מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
WHITE SOFT, PARAFFIN, LIGHT LIQUID, LANOLIN
Reckitt Benckiser Healthcare International Limited Thane Road, Nottingham NG90 2DB, United Kingdom
D02AC
WHITE SOFT PARAFFIN 12.6 % (W/W) LIGHT LIQUID PARAFFIN 1 % (W/W) LANOLIN 1000 % (W/W)
CREAM
WHITE SOFT PARAFFIN 12.6 % (W/W) LIGHT LIQUID PARAFFIN 1 % (W/W) LANOLIN 1000 % (W/W)
OTC
EMOLLIENTS AND PROTECTIVES
Invalid
2008-07-08
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 קרא את המסמך השלם