Streptosil with neomycin 99.5% + 0.5% skin powder 10g

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Superficial skin infections (folliculitis, furunculosis, small burns and infected wounds).

CONTRAINDICATIONS

STREPTOSIL with NEOMICIN is contraindicated in patients with: - Hypersensitivity to the active substances or to any of the excipients listed in paragraph 6.1. - Infections of the ear canal in case of perforation of the tympanic membrane.

WARNINGS AND PRECAUTIONS FOR USE

STREPTOSIL with NEOMICIN is not for ophthalmic use; it is indicated for external use only. The application of STREPTOSIL with NEOMICIN on extensively and deeply damaged skin, such as in skin infections secondary to extensive burns and trophic ulcers, could favor the systemic absorption of its active ingredients, exposing patients to serious secondary effects, such as nephrotoxicity and ototoxicity. The medicine must not be used in ear canal infections in case of perforation of the eardrum since in these cases the topical use of neomycin can cause deafness (see section 4.3). As with other aminoglycosides, the simultaneous and/or sequential systemic or topical administration of other nephrotoxic drugs should be avoided. Duration of treatment The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. As with other antibiotics, prolonged use of neomycin can lead to the development of resistant microorganisms, including fungi. If this occurs it is necessary to discontinue treatment and institute appropriate therapy. After a short period of treatment without appreciable results, or in case of worsening of the patient's condition, it is necessary to consider suspending treatment. Pediatric population In early childhood the product should be administered in cases of actual need, under the direct supervision of the doctor. The application of neomycin on large areas of the skin and for prolonged periods can lead to systemic absorption; this eventuality occurs more easily when occlusive bandage is used, in particular in newborns, since the diaper can act as an occlusive bandage.

INTERACTIONS

Topical neomycin has demonstrated cross-sensitivity with other aminoglycosides; co-administration of another aminoglycoside, especially systemically, is not recommended due to potential ototoxic and nephrotoxic effects. Topical application of sulfathiazole may result in sensitization and preclude subsequent systemic use of sulfonamides.

SIDE EFFECTS

Following the use of STREPTOSIL with NEOMICIN, the side effects indicated below may occur. The frequency of these side effects is not known. Infections and infestations Bacterial and fungal superinfections. Immune system disorders Hypersensitivity reactions Pathologies of the skin and subcutaneous tissue Itching. Systemic pathologies and conditions relating to the administration site Swelling, redness. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetti-reazione-avversa.