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Document: label-leaflet ALMIRALL_PL 33016-0010 change

Balneum Plus Cream

Urea 5,0 %, Lauromacrogols 3,0 %

For the treatment of itching and dry skin associated with eczema, dermatitis and scaling skin conditions

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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 to 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.

The indicated skin conditions worsen when the skin is allowed to become dry.

Do not use:

•    If you are allergic (hypersensitive) to urea, lauromacrogols or to any of the other ingredients.

•    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.

•    On the breasts immediately prior to breast feeding.

•    Talk to your doctor before using Balneum Plus Cream in children.

Warnings and precautions: Your medicine may cause irritation if applied to broken or inflamed skin. Avoid contact to mucous membranes and eyes.

Directions: 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. Your doctor will tell you for how long you need to use the cream. Please tell your doctor or pharmacist if you are using other medicines. Urea may increase the penetration through the skin barrier of other topically applied medicines (e.g. corticosteroides, dithranol and fluorouracil) when used at the same time.

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 the 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:

By reporting side effects you can help provide more information on the safety of this medicine.

Do not use after expiry date (see top of the label, refers to the end of that month.)

Do not store above 25°C.

KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN Active Ingredients: urea Ph Eur 5 % w/w , lauromacrogols 3% w/w. Also contains: dimethicone, phenyl dimethicone, liquid paraffin, cetyl palmitate, stearic palmitic acid, octyldodecanol, polysorbate, carbomer, glycerol, benzyl alcohol, trometamol, purified water. Balneum Plus Cream is a white smooth cream.

PL 33016/0010 Text revised: 03/2015 Licence holder and Manufacturer:

Almirall Hermal GmbH    500

ScholtzstraBe 3, 21465 Reinbek, Germany