Patient leaflet - Balneum Plus cream, Lauromacrogols 3.0% w/w and Urea 5.0% w/w cream
1. What Balneum Plus Cream is and what it is used for
Balneum Plus Cream is an easily absorbed cream containing an ingredient called lauromacrogols which relieves itching. It has a soothing and softening effect on your skin and also works by replacing the much needed oils in your dry skin. This helps to prevent loss of skin moisture.
The cream also contains urea. This substance is found naturally in the skin and helps the skin retain water. Many people with eczema and psoriasis have reduced amounts of urea in their skin and Balneum Plus Cream can help by replacing it.
This cream has been shown to increase skin moisture for up to 24 hours.
Balneum Plus Cream is for the treatment of itching and dry skin seen with eczema, dermatitis and scaling skin conditions. All of these worsen when the skin is allowed to become dry.
2. What you need to know before you use Balneum Plus Cream
Do not use Balneum Plus Cream
- If you are allergic (hypersensitive) to urea, lauromacrogols or any of the other ingredients listed in section 6.
- If you are suffering from severe and widespread reddening of the skin.
- If the affected area has suddenly become inflamed or is oozing and/or infected.
- Talk to your doctor before using Balneum Plus Cream in children.
If this applies to you, do not use this medicine and speak to your doctor.
Warnings and precautions
- Your medicine may cause irritation if applied to broken or inflamed skin.
- Avoid contact to mucous membranes and eyes.
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 Cream
Please tell your doctor or pharmacist if you are taking other medicines. Urea may increase the penetration through the skin barrier of other topically applied medicines (e.g. corticosteroids, dithranol and fluorouracil) when used at the same time
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
- Balneum Plus Cream can be used during pregnancy.
- Do not use this medicine on the breasts immediately prior to breast feeding.
Balneum Plus Cream contains benzyl alcohol
Benzyl alcohol may cause allergic reactions and mild local irritation.
3. How to use Balneum Plus Cream
Always use Balneum Plus Cream exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.
- The medicine is for external use by adults, the elderly and children.
- Using clean hands, apply the cream to the affected areas twice a day until the symptoms have eased.
Duration of treatment
Your doctor will tell you for how long you need to use Balneum Plus Cream
If you have any further questions on the use of this product, ask your doctor or pharmacist.
| Proof: 2 | |||||||||||||||||
Date and Signature Description: Regulatory text: Item Number: Material size: Designer: Date: Colour reference in PMS Bridge Printing Colours PIL Balneum Plus Cream GB Mock up uk-pl-balneum plus cream-May2023.doc (2-2) 00000000 148 x 297 mm 21.09.2023 P 295 | |||||||||||||||||
00000000 / GB / 0523
4. Possible side effects
Like all medicines, Balneum Plus Cream can cause side effects, although not everybody gets them. Treated skin can get worse after using it.
- You may experience a burning sensation, redness, itching or the formation of pustules or your eczema may get worse if Balneum Plus Cream is used on inflamed skin.
- The frequency in which rash and with pustules accompanying rash may occur is not known.
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 Balneum Plus Cream
Keep this medicine out of the sight and reach of children.
Do not use Balneum Plus Cream after the expiry date which is stated on the label, the carton and the tube after EXP.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. 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 Cream contains
The active substances are urea 5% and lauromacrogols 3%.
The other ingredients are dimethicone, phenyl dimethicone, liquid paraffin, cetylpalmitate, stearic palmitic acid, octyldodecanol, glycerol 85 %, polysorbate, carbomer, trometamol, benzyl alcohol and purified water.
What your medicine looks like and content of the pack
Balneum Plus Cream is a white smooth cream.
It comes in either 10g, 35g, 50g, 75g or 100g aluminium tubes with a screw cap or in plastic pump dispensers containing: 175g, 180g, 185g, 190g, 200g and 500g.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Almirall Hermal GmbH
Scholtzstraße 3, 21465 Reinbek, Germany.
Tel: +49-40 727 04-0