Active ingredient
- soya oil
Legal Category
GSL: General Sales List
GSL: General Sales List
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL33016/0008.
Balneum Bath Oil
PACKAGE LEAFLET: INFORMATION FOR THE USER
Balneum
Active substance: soya oil 84.75 %
Bath additive
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you.
What is in this leaflet:
1. What Balneum is and what it is used for
2. What you need to know before you use Balneum
3. How to use Balneum
4. Possible side effects
5. How to store Balneum
6. Content of the pack and other information
1. What Balneum is and what it is used for
Balneum is a bath additive that contains soya oil and is used for the treatment of dry skin disorders such as eczema and dermatitis.
Balneum relieves symptoms associated with dry skin whilst also cleansing, and helping to protect against further drying.
Soya oil is an emollient (moisturiser) which soothes and softens dry skin by helping to replace lost oils. The oil forms tiny droplets in the water which leave a thin film on your skin. This film helps to stop your skin from drying out and so makes it feel soft.
2. What you need to know before you use Balneum
Do not use Balneum
All full baths – including those to which Balneum 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
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
There are no known interactions when using Balneum 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 whilst you are pregnant.
Driving and using machines
Balneum is not expected to have any effect on your ability to drive or use machines.
Balneum contains buthylhydroxytoluene and fragrance containing allergens
Buthylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.
This medicine contains fragrance with allergens. These allergens (benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamyl alcohol, citral, citronellol, coumarin, eugenol, farnesol, geraniol, hydroxycitronellal, isoeugenol, d-limonene, linalool) may cause allergic reactions.
3. How to use Balneum
Always use Balneum exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Measurements:
If you have very dry skin, you can use two or three times the above amounts.
Always clean the bath immediately after you have used Balneum. To do this, rinse the bath and equipment thoroughly with hot water and then clean with a household cleaner.
Duration of treatment
Your doctor will tell you for how long you need to use Balneum.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you use more Balneum than you should
There are no known harmful effects resulting from excessive oil concentrations in the bath water.
4. Possible side effects
Like all medicines, Balneum can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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.
By reporting side effects you can also provide more information on the safety of this medicine.
5. How to store Balneum
Keep out of the sight and reach of children.
Do not use Balneum 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 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 contains
The active substance is soya oil 84,75% .
Other ingredients:
Polyoxyethylene lauryl ether, oleic acid, diethanolamide, perfume oil DV 5171 (benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamyl alcohol, citral, citronellol, coumarin, eugenol, farnesol, geraniol, hydroxycitronellal, isoeugenol, d-limonene, linalool), propylene glycol(E1520), buthylhydroxytoluene (E321), ascorbyl palmitate and citric acid monohydrate.
What Balneum looks like and content of the pack
Balneum is an oily liquid.
Your medicinal product comes in either 20 ml, 95 ml, 100 ml, 150 ml, 200 ml, 225 ml, 250 ml, 300 ml, 500 ml, 2x500ml, 600 ml or 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
Manufacturer
This leaflet was last revised in:
11/2020
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:
Almirall Limited, Harman House, 1 George Street, Uxbridge, Middlesex, UB8 1QQ, UK
+44 (0) 207 160 2500
0800 0087399
0800 0087399