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SAVLON DUAL ACTION GEL

Active substance(s): CETRIMIDE / LIDOCAINE HYDROCHLORIDE / ZINC SULPHATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Savlon Bites & Stings Pain Relief Gel
Or
Savlon Dual Action Gel

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients:

Lidocaine Hydrochloride
Zinc Sulphate
Cetrimide

2.0% w/w
1.0% w/w
0.5% w/w

For excipients, see section 6.1

3

PHARMACEUTICAL FORM
Gel
Colourless, viscous gel with a characteristic menthol odour.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the symptomatic relief of pain, itching, irritation, and for antiseptic protection.
For use in insect bites and stings, and skin reactions such as nettle rash, caused by
contact with plants.

4.2

Posology and method of administration
Adults and children over 12 years: Apply a small amount to the affected area
with a fingertip. Repeat if required up to 3-4 times daily.
Children under 12 years:

Not recommended (insufficient data available).

Route of administration: For cutaneous use.

4.3

Contraindications
Patients with a known hypersensitivity to any ingredient should not use the
product.

4.4

Special warnings and precautions for use

Contact with the eyes should be avoided. For external use only.
Not suitable for animal bites.
Keep out of the sight and reach of children.
4.5

Interaction with other medicinal products and other forms of interaction
No known interactions with other drugs.

4.6

Fertility, Pregnancy and lactation
There are no known adverse effects in normal use of this product in pregnancy and
lactation.

Exposure to systemically absorbed lidocaine from the product is low. The
active ingredients have been in use for many years and no special precautions
are considered necessary.

4.7

Effects on ability to drive and use machines
There are no known adverse effects on driving and using machinery.
The active ingredients have been in use for many years at much higher levels
of exposure and no precautions are considered necessary for use in driving and
using machinery.

4.8
Undesirable effects
Rarely, skin irritation and sensitisation may occur.
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
Overdosage effects are unlikely as the systemic dose from this topical product
is likely to be very low.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Three pharmacological effects are provided:
Lidocaine hydrochloride is a local anaesthetic of the amide type which is widely used
for local application to the skin and mucous membranes. It produces surface
anaesthesia by diminishing or preventing the conduction of sensory nerve impulses.
Cetrimide is a quaternary ammonium antiseptic. As well as having emulsifying and
detergent properties, it has antibacterial activity against gram-positive organisms and
to a lesser extent against some gram-negative organisms.
Zinc sulphate has astringent and soothing properties.

5.2

Pharmacokinetic properties
The product is intended for local action. Lidocaine hydrochloride is well-absorbed
through mucous membranes and more slowly absorbed through intact skin.

5.3

Preclinical safety data
No relevant information is available other than that given in other sections of
the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Hydroxyethylmethylcellulose
Polysorbate 20
Nonoxynol 9
Propylene Glycol
Levomenthol
Purified Water

6.2

Incompatibilities
None known.

6.3

Shelf life
36 months.
Shelf life after opening of the tube: 3 months

6.4

Special precautions for storage
Do not store above 30°C.

6.5

Nature and contents of container
Laminated tube consisting of aluminium foil coated internally and externally
with low density polyethylene or high density polyethylene.
Pack size: 3g, 20g

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 44673/0110

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
05/10/2006

10

DATE OF REVISION OF THE TEXT
24/02/2016

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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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