Boots Pharmaceuticals Bite and Sting Relief Antihistamine 2% w/w Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Mepyramine maleate

Available from:

Taw Pharma (Ireland) Ltd

ATC code:

D04AA; D04AA02

INN (International Name):

Mepyramine maleate

Dosage:

2 percent weight/weight

Pharmaceutical form:

Cream

Therapeutic area:

Antihistamines for topical use; mepyramine

Authorization status:

Not marketed

Authorization date:

2005-12-09

Patient Information leaflet

1
LABELLING
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
1.
NAME OF THE MEDICINAL PRODUCT
(New logo)
Bite & Sting Relief
Antihistamine 2% w/w Cream
Mepyramine Maleate
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
This cream contains Mepyramine Maleate 2% w/w (20 mg/g)
3.
LIST OF EXCIPIENTS
Also contains: purified water, cerostearyl alcohol, white soft
paraffin, liquid paraffin, cetomacrogol 1000,
anhydrous lanolin, sorbitan sesquioleate, sodium citrate, citric acid
monohydrate
4.
PHARMACEUTICAL FORM AND CONTENTS
2% w/w cream
_ _
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
_ _
Read all of this carton for full instructions.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
THE REACH AND SIGHT OF CHILDREN
Keep all medicines out of the sight and reach of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
Cetostearyl alcohol and lanolin may cause skin reactions (e.g. contact
dermatitis).
8.
EXPIRY DATE
Use by:
Use by the date on the end flap of the carton and on the tube edge
(refers to the last day of the month)
9.
SPECIAL STORAGE CONDITIONS
_ _
Do not store above 25°
10.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
After this date return any unused product to your pharmacy for safe
disposal.
2
11.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Taw Pharma (Ireland) Limited, 2 Dublin Landings, North Wall Quay,
Dublin 1, D01 V4A3, Ireland
12.
MARKETING AUTHORISATION NUMBER(S)
PA 23081/003/001
13.
BATCH NUMBER
_ _
Lot:
14.
GENERAL CLASSIFICATION FOR SUPPLY
GSL
15.
INSTRUCTIONS ON USE
Relieves pain, itching and swelling
Soothing relief
WHAT THIS MEDICINE IS FOR:
A soothing antihistamine cream for the relief of pain, itching and
swelling caused by insect bites and stings
and nettle stings.
BEFORE YOU TAKE THIS MEDICINE
_X_ DO NOT TAKE:

IF YOU ARE ALLERGIC
to any of the ingredients or other antihistamines

IF YOU HAVE ECZEMA
or other skin conditions

IF YOU ARE PREGNANT OR BREASTFEEDING
, unless your doctor tel

Summary of Product characteristics

Health Products Regulatory Authority
18 December 2020
CRN00C0M8
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Boots Pharmaceuticals Bite and Sting Relief Antihistamine 2% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of cream contains 20mg mepyramine maleate (2% w/w)
Excipients: contains cetostearyl alcohol 8% w/w and anhydrous lanolin
1% w/w.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
Smooth white cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of insect bites and stings and nettle
stings.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical application to the skin.
For Adults, Children 2 years and over and the Elderly: Rub gently on
to the affected area sparingly two or three times each day
for up to three days.
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
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.
Do not apply to sunburnt skin.
Excipient warnings: Cetostearyl alcohol and anhydrous lanolin may
cause local skin reactions (eg. contact dermatitis)
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
No clinically significant drug interactions expected.
Health Products Regulatory Authority
18 December 2020
CRN00C0M8
Page 2 of 3
4.6 FERTILITY, 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
O