E45 Cream

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

WHITE SOFT, PARAFFIN, LIGHT LIQUID, LANOLIN

Предлага се от:

Reckitt Benckiser Healthcare International Limited Thane Road, Nottingham NG90 2DB, United Kingdom

АТС код:

D02AC

INN (Международно Name):

WHITE SOFT PARAFFIN 12.6 % (W/W) LIGHT LIQUID PARAFFIN 1 % (W/W) LANOLIN 1000 % (W/W)

Лекарствена форма:

CREAM

Композиция:

WHITE SOFT PARAFFIN 12.6 % (W/W) LIGHT LIQUID PARAFFIN 1 % (W/W) LANOLIN 1000 % (W/W)

Вид предписание :

OTC

Терапевтична област:

EMOLLIENTS AND PROTECTIVES

Статус Оторизация:

Invalid

Дата Оторизация:

2008-07-08

Данни за продукта

Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
E45 Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Anhydrous Lanolin
1.0%
w/w
White Soft Paraffin
BP
14.5%
w/w
Light Liquid Paraffin
Ph Eur
12.6%
w/w
3.
PHARMACEUTICAL FORM
Cream
Smooth cream, white or particularly white with a slight odour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief of dry skin conditions, where the use of an
emollient
is indicated, such as flaking, chapped skin, ichthyosis, traumatic
dermatitis,
sunburn, the dry stage of eczema and certain dry cases of psoriasis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For topical application.
Adults, Children and Elderly - Apply to the affected part two or three
times daily.
4.3
CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The labelling states:
For external use only.
If symptoms persist, consult your doctor.
Keep all medicines out of the reach of children.
Patients being dispensed or treated with large quantities (> 100g) of
any paraffin-
based product should be advised to regularly change clothing, bedding
or dressings
impregnated with the product and keep away from naked flames as there
is a fire
hazard.
4.5
INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS OF INTERACTION
Page 2 of 4
The absorption of topical minoxidil can be increased by concurrent
topical
soft paraffin. This could potentiate the hypotensive effects of
vasodilators
4.6
FERTILITY, PREGNANCY AND LACTATION
PREGNANCY
No effects during pregnancy are anticipated, since systemic
exposure to white soft paraffin, liquid paraffin and lanolin is
negligible. As with all medicines, this product should be
used with caution during pregnancy.
BREAST-FEEDING
It is unknown whether soft paraffin, light liquid paraffin and
anhydrous lanolin metabolites are excreted in human milk. A risk to
the newborns/ infants cannot be excluded. Application of the product
to the breast is not recommended during breast feeding.
FERTILITY