Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2011 Publisher: Sandoz Ltd Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom
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.
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.
None known.
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.
None known.
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).
None recorded.
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