1. NAME OF THE MEDICINAL PRODUCT
PSORIDERM™ EMULSION 40% w/v BATH ADDITIVE
Go to top of the page2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Distilled Coal Tar 40.0% w/v.
Go to top of the page3. PHARMACEUTICAL FORM
Bath additive. Buff coloured liquid emulsion.
Go to top of the page4. CLINICAL PARTICULARS
Go to top of the page4.1 Therapeutic indications
For use topically as an aid in the treatment of sub-acute and chronic psoriasis.
Go to top of the page4.2 Posology and method of administration
For adults, children and the elderly. Add 30 ml of the emulsion to a standard bath of warm water. Soak for 5 minutes, pat dry.
Go to top of the page4.3 Contraindications
Not to be used for acute, sore or pustular psoriasis or in the presence of infection.
Not to be used in cases of sensitivity to any of the ingredients.
Go to top of the page4.4 Special warnings and precautions for use
Do not use product undiluted. Keep away from the eyes and broken or inflamed skin. ******* cap after use. Avoid spillage.
Go to top of the page4.5 Interaction with other medicinal products and other forms of interaction
None known.
Go to top of the page4.6 Pregnancy and lactation
No special precautions.
Go to top of the page4.7 Effects on ability to drive and use machines
None known.
Go to top of the page4.8 Undesirable effects
Local side-effects do not normally occur. In rare cases of skin irritation, acne-like eruptions or photosensitivity, discontinue treatment. Rarely, Psoriderm Bath Additive may stain skin, hair or fabric.
Go to top of the page4.9 Overdose
There are no known toxic effects resulting from excessive use of Psoriderm Bath Additive. If accidentally swallowed, patients should contact a doctor or hospital immediately.
Go to top of the page5. PHARMACOLOGICAL PROPERTIES
Go to top of the page5.1 Pharmacodynamic properties
Coal tar has been used dermatologically for hundreds of years and has been shown to be safe and effective in the treatment of scaly skin conditions such as psoriasis. The British Pharmacopoeia contains monographs on coal tar and coal tar solution, and many formulations of coal tar are used in hospitals throughout the country. The coal tar used in Psoriderm Bath Additive has been specially distilled and is based on a neutral fraction which has been shown to be effective in the treatment of psoriasis.
The precise mechanism of action of coal tar is not understood, largely as a result of it comprising up to 10,000 components. There is evidence that topical application of coal tar improves psoriasis by reducing the excessive rate of mitotic epidermal cell division.
Go to top of the page5.2 Pharmacokinetic properties
Dry scales, which are a common feature of psoriasis, generally reduce the effectiveness of topically applied treatments by reducing absorption of the active ingredient. An established means of overcoming this problem is to add a mild softening agent such as lecithin. In the case of Psoriderm Bath Additive, however, no such softening agent is included because the dosage and administration regime involves prolonged soaking (5 minutes) in a warm water emulsion which achieves a similar effect.
Go to top of the page5.3 Preclinical safety data
None.
Go to top of the page6. PHARMACEUTICAL PARTICULARS
Go to top of the page6.1 List of excipients
Polysorbate 20; Triethanolamine; Phenoxyethanol; Water.
Go to top of the page6.2 Incompatibilities
None known.
Go to top of the page6.3 Shelf life
36 months.
Go to top of the page6.4 Special precautions for storage
Do not store above 25°C.
Go to top of the page6.5 Nature and contents of container
Amber glass bottle containing 200 ml. This is supplied as an original pack (OP).
Go to top of the page6.6 Special precautions for disposal and other handling
Not applicable.
Go to top of the page7. MARKETING AUTHORISATION HOLDER
Dermal Laboratories
Tatmore Place, Gosmore
Hitchin, Herts SG4 7QR, UK.
Go to top of the page8. MARKETING AUTHORISATION NUMBER(S)
00173/5003R.
Go to top of the page9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
4 January 2007.
Go to top of the page10. DATE OF REVISION OF THE TEXT
August 2007.
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