COAL TAR (EXOREX) LOTION Cutaneous emulsion (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Exorex Lotion 5% v/w Cutaneous Emulsion.
Qualitative and quantitative composition
The active ingredient is coal tar solution 5% v/w. Excipients with known effect: Methyl hydroxybenzoate (E218) 0.10% w/w Propyl hydroxybenzoate (E216) 0.05% w/w Hydrogenated polyoxyl castor oil 0.45% w/w ...
Pharmaceutical form
Cutaneous emulsion. A smooth mustard coloured emulsion.
Therapeutic indications
Exorex is for the treatment of psoriasis of the skin and scalp.
Posology and method of administration
Adults and children over 12 years of age Ensure that the lesions are clean. Apply a thin layer of Exorex two to three times per day to the affected areas. Massage gently and leave to dry. For young children ...
Contraindications
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 ...
Special warnings and precautions for use
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 ...
Interaction with other medicinal products and other forms of interaction
None known.
Pregnancy and lactation
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 ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Skin and subcutaneous tissue disorders 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 ...
Overdose
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Tars ATC code: D05AA 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 ...
Pharmacokinetic properties
Not applicable.
Preclinical safety data
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, ...
List of excipients
Polysorbate 80 Ethanol dl-Alpha tocopherol Vitamin F ethyl ester Xanthan gum Propyl hydroxybenzoate (E216) Methyl hydroxybenzoate (E218) Hydrogenated polyoxyl castor oil Purified water
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
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. Not all pack sizes may be ...
Special precautions for disposal and other handling
Shake the bottle before use.
Marketing authorization holder
Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom
Marketing authorization number(s)
PL 00289/2306
Date of first authorization / renewal of the authorization
3 November 1999/23 May 2007
Date of revision of the text
11/06/2020
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