Leaflet: information for the user

SILVEDERMA 10 mg/ml skin suspension for topical use

Silver sulfadiazine

SILVEDERMAcontains silver sulfadiazine, which is a topical antibiotic of the sulfonamide group (medications used for the treatment of infections).

This medication is indicated for the treatment and prevention of infections in second- and third-degree burns, as well as varicose and decubitus ulcers.

Do not use SILVEDERMA:

• If you are allergic to silver sulfadiazine or to sulfonamides (a group to which this medication belongs), or to some of the other components of this medication (listed in section 6).

• In case of large surface area injuries in newborns, premature infants, during the last days of pregnancy or during breastfeeding.

• Severe skin eruptions that can be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been described with the use of Silvederma, initially appearing as red, circular spots or patches, often with a central blister.
• Other additional signs that may appear are mouth, throat, nose, genital ulcers, and conjunctivitis (swollen and red eyes).

• These life-threatening skin eruptions, often accompanied by flu-like symptoms, may progress to generalized blistering or skin peeling.

• The period of highest risk for the development of severe skin reactions is during the first weeks of treatment.

• If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Silvederma, do not use Silvederma again at any time.

• If you develop skin eruptions or these symptoms, stop using Silvederma immediately and consult a doctor, informing them that you are using this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Silvederma.

Be especially careful with SILVEDERMA:

• If you have liver or kidney disease, avoid applying this medication to large surface area or open wounds, especially ulcers.
• If you have a reduced number of white blood cells, your doctor will perform regular blood counts.
• If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase.
• Do not expose the treated area to direct sunlight, as it may cause skin discoloration, as well as a gray coloration of the silver sulfadiazine.

Use of SILVEDERMA with other medications:

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication, even those obtained without a prescription.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

Do not use SILVEDERMA during the last days of pregnancy or during breastfeeding.

Driving and operating machinery:

It is unlikely that SILVEDERMA will affect your ability to drive vehicles or operate machinery.

SILVEDERMA contains alcohol

This medication contains 29.84% ethanol by volume, equivalent to 235.76 mg/ml.

It may cause a burning sensation on injured skin.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication is administered superficially by topical application.

Instructions for proper use:

1.- Shake the container before each application.

2.- Sprinkle over the wound, one, two, or more times a day, as deemed by your doctor.

If you use more SILVEDERMA than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to use SILVEDERMA

Do not use a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Severe skin eruptions that may threaten the patient's life (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).

Adverse effects with an unknown frequency (cannot be estimated from available data). If you observe any of the following reactions, inform your doctor immediately:

- Allergic reactions.

- Skin reactions such as burning or pain

- Gray discoloration of the skin in the area of application due to sun exposure (photosensitivity).

- Reduction in the number of white blood cells in the blood (leucopenia).

- Increase in serum osmolality.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them through the Spanish System for Pharmacovigilance of Medicinal Products for Human Usehttps://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD:. The expiration date is the last day of the month indicated.

Do not store above30ºC. Consult the original packaging to protect it from direct sunlight and excessive heat. Do not freeze.

It is recommended not to use this medication near an open flame, lit cigarettes, or some devices (for example, hair dryers) as it contains alcohol.

Pressurized container. Flammable. Do not pierce or incinerate, even if it appears to be empty. Flammable

Medicines should not be disposed of through the drains or in the trash. Deposit the containers and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. By doing so, you will help protect the environment.

Composition of SILVEDERMA

• The active ingredient is sulfadiazine silver. Each ml contains 10 mg of sulfadiazine silver.
• The other components are: isopropyl myristate, colloidal silica dioxide, lavender essence, absolute ethanol, and norflurane (HFA 134a).

Appearance of the product and content of the container

Aluminum container with a continuous valve containing 50 ml of medicinal suspension.

Holder of the marketing authorization and responsible for manufacturing

Laboratorio ALDO-UNIÓN, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

BARCELONA – SPAIN

Date of the last review of this leaflet: January 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/.