Argosulfan

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Argosulfan

20 mg/g, cream

Silver sulfathiazole

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Argosulfan and what is it used for
• 2. Important information before using Argosulfan
• 3. How to use Argosulfan
• 4. Possible side effects
• 5. How to store Argosulfan
• 6. Contents of the package and other information

1. What is Argosulfan and what is it used for

Argosulfan is a cream for topical use, containing silver sulfathiazole, which has a strong antibacterial effect against numerous Gram-negative and Gram-positive bacteria.

Argosulfan is used to treat infections in the following cases:

• skin burns of all degrees (including radiation burns),
• bedsores (wounds caused by constant pressure on skin areas, e.g. from lying in one position for too long),
• chronic leg ulcers (shallow wounds that usually occur on the legs due to poor blood flow in the veins). Argosulfan protects the burn wound from infection, creates a protective layer, ensures proper moisture, and accelerates wound healing.

2. Important information before using Argosulfan

When not to use Argosulfan:

• in breastfeeding women, due to the possibility of the active substance passing into breast milk,
• in premature infants, newborns, and infants up to the age of two months, due to the risk of kernicterus (a disease caused by the accumulation of excess unconjugated bilirubin in the brain and spinal cord),
• in patients with a congenital disease in which the body lacks an enzyme that helps red blood cells function normally (glucose-6-phosphate dehydrogenase deficiency), due to the risk of hemolytic anemia (caused by the rapid breakdown of red blood cells).

Warnings and precautions

Before starting to use Argosulfan, you should discuss it with your doctor or pharmacist.

You should be particularly careful:

• in patients with liver or kidney function disorders, due to the possibility of the medicine accumulating in the body and the associated risk of side effects.

You should avoid contact between the medicine and the eyes and mucous membranes. In case of accidental contact, they should be rinsed with a large amount of water.

You should inform your doctor about any allergies to other medicines, especially sulfonamides. During the use of Argosulfan, allergies to other medicines may occur, such as sulfonylurea derivatives (used to treat diabetes), benzothiadiazines (used to treat hypertension and edema), and p-aminosalicylic acid (used to treat tuberculosis).

If the doctor assesses that the wound treatment is not proceeding properly, the doctor will order microbiological tests and, if necessary, change the treatment.

You should avoid long-term use of the medicine, especially in patients with liver or kidney function disorders.

In the case of prolonged therapy prescribed by the doctor or the use of Argosulfan on large areas of skin, the doctor will monitor:

• the concentration of sulfonamide in the serum, especially in patients with kidney or liver function disorders;
• liver, kidney, and hematopoietic system function, and in particular the white blood cell count, due to the risk of agranulocytosis (a significant decrease or absence of white blood cells - granulocytes in the blood) or anemia.

You should consult a doctor, even if the above warnings concern situations that occurred in the past.

Children

Argosulfan should not be used in premature infants, newborns, and infants up to the age of two months, due to the risk of kernicterus (a disease caused by the accumulation of excess unconjugated bilirubin in the brain and spinal cord).

Argosulfan and other medicines

You should tell your doctor or pharmacist about all medicines that the patient is currently taking or has recently taken, as well as any medicines that the patient plans to take.

You should not use Argosulfan at the same time as other topical medicines.

The use of medicines or other products containing folic acid or p-aminobenzoic acid derivatives may weaken the antibacterial effect of Argosulfan.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine. You should not use the medicine during pregnancy or breastfeeding.

Using Argosulfan in patients with kidney function disorders

Due to the lack of clinical trials, caution should be exercised when using the medicine in patients with kidney function disorders. In patients with severe kidney function disorders, the doctor will order monitoring of the sulfonamide concentration in the serum.

Using Argosulfan in patients with liver function disorders

Due to the lack of clinical trials, caution should be exercised when using the medicine in patients with liver function disorders.

Driving and operating machinery

Argosulfan does not affect the ability to drive vehicles or operate machinery.

Argosulfan contains cetostearyl alcohol, propyl parahydroxybenzoate (E 216), and methyl parahydroxybenzoate (E 218)

Due to the presence of cetostearyl alcohol, the medicine may cause local skin reactions (e.g. contact dermatitis).

Due to the presence of propyl parahydroxybenzoate (E 216) and methyl parahydroxybenzoate (E 218), the medicine may cause allergic reactions (possible late reactions).

The medicine contains sodium lauryl sulfate

The medicine contains 10 mg of sodium lauryl sulfate per 1 g of cream. Sodium lauryl sulfate may cause local skin irritation (such as stinging or burning) or exacerbate skin reactions caused by other medicines used on the same skin area.

3. How to use Argosulfan

This medicine should always be used according to the doctor's recommendations. In case of doubts, you should consult a doctor again.

Argosulfan is intended for use on the skin.

The medicine can be used without a dressing or with dressings (both closed and open).

Recommended dose:

Use in case of burns

The cleaned burn wound should be covered, under aseptic conditions, with a layer of Argosulfan cream 2-3 mm thick. The wound should be covered with the cream throughout the treatment period. If, for any reason, part of the wound is exposed, the exposed areas should be covered with a fresh layer of cream. A dressing on the wound is not necessary, but it can be applied in justified cases.

Argosulfan should be used until the wound heals or a skin transplant is performed.

Use in the treatment of bedsores and chronic leg ulcers

A thin layer of cream should be applied to the affected area 2-3 times a day. During use, exudate may appear. Before reapplying the Argosulfan cream, the wound should be rinsed, e.g. with a 3% aqueous solution of boric acid or a 0.1% aqueous solution of chlorhexidine.

If you feel that the effect of the medicine is too strong or too weak, you should consult a doctor or pharmacist.

Use in children and adolescents

Argosulfan should not be used in premature infants, newborns, and infants up to the age of two months.

In older children, a change in dosage is not necessary.

Using a higher dose of Argosulfan than recommended

In case of using a higher dose than recommended or accidental ingestion of the cream, you should immediately consult a doctor or pharmacist.

Missing a dose of Argosulfan

In case of missing a dose of Argosulfan, you should use it as soon as possible and continue treatment according to the recommendations. You should not use a double dose to make up for the missed dose.

Stopping the use of Argosulfan

In case of any further doubts about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

During the use of Argosulfan, symptoms of irritation and hypersensitivity (burning, itching, redness) may occur.

During long-term treatment, there is a risk of general side effects of sulfonamides, including: kidney and liver damage, changes in blood cell count or damage to blood cells (agranulocytosis, hemolytic anemia, aplastic anemia, and thrombocytopenia, leukopenia), skin reactions and hypersensitivity, e.g. Stevens-Johnson syndrome (manifested as swelling of the mucous membranes), skin peeling.

In some people, during the use of Argosulfan, other side effects may occur.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl

By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Argosulfan

Store in a temperature below 25°C. Do not freeze.

The medicine should be stored in a place that is out of sight and reach of children.

Shelf life after first opening – 6 months.

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

Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Argosulfan contains

• The active substance of the medicine is silver sulfathiazole. 1 g of cream contains 20 mg of silver sulfathiazole.
• The other ingredients are: cetostearyl alcohol, white petrolatum, glycerol, liquid paraffin, disodium phosphate dodecahydrate, sodium lauryl sulfate, potassium dihydrogen phosphate, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), water for injections.

What Argosulfan looks like and what the package contains

Argosulfan is a uniform emulsion mass, white or almost white with a pink to light gray tint.

Argosulfan is available in the following packaging - an aluminum tube with a plastic cap, containing 40 g of cream, in a cardboard box.