1. Name of the medicinal product

AKNICHTHOL® SOFT emulsion for application to the skin

2. Qualitative and quantitative composition

Each 100 g of AKNICHTHOL® SOFT contain:
Active ingredient: sodium bituminosulphonate (ICHTHYOL® sodium), pale, 1 g
For a full list of excipients, see section 6.1

3. Pharmaceutical form

Emulsion for application to the skin

4.    Clinical particulars

4.1 Therapeutic indications

Reduction in the number of comedones in patients with mild to moderate acne vulgaris.

4.2 Dosage and method of administration

AKNICHTHOL® SOFT should be evenly applied to previously cleansed skin areas, twice or three times daily. Do not apply to eyelids and lips.
In children, the daily dose of 0.2 g of salicylic acid (equiv. to 40 g of emulsion) must not be exceeded.

Treatment should not be continued for more than twelve weeks.

4.3 Contraindications

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

4.4 Special warnings and precautions for use

Contact with the eyes has to be avoided.

Owing to its salicylic acid content, AKNICHTHOL® SOFT should not be used for long-term treatment of extended skin areas in patients with renal insufficiency. In exceptional cases, areas not larger than 10 cm² can be treated for up to three days. The use of AKNICHTHOL® SOFT in infants should be avoided.

4.5 Interaction with other medicinal products and other forms of interaction

Pale sodium bituminosulphonate can solubilize other active substances and enhance their absorption through the skin.
The salicylic acid component may enhance the absorption of other topically applied drugs. After absorption, salicylic acid may interact with methotrexate and sulphonylureas.
The concomitant use of other products for topical application may impair the effect of AKNICHTHOL® SOFT.

4.6 Pregnancy and lactation

No data are available about the use of AKNICHTHOL® SOFT in humans during pregnancy and lactation. The data obtained from animal studies concerning reproduction toxicity (see section 5.3) are insufficient. The potential risk of the use of this product by pregnant women and nursing mothers is unknown.

4.7 Effects on ability to drive and use machines

AKNICHTHOL® SOFT 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 may occur in very rare cases (< 0.01 %) after application of AKNICHTHOL® SOFT. Very rare cases of contact allergy have been reported (< 0.01 %).

4.9 Overdose

Symptomatic treatment might be required.

6. Pharmaceutical Particulars

6.1 List of excipients

Salicylic acid, medium-chain triglycerides, macrogol-4-lauryl ether,
Oleth-5 Polyethyleneglycol-7-glycerylcocoate, corn starch, highly dispersed silicon dioxide, titanium dioxide (E 171), iron oxide and iron(III) hydroxide oxide (E 172), flavouring agents, purified water.

6.2 Incompatibilities

Pale 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

Two years.
Shelf life after opening: 6 months

Do not use this product after expiration date.

6.4 Special precautions for storage

AKNICHTHOL® SOFT should not be kept at temperatures exceeding 25°C.

6.5 Nature and contents of container

Bottle containing 30 g of emulsion.

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