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Capasal Therapeutic Shampoo

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SUMMARY 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