Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Lauromacrogols, Soya oil may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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Balneum Plus is a bath additive that contains lauromacrogols and soya oil and is used for the treatment of dry skin disorders such as eczema and dermatitis where itching is a problem. Balneum Plus rapidly relieves symptoms associated with dry, itchy skin whilst also cleansing and helping to protect the skin against further drying. Soya oil is an emollient which soothes and softens dry skin by helping to replace lost oils. The oil forms tiny droplets in the water which leaves a thin film on your skin. This film helps to stop your skin drying out and so makes it feel soft. The lauromacrogols are local anaesthetics for the relief of itching associated with eczema, dermatitis and problem dry skin. 2.
e Balneum Plus
Do not use Balneum Plus
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•
Undiluted Balneum Plus should not be swallowed. If this happens talk to your doctor or pharmacist immediately.
Balneum Plus Always use Balneum Plus exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. •
Balneum Plus is for external use by patients of all ages.
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Always shake the bottle before using Balneum Plus to make sure the ingredients are well mixed.
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Pour the appropriate amount of Balneum Plus liquid into the bath as the bath is filling (please see below for correct measurements), be careful the water is not too hot.
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Stay in the bath for at least 10 minutes but not longer than 20 minutes.
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Do not use soap since this will remove Balneum Plus from your skin and can also dry the skin.
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If only a small area of skin is affected, you may be able to bathe the affected area in a bowl or sink.
Measurements:
Balneum Plus can also be used in the shower. In this case the liquid should be evenly applied over the body without dilution and then rinsed off under the shower.
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After bathing or showering gently pat dry with a towel. If you wipe or rub your skin too much the Balneum Plus will not work as well.
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Adults and children should bathe or shower with Balneum Plus at least 3 times a week or as often as required. Your doctor will advise you how often you should use Balneum Plus depending on how severe your skin condition is. For babies and infants a daily bath is recommended.
Duration of treatment Your doctor will tell you for how long you need to use Balneum Plus. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4.
Like all medicines, this medicine can cause side effects, although not everybody gets them. • • •
Very rarely during use there may be cases of reddening, itching and burning. In very rare cases soya oil may cause allergic reactions. The frequency in which rash and with pustules accompanying rash may occur is not known.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.
Balneum Plus
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and the carton after EXP. The expiry date refers to the last day of that month. You should store Balneum Plus in its original pack. Do not store above 25oC. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
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6.
What Balneum Plus contains
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Almirall Hermal GmbH Scholtzstraße 3, 21465 Reinbek, Germany Manufacturer Almirall Hermal GmbH Scholtzstraße 3, 21465 Reinbek, Germany Industrias Farmacéuticas Almirall, S.A. Ctra. de Martorell 41-61 08740 Sant Andreu de la Barca Barcelona Spain
This leaflet was last revised in: March 2022
OTHER INFORMATION Self Help Measures Eczema and dermatitis have many different causes and there are various self help measures you can adopt. If you want to find out more, you may find the following organisation helpful: National Eczema Society, 11 Murray Street, London, NW1 9RE. Telephone Number: 020 7281 3553
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The active substance in Balneum Plus Bath Oil is lauromacrogols, soya oil.
This leaflet reproduces the patient information leaflet approved for Balneum Plus Bath Oil, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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.
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.
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
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.
A partial bath may be required when condition is localised e.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. The instructions in the section 4.4 “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.
• Hypersensitivity to the active ingredients or to any of the excipients listed in section 6.1.
• 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.
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.
This medicine contains 7.8 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.
The additional use of soaps or syndets neutralises the effect of Balneum Plus.
No special precautions are recommended.
None known.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
Ask anything about Balneum Plus Bath Oil. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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