BUDENOFALK UNO 9mg gastro-resistant pellets medication leaflet

A07EA06 budesonide • Alimentary tract and metabolism | Intestinal antiinflammatory agents | Corticosteroids acting locally

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 last drug list: 01-06-2025

Commercial code: W58169003

Concentration: 9mg

Pharmaceutical form: gastro-resistant pellets

Quantity: 30

Product type: original

Price: 388.43 RON

Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

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

Copayment

Patient

388.43 RON

173.24 RON

215.19 RON