Skip to Content

BOOTS BITE & STING RELIEF

Active substance(s): ARNICA MONTANA TINCTURE / CALENDULA OFFICINALIS TINCTURE / ECHINACEA ANGUSTIFOLIA TINCTURE / HYPERICUM PERFORMATUM TINCTURE 1:10 / LEDUM PALUSTRE TINCTURE / PYRETHRUM PALE EXTRACT / RUMEX CRISPUS TINCTURE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Bite and Sting Relief Antihistamine Cream
Boots Bite & Sting Relief 2 Years Plus Antihistamine Cream (GSL only)

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Mepyramine maleate, Ph Eur

3.

% quantity
2.0% w/w

PHARMACEUTICAL FORM
Cream.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
P:
For the symptomatic relief of insect bites and stings and nettle rash.
GSL: For the symptomatic relief of insect bites and stings and nettle stings.

4.2

Posology and method of administration
P:
For adults, children and the elderly: Rub gently on to the affected area
sparingly two or three times each day for up to three days.
GSL: For adults, elderly and children 2 years of age and over: Rub gently on
to the affected area sparingly two or three times each day for up to three days.
For topical application to the skin.

4.3

Contraindications
Hypersensitivity to any of the ingredients or other antihistamines.

Should not be applied to acute vesicular and exudative dermatoses or eczema.

4.4

Special warnings and precautions for use
P & GSL:
Do not apply to broken skin or eczema.
Not to be applied to large areas of skin.
If rash develops or gets worse stop using the product.
For external use only.
Keep all medicines out of the reach of children.
If symptoms do not go away, talk to your doctor.
In addition GSL:
Do not apply to sunburnt skin.

4.5

Interaction with other medicinal products and other forms of interaction
No clinically significant drug interactions expected.

4.6

Pregnancy and lactation
The safety of this product during pregnancy and lactation has not been
established. In view of the potential for systemic absorption through the skin,
the product should not be used during these periods unless under medical
supervision.

4.7

Effects on ability to drive and use machines
No adverse effects known.

4.8

Undesirable effects
Occasional local hypersensitivity reactions.
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
In cases of excessive application to the skin, sufficient absorption may occur
to give rise to systemic adverse effects. Treatment should be symptomatic.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic Properties
Mepyramine maleate is an H1 receptor antagonist (antihistamine) of the
ethylene diamine type. It diminishes or abolishes the effects of histamine in
the body by competitive reversible blockade of histamine receptor sites on
tissues.

5.2

Pharmacokinetic Properties
Mepyramine maleate is readily absorbed through the skin, metabolised in the
liver and excreted, mainly as metabolites in the urine.

5.3

Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are
additional to that already included.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of Excipients
White soft paraffin BP
Liquid paraffin Ph Eur
Anhydrous lanolin EP
Arlacel 83 HSE
Cetomacrogol 1000 BP
Cetostearyl alcohol Ph Eur
Citric acid monohydrate Ph Eur
Sodium citrate Ph Eur

Purified water Ph Eur

6.2

Incompatibilities
None known.

6.3

Shelf Life
24 months.

6.4

Special Precautions for Storage
Do not store above 25°C.

6.5

Nature and Contents of Container
A collapsible internally lacquered aluminium tube with membrane seal fitted
with a high density polyethylene cap.
Pack size:
P: 25gm, 30gm.
GSL: 20 gm

6.6

Instruction for Use, Handling and Disposal
Not applicable.

7.

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham
NG2 3AA

8.

MARKETING AUTHORISATION NUMBER
PL 00014/0440

9.
DATE OF
AUTHORISATION

FIRST

Date of first authorisation:
Date of last renewal:

10

AUTHORISATION/RENEWAL
28th September 1993
13th November 1998

DATE OF REVISION OF THE TEXT
04/06/2015

OF

THE

Expand Transcript

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.

Hide