E45 CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

E45 Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Anhydrous Lanolin White Soft Paraffin Light Liquid Paraffin

1.0% w/w

BP       14.5%   w/w

PhEur     12.6%   w/w

Excipient(s) with known effect:

Cetyl alcohol 0.5% w/w

Methyl parahydroxybenzoate (E218) 0.15% w/w

Propyl parahydroxybenzoate (E216) 0.04% w/w

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

For external use only

Cetyl alcohol may cause local skin reactions (e.g. contact dermatitis).

Methyl and Propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

If rash develops, use of the product should be discontinued.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

The product should not be applied to the mucous membranes or to broken skin.

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 lactationPregnancy

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.

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.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

5.1 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.

6.4 Special precautions for storage

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.

6.6 Special precautions for disposal

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