Oilatum Gel
SUMMARY OF PRODUCT CHARACTERISTICS
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
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
No Data Held
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 00079/0709
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
7th November 1991.
10 DATE OF REVISION OF THE TEXT
20/02/2014