Capasal Therapeutic Shampoo
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Capasal Therapeutic Shampoo
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Distilled coal tar 1.0% (w/w)
Salicyclic acid 0.5% (w/w)
Coconut oil 1.0% (w/w)
For excipients see 6.1
3 PHARMACEUTICAL FORM
Shampoo
Viscous, golden brown shampoo.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For use as a shampoo in the treatment of dry, scaly scalp conditions such as seborrhoeic eczema, seborrhoeic dermatitis, pityriasis capitis, psoriasis and cradle cap in children. It may also be used to remove previous scalp applications.
4.2. Posology and Method of Administration
For adults, children and the elderly.
Use as a shampoo, daily if necessary. Wet the hair thoroughly. Massage a small amount of the shampoo into the scalp, leaving on for a few minutes before washing out. Repeat, producing a rich lather. Rinse hair well and dry.
4.3. Contra-indications
Not to be used in cases of sensitivity to any of the ingredients.
4.4. Special Warnings and Precautions for Use
Keep away from the eyes.
Keep out of the reach of children.
For external use only.
In case of irritation, discontinue treatment.
4.5. Interactions with other Medicaments and other forms of Interaction
None known.
4.6. Pregnancy and Lactation
No known side effects.
4.7. Effects on Ability to Drive and Use Machines
None known.
4.8 Undesirable effects
None known.
Reporting of suspected adverse reactions
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.
4.9. Overdose
There are no known toxic effects resulting from excessive use of Capasal.
5.1 Pharmacodynamic properties
The preparation has been designed as an aid in the treatment of dry, scaly scalp conditions by incorporating into a shampoo formulation three well known ingredients which have been established as safe and effective for use in this indication. They are as follows:
1.0% distilled coal tar - Anti-pruritic, keratoplastic
0.5% salicylic acid - Mild keratolytic
1.0% coconut oil - Emollient, softening agent and lubricant
The preparation may also be used conveniently to remove any previous topical application.
5.2 Pharmacokinetic Properties
The active ingredients of the formulation are readily available for intimate contact with the skin, as the shampoo is massaged into the scalp and left on for a few minutes before washing out. This is then repeated in order to produce a rich lather.
The detergent effect of the shampoo will also remove any previous application to the scalp.
5.3 Preclinical Safety Data
No relevant information additional to that contained elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lauric acid diethanolamide
Coco amido propyl dimethyl betaine Triethanolamine lauryl sulfate (trolamine lauril sulfate) Phenoxyethanol Ammonium sulfate
Water, purified
6.2. Incompatibilities
None known.
6.3. Shelf Life
36 months in unopened container.
6.4. Special Precautions for Storage
Do not store above 25°C. Keep away from direct sunlight.
6.5. Nature and Contents of Container
30ml high density polyethylene bottles with polypropylene screwcaps.
50, 100, 125, 150, 200, 250, 300, 350 and 500ml high density polyethylene bottles with polypropylene dispensing screwcaps.
10ml aluminium foil/polyester/polyethylene laminate sachets.
These are supplied as original packs (OP).
6.6. Instruction for Use/Handling Not applicable.
7 MARKETING AUTHORISATION HOLDER
Diomed Developments Limited T/A Dermal Laboratories Tatmore Place, Gosmore Hitchin, Herts SG4 7QR
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00173/0048
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24/07/2006
10 DATE OF REVISION OF THE TEXT
17/03/2015