BALNEUM PLUS

Posology Frequency and duration of the application should be adjusted according to the type and severity of the condition, adults should use the bath oil frequently (at least 3 times per week) whilst neonates and infants should be treated daily.

5ml Pediatric population (neonates and children) For bath (~25L) 5ml For neonates and children daily application is recommended. Method of administration After shaking the bottle, Balneum Plus should be added to the bath water and mixed well.

g. the arm. 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. 4 “Special warnings and precautions for use” should be taken into account.

Balneum Plus can also be used in the shower. In this case the preparation should first be evenly applied over the body without dilution. Subsequently the excess is removed under the shower. Soap, which would remove the desired oil film on the skin, should not be used.

Excessive rinsing with water after the bath counteracts the therapeutic action of Balneum Plus. After a bath or shower the skin should only be lightly dabbed with a towel. Vigorous wiping and rubbing decreases the therapeutic effect.

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 (cannot be estimated from the available data) Immune system disorders: In very rare cases, soya oil may cause allergic reactions.

Skin and subcutaneous tissue disorders:

During the use of Balneum Plus there may be very rare cases of reddening, itching and burning. The frequency in which rash and pustular rash may occur is not known. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

As Balneum Plus deposits a film of oil over the skin, care should be taken to avoid slipping, especially in the bath or shower. Contact with the eyes should be avoided and if it occurs the eyes should be washed out with copious amounts of clean water.

Consult an ophthalmologist if irritation continues. Ingestion of the bath oil should be avoided. 8 mg propylene glycol in each ml. This medicine contains fragrance with allergens. These allergens (d-limonene, linalool) may cause allergic reactions.

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. 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.

1. • Hypersensitivity to peanut or soya. • Fresh pustular forms of psoriasis (Psoriasis pustulosa). In the case of • major injuries to the skin and acute skin diseases of unknown cause, • severe febrile and infectious diseases, • cardiac insufficiency, • hypertension, all full baths — including those to which Balneum Plus has been added — should only be taken after consultation with the doctor.