This information is intended for use by health professionals

1. Name of the medicinal product

Oilatum Gel

2. Qualitative and quantitative composition

Light liquid paraffin 70% w/w.

3. Pharmaceutical form

Shower gel.

4. Clinical particulars
4.1 Therapeutic indications

For the treatment of contact dermatitis, atopic dermatitis, senile pruritus ichthyosis and related dry skin conditions.

4.2 Posology and method of administration

Topical

Adults, children and the elderly:

Oilatum Gel may be used as frequently as necessary. Oilatum Gel should always be applied to wet skin, normally as a shower gel.

Shower as usual. Apply Oilatum Gel liberally to wet skin and massage gently. Rinse briefly and lightly pat the skin dry.

4.3 Contraindications

None.

4.4 Special warnings and precautions for use

Take care to avoid slipping in the shower.

Oilatum Gel should not be used on greasy skin.

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

4.5 Interaction with other medicinal products and other forms of interaction

None.

4.6 Pregnancy and lactation

Fertility

There are no data on the use of cutaneous light liquid paraffin on human fertility.

Pregnancy

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

Lactation

It is not known if Oilatum Gel 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

Reporting of suspected adverse reactions

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.

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. Pharmacological properties
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

There are no pre-clinical data of relevance to the prescriber which are additional to those already stated in other sections of the SPC.

6. Pharmaceutical particulars
6.1 List of excipients

Polyethylene

2-octadodecanol

Polyethylene glycol 400 dilaurate.

Polyoxyethylene 40 sorbitol septaoleate

Polypropyleneglycol-2-myristyl ether propionate

Polyphenylmethyl siloxane copolymer

Floral spice.

6.2 Incompatibilities

None.

6.3 Shelf life

a) For the product as packaged for sale

3 years

b) After first opening the container

Comply with expiry date

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

Plastic tubes

High density polyethylene tubes with polypropylene caps

Pack Sizes

15g, 25g, 30g, 50g, 60g, 65g, 70g, 75g, 125g and 150g

Laminate tubes

Polyethylene/ethylene vinyl alcohol co-polymer (EVOH)/polyethylene laminate with a polyethylene shoulder, membrane seal, and a polypropylene cap.

Pack Sizes

30g, 50g and 150g

6.6 Special precautions for disposal and other handling

No Data Held

7. Marketing authorisation holder

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

trading as

Stiefel

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

8. Marketing authorisation number(s)

PL 44673/0034

9. Date of first authorisation/renewal of the authorisation

7th November 1991.

10. Date of revision of the text

27th April 2016