Leaflet FIDAXOMICIN TERAPIA 200mg film-coated tablets

Product code:
W72222001
Indicated for:
bacterial infections
Route of administration:
oral
Substance:
fidaxomycin (antibacterial antibiotic)
ATC
A07AA12 — Alimentary tract and metabolism | Intestinal antiinfectives | Antibiotics

Fidaxomicin is an antibiotic mainly used to treat infections caused by Clostridioides difficile, a bacterium that can cause severe diarrhea and inflammation of the colon. This medicine works locally in the intestine, destroying harmful bacteria without significantly affecting the normal gut flora. Fidaxomicin is especially recommended for patients who have had recurrences or severe forms of infection.

Fidaxomicin is taken orally as tablets, as directed by your doctor. It is important to complete the full course of treatment, even if symptoms improve before finishing, to prevent the infection from returning. Do not stop the treatment without your doctor's approval.

Side effects of fidaxomicin are usually mild and may include nausea, vomiting, abdominal pain, or constipation. In rare cases, allergic reactions or more severe digestive problems may occur. If you notice any unusual or severe symptoms, contact your doctor immediately.

Fidaxomicin is a modern antibiotic, effective in treating difficult intestinal infections. Following medical advice and communicating with your doctor are essential for successful treatment and prevention of complications. Inform your doctor about any other medications you are taking.

General data about FIDAXOMICIN TERAPIA 200mg

Substance:
fidaxomycin
Product code:
W72222001
Concentration:
200mg
Pharmaceutical form:
film-coated tablets
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:
TERAPIA S.A. - ROMANIA
Holder:
TERAPIA S.A. - ROMANIA
Number:
16891/2026/01
Shelf life:
2 years

Precautions:

Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Anaphylaxis

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

Colitis / severe diarrhea

Seek medical advice if severe or persistent diarrhea occurs.