Leaflet BIOPAROX 50mg / 10ml buccopharyngeal and nasal spray, solution

Indicated for: upper respiratory tract infections

Route of administration: buccopharyngeal / nasal

Substance: fusafungina (antibacterial antibiotic)

ATC: R02AB03 (Respiratory system | Throat preparations | Antibiotics)

Precautions:
Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Anaphylaxis
Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Colitis / severe diarrhea
Colitis / severe diarrhea

Seek medical advice if severe or persistent diarrhea occurs.

Fusafungine is an antibiotic and anti-inflammatory agent that was previously used to treat upper respiratory tract infections such as rhinopharyngitis, sinusitis, tonsillitis, and laryngitis. It worked by inhibiting the growth of bacteria and certain fungi while also reducing local inflammation. Fusafungine was administered as a nasal or oral spray, providing a direct effect on the affected mucous membranes.

Although fusafungine was effective in relieving symptoms of respiratory infections, its use was associated with the risk of adverse reactions, including severe allergic reactions such as bronchospasm. Due to these risks and its limited benefits compared to other available treatments, fusafungine was withdrawn from the market in the European Union in 2016, following recommendations from the European Medicines Agency (EMA).

Currently, for mild respiratory conditions, other therapeutic options such as analgesics, nasal decongestants, or systemic antibiotics (when necessary) are recommended under medical guidance.

General data about BIOPAROX 50mg / 10ml

  • Substance: fusafungina
  • Date of latest medicines list: 01-06-2016
  • Product code: W07920002
  • Concentration: 50mg / 10ml
  • Pharmaceutical form: buccopharyngeal and nasal spray, solution
  • Quantity: 1
  • Product type: Original
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.