Silvederma 10 mg/ml suspension for cutaneous spray
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
SILVEDERMA 10 mg/ml cutaneous spray suspension Silver sulfadiazine Read the entire leaflet carefully before you start using this medicine, as it contains important information for you:
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Package leaflet contents:
- What SILVEDERMA is and what it is used for
- What you need to know before using SILVEDERMA
- How to use SILVEDERMA
- Possible side effects
- Storage of SILVEDERMA
- Contents of the pack and other information
1. What SILVEDERMA is and what it is used for
SILVEDERMA contains silver sulfadiazine, which is a topical antibiotic belonging to the sulfonamide group (medications used for the treatment of infections).
Antibiotics are used to treat bacterial infections and are not effective against viral infections.
It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.
Do not store or reuse this medicine. If you have any antibiotic left after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.
This medicine is indicated for the treatment and prevention of infections in second- and third-degree burns, as well as in varicose ulcers and pressure ulcers.
2. What you need to know before using SILVEDERMA
Do not use SILVEDERMA:
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If you are allergic to silver sulfadiazine or to sulfonamides (the group to which this medicine belongs), or to any of the other ingredients of this medicine (listed in section 6).
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In cases of large surface area injuries in newborn infants, premature babies, during the last days of pregnancy, or during breastfeeding.
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Life-threatening skin rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported with the use of Silvederma. These initially appear as red spots or circular patches, often with a central blister.
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Other additional signs that may occur include sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes).
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These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or skin peeling.
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The period of highest risk for severe skin reactions is during the first few weeks of treatment.
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If you have experienced Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Silvederma, you must never use Silvederma again.
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If you develop skin rashes or any of these symptoms, stop using Silvederma immediately, seek medical attention without delay, and inform your doctor that you are using this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Silvederma.
Take special care with SILVEDERMA:
- If you have liver or kidney disease, avoid applying this medicine to large or open wounds, especially ulcers.
- If you have a low white blood cell count, your doctor will perform regular blood cell counts.
- If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase.
- Do not expose the treated area to direct sunlight, as this may cause skin discoloration and also lead to a grayish discoloration of the silver sulfadiazine.
Use of SILVEDERMA with other medicines:
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Pregnancy and breastfeeding:
Consult your doctor or pharmacist before using any medicine.
Do not use SILVEDERMA during the last days of pregnancy or during the breastfeeding period.
Driving and using machines:
It is unlikely that SILVEDERMA will affect your ability to drive or operate machinery.
SILVEDERMA contains alcohol
This medicine contains 29.84% ethanol by volume, equivalent to 235.76 mg/ml.
It may cause a burning sensation on damaged skin.
3. How to use SILVEDERMA
Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
It is administered topically by cutaneous route.
Instructions for proper use:
1.- Shake the container before each application.
2.- Spray onto the wound once, twice, or more times a day, as directed by the physician.
If you use more SILVEDERMA than you should
In case of overdose or accidental ingestion, immediately contact your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount used.
If you forget to use SILVEDERMA
Do not use a double dose to make up for forgotten doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Very rare adverse effects (may affect up to 1 in 10,000 people):
- Skin rashes that may be life-threatening may occur (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).
Adverse effects with unknown frequency (cannot be estimated from available data). If you notice any of the following reactions, inform your doctor immediately:
- Allergic reactions.
- Skin reactions such as burning or pain sensation.
- Grayish skin discoloration in the area of application due to sun exposure (photosensitivity).
- Reduction in the number of white blood cells in the blood (leucopenia).
- Increased serum osmolality.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of SILVEDERMA
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP:. The expiry date refers to the last day of the month indicated.
Do not store above 30°C. Store in the original packaging to protect from direct sunlight and excessive heat. Do not freeze.
It is recommended not to use this medicine near flames, lit cigarettes, or certain devices (e.g. hair dryers) as it contains alcohol.
Pressurized container. Flammable. Do not pierce or throw into fire, even if it appears to be empty. Flammable.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of SILVEDERMA
- The active substance is silver sulfadiazine. Each ml contains 10 mg of silver sulfadiazine.
- The other components are: isopropyl myristate, colloidal silicon dioxide, lavender essence, absolute ethanol, and norflurane (HFA 134a).
This medicinal product contains fluorinated greenhouse gases.
Each container contains 40.46 g of norflurane (HFA-134a), equivalent to 0.0579 tonnes of CO2 (global warming potential GWP = 1,430).
Presentation of the product and pack contents
Aluminum container closed with a continuous valve, containing 50 ml of medicinal suspension.
Marketing Authorization Holder and Manufacturer
Laboratorio Aldo-Unión, S.L.
Baronesa de Maldá, 73
08950 Esplugues de Llobregat (Barcelona)
Spain
Date of the most recent revision of this leaflet: September 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/ .