DOUBLEBASE EMOLLIENT BATH ADDITIVE - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Doublebase Emollient Bath Additive.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Liquid paraffin 65.0% w/w

Excipients with known effect:

Cetostearyl alcohol

For the full list of excipients, see Section 6.1.

3 PHARMACEUTICAL FORM

Bath additive. Dye- and fragrance-free white to off white mobile liquid.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the symptomatic relief of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin disorders.

4.2 Posology and method of administration

Adults, including the elderly:

Shake the bottle to mix contents and add 15 to 20 ml (1^ to 2 inner capfuls) to a standard bath of water (20 cm depth). Immerse and cover the affected areas with the bath water and soak for 10 to 20 minutes. Pat dry with a towel.

Infants and children:

Shake the bottle to mix contents and add 5 to 10 ml ('/z to 1 inner capful) to a small bath or wash basin of water. Immerse and cover the affected areas with the bath water and soak for 10 to 20 minutes. Alternatively, repeatedly gently sponge over the affected areas. Pat dry with a towel.

There is no differentiation between the dosage quantities for the symptomatic relief of the conditions listed.

4.3 Contraindications

Sensitivity to any of the ingredients

4.4 Special warnings and precautions for use

Take care not to slip in the bath. Surfaces that have been in contact with the product should be cleaned with a proprietary detergent. Keep out of the sight and reach of children. For external use only.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

Doublebase Emollient Bath Additive contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

4.5 Interaction with other medicinal products and other forms of interaction None known

4.6 Fertility, pregnancy and lactation

The constituents are not percutaneously absorbed or toxic if ingested. There is no evidence of safety of the drug used in pregnancy or lactation, but the active constituent has been in widespread use and in similar preparations for many years without apparent ill consequence.

4.7 Effects on ability to drive and use machines

None known

4.8 Undesirable effects

Contact sensitivity reactions or mild irritant reactions may occur occasionally. In either case, treatment should be discontinued.

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

Accidental ingestion may result in a purgative action due to the liquid paraffin and the oily nature of the product. Treat symptomatically. Fluid and electrolyte replacement may be necessary.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Code: D02AX – Other emollients

For dry skin conditions it is important to use an emollient while bathing. Doublebase Emollient Bath Additive contains 65% Liquid Paraffin for its moisturising and skin softening properties, and is specially formulated to disperse in bath water.

5.2 Pharmacokinetic properties

The active constituent is not absorbed percutaneously. Pharmacokinetic particulars are thus not relevant.

5.3 Preclinical safety data

No relevant information additional to that contained elsewhere in the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Isopropyl myristate

Glycerol

Macrogol cetostearyl ether (cetomacrogol)

Cetostearyl alcohol

Phenoxyethanol

Purified Water

6.2 Incompatibilities

None known

6.3 Shelf life

50ml: 24 months

200ml, 500ml: 30 months

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

50, 200, 500, or 1000ml white high density polyethylene bottle fitted with a polypropylene screw cap.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

Not applicable

7 MARKETING AUTHORISATION HOLDER

Diomed Developments Limited

T/A Dermal Laboratories

Tatmore Place

Gosmore

Hitchin

Hertfordshire SG4 7QR

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 00173/0200

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION

28/03/2006 / 05/11/2010