Budesonide lek-am

Package leaflet: Information for the patient

Budezonid LEK-AM, 200 micrograms/inhalation dose,
powder for inhalation in hard capsules
Budezonid LEK-AM, 400 micrograms/inhalation dose,
powder for inhalation in hard capsules
Budesonidum

Please read all of this leaflet carefully before using this medicine, because it contains important information for the patient.

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

Contents of the leaflet

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

1. What Budezonid LEK-AM is and what it is used for

Budezonid, the active substance in Budezonid LEK-AM, belongs to a group of medicines called corticosteroids and is used in the treatment of bronchial asthma and chronic obstructive pulmonary disease (COPD).
Budezonid LEK-AM is used to reduce inflammatory changes in the lungs. Asthma is caused by inflammation of the airways. Regular use of Budezonid LEK-AM helps prevent asthma attacks and facilitates breathing in chronic obstructive pulmonary disease.
Do not stop using Budezonid LEK-AM regularly, even if symptoms have improved.
If you have any questions about how this medicine works or why it has been prescribed, please consult your doctor.

2. Important information before using Budezonid LEK-AM

When not to use Budezonid LEK-AM:

• if the patient is allergic to budesonide or to any of the other ingredients of this medicine (listed in section 6). If the patient thinks they may be allergic, they should contact their doctor.
• if the patient has active or past pulmonary tuberculosis. If any of the above situations apply, the patient should not use Budezonid LEK-AM and should inform their doctor as soon as possible.

Warnings and precautions
Before starting treatment with Budezonid LEK-AM, discuss with a doctor if:

• the patient is taking another medicine from the corticosteroid group,
• the patient has breathing difficulties related to diseases other than asthma or COPD.

Immediately inform the doctor if the patient experiences any of the following symptoms:

• respiratory tract infection during treatment with Budezonid LEK-AM (possible symptoms: worsening cough, fever, respiratory secretions),
• breathing difficulties with wheezing or cough after using Budezonid LEK-AM,
• rash, itching, urticaria, difficulty breathing or swallowing, dizziness, swelling of the face or throat during treatment with Budezonid LEK-AM,
• change in body weight, weakness, abdominal obesity, nausea, persistent diarrhoea during treatment with Budezonid LEK-AM,
• blurred vision or other visual disturbances during treatment with Budezonid LEK-AM,
• sleep problems, depression or feeling anxious, motor restlessness, nervousness, excessive excitement or irritability during treatment with Budezonid LEK-AM.

Other special warnings

• Do not swallow Budezonid LEK-AM capsules – they should only be inhaled using the inhaler provided with the package.

• Budezonid LEK-AM capsules should only be used with the inhaler provided in the package. Do not use any other inhaler.

• If symptoms worsen, such as wheezing or shortness of breath, inform the doctor.

• Do not use Budezonid LEK-AM for treating acute attacks of breathlessness. In such cases, other medicines should be used. If the patient has not been prescribed another medicine for this purpose, they should discuss it with their doctor.

• Do not suddenly stop taking oral anti-inflammatory medicines, e.g. oral steroids. For patients previously treated long-term with oral anti-inflammatory medicines, the doctor will gradually reduce the dose of these medicines when starting treatment with Budezonid LEK-AM. The doctor may advise the patient to carry a warning card, because in case of an accident, surgery or severe infection, additional anti-inflammatory treatment may be necessary.

• The mouth should be rinsed with water after each use of Budezonid LEK-AM to reduce the likelihood of developing oral fungal infections. Do not swallow this water.

• To relieve asthma symptoms, the patient should always have a short-acting bronchodilator (e.g. albuterol or salbutamol) available.

• The doctor may periodically perform adrenal function tests.

• It is recommended that patients always carry an identification card stating they have asthma.

• If asthma symptoms worsen, the doctor may recommend increasing the dose of Budezonid LEK-AM and may also recommend treatment with oral corticosteroids and/or antibiotics in case of infection.

• In stressful situations, such as trauma or surgery, the doctor may recommend additional corticosteroid treatment.

• Replacing systemic corticosteroids with inhaled corticosteroids may reveal previously suppressed allergic reactions, such as allergic rhinitis or skin rash. Patients may experience lethargy, muscle and joint pain, nausea or vomiting. Allergic reactions can be treated with antihistamines or locally applied corticosteroids.

• If the patient has liver disease, they should inform their doctor before using Budezonid LEK-AM. The doctor will recommend an appropriate dose.

Children and adolescents
Budezonid LEK-AM should not be used in children under 6 years of age.
If a child inhales steroids at high doses for a prolonged period, the doctor will regularly monitor the child's growth.

