SPRILON 12.5%W/W /1.04%W/W CUTANEOUS SPRAY SUSPENSION
Active substance(s): DIMETICONE / ZINC OXIDE
NAME OF THE MEDICINAL PRODUCT
Sprilon 12.5% w/w / 1.04% w/w Cutaneous Spray, Suspension
QUALITATIVE AND QUANTITATIVE COMPOSITION
12.5 % w/w
1.04 % w/w
For full list of excipients, see section 6.1.
Cutaneous Spray, Suspension.
White, water-repellant, viscous ointment suspended in a propellant.
For the prevention and treatment of pressure sores, and skin damage from
contact with body fluids e.g. around the perineum, fistulae, colostomies,
ileostomies and eczematous area etc.
Protection and treatment of fissures, leg ulcers. Protection of skin beneath
Posology and method of administration
Shake can well. Spray surfaces at right angles from a distance of 20cm (8“).
Two to three seconds should be sufficient for the area the size of the buttocks.
Sprilon can be reapplied as often as necessary.
Do not use on patients with known sensitivity to wool fats.
Special warnings and precautions for use
Avoid inhalation or contact with the eyes. Keep out of the reach and sight of children.
If condition is aggravated, discontinue use and consult doctor.
Interaction with other medicinal products and other forms of interaction
Other topical preparations may disrupt the Sprilon Film.
Pregnancy and lactation
The safety of Sprilon during pregnancy and lactation has not been established, but use
of the product is not considered to be contraindicated during these periods.
Effects on ability to Drive and Use Machines
Unlikely to produce any effect.
Skin irritation has been observed on rare occasions.
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.
It is very unlikely that overdose would occur with Sprilon. Theoretically, frequently
repeated topical application on the same site could lead to skin irritation.
Sprilon consists of dimeticone, which has a liquid repellant effect. The zinc
oxide ointment base helps to moisturise skin. The spray rapidly forms a white,
durable, flexible film which, while protecting the skin and assisting healing,
allows normal transepidermal water loss.
Preclinical safety data
List of excipients
White soft paraffin
Wool fat (anhydrous lanolin)
Wool alcohols (wool wax alcohols)
Propellent: butane/propane mix
Special precautions for storage
Do not store above 25ºC. Highly flammable.
The canister contains a pressurised liquid. Do not expose to temperatures
higher than 50ºC. Do not pierce the canister.
Nature and contents of container
Aluminium pressurised can with plastic cap containing 115g of which Sprilon
cutaneous spray suspension 60g, or containing 150g of which Sprilon
cutaneous spray, suspension 78g.
Special precautions for disposal
No special requirements.
MARKETING AUTHORISATION HOLDER
Ayrton Saunders Ltd
9 Arkwright Road
Astmoor Industrial Estate
MARKETING AUTHORISATION NUMBER
23rd March 2005
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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