Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Balneum Plus Bath Oil

⚠ This medicine appears to have been discontinued

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.

Active substance: Lauromacrogols, Soya oil
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

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.

What you need to know before you take it

e Balneum Plus

Do not use Balneum Plus

  • If you are allergic to soya, peanut or any of the other ingredients of this medicine (listed in section 6).
  • If you suffer from fresh pustular forms of Psoriasis (Psoriasis pustulosa). All full baths – including those to which Balneum Plus has been added – should only be taken after consultation with your doctor in the following cases: major skin injuries, acute skin diseases of unknown cause, feverish and infectious diseases, heart failure and high blood pressure. If the above applies to you, do not use this medicine and talk to your doctor. Warnings and precautions
  • Avoid getting Balneum Plus in your eyes, however, if this should occur, rinse immediately with clean water. If eye irritation remains please see your doctor.

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•

Undiluted Balneum Plus should not be swallowed. If this happens talk to your doctor or pharmacist immediately.

  • Make sure the bath or shower water does not exceed 36°C, as this can make your skin condition worse.
  • Take care not to slip in the bath or shower.
  • Always clean the bath immediately after you have used Balneum Plus. To do this rinse thoroughly with hot water and then clean with a household cleaner.
  • If your symptoms do not get better, go and see your doctor. Do not 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. Other medicines and Balneum Plus There are no known interactions when using Balneum Plus with other medicines but please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Do not use soaps or syndets in addition to Balneum as this neutralises the effect of the product. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. You may use Balneum Plus whilst you are pregnant. Driving and using machines Balneum Plus is not expected to have any effect on your ability to drive or use machines. Balneum Plus contains propylene glycol and fragrance containing allergens 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.

How to take it

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.

•

Always shake the bottle before using Balneum Plus to make sure the ingredients are well mixed.

•

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.

•

Stay in the bath for at least 10 minutes but not longer than 20 minutes.

•

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:

  • For a full bath (Adults dose) – 1 capful (about 20 ml)
  • For a child ́s or baby ́s bath – 1⁄4 of a capful (about 5 ml)
  • For a partial bath in a bowl or sink – 1/8 of a capful (about 2.5 ml) If you have very dry skin, you can use two or three times the above amounts. •

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.

•

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.

•

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.

Possible side effects

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.

How to store it

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.

Contents of the pack and other information

What Balneum Plus contains

  • The active substances are soya oil 82.95% and lauromacrogols 15%. Other ingredients Propylene glycol (E 1520), ascorbyl palmitate, perfume oil (d-limonene, linalool), glyceryl stearate citrate. What Balneum Plus looks like and contents of the pack Balneum Plus is a clear bath oil. Your medicinal product comes in 200 ml, 500 ml and 2 x 500 ml high density polyethylene bottles with a screw cap. Not all pack sizes may be marketed.

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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Frequently asked questions about Balneum Plus Bath Oil

What is the active substance in Balneum Plus Bath Oil?

The active substance in Balneum Plus Bath Oil is lauromacrogols, soya oil.

Where does this information come from?

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.

Can I get Balneum Plus Bath Oil without a prescription?

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.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Lauromacrogols, soya oil (1 medicine), Soya oil (2 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

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

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.

4.3. Contraindications

• 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.

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. 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.

4.5. Interaction with other medicinal products and other forms of interaction

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

4.6. Fertility, pregnancy and lactation

No special precautions are recommended.

4.7. Effects on ability to drive and use machines

None known.

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 (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.

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.

💬 Ask about this leaflet

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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