Budesonide lek-am

Package leaflet: Information for the patient

Budezonid LEK-AM, 200 micrograms/inhalation dose,
inhalation powder in hard capsules
Budezonid LEK-AM, 400 micrograms/inhalation dose,
inhalation powder 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, so that you can read it again if necessary.
• 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. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents

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 in adults, children and adolescents aged above 6 years, as well as in the treatment of chronic obstructive pulmonary disease (COPD).
Budezonid LEK-AM is used to reduce inflammation in the lungs and helps maintain open airways, thereby reducing asthma symptoms. 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 subsided.
If you have any doubts about how Budezonid LEK-AM 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 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 pulmonary tuberculosis (current or past history).

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 the following with your doctor:

• if the patient is taking another corticosteroid medicine at the same time,
• if the patient has breathing difficulties due to respiratory diseases other than asthma or COPD,
• if the patient experiences blurred vision or other visual disturbances, they should contact their doctor.

Contact your doctor immediately if any of the following symptoms occur:

• respiratory tract infection during treatment with Budezonid LEK-AM (possible symptoms: worsening cough, fever, respiratory secretions),
• breathing difficulties with wheezing or cough (paradoxical bronchospasm) after using Budezonid LEK-AM,
• rash, itching, hives, difficulty breathing or swallowing, dizziness, swelling of the face or throat during treatment with Budezonid LEK-AM,
• changes in body weight, weakness, central obesity, nausea, persistent diarrhoea during treatment with Budezonid LEK-AM,
• visual disturbances, including blurred vision 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 used by inhalation via the inhaler supplied with the pack.
• Budezonid LEK-AM capsules should only be used with the inhaler supplied with the pack. Do not use any other inhaler.
• If symptoms worsen, such as wheezing or shortness of breath, inform your doctor.
• Do not use Budezonid LEK-AM for the treatment of acute asthma attacks. Other medicines should be used in such cases. 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, such as 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, as additional anti-inflammatory treatment may be required in case of an accident, surgical procedure, or severe infection.
• Rinse the mouth with water after each use of Budezonid LEK-AM to reduce the risk 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 tests to assess adrenal function.
• 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 prescribe oral corticosteroids and/or an antibiotic if infection is present.
• In stressful situations, such as trauma or surgery, the doctor may recommend additional corticosteroid treatment.
• Replacing systemic corticosteroids with inhaled corticosteroids may unmask underlying allergic reactions such as allergic rhinitis or eczema, which were previously suppressed by oral corticosteroids. Patients may experience lethargy, muscle and joint pain, nausea, or vomiting. Allergic reactions may be treated with antihistamines or locally administered 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 (over 6 years of age)

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

Budezonid LEK-AM and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan 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, cobicistat),
• specific medicines used to treat heart rhythm disorders. If the patient is taking any of the above medicines, a dose adjustment or additional precautions may be necessary.

Pregnancy and breastfeeding

If the patient is pregnant, 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 fetus. The doctor will discuss the risks of using the medicine during pregnancy. The lowest effective dose of budesonide necessary to maintain adequate asthma control should be used.
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 the risks of using the medicine during breastfeeding.

Driving and operating machinery

Budezonid LEK-AM is considered unlikely to affect the ability to drive or operate machinery.

Budezonid LEK-AM contains lactose (milk sugar)

If the patient has previously been diagnosed with an intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to use Budezonid LEK-AM

This medicine should always be used exactly as directed by the doctor. In case of doubt, consult
your doctor. Do not exceed the recommended dose.
Budezonid LEK-AM is available in two strengths in the form of hard capsules. Your doctor has
prescribed the optimal dose for you.

Recommended dose
Asthma
Adults: The recommended dose is 200 to 400 micrograms of budesonide once or twice daily.
In case of asthma exacerbation, when switching from oral corticosteroid therapy to inhaled
budesonide, or when reducing the dose of oral corticosteroids, the budesonide dose may be
increased up to 1600 micrograms daily, 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 to 800 micrograms daily. Children must 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 to 1600 micrograms daily.

If you have any doubts about how to use the 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 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 carefully.
Budezonid LEK-AM capsules must be used only by inhalation with the inhaler provided in the
package.

• Do not use other inhalers.
• Do not swallow the capsules. The powder inside the capsule is intended solely for inhalation.
• Remember that Budezonid LEK-AM is used only to prevent asthma attacks. To treat an asthma attack, a fast-acting rescue inhaler, usually already prescribed to the patient, will be required.

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 the package.
Do not use the same inhaler with another package of medicine.

1. Remove the inhaler cap.

2. Open the inhaler. Hold the inhaler base firmly and twist the mouthpiece in the direction of the arrow.

3. Take one capsule out of the blister pack and place it into the chamber of the inhaler base. Remove the capsule with dry hands 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 you hear a click.

5. Holding the inhaler upright with the mouthpiece pointing upwards, press the two side buttons once fully and simultaneously.

6. Release the inhaler buttons. CAUTION: 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 punctured only once, storage conditions are maintained, and the capsule is removed from the blister immediately before use (see step 3).

7. Before placing the inhaler mouthpiece into your mouth, breathe out calmly and fully. Do not exhale into the inhaler mouthpiece.

