Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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.
Hydrogenated polyoxyl castor oil may cause skin reactions. Methyl and propyl hydroxybenzoates may cause allergic reactions that might be delayed.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
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).
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable.
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