Exorex Lotion 5% v/w Cutaneous Emulsion

Coal Tar Solution 5% v/w.

For a full list of excipients, see 6.1.

Cutaneous emulsion

A smooth mustard coloured emulsion.

Exorex is for the treatment of psoriasis of the skin and scalp.

Adults and children over 12 years of age:

Ensure that the lesions are clean. Apply a thin layer of Exorex two or three times per day to the affected areas. Massage gently and leave to dry.

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

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

Do not use if sensitive to any of the ingredients.

Presence of folliculitis and acne vulgaris.

Exorex should not be used on patients who have disease characterised by photosensitivity such as lupus erythematosus or allergy to sunlight.

Exorex should not be applied to inflamed or broken skin (open exuding wounds or infection of the skin).

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

Coal tar enhances photosensitivity of the skin, and exposure to direct sunlight after application of Exorex 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.

None known.

There is inadequate evidence of 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 be restricted to intermittent use, in a low concentration on a relatively small percentage of body surface and that use during the first trimester be avoided.

None known.

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

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 alone are inconclusive. The risk of toxicity should be taken into account when considering the suitability of this product for the patient (see also Section 5.3).

There is no evidence that overdose of topical Exorex would be harmful other than possibly inducing a hypersensitivity to coal tar. Ingestion of Exorex may require gastric lavage depending on the quantity taken and should be treated symptomatically.

Exorex contains coal tar, an antipruritic and keratoplastic. It is used in eczema, psoriasis and other skin conditions. Tar acids have also been shown to have disinfectant properties. Exorex may be used alone, or as part of a more extensive treatment regimen.

Not applicable.

In animal studies coal tar has been shown to increase the 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 human long term treatment. Nevertheless the possible risk of prolonged treatment should be taken into account when considering the usage of the product.

Polysorbate 80

Ethanol

DL-alpha tocopherol

Complex of esterified essential fatty acids

Xanthan gum

Propyl hydroxybenzoate (E216)

Methyl hydroxybenzoate (E218)

Hydrogenated polyoxyl castor oil

Water

None known

2 years

Do not store above 25°C.

High density polyethylene bottle containing titanium dioxide.

Polypropylene green flip-top caps.

Pack sizes: 100 and 250ml

A professional sales pack of 30ml is also available.

No special requirements.

Forest Tosara Limited

Baldoyle Industrial Estate

Grange Road

Dublin 13

Ireland

PL 06166/0001

3 November 1999 / 16 October 2003

August 2009

GSL