Budezonid Lek-am

Leaflet attached to the packaging: patient information

Budezonid LEK-AM, 200 micrograms/inhalation dose,

inhalation powder in hard capsules

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

Budesonide

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Budezonid LEK-AM and what is it 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 packaging and other information

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

Budesonide, the active substance of Budezonid LEK-AM, belongs to a group of medicines called corticosteroids and is used to treat asthma in adult patients and children and adolescents over 6 years of age, as well as chronic obstructive pulmonary disease (COPD).
Budezonid LEK-AM is used to reduce inflammation in the lungs and help keep the airways open to reduce asthma symptoms. Asthma is caused by inflammation of the airways. Regular use of Budezonid LEK-AM helps prevent asthma attacks and makes breathing easier in chronic obstructive pulmonary disease.
Do not stop using Budezonid LEK-AM regularly, even after the symptoms of the disease have disappeared.
If you have any doubts about how the medicine works and why it has been prescribed, 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 tuberculosis of the lungs (current or past).

If any of the above situations apply to the patient, they should not use Budezonid LEK-AM and should inform their doctor as soon as possible.

Warnings and precautions

Before starting to use Budezonid LEK-AM, the patient should discuss the following with their doctor:

• if the patient is using another corticosteroid medicine at the same time,
• if the patient has difficulty breathing associated with diseases of the airways other than asthma or COPD,
• if the patient experiences blurred vision or other vision disturbances, they should contact their doctor.

The patient should immediately inform their doctor if they experience any of the following symptoms:

• respiratory tract infection while using Budezonid LEK-AM (possible symptoms: increased cough, fever, respiratory secretions),
• difficulty breathing 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 while using Budezonid LEK-AM,
• weight change, weakness, abdominal obesity, nausea, persistent diarrhea while using Budezonid LEK-AM,
• vision disturbances, including blurred vision while using Budezonid LEK-AM,
• sleep disturbances, depression or feeling anxious, restlessness, nervousness, overexcitement or irritability during treatment with Budezonid LEK-AM.

Other special warnings

• Do not swallowBudezonid LEK-AM capsules - they should only be used for inhalation with the inhaler provided with the packaging.
• Budezonid LEK-AM capsules should only be used with the inhaler provided with the packaging. Do not use another inhaler.
• If symptoms worsen, such as wheezing or shortness of breath, inform your doctor.
• Do not useBudezonid LEK-AM to treat acute asthma attacks. In these cases, other medicines are used. If the patient has not been prescribed another medicine for this purpose, they should discuss it with their doctor.
• Do not suddenly stop using oral anti-inflammatory medicines, such as oral steroids. In patients who have been treated with oral anti-inflammatory medicines for a long time, the doctor will gradually reduce the dose of these medicines when starting to use Budezonid LEK-AM. The doctor may recommend that the patient carry a warning card, as in the event of an accident, surgery or severe infection, the patient may need additional anti-inflammatory treatment.
• Rinse your mouth with water after each use of Budezonid LEK-AM to reduce the risk of fungal infections of the mouth.
• To alleviate asthma symptoms, the patient should always carry a short-acting bronchodilator (such as albuterol or salbutamol).
• The doctor may periodically perform an adrenal function test.
• It is recommended that patients always carry an card informing that they have asthma.
• In case of worsening asthma symptoms, the doctor may recommend increasing the dose of Budezonid LEK-AM, or may also recommend the use of oral corticosteroids and/or an antibiotic in case of infection.
• In stressful situations, such as injury or surgery, the doctor may recommend the use of additional corticosteroids.
• Replacing systemic corticosteroids with inhaled corticosteroids may reveal the existence of 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 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 of the medicine.

Children and adolescents (over 6 years old)

Budezonid LEK-AM should not be used in children under 6 years old.
If a child uses a high dose of inhaled steroids for a long time, the doctor will regularly monitor the child's growth.

Budezonid LEK-AM and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. This includes:

• certain medicines used to treat infections (such as itraconazole, ketoconazole, clarithromycin, rifampicin),
• certain medicines used to treat HIV infections (such as ritonavir, nelfinavir, atazanavir, cobicistat),
• certain medicines used to treat heart rhythm disorders. If you are taking any of these medicines, a dose change or other precautions may be necessary.

