient age.

As with other inhaled medicines, paradoxical bronchospasm may occur immediately after using
Pulmicort Turbuhaler. If a severe reaction occurs, contact your doctor immediately.
You should also contact your doctor if symptoms do not improve despite regular use of the prescribed doses.

Children aged 6 years and older

• 100 \μ g to 800 \μ g per day, divided into 2 to 4 doses.
• If the total daily dose does not exceed 400 \μ g, it may be administered once daily.

Adults

• The usual total daily dose ranges from 200 \μ g to 800 \μ g and may be given in 2 to 4 divided doses.
• In severe cases, the total daily dose may be up to 1600 \μ g.
• If the total daily dose does not exceed 400 \μ g, it may be administered once daily.

The lowest effective maintenance dose should be used.
Due to the very small amount of inhaled powder, you may not taste the medicine after inhalation.
Clinical improvement after a single dose of Pulmicort Turbuhaler can be expected within several hours of inhalation. Full therapeutic effect is achieved after several weeks of treatment.
Pulmicort Turbuhaler is intended for long-term treatment and does not provide rapid relief of acute asthma attacks.
When switching from oral glucocorticosteroids to inhaled therapy, the patient should be as stable as possible. For 10 days, high doses of Pulmicort Turbuhaler should be used concomitantly with the previously prescribed oral glucocorticosteroid.
Then, the dose of oral glucocorticosteroid should be gradually reduced. Often, oral glucocorticosteroid treatment can be completely discontinued.

Chronic obstructive pulmonary disease (COPD)

• The recommended dose of Pulmicort Turbuhaler is 400 \μ g twice daily.

For COPD patients previously treated with oral glucocorticosteroids who are being switched to Pulmicort Turbuhaler, the same recommendations as described in the section “Bronchial asthma” should be followed during tapering of oral glucocorticosteroids.
If symptoms of COPD worsen, the patient should contact their physician, who will recommend appropriate treatment.
If there is no noticeable improvement after using short-acting bronchodilators, or if there is a need to use them more frequently than usual, contact your doctor.

Instructions for using Pulmicort Turbuhaler

Preparing the Pulmicort Turbuhaler inhaler for first use
Before the first use of a new Pulmicort Turbuhaler inhaler, prepare it as follows:

• Unscrew and remove the inhaler cap. A characteristic rattling sound may be heard during unscrewing.
• Hold the Pulmicort Turbuhaler inhaler vertically with the base pointing downwards.
• Turn the base fully in one direction, then turn it fully in the opposite direction (the starting direction does not matter). A characteristic click sound will be heard.
• Repeat the above step, turning the base fully in both directions.
• The Pulmicort Turbuhaler inhaler is now ready for use.

Using the inhaler
To perform inhalation, always follow the instructions below.
The Turbuhaler is a multidose inhaler for delivering medicine.

When inhaling through the Turbuhaler, the powder is released into the lungs. Therefore, it is very important to inhale fully and deeply through the mouthpiece. Follow the instructions below.

1. Unscrew and remove the inhaler cap.
2. Hold the inhaler in an upright position , base down (Figure 2). When loading a dose, do not hold the inhaler by the mouthpiece. To load a dose of medicine,

turn the base fully in one direction , then turn it fully in the opposite direction (the starting direction does not matter). A characteristic click sound will be heard. The inhaler is now loaded and ready for use; do not repeat this step. To take a dose, proceed with the next steps.

3. Breathe out. Do not exhale through the inhaler.
4. Place the mouthpiece between your teeth, close your lips around it, and inhale deeply and forcefully

through your mouth.
Do not chew or bite the mouthpiece.
Do not use a damaged inhaler or an inhaler without a mouthpiece.

5. Remove the inhaler mouthpiece from your mouth before exhaling . If more than one dose has been prescribed, repeat steps 2–5.
6. Replace the cap on the inhaler and screw it on.
7. Rinse your mouth after taking the prescribed dose.

Note!
Never exhale through the mouthpiece.
After taking the medicine, always screw the cap back on tightly.
Due to the very small amount of powdered medicinal substance, you may not taste the medicine after inhalation. However, you can be confident that the prescribed dose has been taken if you followed the instructions above.

Cleaning the Pulmicort Turbuhaler inhaler
The outer part of the mouthpiece should be cleaned regularly (once a week) with a dry cloth.
Do not use water to clean the mouthpiece.

