Leaflet FOSFOMICINA LABIANA 3g granules for oral solution in sachet

Product code:
W62829001
Quantity:
1
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 3g

Substance:
fosfomycin
Date of latest medicines list:
01-09-2016
Product code:
W62829001
Concentration:
3g
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:
8998/2016/01
Shelf life:
3 years-after packing for marketing;after reconstitution-it is used immediately

Concentrations available for fosfomycin

  • 2g
  • 3g
  • 40mg/ml