TOBRABACT Eye drops, solution Ref.[50600] Active ingredients: Tobramycin

Sensitivity to topically administered aminoglycosides may occur in some patients. Hypersensitivity reactions may vary in severity from localised to generalised reactions such as erythema, itching, urticaria, skin rash, anaphylaxis or anaphylactoid reactions. If hypersensitivity develops during use of this medicine, treatment should be discontinued.

Cross-hypersensitivity to other aminoglycosides can occur, and the possibility that patients who become sensitized to topical tobramycin may also be sensitive to other topical and/or systemic aminoglycosides should be considered.

Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients systemically treated with tobramycin. Caution is advised when used together with other eye-drop products.

Prolonged use of antibiotics, such as these eye drops, may result in overgrowth of resistant microorganisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.

If no rapid improvement is observed or in the event of prolonged treatment, regular medical monitoring, including bacteriological tests with antibiotic sensitivity tests will allow any resistance to the product to be detected and the treatment can be adapted if necessary.

Wearing contact lenses is not recommended during treatment of an ocular infection. TOBRABACT contains benzalkonium chloride, which may cause eye irritation and discolour soft contact lenses. Avoid contact with soft contact lenses. However, if the healthcare professional considers it appropriate for the patient to wear contact lenses, they must be instructed to remove lenses before applying TOBRABACT and wait at least 15 minutes before reinsertion.

The eye drops should not be used as part of an intraocular or periocular injection.

Although only small amounts of tobramycin pass into the systemic circulation after instillation into the eye, the interactions reported for systemic tobramycin should be taken into account.

The potential ototoxicity and/or nephrotoxicity of tobramycin may be enhanced when used concomitantly with systemically applied other aminoglycosides, polymyxins, cefalotine, loop diuretics, amphotericin B and organoplatins.

Ocular tetracyclines should not be used simultaneously with Tobrabact as tyloxapol, one of the constituents of this product, is chemically not compatible with tetracyclines.

Pregnancy

There are no adequate data with respect to the ocular or systemic use of tobramycin in pregnant women. Some cases of neonatal cochleovestibular damage have been reported after systemic administration of other aminoglycosides to pregnant women. Animal studies performed in several species with aminoglycosides have revealed cochleovestibular and renal injuries. Therefore, ophthalmic tobramycin should be used during pregnancy only when clearly indicated.

Lactation

Aminoglycosides after systemic administration pass into the milk in low quantity. Breastfeeding is possible with ophthalmic tobramycin considering the negligible amount of this substance possibly absorbed by the neonate.

There may be visual disturbances related to instillation of the solution. If this happens, the patient should avoid driving or using machinery while the problems persist.

Summary of the safety profile

In clinical studies involving 1016 patients, the most frequently reported adverse reactions were ocular hyperaemia and ocular discomfort, occurring in around 1.4% and 1.2% of patients, respectively.

Tabulated list of adverse reactions

The following adverse reactions have been reported with tobramycin eye drops and are classified according to the subsequent convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000), and not known (cannot be estimated from the available data).

Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. Adverse reactions are reported during clinical trials or during post marketing experience.

Description of selected adverse reactions

Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic treatment with tobramycin (see section 4.4). Sensitivity to topically administered aminoglycosides may occur in some patients. Hypersensitivity reactions may vary in severity from being localised to generalised reactions such as erythema, itching, urticaria, skin rash, anaphylaxis or anaphylactoid reactions (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V*.

Not applicable.