Budezonid LEK-AM and other medicines
Tell 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. This particularly includes the following medicines:

• certain medicines used to treat infections (e.g. itraconazole, ketoconazole, clarithromycin, rifampicin),
• certain medicines used to treat HIV infection (e.g. ritonavir, nelfinavir, atazanavir),
• certain medicines used to treat heart rhythm disorders (e.g. amiodarone). If the patient is taking any of the above medicines, a dose adjustment or additional precautions may be necessary.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
This medicine may be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the foetus. The doctor will discuss with the patient the risks associated with using the medicine during pregnancy.
Use of Budezonid LEK-AM during breastfeeding is not recommended. If a woman is breastfeeding, she should inform her doctor before using this medicine. The doctor will discuss with the patient the risks associated with using the medicine during breastfeeding.

Driving and operating machinery
It is considered unlikely that Budezonid LEK-AM has an effect on the ability to drive or operate machinery.

Budezonid LEK-AM contains lactose (milk sugar)
If the patient has been diagnosed with an intolerance to certain sugars, e.g. lactose, the patient should contact their doctor before using Budezonid LEK-AM.

3. How to use Budezonid LEK-AM

This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult your
doctor. Do not exceed the recommended dose.
Recommended dose
Asthma
Adults: The recommended dose is 200 to 400 micrograms of budesonide once or twice daily.
If asthma symptoms worsen, when switching from oral corticosteroid treatment to inhaled
budesonide, or when reducing the dose of oral corticosteroids, the budesonide dose may be
increased up to 1600 micrograms per day, administered in 2 to 4 inhalations.
Children over 6 years of age: The recommended dose is 200 micrograms of budesonide once or
twice daily. If necessary, the doctor may increase the dose up to 800 micrograms per day.
Children should use Budezonid LEK-AM under adult supervision.
Chronic obstructive pulmonary disease (COPD)
Adults: The recommended dose is 200 to 400 micrograms of budesonide twice daily. If necessary,
the doctor may increase the dose up to 1600 micrograms per day.
If you have any doubts about using this medicine, consult your doctor or pharmacist.
Depending on the patient's response to treatment, the doctor may prescribe a higher or lower dose.
When to use Budezonid LEK-AM
Budezonid LEK-AM should be used at the same time each day.
If you feel that the effect of Budezonid LEK-AM is too strong or too weak, consult your doctor.
How to use Budezonid LEK-AM
Follow the instructions below.
Budezonid LEK-AM capsules must be used by inhalation only with the inhaler provided in the
package.
Do not swallow the capsules. The powder inside the capsule is intended for inhalation only.
If you experience breathing difficulties or wheezing after using Budezonid LEK-AM, stop using the
medicine immediately and contact your doctor.
Before using the medicine, read the “Inhaler User Instructions” carefully.
Inhaler User Instructions
The inhaler is designed to deliver powder from the number of capsules contained in a given
package. Do not use the same inhaler for a different package of medicine.

1. Remove the inhaler cap.

2. Open the inhaler by firmly holding the inhaler base and twisting the mouthpiece in the direction of the arrow.

3. Remove 1 capsule from the blister and place it into the chamber of the inhaler base. Remove the capsule from the foil blister immediately before use. IMPORTANT: do not place the capsule into the mouthpiece.

4. Close the inhaler chamber by twisting the mouthpiece in the direction of the arrow (until a click is heard).

5. Holding the inhaler in an upright position with the mouthpiece pointing upwards, press the inhaler buttons simultaneously once, fully down.

6. Release the inhaler buttons. NOTE: At this point, the capsule may break, and small fragments of the capsule shell may enter the mouth or throat. Ingestion of such fragments is not harmful. The likelihood of this occurring is minimal if the capsule is not pierced more than once, storage conditions are maintained, and the capsule is removed from the blister immediately before use (see step 3).
7. Breathe out calmly. Do not exhale into the inhaler.

8. Tilt your head slightly backward, place the inhaler mouthpiece into your mouth, and seal your lips tightly around it.

9. Inhale quickly, deeply, and evenly. During inhalation, a characteristic sound should be heard. If no sound is heard, the capsule may be stuck in the inhaler base chamber. In this case, open the inhaler and remove the capsule by gently prying it out. Do not pry out the capsule by repeatedly pressing the buttons. Then repeat the steps described in point 9.
10. After inhaling, hold your breath as long as possible, without discomfort. Then remove the inhaler from your mouth and exhale through your nose.
11. Open the inhaler and check whether any powder remains in the capsule. If powder remains, repeat the procedure from step 7 to step 10.
12. After use, open the inhaler (see step 2 of these instructions), remove the empty capsule. To remove any residual powder, wipe the mouthpiece and the capsule chamber (where the capsule is placed) with a DRY cloth. A soft brush may also be used for this purpose. Do not use water to clean the inhaler.
13. Close the inhaler chamber and replace the cap.

