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1.    NAME OF THE MEDICINAL PRODUCT

Balneum

Soya oil 84.75 % w/w bath additive

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Soya oil, 84.75% w/w

For the full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Oily liquid for external use.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Dry skin conditions including those associated with dermatitis and eczema.

4.2    Posology and Method of Administration

Bath additive

The liquid should be added to bath water and thoroughly mixed until evenly distributed For full bath (approx. 100 litres)    20ml (1 measure)

For child's bath (approx. 25 litres)    5ml (1/4 measure)

For partial bath (approx. 5 litres)    2.5ml (1/8 measure)

In particularly dry skin, 2-3 times the above quantities can be used

Generally, 2-3 baths should be taken weekly. For babies and infants a daily bath is recommended.

The temperature of the bath water should not exceed 36 °C as the regreasing effect is diminished at higher temperatures.

For the treatment of pruritus the temperature should be 32 °C or as low as can be tolerated.

The bath should not be longer than 20 minutes. In the case of infants and small children a bath of only a few minutes is mostly sufficient.

The duration of the therapy depends on the course of the disease. The instructions in the section

4.4 “Special warnings and precautions for use” should be taken into account.

4.3. Contraindications

•    hypersensitivity to the active ingredient or to any of the excipients listed in section 6.1.

•    hypersensitivity to peanut or soya

•    fresh pustular forms of psoriasis (Psoriasis pustulosa).

In cases of

•    major injuries to the skin and acute skin diseases of unknown cause

•    severe febrile and infectious diseases

•    cardiac muscle weakness (cardiac insufficiency)

•    high blood pressure (hypertension)

full baths should only be taken - irrespective of the ingredients - after consultation with a doctor.

4.4 Special Warnings and Precautions for Use

Do not apply in the area of the eyes. In cases of accidental contact with the eyes rinse

out immediately with copious amounts of cold water. Consult an ophthalmologist if irritation continues.

Butyl hydroxytoluene may cause local skin irritations (e.g. contact dermatitis), irritations of the eyes and mucous membranes.

Propylene glycol can cause skin irritations.

Benzyl benzoate contained in the perfume oil may cause light irritations of the skin, eyes and mucous membranes.

There is an increased risk of slipping due to the oil film on the skin and the oil film in the

bath or shower.

The bathtub, shower and children's bathtub (if applicable) should be cleaned immediately after every bath using conventional household detergent and then rinsed out with hot water.

4.5 Interactions with other Medicinal Products and other Forms of Interaction

The additional use of soaps or syndets neutralises the effect of Balneum.

4.6 Fertility, Pregnancy and Lactation

There are no known restrictions with respect to use during pregnancy and the lactation period.

4.7 Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable Effects

The data given for frequency of adverse reactions is based on the following categories:

Very common (> 1/10)

Common (> 1/100 to < 1/10)

Uncommon (> 1/1,000 to < 1/100)

Rare (> 1/10,000 to 1/1,000)

Very rare (< 1/10,000)

Not known (frequency based on available data not assessable)

Skin and subcutaneous tissue disorders:

During the use of Balneum there may be very rare cases of reddening, itching and burning. Immune system disorders:

Soya oil may cause allergic reactions in very rare cases (<1/10,000).

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, Website: www. mhra. gov.uk/yellowcard.

4.9 Overdose

There are no known harmful effects resulting from excessive oil concentrations in the bath water.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Balneum was developed in response to the need for a suitable non-irritant cleansing agent for patients with eczema. As the skin in this condition requires the application of large amounts of fat, cleansing properties as well as greasing properties were combined. Balneum is a mixture of plant oils having a high proportion of unsaturated fatty acid (linolic acid up to 60%). The emulsifier used is a mixture of fatty acid amides with aliphatic alcohol and readily dispersible polyoxyethylene lauryl ester. Butylhydroxytoluene is added as an antioxidant.

5.2 Pharmacokinetic properties

Not applicable.

Preclinical safety data

Not applicable.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Polyoxyethylene lauryl ether (4mol EO), oleic acid diethanolamide, perfume oil DV5171, propylene glycol, butylated hydroxytoluene, ascorbyl palmitate, citric acid monohydrate.

6.2    Incompatibilities

None.

6.3    Shelf life

HDPE bottle - 5 years Foil Laminate sachet - 5 years Blister pack (20ml) - 2 years

6.4    Special precautions for storage

None.

6.5    Nature and contents of container

Container: HDPE bottle with polyethylene or polypropylene cap and with or without LDPE dispensing insert.

10/07/2010

DATE OF REVISION OF THE TEXT

18/06/2015