Package leaflet

OROBICIN 2500 UI + 25 mg tablets

Bacitracin + Neomycin
16 tablets
PHARMACEUTICAL CATEGORY
Antibiotic.
INDICATIONS:
Intestinal tract infections caused by microorganisms sensitive to Neomycin and Bacitracin. Preparation of the colon prior to surgical procedures.
CONTRAINDICATIONS:
Known hypersensitivity to Neomycin and Bacitracin; renal insufficiency; myasthenic syndromes; malabsorption. Oral products containing Neomycin are contraindicated in children under two years of age. Furthermore, the antibiotic must not be administered concurrently with potentially nephrotoxic agents (kanamycin, streptomycin, gentamicin, polymyxin, viomycin, colistin, cephalosporins, etc.). Intestinal obstruction, even partial.
PRECAUTIONS FOR USE:
Prolonged or repeated administration may lead to the development of non-sensitive microorganisms; in particular, staphylococcal enterocolitis may occur. In such cases, patients must be closely monitored and appropriate therapy initiated. During treatment, periodic monitoring of renal function and audiometric tests are advisable to detect early signs of nephrotoxicity and ototoxicity. Anti-emetic or anti-kinetotic drugs should not be administered concurrently, as they may mask the early symptoms of ototoxicity. Particular caution is required when treating patients with hepatic impairment, even mild, due to the possibility of accumulation of small antibiotic doses, which may occasionally be absorbed, especially at the site of intestinal lesions.
INTERACTIONS:
Neomycin should be used with caution in patients receiving potentially ototoxic drugs, anticoagulants, and neuromuscular blocking agents. Concomitant use of highly active diuretics should be avoided due to the potential enhancement of adverse effects on the kidneys and auditory nerve.
SPECIAL WARNINGS
Pregnancy, lactation
This product should be used during pregnancy and in children only when strictly necessary and under direct medical supervision.
DOSAGE, METHOD AND DURATION OF ADMINISTRATION
For oral use.
Daily dosage and treatment duration must be determined by the attending physician. The average daily dosage in adults ranges from 4 to 10 tablets per day, depending on the case, divided throughout the day.
It is advisable to discontinue therapy once symptoms related to the infection have resolved (treatment should not extend beyond 3–5 days).
OVERDOSE
During prolonged or repeated treatments, a malabsorption syndrome may occur, characterized by diarrhea and steatorrhea, likely due to inhibition of lipases, as well as signs of nephrotoxicity and ototoxicity.
UNDESIRABLE EFFECTS
The most frequently reported adverse effects are nausea, vomiting, and constipation. Rarely, hypersensitivity reactions with skin eruptions of various types and locations may occur. If any adverse effects not described here occur, patients are expressly advised to inform their physician or pharmacist.
EXPIRY DATE AND STORAGE
See expiry date on the packaging.
The expiry date refers to the product stored in its original, undamaged packaging under proper storage conditions.
Warning: Do not use the medicine after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
COMPOSITION
Each tablet contains:
Active substances:
Bacitracin 2500 IU
Neomycin sulfate equivalent to Neomycin 25 mg;
Excipients:
starch, talc.
PHARMACEUTICAL FORM AND CONTENT
Tablets. Carton containing 16 tablets.
MARKETING AUTHORISATION HOLDER
PHARMADAY PHARMACEUTICAL S.R.L. UNIPERSONALE
Via Vistarino n. 14/F – 27010 Copiano (PV)
MANUFACTURER
FULTON MEDICINALI S.p.A.
Via G. Marconi n. 28/9 – 20020 Arese (MI)
REVISION OF THE PACKAGE LEAFLET BY THE ITALIAN MEDICINES AGENCY (AIFA):
FEBRUARY 2013