Leaflet: information for the user

Silvederma 10 mg/g cream

Silver sulfadiazine

Read this leaflet carefully before you start using the medicine because it contains important information for you.

1. What Silvederma 10 mg/g cream is and what it is used for

2. What you need to know before using Silvederma 10 mg/g cream

3. How to use Silvederma 10 mg/g cream

4. Possible side effects

5. Storage of Silvederma 10 mg/g cream

6. Contents of the pack and additional information

This medication contains silver sulfadiazine, which is an antibiotic in the sulfonamide group (a useful medication for the treatment ofinfections).

This medicationis 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 10 mg/g cream:

• If you are allergic (hypersensitive) to silver sulfadiazine, sulfonamides (a group to which this medication belongs), or to any of the other components of this medication (listed in section 6).
• In case of large surface area wounds in newborns, premature infants, during the last days of pregnancy, or during breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Silvederma 10 mg/g cream.

• Severe skin reactions that may be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported with the use of Silvederma 10 mg/g cream, initially appearing as red circular spots or patches, often with a central blister.
• Other additional signs that may appear are mouth sores, throat, nose, genital, and conjunctivitis (swollen and red eyes).

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

• The period of highest risk for 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 10 mg/g cream, do not use Silvederma cream again at any time.

• If you develop skin eruptions or these symptoms, stop using Silvederma 10 mg/g cream, and immediately seek medical attention and inform your doctor that you are using this medication.

Be especially careful with Silvederma 10 mg/g cream:

• If you have liver or kidney disease, avoid applying the cream to large surface area or open wounds, especially ulcers.
• If you have a reduced number of white blood cells in your blood, 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 and a grayish color of the cream.

Use of Silvederma 10 mg/g cream with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

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

Silvederma contains propylene glycol, cetearyl alcohol, and methyl parahydroxybenzoate (E218)

This medication may cause skin irritation due to propylene glycol.

This medication may cause local skin reactions (such as contact dermatitis) due to cetearyl alcohol.

This medication may cause allergic reactions (possibly delayed) due to methyl parahydroxybenzoate (E-218).

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.

It is administered superficially by topical application.

Initially, the wound should be washed and cleaned. Then, with a sterile spatula or with a hand covered with a sterile glove, a layer of 3 mm thickness should be applied over the affected area, covering it with an appropriate dressing.

Normally, the dressing change will be performed 1-2 times a day, and it can be renewed every 4-6 hours in the case of highly contaminated wounds.

At each dressing change and medication replacement, the remnants of the previous application should be removed first, carefully washing the wound with warm boiled water or isotonic saline solution.

Each package should be used for a single patient.

Instructions for correct administration of the preparation:

The tube has a seal whose opening is made by following the instructions in the drawing:

If you use more Silvederma 10 mg/g cream 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 ingested or used.

If you forgot to use Silvederma 10 mg/g cream

If you forget to apply a dose, apply it as soon as you remember. Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people will 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.
• Reduction in the number of white blood cells in the blood (leucopenia).
• Increased osmolality in serum.

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 on the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required. Store in the original packaging to protect it from light.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.In case of doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Silvederma 10 mg/g cream:

• The active ingredient is sulfadiazine silver. Each gram of cream contains 10 milligrams of sulfadiazine silver.
• The other components are: Cetostearyl alcohol, isopropyl myristate, white vaseline, polyoxy 40 stearate, sorbitan oleate, propylene glycol (E-1520), methyl parahydroxybenzoate (E-218) and purified water.

Appearance of the product and contents of the packaging

Silvederma 10 mg/g cream is a white or bone-white cream, presented in tubes of 50 grams or 100 grams and in a 500-gram jar. It is packaged in a cardboard box.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorio ALDO-UNIÓN, S.L.

Calle Baronesa de Maldá, 73

08950 Esplugues de Llobregat

BARCELONA – SPAIN

This leaflet was approved in May 2007

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