Balneum
PACKAGE LEAFLET: INFORMATION FOR THE USER
Balneum Plus
Active substances: lauromacrogols 15 %, soya oil 82.95 % Bath additive
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Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Balneum Plus is and what it is used for
2. What you need to know before you use Balneum Plus
3. How to use Balneum Plus
4. Possible side effects
5. How to store Balneum Plus
6. Content of the pack and other information
1. WHAT BALNEUM PLUS IS AND WHAT IT IS USED 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 USE BALNEUM PLUS Do not use Balneum Plus
• If you are allergic (hypersensitive) 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.
• 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.
Other medicines and Balneum
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 syndet 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. Important information about some of the ingredients of Balneum Plus
Due to its propylene glycol content this medicine may cause skin irritation.
Balneum Plus contains soya oil: If you are allergic to peanut or soya, do not use this medicinal product.
The perfume contains benzylbenzoate which may be mildly irritant to the skin, eyes and mucous membranes.
3. HOW TO USE 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.
• 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 - % 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, Balneum Plus can cause side effects, although not everybody gets them.
• Very rarely during use there may be cases of reddening, itching and burning.
• The frequency in which rash and with pustules accompanying rash may occur is not known.
• In very rare cases soya oil may cause allergic reactions.
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. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE BALNEUM PLUS
Keep out of the reach and sight of children.
Do not use Balneum Plus 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.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. CONTENT OF THE PACK AND OTHER INFORMATION What Balneum Plus contains
The active substances are soya oil 82.95 % and lauromacrogols 15 %.
The other ingredients are ascorbyl palmitate, glyceryl stearate citrate, propylene glycol and perfume oil.
What Balneum Plus looks like and content of the pack Balneum Plus is a clear bath oil.
Your medicinal product comes in either 20 ml, 95 ml, 100 ml, 150 ml, 200 ml, 225 ml, 250 ml, 300 ml, 500 ml, 600 ml, and 1000 ml high density polyethylene bottles with a screw cap and also in 10 ml and 20 ml foil laminate sachets and 20 ml polyethylene/foil blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Almirall Hermal GmbH
ScholtzstraGe 3, 21465 Reinbek, Germany
Tel: +49 -40 727 04-0
Fax: +49 -40 722 92 96
This leaflet was last revised in: 09/2013
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,
Hill House, Highgate Hill, London, N 19 5 NA.
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HI
Telephone Number: 020 7281 3553
8000xxx5/GB / 0713