1. Name of the medicinal product

LEUKICHTAN® gel
Active ingredient: sodium bituminosulphonate, pale

2. Qualitative and quantitative composition

Each 100 g of gel contain:
Active ingredient: sodium bituminosulphonate (ICHTHYOL® sodium), pale, 10.0 g

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Gel

4. Clinical particulars

4.1 Therapeutic indications

Symptomatic treatment of wounds also varicose ulcer in patients with chronic venous insufficiency.

4.2 Dosage and method of administration

Treatment of varicose ulcer:
The wound should be cleansed before application of the gel.
Apply a thick layer of LEUKICHTAN® gel (2-2.5 mm, about half the size as squeezed from the tube) to the affected area. Treatment should be continued for twenty weeks. (There is no experience with treatments over longer periods.).
The gel should be covered with fat gauze, sterile compresses and an elastic bandage. An additional compression therapy is indispensable (Pütter bandage or elastic stockings). During the daily change of the dressing, the wound should be showered with clear water to remove any foreign material and gel residues.
Any deposits or necrotic tissues should be cautiously debrided.

Treatment of cuts, abrasions and burns:
Cleanse the wound, apply the gel twice daily and cover the affected area with an adhesive tape or a dressing.

4.3 Contraindications

Established hypersensitivity to sulphonated shale oils such as ammonium bituminosulphonate and/or sodium bituminosulphonate and/or to any of the excipients.

4.4 Special warnings and precautions for use

Butyl hydroxytoluene may cause local irritation of the skin (e. g. contact dermatitis), of the eyes and of mucous membranes.

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant use of other products for topical application my impair the effect of LEUKICHTAN® gel .

4.6 Pregnancy and lactation

With the normal therapeutic dosages, there is no evidence of any risk of application for human beings or animals. Medicinal products during pregnancy and lactation should be only used after accurate diagnosis.

4.7 Effects on ability to drive and use machines

LEUKICHTAN® gel has no influence on the ability to drive and use machines.

4.8 Undesirable effects

The evaluation of side-effects is based on the following incidence rates:
very frequently (≥ 1/10)
frequently (≥ 1/100 to < 1/10)
occasionally (≥ 1/1,000 to < 1/100)
rarely (≥ 1/10,000 to < 1/1,000)
very rarely (< 1/10,000)

In rare cases (< 0.1 %), the application of the gel may be followed by a temporary burning sensation in the affected area. In general, treatment need not be stopped in such cases.
Skin reactions manifested as contact allergy (e. g. to propylene glycol), itching, redness of the skin, formation of vesicles beyond the area being treated (spreading reaction) have been reported in rare cases (< 0.1 %).

4.9 Overdose

Not relevant.

6. Pharmaceutical Particulars

6.1 List of excipients

Poloxamer 407, propylene glycol, purified water.

6.2 Incompatibilities

Pale sulphonated shale oil can solubilize other active substances and enhance their absorption through the skin.

6.3 Shelf life

Three years.
Do not use this product after expiry date.

6.4 Special precautions for storage

LEUKICHTAN® gel should not be kept at temperatures exceeding 25°C.

6.5 Nature and contents of container

Not all package sizes will probably be offered for sale.
Original packages: tubes containing 30 g and 120 g of gel.

6.6 Special precautions for disposal

No special requirements.

7. Marketing authorisation holder

ICHTHYOL-GESELLSCHAFT
Cordes, Hermanni & Co. (GmbH & Co.) KG
Sportallee 85
D-22335 Hamburg
Phone: + 49 40 50714-0
Fax: +49 40 50714-110
E-mail: info[at]ichthyol.de