Medication Guide App

SPRILON 12.5%W/W /1.04%W/W CUTANEOUS SPRAY SUSPENSION

Active substance: ZINC OXIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

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
Dimeticone 350

12.5 % w/w
1.04 % w/w

Ph. Eur.
Ph. Eur

5.19% w/w
0.519% w/w

BP
Ph.Eur.

Excipients:
Wool fat
Cetostearyl alcohol

For full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Cutaneous Spray, Suspension.
White, water-repellant, viscous ointment suspended in a propellant.

4.1.

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

Contra-indications
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 reach and sight of children.
If condition is aggravated, discontinue use and consult doctor.

4.5

Interaction with other medicinal products and other forms of interaction
Other topical preparations may disrupt the Sprilon Film.

4.6

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.

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
Propellent: butane/propane mix

6.2

BP
BP
Ph. Eur.
Ph. Eur.
Ph. Eur.
HSE
Ph. Eur.
HSE

Incompatibilities
None

6.3

Shelf Life
3 years

6.4

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.

6.5

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.

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Ayrton Saunders Ltd
9 Arkwright Road
Astmoor Industrial Estate
Runcorn
Cheshire
WA7 1NU

8.

MARKETING AUTHORISATION NUMBER
PL 16431/0020

9.
DATE OF
AUTHORISATION

FIRST

AUTHORISATION/RENEWAL

23rd March 2005

10

DATE OF REVISION OF THE TEXT
09/09/2011

OF

THE

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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