Argosulfan

Leaflet attached to the packaging: patient information

ARGOSULFAN, 20 mg/g, cream

Sulfathiazole silver

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. 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 packaging 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 strong antibacterial activity 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),
• pressure sores (wounds caused by constant pressure on skin areas, e.g. from prolonged bed rest),
• chronic leg ulcers (shallow wounds that usually occur on the legs due to poor blood circulation in the veins). Argosulfan protects the burn wound from infection, creates a protective layer, ensures proper humidity, and accelerates wound healing.

2. Important information before using Argosulfan

When not to use Argosulfan:

• if the patient is allergic to sulfathiazole, other sulfonamides, or any of the other ingredients of this medicine (listed in section 6),
• in breastfeeding women, due to the possibility of the active substance passing into breast milk,
• in premature infants, newborns, and infants up to 2 months of age, due to the risk of kernicterus (a disease caused by the accumulation of unconjugated bilirubin in the brain and spinal cord),
• in patients with a congenital disease characterized by a lack of the enzyme that helps red blood cells function normally (glucose-6-phosphate dehydrogenase deficiency), due to the risk of hemolytic anemia.

Warnings and precautions

Before starting to use Argosulfan, the patient should discuss it with their doctor or pharmacist.
Particular caution should be exercised:

• if the patient has extensive burn wounds and is in shock or if the patient has burn wounds and contact with them is difficult,
• 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. Contact between the medicine and the eyes or mucous membranes should be avoided. In case of accidental contact, they should be rinsed with plenty of water. The patient should inform their 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), or para-aminobenzoic acid (used to treat tuberculosis). If the doctor assesses that the wound healing is not proceeding properly, they will order microbiological tests and, if necessary, change the treatment. Long-term use of the medicine should be avoided, 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 skin areas, the doctor will monitor:
• the sulfonamide concentration 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 or anemia.

Children:

Argosulfan should not be used in premature infants, newborns, and infants up to 2 months of age, due to the risk of kernicterus.

Argosulfan and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Argosulfan should not be used simultaneously with other topical medicines.
The use of medicines or preparations containing folic acid or para-aminobenzoic acid derivatives may weaken the antibacterial activity 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 their doctor or pharmacist before using this medicine. Argosulfan should not be used 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 monitor 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 using machines

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

Argosulfan contains cetostearyl alcohol, propyl parahydroxybenzoate, and methyl parahydroxybenzoate

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 and methyl parahydroxybenzoate, 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 as directed by the doctor. In case of doubts, the patient should consult their 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 burn cases
The cleaned burn wound should be covered with a 2-3 mm thick layer of Argosulfan cream, under aseptic conditions. The wound should be covered with the cream throughout the treatment period. If part of the wound is exposed for any reason, the exposed areas should be covered with a new 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 graft is performed.
Use in the treatment of pressure sores 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 cream, the wound should be rinsed, e.g. with a 3% boric acid solution or a 0.1% chlorhexidine solution. If the patient feels that the medicine's action is too strong or too weak, they should consult their doctor or pharmacist.

Use in children and adolescents

Argosulfan should not be used in premature infants, newborns, and infants up to 2 months of age.
In older children, dose adjustment 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, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Argosulfan

In case of missing a dose, the patient should use it as soon as possible and continue treatment as directed. The patient 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 using this medicine, the patient should consult their 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 sulfonamide side effects, including kidney and liver damage, changes in blood cell count or damage to blood cells (agranulocytosis, hemolytic anemia, aplastic anemia, thrombocytopenia, leukopenia), skin reactions and hypersensitivity, such as Stevens-Johnson syndrome (manifested as swelling of the mucous membranes), skin exfoliation. Some people may experience other side effects during the use of Argosulfan.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Argosulfan

Store at a temperature below 25°C. Do not freeze.
The medicine should be stored 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. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging 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, propyl parahydroxybenzoate, water for injections.

What Argosulfan looks like and what the packaging 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:

• aluminum tube containing 40 g of cream, in a cardboard box
• aluminum tube containing 100 g of cream, in a cardboard box

Marketing authorization holder and manufacturer

Marketing authorization holder

BAUSCH + LOMB IRELAND LIMITED
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland

Date of last revision of the leaflet: