BUDELIN NOVOLIZER

This medicine contains the active ingredient budesonide which belongs to a group of medicines called corticosteroids. It is used for regular treatment of persistent asthma. Budesonide inhaler should not be used for treatment of sudden acute asthma attack or Status asthmaticus (asthma attacks occurring very frequently and/or persisting for several days).

Is Budesonide suitable for me?

Budesonide is not suitable for everyone. Do not use it

• if you are allergic to budesonide or to other ingredients of this medicine
• if it is meant for children under 6 years of age

In particular, you must tell the doctor if you:

• have or had lung tuberculosis or fungal infection or other infection of the airways
• have a serious bacterial, viral, or fungal infection
• have a weak immune system
• have cirrhosis or other liver disease
• have any allergies
• have a personal or family history of diabetes or glaucoma
• are planning a surgery
• are pregnant or breastfeeding

Budesonide interacts with other medicines. It is most important that you tell the doctor all the medications and herbal supplements that you are currently taking.

See the package leaflet for a complete list of possible contraindications and warnings.

How should I take Budesonide?

This medicine is available in form of inhalation powder.

You should take budesonide exactly as instructed by your doctor or pharmacist.

• Adults (including older people) and children/adolescents over 12 years of age:

Initial recommended dose: 1 -2 single doses (200 - 400 micrograms) once or twice daily Maximum recommended dose: 4 single doses (800 micrograms) twice daily (daily dose: 1600 micrograms).

• Children aged 6 to 12 years:

Initial recommended dose: 1 single dose (200 micrograms) twice or 200 - 400 micrograms once a day Maximum recommended dose: 2 single doses (400 micrograms) twice daily (daily dose: 800 micrograms) In case of once daily dosing, it is recommended to take this dose in the evening.

Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor instructed. Do not take two doses together if you miss a dose.

Read the information leaflet provided with your medication for additional information. Talk to your doctor if you have any additional questions.

What are Budesonide side effects?

Like all medicines budesonide can cause side effects, including:

• irritation of the oral mucosa (throat irritation)
• difficulty in swallowing
• hoarseness and cough
• fungal disease in the mouth and the throat (oropharyngeale candidiasis)

Consult a doctor if the side effects are severe. See the package leaflet for a complete list of side effects.