Leaflet FOSFOMICINA LABIANA 2g granules for oral solution in sachet

Indicated for: bacterial infections

Route of administration: oral

Substance: fosfomycin (antibacterial antibiotic)

ATC: J01XX01 (Antiinfectives for systemic use | Other antibacterials)

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.

Fosfomycin is an antibiotic mainly used to treat urinary tract infections, including acute uncomplicated cystitis in adults and adolescents. It works by inhibiting the synthesis of the bacterial cell wall, thereby destroying the bacteria responsible for the infection. Fosfomycin is effective against many bacteria, including some strains resistant to other antibiotics.

Fosfomycin is usually administered as a powder dissolved in water and taken orally, with a single dose being sufficient in most cases of uncomplicated urinary infections. For other types of infections or in patients with special conditions, the doctor may recommend a different dosing regimen.

Common side effects include digestive disturbances such as nausea, diarrhea, or abdominal pain. Allergic reactions are rare but may include skin rashes, itching, or, in very rare cases, severe reactions. It is important for patients to inform their doctor about any unusual symptoms.

Fosfomycin is a valuable antibiotic for the rapid and effective treatment of urinary infections, but its use should be responsible and according to the doctor's instructions to prevent the development of bacterial resistance.

General data about FOSFOMICINA LABIANA 2g

  • Substance: fosfomycin
  • Date of latest medicines list: 01-09-2016
  • Product code: W62828001
  • Concentration: 2g
  • Pharmaceutical form: granules for oral solution in sachet
  • Quantity: 1
  • Product type: Generic medicine
  • Prescription status: P-6L - Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.

Marketing authorisation

  • Manufacturer: LABIANA PHARMACEUTICALS, S.L.U. - SPANIA
  • Holder: LABIANA PHARMACEUTICALS, S.L.U. - SPANIA
  • Number: 8997/2016/01
  • Shelf life: 3 years-after packing for marketing;after reconstitution-it is used immediately

Concentrations available for fosfomycin

  • 2g
  • 3g
  • 40mg/ml