Argosulfan

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
ARGOSULFAN (ARGOSULFAN)
20 mg/g, cream
Sulfathiazolum argentum
ARGOSULFAN and АРГОСУЛФАН are the same brand names of the same medicinal product written in Polish and Bulgarian.
Please read the leaflet carefully before use, 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, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are identical.
• If you experience 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:

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

• skin burns of all degrees (including radiation burns);
• pressure ulcers (wounds caused by prolonged pressure on skin areas, e.g. due to lying too long in one position);
• chronic leg ulcers (shallow wounds typically appearing on the legs due to impaired venous blood flow).
  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 produced during the breakdown of red blood cells – in the brain nuclei and spinal cord);

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• in patients with a congenital disorder in which the body lacks the enzyme necessary for normal red blood cell function (glucose-6-phosphate dehydrogenase deficiency), due to the risk of haemolytic anaemia (caused by rapid destruction of red blood cells).

Warnings and precautions
Before starting treatment with Argosulfan, discuss it with 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 the associated risk of adverse effects.

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

• serum sulfonamide levels, particularly in patients with impaired kidney or liver function;
• liver and kidney function and haematopoietic system, especially white blood cell count, due to the risk of agranulocytosis (a significant decrease or absence of granulocytes in the blood) or anaemia.

Consult your doctor, even if the above warnings relate to conditions that occurred in the past.
Children
Do not use Argosulfan in premature infants, newborns, and infants under two months of age, due to the risk of developing kernicterus (a condition caused by deposition of excess unconjugated bilirubin – a substance produced during the breakdown of red blood cells – in the brain nuclei and spinal cord).
Argosulfan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using, has recently used, or 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 may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not use this medicine during pregnancy or while breastfeeding.
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Use of Argosulfan in patients with impaired kidney function
Due to the lack of clinical data, caution should be exercised when using the medicine 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 the lack of clinical data, caution should be exercised when using the medicine in patients with impaired liver function.
Driving and operating machinery
Argosulfan does not affect 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, 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 (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 area of skin.

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 under dressings (both occlusive and non-occlusive).
Recommended dosage:
Use in burns
The cleaned burn wound should be covered aseptically with a 2–3 mm thick layer of Argosulfan cream. The wound should remain covered with the cream throughout 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 necessary, but may be applied when clinically justified.
Argosulfan should be used until wound healing or until skin grafting is performed.
Use in the treatment of pressure ulcers and chronic leg ulcers
Apply a thin layer of cream to the affected area 2–3 times daily. Exudate may occur during treatment. Before reapplying Argosulfan cream, clean the wound, for example, with aqueous 3% boric acid solution or aqueous 0.1% 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.
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Use of a higher than recommended dose of Argosulfan
In case of application of a higher than recommended dose 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 according to instructions. Do not use a double dose to make up for the missed dose.
Discontinuation of Argosulfan
If you have any further doubts regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
During treatment with Argosulfan, symptoms of irritation and hypersensitivity may occur (burning, itching, erythema).
With prolonged treatment, there is a risk of general adverse reactions associated with sulfonamides, including: kidney and liver damage, changes in blood cell counts or blood cell damage (agranulocytosis, haemorrhagic diathesis, aplastic and haemolytic anaemia, thrombocytopenia, leukopenia), skin and hypersensitivity reactions, e.g. Stevens-Johnson syndrome (manifesting as mucosal swelling), skin desquamation.
Other adverse reactions may occur in some individuals during treatment with Argosulfan.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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 reactions enables further information on the safety of the medicine to be collected.

5. How to store Argosulfan

Store below 25°C. Do not freeze.
Keep the medicine in a place out of sight and reach of children.
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.
Usable period after first opening of the tube – 6 months.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
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6. Contents of the packaging 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, white or almost white with a pinkish to light grey tint.
Argosulfan is available in the following pack sizes:

• Aluminium tube with HDPE cap containing 40 g of cream, packed in a cardboard box.

For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Bulgaria, the country of export:
BAUSCH + LOMB IRELAND LIMITED, 3013 Lake Drive, Citywest Business Campus, Dublin
24, D24PPT3, Ireland
Manufacturer:
Jelfa S.A. Pharmaceutical Company, ul. Wincentego Pola 21, 58-500 Jelenia Góra, Poland
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation number in Bulgaria, the country of export: 20020311
Parallel Import Authorisation Number: 15/26
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