E45 Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 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 |
PhEur |
12.6% |
w/w |
Excipient(s) with known effect:
Cetyl alcohol
Methyl hydroxybenzoate (E218)
Propyl hydroxybenzoate (E216)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
A cream
Smooth cream, white or practically 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
Posology
Adults, the elderly, children and infants over the age of 1 month - apply to the affected part two or three times daily.
Method of administration
For topical administration.
4.3 Contraindications
Hypersensitivity to white soft paraffin, light liquid paraffin and anhydrous lanolin or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
If rash develops, use of the product should be discontinued.
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 medicinal products and other forms of interaction
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
No data on human fertility are available.
4.7 Effects on ability to drive and use machines
The product has no or negligible influence on the ability to drive and use machines
4.8 Undesirable effects
Occasionally, hypersensitivity reactions, otherwise adverse effects are unlikely. Should this occur, use of the product should be discontinued.
Adverse events which have been associated with white soft paraffin, light liquid paraffin and anhydrous lanolin are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (>1/10); Common (>1/100 and
<1/10); Uncommon (>1/1000 and <1/100); Rare (>1/10,000 and <1/1000);
Very rare (< 1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
|
System Organ Class |
Frequency |
Adverse Events |
|
Immune System Disorders |
Not known |
Hypersensitivity, Dermatitis allergic |
|
Skin and Subcutaneous Tissue Disorders |
Not known |
Acne |
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
E45 cream is of low toxicity. If accidental ingestion occurs, conservative treatment only is required. There have been no reports of over dosage with use of this product.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group:
Dermatologicals; Soft Paraffin and Fat Products ATC Code: D02AC
Lanolin, light liquid paraffin and white soft paraffin have emollient moisturising properties.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
There are no pre-clinical safety data of relevance to the consumer.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Empilan GMS, cetyl alcohol, sodium cetostearyl sulphate, carbomer, methyl hydroxybenzoate, propyl hydroxybenzoate, sodium hydroxide, citric acid monohydrate, purified water.
6.2 Incompatibilities
Compatibility problems may be encountered with the stronger acids, calcium, magnesium and aluminium salts, quaternary compounds, acridines, basic dyestuffs and alkaloids.
6.3 Shelf life
Aluminium tubes and polypropylene tubs: 3 years. All other containers: 2 years.
Store below 25°C for polyethylene tubes and pump pack, made of polypropylene and polyethylene and consisting of a plastic bottle and a pump system with a dip tube. None for aluminium tubes and polypropylene tubs.
6.5 Nature and contents of container
A collapsible aluminium tube, internally lacquered with a membrane seal and plastic screw cap. Pack sizes: 15, 50 or 100 g.
(The 100 g tube is for dispensing only. One hundred tubes will be packed in an outer carton, labelled with the same wording as an OTC pack and the additional statement 'For dispensing only - not for retail sale'.)
A polyethylene tube with membrane seal and plastic screw cap. Pack sizes 15 or 50 g.
A polypropylene securipot with a white polythene pilfer-proof screw cap. Pack sizes: 125, 350 or 500 g.
A white polypropylene jar with a white polyethylene push-on, tamper-evident closure. Pack sizes: 250, 300 or 500 g.
((The 500 g jar is for dispensing only. Thirty-six jars will be packed in an outer carton, labelled with the same wording as an OTC pack and the additional statement 'For dispensing only - not for retail sale'.)
A polypropylene securipot with a polythene pilfer-proof screw cap fitted with a HDPE or polypropylene dispenser having a polythene covered follower plate.
Pack sizes: 500 or 900 g.
A pump pack made of polypropylene and polyethylene, consisting of a plastic bottle and a pump system with a dip tube. Pack size: 500 g.
A pump pack made of polypropylene and polyethylene, consisting of a piston pump system with an airless dispenser. Pack size: 500g
Not all pack sizes are necessarily marketed.
None.
7 MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
Wellcroft Road
Slough,
SL1 4AQ United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00063/0404
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
25th September 1991
10 DATE OF REVISION OF THE TEXT
22/09/2016