1. Name of the medicinal product

ICHTHOLAN® 50 % ointment
Active ingredient: ammonium bituminosulphonate

2. Qualitative and quantitative composition

Each gram of ointment contains:
Active ingredient: ammonium bituminosulphonate, 0.50 g
For a full list of excipients, see section 6.1

3. Pharmaceutical form

Ointment

4.    Clinical particulars

4.1 Therapeutic indications

Maturation of furuncles and abscess-forming processes, osteoarthritis, arthritis (inflammation of a joint), tendovaginitis (inflammation of a tendon sheath), epicondylitis (e. g. tennis elbow), periarthritis (inflammation of the tissues around a joint), bursitis (inflammation of a bursa), blunt trauma of a joint.

4.2 Dosage and method of administration

Apply a thick layer of ICHTHOLAN® 50 % ointment to the affected skin area, which should be covered with an air-permeable dressing.

Apply a thick layer of ointment to the affected area and cover it with a dressing. Continuous dressings with ICHTHOLAN® 50 % ointment should not remain in place for more than three days. The dressing must be permeable to air. Any residues of the ointment should be removed before renewing the dressing. The duration of treatment should not exceed nine days.
ICHTHOLAN® 50 % ointment is suitable for application by means of iontophoresis. This electrotherapy enhances the introduction of the active substance through the skin. The ointment has to be applied below the negative electrode (cathode).
The container must be kept tightly closed after removal of ointment.

4.3 Contraindications

Established hypersensitivity to sulphonated shale oils such as ammonium bituminosulphonate and/or sodium bituminosulphonate or to any of the excipients. Contact with the eyes has to be avoided.

4.4 Special warnings and precautions for use

Wool fat may cause local skin reactions (e. g. contact dermatitis).

4.5 Interaction with other medicinal products and other forms of interaction

Ammonium bituminosulphonate can solubilize other active substances and enhance their absorption through the skin. The concomitant use of other ointments or creams may impair the effect of ICHTHOLAN® 50 % ointment.

4.6 Pregnancy and lactation

Based on the available data about the safety of ICHTHOLAN® 50 % ointment, this product can be used during pregnancy and lactation, in consultation with the physician.

4.7 Effects on ability to drive and use machines

ICHTHOLAN® 50 % ointment 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)

Skin reactions manifested as a burning sensation and/or redness of the skin are uncommon (0.1 % to 1 %). Formation of vesicles is seen in isolated cases ( 0.01 %). In the package leaflet, patients have been instructed to consult a doctor in such circumstances.

Note
A purulent inflammation of the skin may spread further through smear infection. This can be prevented by properly applied dressings, cleanliness, cleansing and disinfection of the surrounding skin and by covering the affected area with a bandage that does not slip or chafe the skin.

4.9 Overdose

Treatment with ICHTHOLAN® 50 % ointment should be stopped in the presence of a severe irritation of the skin. Symptomatic treatment might be required.

6. Pharmaceutical Particulars

6.1 List of excipients

Yellow petrolatum, Cera Microchristallina, wool fat, purified water.

6.2 Incompatibilities

Dark sulphonated shale oil can solubilize other active substances and enhance their absorption through the skin. Precipitation may occur after addition of highly concentrated acids and salts.

6.3 Shelf life

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

6.4 Special precautions for storage

ICHTHOLAN® 50 % should be kept well closed and not at temperatures exceeding 25°C!

6.5 Nature and contents of container

Original packages:
Tube containing 25 g of cream, 40 g of cream

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