Argosulfan

Package Leaflet: Information for the Patient

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

Argosulfan

20 mg/g, cream
Sulfathiazolum argentum

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 you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and should not be given to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 pack 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 many 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 prolonged bed rest),
• 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 also 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,

Warnings and precautions

Before starting to use Argosulfan, you should discuss it with your doctor or pharmacist.
You should be particularly careful:

You should avoid contact between the medicine and your eyes and mucous membranes. If accidental contact occurs, you should rinse them with a large amount of water.
You should inform your doctor about any allergies to other medicines, especially sulfonamides. During the use of Argosulfan, you may experience allergies to other medicines, such as sulfonylurea derivatives (used to treat diabetes), benzothiadiazines (used to treat hypertension and edema), or para-aminosalicylic acid (used to treat tuberculosis).
If your doctor assesses that wound healing is not proceeding properly, they 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 your doctor or the use of Argosulfan on large skin areas, your doctor will monitor:

• the concentration of sulfonamide in 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 your 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 2 months of age, 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 you are currently taking or have recently taken, as well as any medicines you plan 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 para-aminobenzoic acid derivatives may weaken the antibacterial effect of Argosulfan.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your 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 studies, you should be cautious when using the medicine in patients with kidney function disorders. In patients with severe kidney function disorders, your doctor will monitor the concentration of sulfonamide in serum.

Using Argosulfan in patients with liver function disorders

Due to the lack of clinical studies, you should be cautious when using the medicine in patients with liver function disorders.

Driving and using machines

Argosulfan does not affect your 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 your doctor. If you are unsure, you should consult your 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 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 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 graft 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 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 your 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, you should immediately consult your 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 as directed. 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 your 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, you may experience symptoms of irritation and hypersensitivity (burning, itching, redness).
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), skin reactions and hypersensitivity, e.g. Stevens-Johnson syndrome (manifested as swelling of the mucous membranes), skin peeling.
Some people may experience other side effects during the use of Argosulfan.

Reporting side effects

If you experience any side effects, including those 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

Do not store above 25°C. Do not freeze.
The medicine should be stored out of sight and reach of children.
Shelf life after first opening – 2 months.
Medicines should not be disposed of via wastewater or household waste. 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 pack 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: liquid paraffin, cetostearyl alcohol, white petrolatum, sodium lauryl sulfate, glycerol, propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218), potassium dihydrogen phosphate, disodium phosphate dodecahydrate, water for injections.

Argosulfan is a homogeneous emulsive mass, white or almost white with a pink to light gray tint.
Argosulfan is available in a 40 g aluminum tube.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, the country of export:

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:

Pharmaceutical Works Jelfa S.A.
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland

Parallel importer:

Pharmapoint SA
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp.z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Marketing authorization number in Lithuania, the country of export: LT/1/96/3284/001
Parallel import authorization number: 250/18
Date of leaflet approval: 01.03.2022
[Information about the trademark]