This information is intended for use by health professionals

1. Name of the medicinal product

Oilatum Shower Gel Fragrance-Free

2. Qualitative and quantitative composition

Light liquid paraffin 70.0% w/w

3. Pharmaceutical form

Gel for topical use

4. Clinical particulars
4.1 Therapeutic indications

Oilatum Shower Gel Fragrance-Free is indicated in the treatment of contact dermatitis, atopic dermatitis, senile pruritis, ichthyosis and related dry skin conditions.

4.2 Posology and method of administration

Adults, children and the elderly:

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

Shower as usual. Apply Oilatum Shower Gel Fragrance-Free 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

Oilatum Shower Gel Fragrance-Free should not be used on greasy skin.

Use care to avoid slipping in the shower.

Oilatum Shower Gel Fragrance-Free 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.

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 Oilatum Shower Gel Fragrance-Free on human fertility.

Pregnancy

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

Lactation

It is not known if Oilatum Shower Gel Fragrance-Free 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 in the stratum corneum. This prevents excessive evaporation of water from the skin surface thus improving hydration.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Not applicable. The relevant information is given in Section 4 of the Summary of Product Characteristics

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

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

For the product as packaged for sale

3 years

6.4 Special precautions for storage

Store below 25 °C.

6.5 Nature and contents of container

High density polyethylene tube fitted with a polypropylene screw cap. Capacity 25 g, 30 g, 125 g and 150g.

Polyethylene/ethylene vinyl alchol co-polymer (EVOH)/polyethylene laminate with a polyethylene shoulder, membrane seal, and a polypropylene cap. Capacity 30g and 150g.

6.6 Special precautions for disposal and other handling

There are no special instructions for use or handling of Oilatum Shower Gel Fragrance-Free.

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 44673/0033

9. Date of first authorisation/renewal of the authorisation

24 June 1993

10. Date of revision of the text

27th April 2016