NETTACIN VISCOSO

Package Leaflet

NETTACIN VISCOSO 0.3%

Ophthalmic Ointment
NETILMICIN
Composition
100 g contains:
Active substance: netilmicin sulfate 0.455 g, equivalent to netilmicin 0.300 g
Excipients: Liquid paraffin – Anhydrous lanolin – Purified water – White vaseline
Pharmaceutical forms and contents
Ophthalmic ointment in a 5 g tube
Pharmacotherapeutic category
Netilmicin is an aminoglycoside antibiotic.
Marketing Authorization Holder
S.I.F.I. S.p.A. – Via Ercole Patti, 36 – Aci S. Antonio (CT)
Manufacturer and final controller
S.I.F.I. S.p.A. – Aci S. Antonio (CT) facility
Marketing distributor
EYELAB S.R.L. - Via Ercole Patti, 36 – 95025 Aci S. Antonio (CT)
Therapeutic indications
Topical treatment of external ocular infections and of the adnexa caused by microorganisms sensitive to netilmicin.
Contraindications
Hypersensitivity to the components of the product or to other aminoglycosides.
Generally contraindicated during pregnancy and breastfeeding.
Precautions for use
During pregnancy, the product should be administered only when clearly needed and under direct medical supervision. Use during breastfeeding is not recommended.
Interactions
No pharmacological interactions are known with the use of NETTACIN VISCOSO.
Special warnings
Prolonged use of topical antibiotics may lead to local overgrowth of resistant microorganisms. If, after a reasonable period of time, no clinical improvement is observed or if irritative phenomena occur, treatment should be discontinued and a physician consulted to initiate appropriate therapy.
The safety of NETTACIN VISCOSO during pregnancy has not been established. Although topical administration of netilmicin is not associated with systemic absorption, the product should be used during pregnancy only when clearly necessary and under direct medical supervision.
Netilmicin is excreted in breast milk in small amounts. Therefore, even in the absence of significant systemic absorption, the use of NETTACIN VISCOSO is not recommended during breastfeeding.
Dosage, method and duration of administration
Apply a single dose (half to 1 cm) into the conjunctival sac three to four times daily. If netilmicin eye drops are also prescribed, a single evening application of the ointment is sufficient.
Avoid contact of the container tip with the eye or any other surface.
Undesirable effects
NETTACIN VISCOSO may rarely cause mild and transient local intolerance or hypersensitivity reactions such as conjunctival redness, burning, or itching.
Following the instructions in this leaflet reduces the risk of undesirable effects.
It is important to inform your doctor or pharmacist if any undesirable effect occurs, even if not described in this leaflet.
Expiry date and storage
Refer to the packaging for the expiry date.
Warning: do not use the medicine after the expiry date stated on the packaging.
Store below 25 °C.
NETTACIN VISCOSO ophthalmic ointment must not be used more than 28 days after first opening.
FOR OPHTHALMIC USE
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN
June 2009