When to start using a new inhaler
Dose indicator
When a red mark first appears in the dose counter window, this indicates that approximately 20 doses remain in the device (Fig. 1).
When the red mark reaches the lower edge of the counter window (Fig. 2), the inhaler should no longer be used, as the dose delivered may be too low.
A characteristic sound of the moisture-absorbing agent shifting may be heard when shaking the inhaler.

Fig. 1 Fig. 2
If you feel that the effect of Pulmicort Turbuhaler is too strong or too weak, consult your doctor.

Taking more than the recommended dose of Pulmicort Turbuhaler
It is important that the patient uses the medicine exactly as prescribed by the doctor. Do not increase or decrease the dose without consulting your doctor.
If more than the recommended dose has been taken, contact your doctor immediately.

Missed dose of Pulmicort Turbuhaler
Pulmicort Turbuhaler powder for inhalation should be taken exactly as prescribed by your doctor, and only the prescribed number of doses should be used. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The use of Pulmicort Turbuhaler must be discontinued and immediate contact with a doctor must be made
if the patient experiences any of the following symptoms: severe allergic reactions, such as facial swelling,
especially around the mouth (of the tongue and (or) throat and (or) difficulty swallowing), or hives occurring
together with breathing difficulties (angioedema), bronchospasm, and (or) sudden onset of weakness (fainting).

Other adverse reactions

Common adverse reactions (occurring in less than 1 in 10 patients)

• Fungal infections (candidiasis) of the mouth and throat. The mouth should be rinsed with water after each dose to reduce the risk of developing oral or throat candidiasis.
• Throat irritation, 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, as they may indicate a lung infection:

• Fever or chills,
• Increased mucus production, change in mucus color,
• Worsening cough or increased difficulty breathing.

Uncommon adverse reactions (occurring in less than 1 in 100 people)

• Cataracts,
• Blurred vision,
• Muscle cramps,
• Muscle tremors,
• Depression,
• Anxiety.

Rare adverse reactions (occurring in less than 1 in 1000 patients)

• Immediate and delayed hypersensitivity reactions, including rash, contact dermatitis, urticaria, angioedema (swelling of soft tissues due to increased vascular permeability: swelling of eyelids, face, lips, tongue, larynx), severe allergic reactions,
• Easy bruising (bruises),
• Bronchospasm,
• Nervousness, behavioral changes (mainly in children),
• Systemic effects of glucocorticosteroids, including suppression of adrenal cortex function and growth retardation (in children and adolescents),
• Loss of voice (in children),
• Hoarseness (in children).

Adverse reactions with unknown frequency

• Glaucoma,
• Sleep disorders,
• Anxiety,
• Psychomotor hyperactivity,
• Aggression.

Possible systemic effects include: Cushing's syndrome, signs of Cushing's syndrome, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, glaucoma, and psychiatric symptoms or behavioral disorders such as psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (especially in children).

If any of the listed adverse reactions occur, contact a doctor immediately or go to the nearest hospital.

Reporting of adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, inform your doctor. Adverse reactions 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, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.

Adverse reactions can also be reported to the responsible entity.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Pulmicort Turbuhaler

Store at a temperature not exceeding 30 °C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Pulmicort Turbuhaler contains
The active substance is budesonide.
One dose contains 100 micrograms (μg) or 200 micrograms (μg) of budesonide.

What Pulmicort Turbuhaler looks like and contents of the pack
A dosing container with an inhalation nozzle and a protective cap in a cardboard box.
Pulmicort Turbuhaler 100 μg contains 200 doses.
Pulmicort Turbuhaler 200 μg contains 100 doses.

Each inhaler is additionally labelled with:
200 DOSES BUDESONIDE 100 μg/DOSE
LOT/CH.-B/LOTE ZM 1234
EXP/VERW.BIS/CAD MM-YYYY
or
100 DOSES BUDESONIDE 200 μg/DOSE
LOT/CH.-B/LOTE ZM 1234
EXP/VERW.BIS/CAD MM-YYYY

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
AstraZeneca AB
S-151 85 Sodertalje
Sweden

Manufacturer:
AstraZeneca AB
Forskargatan 18
151 36 Södertälje
Sweden

For further information, please contact the representative of the Marketing Authorisation Holder:
AstraZeneca Pharma Poland Sp. z o.o.
ul. Postępu 14
02-676 Warsaw
Poland
Tel: +48 22 245 73 00
Fax: +48 22 485 30 07