Silvederma 10 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Silvederma 10 mg/g cream

Silver sulfadiazine

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

Package leaflet contents:

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. How to store Silvederma 10 mg/g cream
6. Contents of the pack and other information

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

This medicinal product contains silver sulfadiazine, which is an antibiotic belonging to the sulfonamide group (a medicine useful 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 the instructions regarding dose, dosing interval, and duration of treatment as indicated by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of 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 10 mg/g cream

Do not use Silvederma 10 mg/g cream:

• If you are allergic (hypersensitive) to silver sulfadiazine, sulfonamides (the group to which this medicine belongs), or to any of the other ingredients of this medicine (listed in section 6).
• In case of large surface area lesions in newborn infants, 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.

• Life-threatening skin rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported with the use of Silvederma 10 mg/g cream. These initially appear as red spots or circular lesions, often with a central blister.

• Other additional signs that may occur include sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes).

• These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash 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 while using Silvederma 10 mg/g cream, you must never use Silvederma cream again.

• If you develop skin rashes or these symptoms, stop using Silvederma 10 mg/g cream immediately, seek medical attention right away, and inform the doctor that you are using this medicine.

Take special care with Silvederma 10 mg/g cream:

• If you have liver or kidney disease, avoid applying the cream to large or open skin lesions, especially ulcers.
• If you have a reduced number of white blood cells, your doctor will perform regular blood counts.
• If you have glucose-6-phosphate dehydrogenase (G6PD) enzyme deficiency.
• Do not expose areas treated with this medicine to direct sunlight, as this may cause skin discoloration as well as a grayish discoloration of the cream.

Use of Silvederma 10 mg/g cream with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not use this medicine during the last days of pregnancy or during breastfeeding.

Driving and use of machines

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

Silvederma contains propylene glycol, cetostearyl alcohol, and methylparaben (E218)

This medicine may cause skin irritation because it contains propylene glycol.

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol.

This medicine may cause allergic reactions (possibly delayed) because it contains methylparaben (E218).

3. How to use Silvederma 10 mg/g cream

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is administered topically by cutaneous route.

First, clean and wash the wound. Then, using a sterile spatula or your hand covered with a sterile glove, apply a 3 mm thick layer over the affected area, and cover it with an appropriate dressing.

Dressing changes are usually carried out 1–2 times a day, but may be performed every 4–6 hours in the case of heavily contaminated wounds.

At each dressing change and reapplication of the medicine, remove any residue from the previous application first, and carefully wash the wound with lukewarm boiled water or isotonic saline solution.

Each container must be used for one patient only.

Instructions for correct administration of the preparation:

The tube has a seal which is opened 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested or used.

If you forget to use Silvederma 10 mg/g cream

If you forget to apply a dose, apply it as soon as you remember. Do not use a double dose to make up for forgotten doses.

If you have any doubts about how to use 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 sensation or pain.
• Grayish discoloration of the skin in the area of application due to sun exposure.
• Decrease 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 at https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Silvederma 10 mg/g cream

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

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

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Silvederma 10 mg/g cream:

• The active substance is silver sulfadiazine. Each gram of cream contains 10 milligrams of silver sulfadiazine.
• The other components are: Cetostearyl alcohol, isopropyl myristate, white soft paraffin, polyoxyl 40 stearate, sorbitan oleate, propylene glycol (E-1520), methylparaben (E-218) and purified water.

Appearance of the medicine and contents of the pack

Silvederma 10 mg/g cream is a white or off-white cream, supplied in tubes containing 50 grams or 100 grams, and in jars containing 500 grams of cream. It is packaged in a cardboard box.

Marketing Authorization Holder and Manufacturer:

Laboratorio ALDO-UNIÓN, S.L.

Calle Baronesa de Maldá, 73

08950 Esplugues de Llobregat

BARCELONA – SPAIN

This leaflet was approved in May 2007.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es