Pregnancy, breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor or pharmacist before using this medicine.
The medicine should only be used during pregnancy if the doctor considers that the benefits to the mother outweigh the potential risks to the fetus. The doctor will discuss the risks and benefits of using the medicine during pregnancy with you. You should use the lowest effective dose of budesonide necessary to maintain adequate control of asthma.
It is not recommended to use Budezonid LEK-AM during breastfeeding. If you are breastfeeding, tell your doctor before using this medicine. The doctor will discuss the risks and benefits of using the medicine during breastfeeding with you.

Driving and using machines

It is unlikely that Budezonid LEK-AM will affect your ability to drive or use machines.

Budezonid LEK-AM contains lactose (milk sugar)

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to use Budezonid LEK-AM

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor. Do not exceed the recommended dose.
Budezonid LEK-AM is available in two doses. 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 a day.
In case of worsening asthma symptoms, when switching from oral corticosteroids to budesonide inhalation, or when reducing the dose of oral corticosteroids, the dose of budesonide can be increased to 1600 micrograms per day in 2 to 4 inhalations.
Children over 6 years old: The recommended dose is 200 micrograms of budesonide once or twice a day. If necessary, the doctor may increase the dose of budesonide to 800 micrograms per day. Children should use Budezonid LEK-AM under adult supervision.

Chronic obstructive pulmonary disease

Adults: The recommended dose is 200 to 400 micrograms of budesonide twice a day. If necessary, the doctor may increase the dose to 1600 micrograms per day.
If you have any doubts about using the medicine, consult your doctor or pharmacist.
Depending on the patient's response to treatment, the doctor may recommend a higher or lower dose of the medicine.

When to use Budezonid LEK-AM

It is best to use Budezonid LEK-AM at the same time every 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.
Use Budezonid LEK-AM capsules only by inhalation with the inhaler provided in the packaging.

• Do not use other inhalers.
• Do not swallow the capsules. The powder in the capsule is for inhalation only.
• Remember that Budezonid LEK-AM is used to prevent asthma attacks. To treat an asthma attack, you will need to use a rescue inhaler, usually used by the patient.

Before using the medicine, read the "Inhaler Instructions".

Inhaler Instructions

The inhaler is designed to deliver the powder from the number of capsules in the packaging. Do not use the same inhaler for another packaging of the medicine.

• 1. Remove the inhaler cap.

• 2. Open the inhaler. To do this, hold the base of the inhaler firmly and turn the mouthpiece in the direction indicated by the arrow.

• 3. Remove 1 capsule from the blister pack and place it in the base chamber of the inhaler. The capsule should be removed from the blister pack with dry hands immediately before use. IMPORTANT: do not place the capsule in the mouthpiece.

• 4. Close the inhaler chamber by turning the mouthpiece in the direction indicated by the arrow (until you hear a click).

• 5. Holding the inhaler upright with the mouthpiece facing upwards, press the side buttons once, until they stop.

• 6. Release the side buttons. NOTE:at this point, the capsule may break, and small pieces of the capsule shell may enter the mouth or throat. Swallowing a piece of the shell is not harmful. The likelihood of this happening is minimal if the capsule is not pierced more than once, storage conditions are maintained, and the capsule is removed from the blister pack immediately before use (see point 3).

Before putting the mouthpiece in your mouth, exhale slowly and deeply. Do not exhale into the mouthpiece.

• 7. Put the mouthpiece in your mouth and seal it with your lips.

• 8. Tilt your head back slightly, put the mouthpiece in your mouth, and seal it with your lips.

• 9. Take a quick, deep, and even breath in. You should hear a characteristic sound while inhaling. If this sound does not appear, it may mean that the capsule is stuck in the base chamber of the inhaler. In this case, open the inhaler and gently loosen the capsule by tapping the base of the inhaler. Do nottry to remove the capsule by pressing the side buttons multiple times. Then repeat the steps described in point 9.
• 10. After inhaling, hold your breath for as long as possible without feeling uncomfortable. Then remove the mouthpiece from your mouth and exhale through your nose.
• 11. Open the inhaler and check if there is still powder in the capsule. If powder remains in the capsule, repeat the procedure from point 7 to point 10. Most people can empty the capsule in one or two inhalations. If the capsule is empty, it means that a sufficient amount of medicine has reached the lungs.
• 12. After use, open the inhaler (see point 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 remaining powder, wipe the mouthpiece and the chamber of the inhaler (where the capsule is placed) with a drycloth. You can also use a soft brush for this purpose. Do not use water to clean the inhaler.
• 13. Close the inhaler chamber and put the cap back on.

