Summary of medicine characteristics - BALNEUM, SOYA OIL 84.75 % W/W BATH ADDITIVE
Balneum
Soya oil 84.75 % w/w bath additive
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITIONSoya oil, 84.75% w/w
Excipients with known effect:
1 g of bath additive contains 0.1 mg of buthylhydroxytoluene (E321) and fragrance containing allergens.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
3 PHARMACEUTICAL FORMOily 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)
2.5ml (1/8 measure)
For partial bath (approx. 5 litres)
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 re-greasing 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 reactions (e.g. contact dermatitis), irritations of the eyes and mucous membranes.
This medicine contains fragrance with allergens. These allergens (d-limonene, linalool) may cause allergic reactions.
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.
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
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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store
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.
5.3 Pre-clinical safety data
Not applicable.
6.1 List of excipients
Polyoxyethylene lauryl ether (4mol EO), oleic acid diethanolamide, perfume oil (d-limonene, linalool),), propylene glycol (E1520), butylated hydroxytoluene (E321), 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 content of container
Container: HDPE bottle with polyethylene or polypropylene cap and with or without LDPE dispensing insert.
Contents: Each bottle contains one of the following amounts; – 20ml, 95ml, 100ml, 150ml, 200ml,225ml, 250ml, 300ml, 500ml, 2×500ml, 600ml, 1000ml.
Also
Container: Foil laminate sachets.
Contents: Each sachet contains one of the following amounts: 10ml, 20ml.
Also
20ml blister pack, consisting of blister foil (PET/PB) and cover foil (PET/aluminum/PE)
6.6. Special precautions for disposal
6.6. Special precautions for disposalAny unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
Almirall Hermal GmbH
Scholtzstrasse 3
D-21465,
Reinbek
Germany