Sprilon 12.5 % Zinc Oxide and 1.04 % Dimeticone Cutaneous Spray, Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zinc oxide; Dimeticone 350

Available from:

Ayrton Saunders Ltd

ATC code:

D02AB

INN (International Name):

Zinc oxide; Dimeticone 350

Dosage:

12.5%w/w + 1.04 percent weight/weight

Pharmaceutical form:

Cutaneous spray, solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Zinc products

Authorization status:

Marketed

Authorization date:

1996-05-21

Patient Information leaflet

1. WHAT SPRILON IS USED FOR
Sprilon is used for the prevention and treatment of pressure sores,
and skin damage from contact with body fluids, e. g. around the
perineum, fistulae, colostomies, ileostomies eczematous areas etc.
It is also used for the protection and treatment of fissures and
leg ulcers, and the protection of skin beneath plaster casts.
2. BEFORE YOU USE SPRILON
Do not use Sprilon and talk to your doctor if:
•
You are allergic (hypersensitive) to zinc oxide, dimeticone,
wool fat or any of the other ingredients.
•
You are sensitive to cetostearyl alcohol.
Ask your doctor for advice before taking any medicine if you are
pregnant or breast-feeding.
Warnings and precautions
Do not 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.
3. HOW TO USE SPRILON
For external use only.
Avoid inhalation or contact with the eyes.
Shake the can well. Hold the can 20cm (8”) away from the
skin surface, at a right angle. Gently press the nozzle to apply
a thin even layer.
Two to three seconds of spraying should be sufficient to cover
an area the size of the buttocks. A mild cooling sensation may
be experienced. Re-apply as often as necessary.
Frequent, repeated application to the same area could lead to
skin irritation.
Other skin preparations may disrupt the Sprilon film if applied
to the same area. If you accidentally spray into your eyes, bathe
them throughly in water and talk to your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Sprilon can cause side effects,
although not everybody gets them. Stop use and
talk to your doctor or pharmacist if:
AYRTON SAUNDERS LTD.
115G
12.5%W/W / 1.04%W/W
CUTANEOUS SPRAY SUSPENSION
ZINC OXIDE / DIMETICONE
NON-IRRITANT
PROTECTIVE
WATER-REPELLENT
SPRAY OINTMENT
PA501/5/1
MA Holder: Ayrton Saunders Ltd.,
9 Arkwright Road, Astmoor Industrial Estate,
Ru

Summary of Product characteristics

Health Products Regulatory Authority
25 July 2019
CRN009732
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sprilon 12.5 % Zinc Oxide and 1.04 % Dimeticone Cutaneous Spray,
Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinc Oxide
12.5
% w/w
Dimeticone 350
1.04
% w/w
_ Excipients_
Wool Fat
5.19
% w/w
Cetostearyl Alcohol
0.519
% w/w
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, eczematous areas etc.
Protection and treatment of fissures and 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 20
cm (8”). Two to three seconds should be sufficient for the
area the size of the buttocks. Sprilon can be re-applied 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
Health Products Regulatory Authority
25 July 2019
CRN009732
Page 2 of 4
Avoid inhalation or contact with the eyes. Keep out of the reach and
sight of children.
If condition is aggravated, discontinue use and consult the 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
INTERACTIONS
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 useof the product is not considered to be
contraindicated during t