How long to use Budezonid LEK-AM
It is important to use Budezonid LEK-AM regularly as directed by the doctor. Budezonid LEK-AM should be used even when asthma symptoms are not present, as it helps prevent asthma attacks. If you have any doubts about how long to continue treatment with Budezonid LEK-AM, consult your doctor.
Use of a higher than recommended dose of Budezonid LEK-AM
If a higher than recommended dose has been taken, or if someone else accidentally takes the medicine, contact your doctor or go to the hospital immediately. Bring the medicine packaging with you. Appropriate treatment may be necessary.
It is important to use the prescribed dose as directed by the doctor. Do not increase or decrease the dose without consulting your doctor.
Missed dose of Budezonid LEK-AM
If a dose is missed, take the next dose at the usual time. Do not use a double dose to make up for the missed dose.
Stopping treatment with Budezonid LEK-AM
Stopping treatment with Budezonid LEK-AM may worsen asthma symptoms. Do not stop using Budezonid LEK-AM suddenly unless instructed by your doctor.
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 everybody gets them.
Some adverse reactions may be serious.
Adverse reactions occurring in 1 to 10 out of 10,000 patients

• Breathing difficulties with wheezing, cough.
• Severe skin allergic reactions with rash, itching, urticaria, breathing or swallowing difficulties, dizziness and (or) swelling of the face and throat.
• Extreme weakness, weight loss, nausea, persistent diarrhoea; these may be symptoms of adrenal insufficiency.
• Weight gain, moon-shaped face, muscle weakness and (or) abdominal obesity; these may be symptoms of hormonal disorder, so-called Cushing's syndrome.
• Visual disturbances: blurred vision (cataract) or increased intraocular pressure (glaucoma). If any of the above symptoms occur, contact your doctor immediately.

Frequently occurring adverse reactions
Reactions occurring in 1 to 10 out of 100 patients

• Lung infection (lung infection) in patients with COPD.

Tell your doctor if any of the following symptoms occur during budesonide treatment; they may be signs of lung infection:

• fever or chills
• increased mucus production, change in mucus colour
• worsening cough or increased breathing difficulties.

Uncommon adverse reactions
Reactions occurring in 1 to 10 out of 1,000 patients

• Blurred vision.

Rare adverse reactions
Reactions occurring in 1 to 10 out of 10,000 patients

• Growth retardation in children and adolescents.
• Weakening of bone structure.
• Infections of the mouth and throat (e.g. candidiasis).
• Outbursts of anger or other behavioural disorders (including depression) in children.
• Hoarseness.
• Pain or irritation of the throat.

If any of the listed reactions occur in a patient, inform the doctor.
Other adverse reactions may also occur, but their frequency is unknown

• Sleep problems, depression or feeling anxious, restlessness, nervousness, excessive excitement or irritability. These reactions are more likely to occur in children.
• Contact dermatitis, which may occur as a result of skin contact with specific external substances (allergens or irritants). If any of the listed reactions occur in a patient, inform the doctor.

Other adverse reactions reported in the literature in patients taking similar
medicines (containing the same active substance as Budezonid LEK-AM) for the treatment of COPD over
a long period (3 years):

• Bruising. If this reaction occurs to a significant extent in a patient, contact your doctor immediately.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, tell your doctor or pharmacist. Adverse reactions 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
e-mail: [email protected]
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to collect more information on the safety of the medicine.

5. How to store Budezonid LEK-AM

Keep in the original packaging.
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 “Expiry date”. The expiry date refers to the last day of the specified month.
Do not use this medicine if you notice that the packaging is damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Budezonid LEK-AM contains

• The active substance in Budezonid LEK-AM is budesonide. One capsule (i.e. one inhalation dose) of Budezonid LEK-AM contains either 200 or 400 micrograms of budesonide.
• The other components are: lactose monohydrate 230, lactose monohydrate 251, and the capsule shell: hypromellose, purified water.

What Budezonid LEK-AM looks like and contents of the pack
Budezonid LEK-AM is a powder for inhalation contained in transparent, colourless capsules. The powder inside the capsule is intended for inhalation into the lungs using a capsule inhaler provided with the pack.
The pack contains 30, 60, 90 or 120 capsules in blisters and an inhaler.

Marketing Authorisation Holder and Manufacturer
Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
ul. Ostrzykowizna 14A
05-170 Zakroczym
Poland
tel.: +48 22 785 27 60
fax: +48 22 785 27 60 ext. 106