ANTHISAN 2 %w/w Cream
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
MEPYRAMINE MALEATE
Available from:
G & A Licensing Limited
INN (International Name):
MEPYRAMINE MALEATE
Dosage:
2 %w/w
Pharmaceutical form:
Cream
Prescription type:
Product not subject to medical prescription
Authorization status:
Withdrawn
Authorization date:
2013-02-27
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anthisan 2% w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Mepyramine maleate 2% w/w
Excipients: includes methyl parahydroxybenzoate (E218), cetostearyl alcohol and benzyl benzoate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
_Product imported from the UK_
Smooth homogenous cream of fairly firm consistency, off-white to pale in colour
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anthisan has analgesic, anti-histaminic and anti-pruritic properties.
Symptomatic relief in insect bites, stings and nettle rash.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is topical.
Recommended Dosage
Apply to affected area 2 to 3 times daily for up to 3 days or as directed by the physician.
4.3 CONTRAINDICATIONS
Acute vesicular and exudative dermatoses.
Use on broken skin.
Use with occlusive dressings.
Use in patients hypersensitive to mepyramine maleate or any of the excipients of Anthisan Cream.
Use in premature infants and neonates.
Pregnancy and lactaction.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms persist, consult a doctor.
Contains methyl parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed).
Contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
Contains benzyl benzoate : mildly irritant to the skin, eyes and mucous membrane
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 26/10/2011_
_CRN 2107054_
_page number: 1_
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None.
4.6 FERTILITY, PREGNANCY AND LACTATION
There is no evidence of the safety of Mepyramine Maleate in human pregnancy.
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