Phytex Paint Cutaneous Solution
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phytex Paint Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Solution contains tannic acid 4.886% w/v, boric acid 3.1245 w/v, salicylates (as salicylic acid 0.89% w/v and methyl salicylate 0.526% v/v).
3 PHARMACEUTICAL FORM
A clear, pale straw-coloured cutaneous solution for application to skin and nails.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of infections of the skin and nails due to superficial dermatophytes of Candida.
4.2 Posology and method of administration
For adults, including the elderly, and children over five years:
The tincture is painted onto the affected areas morning and evening and after washing. Several weeks of treatment may be required to prevent relapse.
Children under five years: Contraindicated.
Contraindications
4.3
Known sensitivity to any of the ingredients. Do not use in children under five. Should not be used on broken or inflamed skin, Use in pregnancy.
4.4 Special warnings and precautions for use
Do not use for longer than 10 days without consulting a doctor. For use on nail areas and feet only. Phytex should be used with caution in patients with impaired circulation and diabetics. Phytex is for topical use only and may be harmful if taken internally.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Fertility, Pregnancy and lactation
Contraindicated
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Slight stinging may occur on application. Any further discomfort caused by dryness of the skin may be due to the astringent nature of the product.
4.9 Overdose
Not applicable.
5.1 Pharmacodynamic properties
Borotannic complex possesses bacteriostatic and fungistatic properties. After application the solvent evaporates to leave a clear film over the infected area. Perspiration subsequently dissolves the active complex which ionises producing a low pH (about 2.0) that is fungicidal. Salicylic acid facilitates penetration of infected skin.
5.2 Pharmacokinetic properties
Salicytic acid and methyl salicylate are absorbed through the skin, however, the quantities present in Phytex would make the possibility of systemic salicylate poisoning remote. Unbound boric acid or Tannic acid may be absorbed through damaged skin. The quantities present in Phytex would indicate that systemic effects are highly unlikely.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glacial acetic acid Industrial methylated spirit Ethyl acetate
6.2 Incompatibilities
Not applicable
6.3 Shelf life
Three years
6.4 Special precautions for storage
Do not store above 25°C. Keep bottle firmly closed.
6.5 Nature and contents of container
Amber glass bottle with polypropylene screw cap and applicator brush, containing 25 ml.
6.6 Special precautions for disposal
No special requirements
7 MARKETING AUTHORISATION HOLDER
Wynlit Laboratories Limited 7 Birchington Road London N8 8HR
8 MARKETING AUTHORISATION NUMBER(S)
PL 00365/0001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23 March 1984/28 June 2011
10 DATE OF REVISION OF THE TEXT