SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Oilatum Bath Formula Oilatum Emollient

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Light Liquid Paraffin 63.4% w/w

3 PHARMACEUTICAL FORM

Liquid Bath Additive

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Oilatum Emollient is indicated in the treatment of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin conditions. Oilatum Emollient replaces oil and water and hydrates the keratin. Oilatum Emollient is particularly suitable for infant bathing. The preparation also overcomes the problem of cleansing the skin in conditions where the use of soaps, soap substitutes and colloid or oatmeal baths proves irritating.

4.2 Posology and method of administration

Oilatum Emollient should always be used with water, either added to the water or applied to wet skin.

Adult bath:

Add 1-3 capfuls to an 8-inch bath of water, soak for 10-20 minutes. Pat dry.

Infant bath:

Add V-2 capfuls to a basin of water, Apply gently over entire body with a sponge. Pat dry.

Skin cleansing:

Rub a small amount of oil into wet skin. Rinse and pat dry.

Where conditions permit, and particularly in cases of extensive areas of dry skin, Oilatum Emollient should be used as a bath oil, ensuring complete coverage by immersion. In addition to the therapeutic benefits, this method of use provides a means of sedating tense patients, particularly relevant in cases of acute pruritic dermatoses where relaxation of tension appears to relieve symptoms.

The product is suitable for use in adults, children and the elderly.

4.3 Contraindications

None

4.4 Special warnings and precautions for use

The patient should be advised to use care to avoid slipping in the bath. If a rash or skin irritation occurs, stop using the product and consult your doctor.

Oilatum Emollient should be used with caution in patients with a known sensitivity or allergy to light liquid paraffin (LLP) or to any of the excipients in the preparation.

Interaction with other medicinal products and other forms of interaction

None known

4.6 Pregnancy and lactation Fertility

There are no data on the use of Oilatum Emollient on human fertility.

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to Oilatum Emollient is expected to be low.

Lactation

It is not known if Oilatum Emollient 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

4.8 Undesirable effects

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 irritation, rash, erythema, pruritus

Immune System Disorders

Rare: Application site hypersensitivity reactions including application site dermatitis

4.9 Overdose

Symptoms and signs

The product is intended for cutaneous use only. Accidental ingestion may cause gastrointestinal irritation with nausea, vomiting and diarrhoea.

Treatment

In case of accidental ingestion, management should be as clinically indicated or as recommended by the national poisons centre, where available.

5.1 Pharmacodynamic properties

Light liquid paraffin exerts an emollient effect by forming an occlusive oil film on the stratum corneum. This prevents excessive evaporation of water from the skin surface and aids in the prevention of dryness.

5.2 Pharmacokinetic properties

Not applicable

5.3 Preclinical safety data

Not applicable

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Acetylated Lanolin Alcohols

Isopropyl Palmitate Polyethylene Glycol 400 dilaurate Polyoxyethylene 40 sorbital septaoleate Floral Spice

6.2 Incompatibilities

None

Shelf life

5 years

6.4 Special precautions for storage

None

6.5 Nature and contents of container

High density polyethylene bottles with a screw cap. Capacity: 25ml, 150ml, 200ml, 250ml, 300ml, 350ml, 400ml, 500ml, 600ml, 1000ml.

6.6 Special precautions for disposal

There are no special instructions for use or handling.

7    MARKETING AUTHORISATION HOLDER

Beecham Group plc, trading as Stiefel

980 Great West Road Brentford Middlesex TW8 9GS United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 00079/0707

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

08/12/1989 / 13/01/2003

DATE OF REVISION OF THE TEXT

20/02/2014