4.1. Therapeutic indications

Topical as a bath additive.

For the prophylactic treatment of eczemas at risk from infection.

4.2. Posology and method of administration

For cutaneous use only.

Oilatum Plus must always be used diluted in water. It is an effective cleanser and should not be used with soap.

Use once daily. Do not exceed the recommended dose:

Adults, adolescents and children:In an eight inch bath (20 cm) add 2 capfuls (20 ml); in a four inch (10 cm) bath add 1 capful (10 ml). Mix well.

Soak for 10-15 minutes. Gently pat the skin dry with a clean towel.

Infants over 6 months of age: Add 1 ml (just sufficient to cover the bottom of the cap) to a baby bath containing approximately 15 litres of water and mix well. Soak for 10-15 minutes. Gently pat the skin dry with a clean towel.

The safety and efficacy of Oilatum Plus has not been established in children less than 6 months of age. Oilatum Plus is not recommended for use in children under 6 months of age.

Elderly: No dosage adjustment is required in the elderly.

4.3. Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1

4.4. Special warnings and precautions for use

Oilatum Plus contains benzalkonium chloride which is irritant and may cause skin reactions.

Contains Lanolin which may cause local skin reactions (e.g. contact dermatitis).

Keep out of reach and sight of children.

If irritation or rash occurs when the product is used in the correct dilution, use should be discontinued.

If the undiluted product comes into contact with the eye, reddening may occur. The patient should be advised to perform eye irrigation for 15 minutes. If there is persistent irritation the patient should be advised to contact a doctor.

Avoid contact of the undiluted product with the eyes and skin.

If undiluted product is applied directly to the skin, it may cause application site skin irritation and hypersensitivity reactions including skin exfoliation, pain, blister, caustic injury and necrosis. The patient should be advised to contact a doctor.

The patient should be advised to use care to avoid slipping in the bath.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

4.5. Interaction with other medicinal products and other forms of interaction

None known.

4.6. Fertility, pregnancy and lactation

Fertility

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

Pregnancy

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

Lactation

It is not known if Oilatum Plus 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 known.

4.8. Undesirable effects

Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as not known (cannot be estimated from the available data).

Post-marketing data

Skin and subcutaneous tissues disorders

Not Known: Application site reactions including- skin exfoliation, erythema, dermatitis, pruritus and burning sensation.

Immune System disorders

Not known: Application site hypersensitivity

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

Oilatum Plus is intended for cutaneous use only. Accidental ingestion may cause gastrointestinal irritation with nausea, vomiting and diarrhoea. It may also cause oesophageal erosion and necrosis.

Oilatum Plus is unlikely to have any systemic effects. Using more frequently than recommended may cause skin irritation and rash (see 4.8 Undesirable effects).In case of accidental ingestion, management should be as clinically indicated or as recommended by the national poisons centre, where available.