Summary of Product Characteristics (SmPC) - Sprilon 12.5%w/w /1.04%w/w cutaneous spray, suspension
1 NAME OF THE MEDICINAL PRODUCT
Sprilon 12.5% w/w / 1.04% w/w Cutaneous Spray, Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinc Oxide 12.5 % w/w Ph. Eur.
Dimeticone 350 1.04 % w/w Ph. Eur
Excipients:
Wool fat 5.19% w/w BP
Cetostearyl alcohol 0.519% w/w Ph.Eur.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Spray, Suspension.
White, water-repellant, viscous ointment suspended in a propellant.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
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 plaster casts.
4.2 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.
4.3 Contraindications
Do not use on patients with known sensitivity to wool fats.
4.4 Special warnings and precautions for use
Avoid inhalation or contact with the eyes. Keep out of the sight and reach of children.
If condition is aggravated, discontinue use and consult doctor.
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.
4.5 Interaction with other medicinal products and other forms of interaction
Other topical preparations may disrupt the Sprilon Film.
4.6 Fertility, 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.
4.7 Effects on ability to drive and use machines
Unlikely to produce any effect.
4.8 Undesirable effects
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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9 Overdose
It is very unlikely that overdose would occur with Sprilon. Theoretically, frequently repeated topical application on the same site could lead to skin irritation.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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.
5.2 Pharmacokinetic properties
Not applicable
5.3 Preclinical safety data
Not stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
White soft paraffin
Wool fat (anhydrous lanolin)
Liquid paraffin
Cetostearyl alcohol
Wool alcohols (wool wax alcohols)
Dextran CB
Purified Water
Propellant: Isobutane
6.2 Incompatibilities
None
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25ºC. Extremely flammable.
The canister contains a pressurised liquid. Do not expose to temperatures higher than 50ºC. Do not pierce the canister.
6.5 Nature and contents of container
Aluminium pressurised can with plastic cap containing 115g of which Sprilon cutaneous spray suspension is 60g.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Brown & Burk UK Limited,
Micro House,
Bury Street,
Ruislip,
HA4 7TL
8 MARKETING AUTHORISATION NUMBER(S)
PL 25298/0460
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23rd March 2005
10 DATE OF REVISION OF THE TEXT
18/03/2026