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

9. Take a fast, deep, and steady breath in. During inhalation, you should hear a characteristic sound. If no sound is heard, the capsule may be stuck in the base chamber. In this case, open the inhaler and gently loosen the capsule by lightly tapping the base of the inhaler. Do not attempt to dislodge the capsule by repeatedly pressing the side buttons. Then repeat the steps described in point 9.
10. After inhalation, hold your breath as long as possible, without discomfort. Then remove the inhaler mouthpiece from your mouth and breathe out 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. Most people are able to empty the capsule in one or two inhalations. When the capsule is empty, a sufficient amount of medicine has reached the lungs.
12. After use, open the inhaler (see step 2 of these instructions), remove the empty capsule by tilting the inhaler so that the capsule falls out of the chamber. Dispose of the empty capsule. To remove any residual powder, wipe the mouthpiece and the capsule chamber 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.
14. After taking the medicine, rinse your mouth thoroughly with water. Spit out the water used for rinsing. This helps reduce the risk of developing fungal infections (e.g. oral thrush) in the mouth.

Important

• Do not swallow Budezonid LEK-AM capsules.
• Use only the inhaler provided in this package.
• Capsules must always be stored in their blister packs and removed immediately before use.
• Never place the Budezonid LEK-AM capsule directly into the inhaler mouthpiece.
• Do not press the side buttons more than once.
• Never blow air into the inhaler mouthpiece.
• Always release the side buttons before performing inhalation.
• Never wash the inhaler with water. The inhaler must remain dry. See the section “Inhaler User Instructions”.
• Never disassemble the inhaler into parts.
• Always use a new inhaler provided with a new package of Budezonid LEK-AM. After finishing a package, always dispose of the inhaler.
• Do not store capsules in the inhaler.
• Always store the inhaler and Budezonid LEK-AM capsules in a dry place.

How long to use Budezonid LEK-AM
It is important to use Budezonid LEK-AM regularly as directed by your doctor. Budezonid LEK-AM
should be used even when symptoms of bronchial asthma are not present, as it helps prevent asthma attacks. If you have any doubts about how long to continue using Budezonid LEK-AM, consult your doctor.

Taking more Budezonid LEK-AM than recommended
If you have taken more medicine than recommended, or if someone else has accidentally taken the dose, contact your doctor or go to hospital immediately. Take the medicine packaging with you. Specific treatment may be required.
It is important to use the medicine exactly as prescribed by your doctor. Do not increase or decrease the dose without consulting your doctor.

Missing a dose of Budezonid LEK-AM
If you miss a dose, take the next dose at your usual time. Do not take a double dose to make up for the missed dose.

Stopping Budezonid LEK-AM
Stopping treatment with Budezonid LEK-AM may lead to worsening of 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some rare side effects may be serious.

• Breathing difficulties with wheezing, cough. The medicine must be stopped immediately and a doctor contacted without delay.
• Severe allergic skin reactions with rash, itching, urticaria, difficulty breathing or swallowing, dizziness and (or) swelling of the face and throat; these may be symptoms of a severe allergic reaction.
• Severe weakness, weight loss, nausea, persistent diarrhoea; these may be symptoms of adrenal insufficiency.
• Weight gain, moon-shaped face, muscle weakness and (or) central obesity; these may be symptoms of a hormonal disorder (Cushing's syndrome associated with adrenal overactivity).
• Increased intraocular pressure (glaucoma). If any of the above symptoms occur, contact a doctor immediately.

Other side effects
Common side effects
Side effects which may affect up to 1 in 10 people

• Fungal infections (candidiasis) of the mouth and throat. Rinse the mouth with water after each dose to reduce the risk of developing oral or throat candidiasis.
• Cough. If this symptom is severe, inform the doctor.
• Hoarseness.
• Throat irritation.
• Dysphonia (voice function disorder, weakened voice or change in voice quality to a lower pitch).
• Pneumonia (lung infection) in patients with COPD.

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

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

Uncommon side effects
Side effects which may affect up to 1 in 100 people

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

Rare side effects
Side effects which may affect up to 1 in 1,000 people

• Growth retardation in children and adolescents.
• Weakening of bone structure.
• Nervousness, behavioural changes (mainly in children).
• Immediate and delayed hypersensitivity reactions, including rash, contact dermatitis, urticaria, angioedema, itching and severe allergic reactions.
• Easy bruising (bruises).

If any of the listed side effects occur in a patient, inform the doctor.
Other side effects may also occur, but their frequency cannot be determined from the available data.

• Sleep disturbances, excessive psychomotor activity, aggression. These side effects are more likely to occur in children. If any of the listed side effects occur in a patient, inform the doctor.

If any of the side effects worsen or if any unlisted side effects occur, tell the doctor or pharmacist.
Reporting of side effects
If any side effects occur, including any unlisted side effects, tell the doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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.
Reporting of side effects helps provide more information on the safety of the medicine.

5. How to store Budezonid LEK-AM

Store 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: EXP.
The expiry date refers to the last day of the stated 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 pack 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 ingredients are: lactose monohydrate 230, lactose monohydrate 251, and capsule shell: hydroxypropylmethylcellulose, 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 supplied with the pack.
Aluminium/Aluminium blisters and a capsule inhaler, contained in a cardboard box.
The pack contains 30, 60, 90 or 120 capsules.

Marketing Authorisation Holder and Manufacturer
LEK-AM Pharmaceutical Company 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