SILVEDERMA 10 mg/ml CUTANEOUS SPRAY SUSPENSION

Introduction

Package Leaflet: Information for the User

SILVEDERMA 10 mg/ml suspension for cutaneous spray

Silver Sulfadiazine

Contents of the package leaflet:

1. What is SILVEDERMA and what is it used for
2. What you need to know before you use SILVEDERMA
3. How to use SILVEDERMA
4. Possible side effects
5. Storage of SILVEDERMA
6. Contents of the pack and further information

1. What is SILVEDERMA and what is it used for

SILVEDERMA contains silver sulfadiazine, which is a topical antibiotic of the sulfonamide group (medicines used to treat infections).

Antibiotics are used to treat bacterial infections and are not effective against viral infections.

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing the 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 and pressure ulcers.

2. What you need to know before you use SILVEDERMA

Do not use SILVEDERMA:

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

• In case of large surface lesions in newborns, premature babies, during the last days of pregnancy, or during breastfeeding.

• Life-threatening skin rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported with the use of Silvederma. Initially, they appear as red, circular spots or patches, often with a central blister.
• Other additional signs that may appear are sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes).

• These life-threatening skin rashes are often accompanied by flu-like symptoms. The rash can progress to the formation of generalized blisters or skin peeling.

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

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use Silvederma.

Be particularly careful with SILVEDERMA:

• If you have liver or kidney disease, you should avoid applying this medicine to large or open lesions, especially ulcers.
• If you have a reduced white blood cell count, your doctor will perform control tests.
• 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.

Using SILVEDERMA with other medicines:

Inform your doctor or pharmacist if you are using or have recently used or may need to use 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 breastfeeding.

Driving and using machines:

It is unlikely that SILVEDERMA will have any effect on 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 administration instructions for this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

It is administered superficially via the cutaneous route.

Instructions for proper use:

1. Shake the container before each application.

2. Spray over the wound, once, twice, or more times a day, at the discretion of the healthcare professional.

If you use more SILVEDERMA than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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 other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).

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

• Allergic reactions.
• Skin reactions such as burning sensation or pain.
• Gray skin discoloration in the application area due to sun exposure (photosensitivity).
• Reduced white blood cell count (leukopenia).
• Increased osmolality in serum.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es.

By reporting side 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 is 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 a flame, lit cigarettes, or some devices (e.g., hair dryers) because it contains alcohol.

Pressurized container. Flammable. Do not pierce or throw into a fire, even if it appears to be empty. Flammable.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of SILVEDERMA

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

Appearance of the product and pack contents

Aluminum container 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 last revision of this leaflet: January 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es/.