• 14. After taking the medicine, rinse your mouth with water. Spit out the water used for rinsing. This will reduce the risk of fungal infections (thrush) in the mouth.

Important

• Do not swallow Budezonid LEK-AM capsules.
• Use only the inhaler provided with this packaging.
• Capsules must always be stored in blisters and removed from them immediately before use.
• Never place a Budezonid LEK-AM capsule directly in the mouthpiece of the inhaler.
• Never press the side buttons more than once.
• Never blow air into the mouthpiece of the inhaler.
• Always release the side buttons before inhaling.
• Never wash the inhaler with water. The inhaler must be dry. See the "Inhaler Instructions" section.
• Never disassemble the inhaler into parts.
• Always use a new inhaler provided with a new packaging of Budezonid LEK-AM. After finishing the packaging, 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 prescribed by your doctor. Budezonid LEK-AM should be used even when asthma symptoms do not occur, as it prevents the occurrence of asthma attacks. If you have any doubts about how long to use Budezonid LEK-AM, consult your doctor.

Using a higher dose of Budezonid LEK-AM than recommended

If you have taken a higher dose of the medicine than recommended, or if someone else has taken the dose by mistake, contact your doctor or go to the hospital immediately. Take the packaging of the medicine with you. Appropriate treatment may be necessary.
It is important to use the doses of the medicine as recommended 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 of the medicine, take the next dose at the usual time. Do nottake a double dose to make up for the missed dose.

Stopping use of Budezonid LEK-AM

Stopping the use of Budezonid LEK-AM may cause worsening of asthma symptoms.
Do not stop using Budezonid LEK-AM suddenlyunless your doctor advises you to do so.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Budezonid LEK-AM can cause side effects, although not everybody gets them.

Some rare side effects can be serious.

• Difficulty breathing with wheezing, cough. Stop using the medicine and contact your doctor immediately.
• Severe allergic reactions on the skin with rash, itching, hives, difficulty breathing or swallowing, dizziness, and (or) swelling of the face and throat; these may be symptoms of a severe allergic reaction.
• Extreme weakness, weight loss, nausea, persistent diarrhea; these may be symptoms of adrenal insufficiency.
• Weight gain, moon face, weakness, and (or) abdominal obesity; these may be symptoms of a hormonal disorder (Cushing's syndrome related to adrenal hyperfunction).
• Increased pressure in the eyeball (glaucoma). If you experience any of the above symptoms, contact your doctor immediately.

Other side effects

Common side effects

Side effects that may affect up to 1 in 10 people

• Fungal infections (candidiasis) of the mouth and throat. Rinse your mouth with water after each use of the medicine to reduce the risk of fungal infections of the mouth and throat.
• Cough. If this symptom is severe, tell your doctor.
• Hoarseness.
• Irritation of the throat.
• Dysphonia (voice disorder, voice weakness or change in voice pitch to low).
• Pneumonia (lung infection) in patients with COPD.

Tell your doctor if you experience any of the following symptoms, which may be symptoms of a lung infection:

• fever or chills;
• increased production of sputum, change in sputum color;
• worsening cough or increased difficulty breathing.

Uncommon side effects

Side effects that may affect up to 1 in 100 people

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

Rare side effects

Side effects that may affect up to 1 in 1000 people

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

If you experience any of the above side effects, tell your doctor.

Other side effects

Other side effects may occur, but their frequency cannot be determined from the available data.

• Sleep disturbances, excessive psychomotor activity, aggression. The occurrence of these side effects is more likely in children. If you experience any of the above side effects, tell your doctor.

If any of the side effects worsen or if you experience side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Jerozolimskie Avenue 181C
02-222 Warsaw,
phone: +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 authorization holder.
Reporting side effects will help to gather 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 after: EXP.
The expiry date refers to the last day of the month stated.
Do not use this medicine if you notice that the packaging is damaged.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist 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 Budezonid LEK-AM contains

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

What Budezonid LEK-AM looks like and contents of the packaging

Budezonid LEK-AM is a powder for inhalation in transparent, colorless capsules. The powder in the capsule is for inhalation only, using the capsule inhaler provided with the packaging.
Aluminum/Aluminum blisters and a capsule inhaler, placed in a cardboard box.
The packaging contains 30, 60, 90, or 120 capsules.

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
Poland
phone: +48 22 785 27 60
fax: +48 22 785 27 60 ext. 106

Date of last revision of the leaflet: