Product Description:

• The medicine is a glucocorticoid for inhalation.

The medicine is applied:

• For long-term therapy in persistent (persistent) bronchial asthma in adults and children over 6 years of age.


• In adults to reduce the frequency and severity of acute flare-ups (exacerbations) and general health status in advanced chronic obstructive (narrowing) pulmonary disease (COPD) when a response to inhaled glucocorticoids is improved by improving symptoms and/or lung function could be proven.


• The drug is not suitable for the treatment of acute shortness of breath.

How To Use:

• Always use the medicine exactly as your doctor has told you.


• Check with your doctor or pharmacist if you are not sure.


• It is necessary that you use the drug regularly to achieve the full therapeutic effect. The effect sets in after about 10 days. The full therapeutic effect is achieved after 2 - 4 weeks of continuous treatment.


• The recommended dose, unless otherwise prescribed by the doctor, is


• In bronchial asthma

Adolescents from 12 years and adults:

• 1 - 2 aerosol puffs twice a day, corresponding to 400 - 800 micrograms of budesonide per day.


• Children from 6 years to 12 years:


• 1 aerosol puff twice a day, equivalent to 400 micrograms of budesonide per day.

Children under 6 years old:

• The experience of use in children under 6 years of age is limited.


• As a rule, the maximum daily dose of budesonide should not exceed 800 micrograms for children under the age of 12 and 1600 micrograms for adolescents over the age of 12 and adults.

A notice:

• The use of an inhalation device (spacer) is strongly recommended in children who have difficulties coordinating the inhalation manoeuvre, in patients with a high need for budesonide and in elderly patients.


• The dosage recommendations given above also refer to inhalation with these inhalation aids. However, regular clinical monitoring and, if necessary, dose adjustment by the doctor appear advisable.


• Please note that when this medicine is used with a spacer, the dose may need to be adjusted.


• In chronic obstructive (narrowing) pulmonary disease (COPD)

Adult:

• 1 - 2 aerosol puffs twice a day, corresponding to 400 - 800 micrograms of budesonide per day.

Children and young people under the age of 18:

• No data is available.


• If efficacy has been demonstrated, the dose should be based on the needs of the individual patient (e.g. Severity of the disease).


• The maximum daily dose of 1600 micrograms budesonide should not be exceeded.


• If possible, daily doses above 800 micrograms should not be used in the long term.


• The use of an inhalation aid (spacer) is urgently recommended for patients with a high need for budesonide and for elderly patients.


• Please note that when used in conjunction with a spacer, the dose may need to be adjusted.


• The daily dose should be divided into 2 doses (morning and evening).


• In special cases (lack of effectiveness in the interval) it can be divided into 3 - 4 individual doses. Please speak to your doctor about this.


• Once-daily dosing is also possible in some patients.


• Once disease symptoms have stabilized, the dose should be reduced to the lowest at which effective disease control is maintained.

Duration of use:

• The duration of the usage will be decided by the medicating doctor.


• The preparation is a medicine for long-term treatment.

If you use more than you should:

• It is important that you use the dose prescribed by your doctor.


• Do not increase or decrease the dose without medical advice.


• In case of acute poisoning (intoxication) with budesonide, even with excessively high dosages, no serious problems are to be expected.


• In the case of long-term overdoses, increased side effects, in particular an effect on the adrenal cortex function, are to be expected.


• Discuss how to proceed with your doctor.

If you forgot the application:

• Do not apply twice if you forget the previous application.


• For the next application, continue treatment with the prescribed dose.

If you cancel the application:

• If you stop treatment without consulting your doctor, the symptoms of the disease may intensify or reoccur.


• Because your adrenal gland may not produce enough endogenous cortisol as a result of treatment with budesonide, stopping treatment suddenly can be dangerous.


• Contact the doctor treating you. He will discuss with you whether and how you can end the treatment and whether you may need to take glucocorticoids in the form of tablets (cortisone tablets) in certain situations.


• If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Warnings And Precautions:

• Please talk to your doctor before using this medicine:


• if you have an ulcer in the gastrointestinal tract, tuberculosis of the lungs or other infections in the airways (e.g. fungal infections).


• This also applies if these diseases have existed in the past.


• Inhaled glucocorticoids can cause side effects, particularly when high doses are given for long periods of time. Such reactions occur much less frequently than when taking glucocorticoid tablets.

Tell your doctor if you get any of the following while using budesonide - these could be symptoms of pneumonia:

• fever or chills


• increased formation of mucus, change in color of mucus


• increased cough or difficulty breathing

When treated with high doses:

• especially when the recommended dose is exceeded, a clinically relevant functional impairment of the adrenal cortex can occur with reduced production of endogenous glucocorticoids, or production of endogenous glucocorticoids that can no longer be increased sufficiently in the event of increased demand (stressful situations).

In such cases:

• temporary additional glucocorticoid administration should be considered in stressful situations (e.g. before surgery, in the case of severe infections and injuries) to compensate for the reduced natural glucocorticoid production.


• As with other inhalation treatments, there is a risk of worsening symptoms such as shortness of breath and wheezing immediately after using budesonide, known as paradoxical bronchospasm. In this case, you should stop treatment with budesonide immediately.


• You should immediately use your rescue spray (rapid-acting bronchodilator) and see your doctor. He will assess your asthma or COPD and, if necessary, switch you to another treatment.


• If acute shortness of breath occurs despite having a well-controlled illness, you should use your rescue spray and see your doctor.


• If you suffer from severe liver disease, the breakdown of budesonide may be impaired.

This can lead to increased levels of budesonide in the blood.

If you experience blurred vision or other vision problems, contact your doctor.

Ingredients:

• 2 mg budesonide

Product Details:

• Manufacturer: Budiair
• Product Form: Inhalation
• Quantity: 1 Pc