Leaflet BUDENOFALK UNO 9mg gastro-resistant granules

Product code:
W58169003
Quantity:
30
Indicated for:
asthma; inflammatory bowel disease
Route of administration:
oral
Substance:
budesonide (glucocorticoid)
ATC
A07EA06 — Alimentary tract and metabolism | Intestinal antiinflammatory agents | Corticosteroids acting locally

Precautions:

Glaucoma warning

Use caution if you have glaucoma or increased eye pressure.

Hyperglycemia

This medicine may increase blood sugar.

Immunosuppression / infection risk

This medicine may increase the risk of infections.

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Use during pregnancy only on medical advice.

Budesonide is a corticosteroid used to treat inflammation in various chronic conditions. It is commonly prescribed for respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD), as well as for inflammatory bowel diseases like Crohn's disease and ulcerative colitis.

For asthma and COPD, budesonide is administered via an inhaler, reducing airway inflammation and preventing breathing difficulties. It is a maintenance treatment and not intended for rapid relief of acute symptoms.

For intestinal conditions, budesonide is available in capsule or enema form, acting locally to reduce inflammation in the intestinal lining. It is preferred over other corticosteroids due to its reduced systemic effects, making it safer for long-term use.

Side effects may include dry mouth, throat irritation, hoarseness, or oral fungal infections (thrush) when using the inhaler. For oral administration, side effects may include headaches, nausea, fatigue, or weight gain. Long-term use may increase the risk of osteoporosis, high blood pressure, or adrenal suppression.

Patients should strictly follow their doctor’s instructions regarding dosage and treatment duration. Rinsing the mouth after using the inhaler is important to prevent oral infections. Additionally, patients should inform their doctor about other medications they are taking or any pre-existing conditions.

General data about BUDENOFALK UNO 9mg

Substance:
budesonide
Date of latest medicines list:
01-06-2026
Product code:
W58169003
Concentration:
9mg
Pharmaceutical form:
gastro-resistant granules
Quantity:
30
Product type:
Original
Price:
395.55 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
DR. FALK PHARMA GMBH - GERMANIA
Holder:
DR. FALK PHARMA GMBH - GERMANIA
Number:
11054/2018/03
Shelf life:
4 years

Concentrations available for budesonide

  • 0.125mg/ml
  • 0.25mg/ml
  • 0.5mg/2ml
  • 0.5mg/ml
  • 200mcg/dose
  • 2mg/dose
  • 32mcg/dose
  • 3mg
  • 400mcg/dose
  • 4mg
  • 50mcg/dose
  • 9mg

Compensation lists for BUDENOFALK UNO 9mg Dr. Falk

B - Sublist B with 50% discount from the reference price

Price
395.55 RON
Copayment
176.42 RON
Patient
219.13 RON