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Stiefel Ireland
GlaxoSmithKline (Ireland) Ltd, Stonemason's Way, Rathfarnham, Dublin 16,
Telephone: +353 1 495 5000
Fax: +353 1 495 5105
Medical Information Direct Line: +353 1 800 244 255
Medical Information Facsimile: +353 1 495 5242


Summary of Product Characteristics last updated on medicines.ie: 18/08/2011
SPC Oilatum Cream



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1. NAME OF THE MEDICINAL PRODUCT

Oilatum Cream


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Contains Light Liquid Paraffin 6.0% w/w and White Soft Paraffin 15.0% w/w in a cream base.

Also contains cetostearyl alcohol and potassium sorbate.

For a full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Cream.

A white to off-white cream.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Oilatum Cream is indicated in the treatment of contact dermatitis, atopic eczema, senile pruritus, ichthyosis and related dry skin conditions.


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4.2 Posology and method of administration

Oilatum Cream may be used as often as required. Apply to the affected area and rub in well. It is especially effective after washing, when the sebum content of the stratum corneum may be depleted resulting in excessive moisture loss.

Oilatum Cream is suitable for use in adults, children and the elderly.


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4.3 Contraindications

Should not be used in patients with known hypersensitivity to any of the ingredients.


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4.4 Special warnings and precautions for use

Cetostearyl alcohol and potassium sorbate may cause local skin reactions (e.g. contact dermatitis)


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4.5 Interaction with other medicinal products and other forms of interaction

None


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4.6 Pregnancy and lactation

There are no restrictions on the use of Oilatum Cream during pregnancy or lactation.


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4.7 Effects on ability to drive and use machines

None


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4.8 Undesirable effects

May cause irritation in patients hypersensitive to any of the ingredients.


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4.9 Overdose

Accidental ingestion may cause nausea and vomiting. Administer copious quantities of water as required. Excessive topical application should cause no untoward effects other than greasy skin.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Light Liquid Paraffin and White Soft Paraffin exert an emollient effect by forming an occlusive film which reduces trans-epidermal water loss, thus helping to maintain normal skin humidity levels. Polyvinyl pyrrolidone enhances the strength and longevity of the occlusive film formed by the oil on the skin.


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5.2 Pharmacokinetic properties

Not applicable.


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5.3 Preclinical safety data

White Soft Paraffin and Light Liquid Paraffin have been used in pharmaceutical and cosmetic preparations for many years. The formulation contains excipients that are commonly used in such preparations. The safety of these substances is well established by common use over long periods in man.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Macrogol 1000 Monostearate

Cetostearyl alcohol

Glycerol

Potassium sorbate

Benzyl alcohol

Citric acid monohydrate

Povidone

Purified water


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6.2 Incompatibilities

None


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6.3 Shelf life

3 years


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6.4 Special precautions for storage

Store below 25°C.


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6.5 Nature and contents of container

Internally lacquered, membrane sealed aluminium tubes fitted with a polypropylene screw cap and packed into a carton. Pack sizes of 40g and 80g.

And 25 g, 50 g and 150 g in a high density polyethylene tube

Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

None


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7. MARKETING AUTHORISATION HOLDER

GlaxoSmithKline (Ireland) Ltd

Stonemasons Way

Rathfarnham

Dublin 16

Ireland

Trading as Stiefel


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8. MARKETING AUTHORISATION NUMBER(S)

PA 1077/124/001


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 7 March 2003.

Date of last renewal: 7 December 2010


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10. DATE OF REVISION OF THE TEXT

27th May 2011



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Active Ingredients

 
  White Soft Paraffin
  Light Liquid Paraffin