Leaflet ROVAMYCINE 1.5MUI film-coated tablets

Indicated for: bacterial infections

Route of administration: oral

Substance: spiramycin (macrolide antibiotic)

ATC: J01FA02 (Antiinfectives for systemic use | Macrolides, lincosamides and streptogramins)

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.

Major drug interactions

This medicine may have important interactions with other medicines.

Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.

Spiramycin is a macrolide antibiotic used to treat infections caused by susceptible bacteria. It is effective against respiratory infections, skin and soft tissue infections, but is particularly used for the prevention and treatment of toxoplasmosis in pregnant women to reduce the risk of transmission to the fetus.

It is administered orally, usually in tablet form, or intravenously, depending on the severity of the infection. The dosage and duration of treatment are determined by the doctor based on the type and severity of the infection.

Common side effects include nausea, vomiting, diarrhea, abdominal pain, and allergic reactions such as skin rashes. In rare cases, it may cause more severe reactions, such as hepatotoxicity or severe allergic responses.

Spiramycin is contraindicated in individuals with hypersensitivity to macrolides. It is important for patients to strictly follow their doctor's instructions and not discontinue treatment prematurely to prevent the development of bacterial resistance.

ROVAMYCINE 1.5MUI film-coated tablets SANOFI, spiramycin

General data about ROVAMYCINE 1.5MUI

Substance: spiramycin
Date of latest medicines list: 01-06-2026
Product code: W63533001
Concentration: 1.5MUI
Pharmaceutical form: film-coated tablets
Quantity: 16
Product type: Original
Price: 13.36 RON
Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer: FAMAR LYON - FRANTA
Holder: SANOFI ROMANIA S.R.L. - ROMANIA
Number: 10034/2017/01
Shelf life: 3 years

Concentrations available for spiramycin

1.5MUI
3MUI

Compensation lists for ROVAMYCINE 1.5MUI Sanofi

B - Sublist B with 50% discount from the reference price

Price

Copayment

Patient

13.36 RON

6.68 RON

NHP 1.A (C2) - People with HIV/AIDS and post-exposure treatment