1. Name Of The Medicinal Product
Balneum Plus
2. Qualitative And Quantitative Composition
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3. Pharmaceutical Form
Bath oil
4. Clinical Particulars
4.1 Therapeutic Indications
Balneum Plus is a bath oil the active ingredients of which have emollient and local anaesthetic properties and provide relief of pruritus. It is recommended for the treatment of dry skin conditions including those associated with dermatitis and eczema where severe pruritus is also experienced.
4.2 Posology And Method Of Administration
After shaking the bottle, Balneum Plus should be added to the bath water and mixed well.
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.
Dosage
The following quantities are recommended: (If the skin requires considerable moisturising, 2-3 times these quantities can be used)
Adults (including the elderly)
For full bath (~100L) 20ml
For partial bath (~5L) 2.5ml
Neonates and children
For bath (~25L) 5ml
For neonates and children daily application is recommended.
Method of administration
A partial bath may be required when condition is localised e.g. the arm.
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.
4.3 Contraindications
• Hypersensitivity to the active ingredients or to any of the excipients listed in section 6.1 .
• Hypersensitivity to peanut or soya.
4.4 Special Warnings And Precautions For Use
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.
Ingestion of the bath oil should be avoided
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
No special precautions are recommended.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
None known.
4.9 Overdose
In the event of oral ingestion the occurrence of symptoms is very unlikely owing to the low toxicity of the ingredients. No specific antidote or treatment is recommended.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Lauromacrogols (polidocanol) is a local anaesthetic and has an antipruritic action. It is an effective infiltration and conduction anaesthetic.
5.2 Pharmacokinetic Properties
Polidocanol diffuses from skin and mucous membranes to the sensory nerves and therefore has an alleviating effect on the sensation of itch.
Although it has been suggested that local anaesthetics in general have little effect over the intact stratum corneum because of their inability to penetrate this barrier; this seems to apply only to the pure substance without a fatty base.
5.3 Preclinical Safety Data
None relevant to the prescriber which are not mentioned elsewhere in this Summary of Product Characteristics.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Ascorbyl palmitate
Glyceryl stearate citrate
Propylene glycol
Perfume oil
6.2 Incompatibilities
None known.
6.3 Shelf Life
3 years
6.4 Special Precautions For Storage
None stated.
6.5 Nature And Contents Of Container
Balneum Plus is supplied in high density polyethylene bottles in the following sizes: 20ml, 95ml, 100ml, 150ml, 200ml, 225ml, 250ml, 300ml, 500ml, 2x500ml, 600ml and l000ml and also in l0ml and 20ml foil laminate sachets and 20 ml polyethylene/foil blisters.
6.6 Special Precautions For Disposal And Other Handling
None stated.
ADMINISTRATIVE DATA
7. Marketing Authorisation Holder
Allmirall Hermal GmbH
Scholtzstrasse 3
D-21465,
Reinbek
Germany
8. Marketing Authorisation Number(S)
PL 33016/0009
9. Date Of First Authorisation/Renewal Of The Authorisation
31 July 1998
10. Date Of Revision Of The Text
17 November 2011
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