Leaflet FRENOLYN 200 200mcg / dose inhalation powder

Indicated for: asthma; inflammatory bowel disease

Route of administration: inhalation

Substance: budesonide (glucocorticoid)

ATC: R03BA02 (Respiratory system | Other drugs for obstructive airway diseases, inhalants | Glucocorticoids)

Precautions:
Glaucoma warning
Glaucoma warning

Use caution if you have glaucoma or increased eye pressure.

Hyperglycemia
Hyperglycemia

This medicine may increase blood sugar.

Immunosuppression / infection risk
Immunosuppression / infection risk

This medicine may increase the risk of infections.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
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 FRENOLYN 200 200mcg / dose

  • Substance: budesonide
  • Date of latest medicines list: 01-07-2013
  • Product code: W43881002
  • Concentration: 200mcg / dose
  • Pharmaceutical form: inhalation powder
  • Quantity: 1
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: MEDOCHEMIE LTD. -FACTORY AV - CIPRU
  • Holder: MEDOCHEMIE ROMANIA SRL - ROMANIA
  • Number: 5989/2013/02
  • Shelf life: 3 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