Sofargen 1% 120g cream

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

INDICATIONS

Prophylaxis and local antibacterial treatment of infections in case of 2nd and 3rd degree burns; local antibacterial treatment of varicose ulcers and infected bedsores and in general of dermatological conditions that are infected or susceptible to superinfections.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients. Since sulphonamides may increase the risk of neonatal jaundice, Sofargen should not be used in women at the end of pregnancy, in premature babies and in newborns in the first months of life.

WARNINGS AND PRECAUTIONS FOR USE

Sofargen should be applied with caution in the presence of hepatic or renal insufficiency. The use of Sofargen may be risky in subjects with manifest glucose-6-phosphate dehydrogenase deficiency, as hemolytic phenomena may occur. Prolonged use of the product may give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and adopt suitable therapeutic measures. The same applies in case of superinfection by resistant microorganisms. In the treatment of burns of a large part of the body, serum concentrations of sulphonamide can reach therapeutic levels in adults. Therefore, in these patients it would be advisable to monitor these serum levels, renal function, the presence of any sulphonamide crystals in the urine and liver function, interrupting therapy if liver and/or renal function is compromised. Furthermore, given that propylene glycol, present as an excipient in the composition, can cause hyperosmolality when the product is applied to large burn areas, serum osmolality must be periodically checked and, if necessary, the treatment must be interrupted.

INTERACTIONS

Local proteolytic enzymes, applied simultaneously with Sofargen, can be inactivated by the presence of silver ions.

SIDE EFFECTS

Some cases of transient leukopenia (0.4%), rare local disorders (pain and burning) and rare local allergic reactions (0.3%) have been reported. The classic side effects of systemically administered sulphonamides cannot be excluded when treating large parts of the body. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous 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 at www.agenziafarmaco.gov.it/it/responsabili.