PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Argosulfan
20 mg/g, cream
Sulfathiazolum argentum
Please read carefully the entire leaflet before using the medicine, as it contains important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Argosulfan is and what it is used for
Important information before using Argosulfan
How to use Argosulfan
Possible side effects
How to store Argosulfan
Contents of the pack and other information

1. What Argosulfan is and what it is used for

Argosulfan is a topical cream containing silver sulfathiazole, which exhibits strong antibacterial activity against numerous Gram-negative and Gram-positive bacteria.
Argosulfan is used in the treatment of infections in cases of:

burns of all degrees (including radiation burns),
pressure ulcers (wounds caused by continuous pressure on areas of skin, e.g. due to prolonged lying in one position),
chronic leg ulcers (shallow wounds usually appearing on the legs due to impaired blood circulation in veins).
Argosulfan protects the burn wound against infection, forms a protective layer, ensures proper moisture, and also 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 the age of two months, due to the risk of developing kernicterus (a condition caused by deposition of excess unconjugated bilirubin—a substance formed during the breakdown of red blood cells—in the brain nuclei and spinal cord),
in patients with a congenital disorder characterized by deficiency of the enzyme essential for normal red blood cell function (glucose-6-phosphate dehydrogenase deficiency), due to the risk of hemolytic anemia (caused by rapid destruction of red blood cells).

Warnings and precautions
Before starting treatment with Argosulfan, consult your doctor or pharmacist.
Exercise particular caution:

if the patient has extensive burn wounds and is in shock, or if the patient has burn injuries and contact with them is difficult,
in patients with impaired liver or kidney function, due to the risk of drug accumulation in the body and associated risk of adverse effects.

Avoid contact of the medicine with eyes and mucous membranes. In case of accidental contact, rinse thoroughly with large amounts of water.
Inform your doctor about any allergies to other medicines, especially sulfonamides. During treatment with Argosulfan, cross-sensitivity may occur to other drugs, such as sulfonylureas (medicines used in diabetes treatment), benzothiadiazines (medicines used to treat hypertension and edema), and para-aminosalicylic acid (a medicine used in tuberculosis treatment).
If, in the doctor's opinion, wound healing is not progressing adequately, the doctor may order microbiological tests and, if necessary, change the treatment.
Prolonged use of the medicine should be avoided, especially in patients with impaired liver or kidney function.
In cases of long-term treatment prescribed by a doctor or when Argosulfan is applied over large skin areas, the doctor will monitor:

serum sulfonamide concentration, particularly in patients with impaired kidney or liver function;
liver and kidney function and hematopoietic system, especially white blood cell count, due to the risk of agranulocytosis (marked decrease or absence of granulocytes in the blood) or anemia.

Consult your doctor, even if the above warnings refer to conditions that occurred in the past.
Children
Argosulfan must not be used in premature infants, newborns, and infants up to the age of two months, due to the risk of developing kernicterus (a disease caused by deposition of excess unconjugated bilirubin—the substance formed during red blood cell breakdown—in the brain nuclei and spinal cord).
Argosulfan with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
Do not use Argosulfan simultaneously with other topical medicines.
The use of medicines or other preparations containing folic acid or derivatives of para-aminobenzoic acid may reduce the antibacterial effect of Argosulfan.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine. This medicine should not be used during pregnancy or breastfeeding.
Use of Argosulfan in patients with impaired kidney function
Due to lack of clinical data, caution should be exercised when using Argosulfan in patients with impaired kidney function. In patients with severe kidney impairment, the doctor will order monitoring of serum sulfonamide concentration.
Use of Argosulfan in patients with impaired liver function
Due to lack of clinical data, caution should be exercised when using Argosulfan in patients with impaired liver function.
Driving and operating machinery
Argosulfan has no effect on the ability to drive motor vehicles or operate machinery.
Argosulfan contains cetostearyl alcohol, propyl parahydroxybenzoate (E 216), and methyl parahydroxybenzoate (E 218)
Due to the presence of cetostearyl alcohol, this medicine may cause local skin reactions (e.g., contact dermatitis).
Due to the presence of propyl parahydroxybenzoate (E 216) and methyl parahydroxybenzoate (E 218), this medicine may cause allergic reactions (including delayed-type 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 applied to the same skin area.

3. How to use Argosulfan

This medicine should always be used as directed by the physician. In case of doubt, consult the
physician again.
Argosulfan is intended for topical use on the skin.
The medicine may be applied without a dressing or with dressings (both occlusive and non-occlusive).
Recommended dosage:
Use in burns
The cleaned burn wound should be covered under aseptic conditions with a 2–3 mm thick layer of
Argosulfan cream. The wound should remain covered with cream throughout the entire treatment.
If, for any reason, part of the wound becomes exposed, the exposed areas should be covered with a
fresh layer of cream. A dressing is not required, but may be applied when clinically justified.
Argosulfan should be used until wound healing or skin grafting is performed.
Use in the treatment of pressure ulcers and chronic leg ulcers
A thin layer of cream should be applied to the affected area 2–3 times daily. Exudate may appear
during treatment. Before reapplying Argosulfan cream, the wound should be rinsed, e.g. with aqueous
3% boric acid solution or 0.1% aqueous chlorhexidine solution. If the effect of the medicine seems
too strong or too weak, consult the physician or pharmacist.
Use in children and adolescents
Argosulfan should not be used in premature infants, newborns, or infants under two months of age.
In older children, dosage adjustment is not necessary.
Use of a higher than recommended dose of Argosulfan
In case of application of a higher dose than recommended or accidental ingestion of the cream, seek
immediate advice from a physician or pharmacist.
Missed dose of Argosulfan
If a dose of Argosulfan is missed, apply it as soon as possible and continue treatment as directed.
Do not apply a double dose to make up for the missed dose.
Discontinuation of Argosulfan use
In case of any further doubts regarding the use of this medicine, consult the physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
When using Argosulfan, symptoms of irritation and hypersensitivity may occur (burning, itching, erythema).
With prolonged treatment, there is a risk of developing general adverse effects associated with sulfonamides, including: kidney and liver damage, changes in blood cell counts or blood cell damage (agranulocytosis, hemorrhagic diathesis, aplastic and hemolytic anemia, thrombocytopenia, leukopenia), skin reactions and hypersensitivity, e.g. Stevens-Johnson syndrome (manifested as mucosal swelling), skin desquamation. In some individuals, other adverse effects may occur during treatment with Argosulfan.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Argosulfan

Store below 25°C. Do not freeze.
Keep the medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Argosulfan contains

The active substance is silver sulfadiazine. 1 g of cream contains 20 mg of silver sulfadiazine.
The other ingredients are: cetostearyl alcohol, white soft paraffin, 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 contents of the pack
Argosulfan is a homogeneous emulsion mass, white or almost white with a pinkish to light grey tint. Argosulfan is available in the following pack: an aluminium tube with a screw cap made of plastic material containing 40 g of cream, packed in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Responsible party in Lithuania, country of export:
BAUSCH + LOMB IRELAND LIMITED
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Manufacturer:
Przedsiębiorstwo Farmaceutyczne Jelfa S.A.
ul. Wincentego Pola 21
58-500 Jelenia Góra
Poland
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing Authorization number in Lithuania, country of export: LT/1/96/3284/001
Parallel import licence number: 430/22