SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Carbo-Dome* Cream.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 100g of cream contains coal tar solution BP 10g.

For a full list of excipients, see section 6.1.

3.    Pharmaceutical Form

Cream.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

The coal tar solution in Carbo-Dome* Cream has a keratoplastic and antipruritic effect in psoriasis.

Indications

Psoriasis.

4.2    Posology and method of administration

For topical application only.

Adults and children over 12 years of age:

Ensure that the lesions are clean. Apply a thin layer of Carbo-Dome* Cream two or three times a day on to the affected areas massage in gently and leave to dry.

For young children under 12 years of age and the elderly:

The emulsion may be diluted by mixing it with a few drops of cooled freshly boiled in the palm of the hand.

4.3    Contraindications

Coal tar should not be used when a patient has known sensitivity to coal tar or any of the other ingredients.

If you have folliculitis and acne vulgaris.

Carbo-Dome* Cream should not be used on patients who have disease characterised by photosensitivity such as lupus erythematosus or allergy to sunlight.

Carbo-Dome* Cream should not be applied to inflamed or broken skin.

4.4    Special warnings and precautions for use

For topical administration only.

Coal tar may cause skin irritation, should this occur the treatment should be reviewed and if necessary discontinued.

Coal tar enhances photosensitivity of the skin after applying Carbo-Dome* Cream exposure to direct sunlight should be avoided.

Use with care near the eyes and mucous membranes. If any emulsion should accidentally enter the eye, flush with normal saline solution or water.

Do not apply to genital and rectal areas.

Apply with caution to the face do not get in the eyes.

Hydrogenated polyoxyl castor oil may cause skin reactions. Methyl and propyl hydroxybenzoates may cause allergic reactions that might be cause a delayed reaction.

4.5    Interactions with other medicinal products and other forms of interaction

None known

4.6    Pregnancy and lactation

There is no direct evidence of the safety in pregnant and lactating women but coal tar preparations have been in use for many years without apparent ill-consequence and no harmful effects on the health of the child is anticipated with the proper use of this product. However it is recommended that the use of coal tar in pregnancy and lactation is restricted to intermittent use in low concentrations on a small percentage of body’s surface, use during the first trimester be avoided.

4.7    Effects on Ability to Drive and Use Machines

None known.

Undesirable effects

Skin and subcutaneous tissue disorders:

Skin irritation, photosensitivity of the skin, coal tar may cause acne-like eruptions of the skin.

There is an increased risk of skin cancer in psoriatic patients treated with a combination of coal tar and UVB radiation has been reported. However epidemiological studies of patients treated with coal tar on its own are inconclusive. The risk of toxicity should be taken into account when considering the prescribing this product for the patient (see also Section 5.3).

4.9 Overdose

There is no evidence that an overdose of topical Carbo-Dome* Cream would be harmful other than a hypersensitivity to coal tar. Ingestion of Carbo-Dome* Cream may require gastric lavage depending on the quantity taken and should be treated symptomatically.

5 PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Carbo-Dome* Cream contains coal tar an antipruritic and keratoplastic. Its used in the treatment eczema, psoriasis and other skin conditions. Tar acids have also been shown to have disinfectant properties. Carbo-Dome* Cream may be used on its own or as part of a more extensive treatment regimen.

5.2    Pharmacokinetic Properties

The product is designed for external use only. Absorption of the coal tar is not reported in ‘Martindale’ and therefore the pharmacokinetics is not addressed.

5.3 Preclinical safety data

In animal studies on coal tar has an increase in incidence of epidermal carcinomas and self-limiting keratoacanthomas.

While the ingredients of coal tar have been shown to express genotoxic properties, epidemiological studies with patients have been shown to be inconclusive concerning the potential carcinogenic risks of coal tar products in long term treatment. Nevertheless the possible risk of prolonged treatment should be taken into account when using this product.

6.1    List of excipients

Dehydag wax SX, beeswax, white soft paraffin, light liquid paraffin, glycerol, sodium lauryl sulphate, methyl-p-hydroxybenzoate and purified water.

6.2    Incompatibilities

None recorded.

6.3    Shelf Life

36 months.

6.4    Special Precautions    for Storage

Store in a cool place.

6.5 Nature and Contents of Container

Tubes (aluminium). Pack sizes: 30g and 100g.

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Sandoz Limited Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR,

United Kingdom.

MARKETING AUTHORISATION NUMBER(S)

4416/0106

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

12 February 1986 Renewed 12 April 2001

10    DATE OF REVISION OF THE TEXT

03/08/2011