Oilatum Junior
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oilatum Cream Oilatum Junior Cream
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.
3 PHARMACEUTICAL FORM
Cream.
A white to off-white cream.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Oilatum Cream is indicated in the treatment of contact dermatitis, atopic eczema, senile pruritus, ichthyosis and related dry skin conditions.
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 adults, children and the elderly.
4.3 Contraindications
Should not be used in patients with known hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Oilatum Cream should be used with caution in patients with a known sensitivity or allergy to white soft paraffin or light liquid paraffin (WSP-LLP) or to any of the excipients in the preparation.
Cetostearyl alcohol and potassium sorbate may cause local skin reactions (e.g. contact dermatitis).
4.5 Interaction with other medicinal products and other forms of interaction
None.
4.6 Fertility, pregnancy and lactation Fertility
There are no data on the use of topical Oilatum Cream on human fertility Pregnancy
There are no data on the use of topical Oilatum Cream in pregnant women. No effects during pregnancy are anticipated, since systemic exposure to WSP-LLP is low.
Lactation
It is not known if Oilatum Cream is excreted in human milk. Risk to the infant is likely to be low since systemic exposure is low. Patients should be advised to ensure that any residual product is fully washed off the breast prior to breast-feeding.
4.7 Effects on ability to drive and use machines
None.
Undesirable effects
4.8
May cause irritation in patients hypersensitive to any of the ingredients.
Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (>1/10), common (>1/100 and <1/10), uncommon (>1/1,000 and < 1/100), rare (>1/10, 000 and <1/1,000); very rare (<1/10, 000) and not known (cannot be estimated from the available data).
Post-marketing data
Skin and Subcutaneous Tissue Disorders
Rare: Application site reactions including application site erythema, rash, pain, pruritus, skin burning sensation.
Immune System Disorders
Rare: Application site hypersensitivity reactions including application site dermatitis.
4.9 Overdose
Symptoms and signs
The product is intended for topical use only. Ingestion may cause gastrointestinal irritation with nausea, vomiting and diarrhoea. Excessive topical application should cause no untoward effects other than greasy skin.
Treatment
In case of accidental ingestion, management should be as clinically indicated or as recommended by the national poisons centre, where available.
5 PHARMACOLOGICAL PROPERTIES
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.
5.2 Pharmacokinetic properties
Not applicable.
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.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Macrogol 1000 Monostearate Cetostearyl alcohol Glycerol
Potassium sorbate Benzyl alcohol Citric acid monohydrate Povidone Purified water
6.2 Incompatibilities
None.
6.3 Shelf life
Three years.
6.4 Special precautions for storage
Store below 25 °C
6.5 Nature and contents of container
Internally lacquered, membrane sealed aluminium tube fitted with a polypropylene screw cap and packed into a carton. Pack size 40g and 80g.
Internally lacquered, membrane sealed aluminium tube fitted with a polyethylene screw cap and packed into a carton. Pack size 30g and 50g.
Laminate tubes with polypropylene caps packed into cartons. Pack sizes 100g and 150g
And 25g, 50g & 150g in a high density polyethylene tube.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Beecham Group PLC 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 00079/0706
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
07/12/2010
10 DATE OF REVISION OF THE TEXT
05/09/2013