SOFARGEN*CREAM 120G 1%

Sofargen 1% cream
Micronized silver sulfadiazine

What it is and what it is used for
Sofargen contains the active ingredient silver sulfadiazine and belongs to a group of medicines called sulfonamides. Silver sulfadiazine is a sulfonamide antibiotic capable of blocking bacterial replication mechanisms thanks to the action of the sulfadiazine radical and exerts a broad-spectrum bactericidal action, thanks to the presence of the silver ion.

Sofargen is a topical antibiotic indicated:
- in the prevention and treatment of bacterial infections that develop on burns that have affected more or less deep layers of the skin (second and third-degree burns);
- in the treatment of bacterial infections developed on lesions that usually form near the ankle due to circulatory disorders of the blood (varicose ulcers) and on wounds that are difficult to heal that can occur as a result of prolonged immobility (pressure ulcers);
- in the treatment of skin diseases that have a bacterial infection or that may be at risk of further infections.

What you need to know before taking the medicine
Do not use Sofargen if:
- you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
- you are in the last months of pregnancy.

Do not use Sofargen on your premature baby or in the first months of life (see section Children and adolescents).

Warnings and precautions
Talk to your doctor or pharmacist before using Sofargen if:
- you have liver problems (liver failure);
- you have kidney problems (kidney failure);
- you have a deficiency of an enzyme called glucose-6 phosphate dehydrogenase.

Stop treatment with Sofargen and consult your doctor if you experience:
- hypersensitivity reactions (allergic reactions) developed as a result of prolonged use of the cream;
- secondary infections (superinfections) caused by microorganisms resistant to treatment with Sofargen.

If you need to apply Sofargen to large areas of the skin (for example, in the case of large burns), your doctor will prescribe tests to check the concentration of sulfadiazine in the blood, the function of your kidneys and liver, and the presence of any sulfonamide crystals in the urine. Your doctor will tell you to stop treatment with Sofargen if kidney or liver failure is found.

Children and adolescents
Sofargen should not be used in premature babies and in newborns in the first months of life, as sulfonamides increase the risk for your baby of developing yellow skin discoloration associated with an increased level of bilirubin in the blood (neonatal jaundice).

Possible side effects
Like all medicines, Sofargen can cause side effects, although not everybody gets them.

Uncommon side effects (may affect up to 1 in 100 people)
- temporary reduction in the number of white blood cells in the blood (transient leukopenia);
- local reactions, such as pain and burning, and hypersensitivity reactions (allergic reactions) at the administration site.

Following the application of Sofargen to large areas of the skin, you may experience the side effects usually observed with the oral or injectable (systemic routes) administration of sulfonamide-based medicines.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.