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Reckitt Benckiser Ireland Limited
7 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 468 9200
Fax: +353 1 468 9299


Summary of Product Characteristics last updated on medicines.ie: 05/02/2010
SPC E45 Cream



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1. NAME OF THE MEDICINAL PRODUCT

E45 Cream

White Soft Paraffin 14.5% w/w

Light Liquid Paraffin 12.6% w/w

Anhydrous Lanolin 1.0% w/w


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

White Soft Paraffin

14.5% w/w

Light Liquid Paraffin

12.6% w/w

Anhydrous Lanolin

1.0% w/w

Also contains:

Cetyl alcohol

0.5% w/w

Methyl Hydroxybenzoate (E218)

0.15% w/w

Propyl Hydroxybenzoate (E216)

0.04% w/w

For a full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Cream.

Smooth white or practically white cream with not more than a slight odour.


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4. CLINICAL PARTICULARS

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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, dermatitis, sunburn, the dry stage of eczema.


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4.2 Posology and method of administration

For topical application.

Adults, Children and Elderly - Apply to the affected part two or three times daily.


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4.3 Contraindications

Hypersensitivity to any of the ingredients.


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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 and sight of children.

May cause allergic reactions (possibly delayed), such as local skin reactions.


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4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant interactions known.


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4.6 Pregnancy and lactation

No clinically significant interactions known.


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4.7 Effects on ability to drive and use machines

No adverse effects known.


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4.8 Undesirable effects

Occasionally, hypersensitivity reactions, otherwise adverse effects are unlikely, but should they occur, may take the form of an allergic rash. Should this occur, use of the product should be discontinued.


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4.9 Overdose

E45 cream is of low toxicity. If accidental ingestion occurs, conservative treatment only is required.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Lanolin, light liquid paraffin and white soft paraffin have emollient moisturising properties.


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5.2 Pharmacokinetic properties

Not applicable.


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5.3 Preclinical safety data

There are no preclinical safety data of relevance to the consumer.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Glyceryl monostearate

cetyl alcohol,

sodium cetostearyl sulphate

carbomer

methyl hydroxybenzoate (E218)

propyl hydroxybenzoate (E216)

sodium hydroxide

citric acid monohydrate

purified water.


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6.2 Incompatibilities

Compatibility problems may be encountered with the stronger acids, calcium, magnesium and aluminium salts, quaternary compounds, acridines, basic dyestuffs and alkaloids.


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6.3 Shelf life

2 years-Polyethylene tubes

3 years-Aluminium tubes, polypropylene tubs/pots


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6.4 Special precautions for storage

Do not store above 25°C.


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6.5 Nature and contents of container

A polyethylene tube with membrane seal and plastic screw cap.

Pack sizes 15 or 50g.

A polypropylene securipot with a white polythene pilfer-proof screw cap.

Pack sizes: 125g, 350g and 500g.

A polypropylene securipot with a polythene pilfer-proof screw cap fitted with a HDPE or a polypropylene dispenser having a polythene covered follower plate.

Pack sizes: 500 or 900g.

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.


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Ireland Ltd.,

7 Riverwalk,

Citywest Business Campus,

Dublin 24.


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8. MARKETING AUTHORISATION NUMBER(S)

PA 979/43/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 6th June 1984

Date of last renewal: 6th June 2009


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10. DATE OF REVISION OF THE TEXT

January 2010



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