Doublebase Gel
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Doublebase Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Isopropyl Myristate 15% w/w Liquid Paraffin 15% w/w
For excipients see Section 6.1
3 PHARMACEUTICAL FORM
White opaque gel
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A highly emollient and protective hydrating base for regular first-line treatment and prophylaxis of dry or chapped skin conditions which may also be pruritic (itchy) or inflamed. Doublebase may also be used as an adjunct to other topical treatments.
4.2 Posology and method of administration
For external use only
Before using the 500g bottle, turn the top of the pump dispenser anticlockwise to unlock it.
For adults, the elderly, infants and children
• Apply Doublebase to the affected areas as often as necessary. For the best results use a few gentle strokes to smooth Doublebase across the skin in the same direction as hair growth. If necessary, allow time for any excess to soak in. Do not rub vigorously.
• Doublebase may also be applied before washing, showering or having a bath to prevent further drying of the skin.
If additional topical treatments are being used on the same skin areas, Doublebase should be applied between these applications.
4.3 Contraindications
Do not use in cases of known sensitivity to any of the ingredients
4.4 Special warnings and precautions for use
None
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Pregnancy and lactation
No special precautions
4.7 Effects on ability to drive and use machines
No special precautions
4.8 Undesirable effects
Although Doublebase has been specially formulated for use on dry, problem or sensitive skin, local skin reactions can occur in rare cases. In this event, 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
Not applicable
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The oily ingredients, isopropyl myristate and liquid paraffin, encourage rehydration and softening of dry skin by forming an occlusive barrier within the skin surface, thus reducing drying from evaporation of water that diffuses from the underlying layers.
5.2 Pharmacokinetic properties
Because Doublebase is designed to deliver the emollient ingredients into the stratum corneum when gently applied to areas of dry skin, it is relatively nongreasy despite its high oil content.
5.3 Preclinical safety data
No relevant information additional to that contained elsewhere in this SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycerol Carbomer Sorbitan laurate Trolamine Phenoxyethanol Purified water
6.2 Incompatibilities
None known
6.3 Shelf life
36 months
6.4 Special precautions for storage
Do not store above 25 °C Do not freeze
6.5 Nature and contents of container
PVC BOTTLE (500g) with polypropylene METERING PUMP Polyethylene laminate tube (25g and 100g) with polypropylene SCREW CAP
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
MARKETING AUTHORISATION NUMBER
PL 00173/0183
9
10
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/03/2001 / 13/07/2006
DATE OF REVISION OF THE TEXT
27/10/2015