Streptosyl neomycin 2% + 0.5% 20 g ointment

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

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

ACTIVE INGREDIENTS

10 g of powder contains: sulfathiazole 9.95 g and neomycin sulfate 0.05 g. 20 g of ointment contains: sulfathiazole 0.4 g and neomycin sulfate 0.1 g.

EXCIPIENTS

skin powder: none. ointment: Vaseline oil, white Vaseline, white wax.

CONTRAINDICATIONS AND SIDE EFFECTS

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.

DOSAGE

Skin dust Lift the colored cap, rhythmically and thoroughly press the two faces of the bottle, holding it horizontally or slightly obliquely; lightly sprinkle the affected region with the powder and cover with sterile gauze; renew the application twice a day. It is recommended to apply a light sprinkling, using the minimum amount of powder necessary to avoid the formation of crusts and allow rapid dissolution and diffusion of the components. Do not exceed the recommended doses. Ointment Apply a thin layer of ointment 2-3 times a day. Do not exceed the recommended doses.

CONSERVATION

No special precautions for storage.

WARNINGS

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.

OVERDOSE

In the event of prolonged applications on large surfaces or lesions, systemic absorption of the medicine may occur with passage of sulfathiazole and/or neomycin into circulation. If overdose is suspected, treatment should be discontinued.

PREGNANCY AND BREASTFEEDING

Pregnancy The safety of topical use of sulfonamides or neomycin during pregnancy has not been established. In pregnant women, the product should be administered in cases of actual need, under the direct supervision of a doctor. Breastfeeding There are no adequate studies available to evaluate the effects in women during breastfeeding and therefore to determine the risk in infants. The product should be used in breastfeeding women only if strictly necessary, under the direct supervision of a doctor. Fertility No studies have been conducted to evaluate the effects on fertility in humans.

EFFECTS ON DRIVING ABILITY

STREPTOSIL with NEOMICIN has no or negligible influence on the ability to drive and use machines.