Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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 Urea, Lauromacrogols may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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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 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.
e 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.
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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.
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. 4.
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.
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5.
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 This leaflet was last revised in: September 2019
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Balneum Plus Cream comes as cream. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Balneum Plus Cream is urea, lauromacrogols.
Medicines with the same active substance, strength and form include: E45 Itch Relief Cream. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Balneum Plus Cream, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the treatment of pruritus, eczema, dermatitis, and scaling skin conditions where an antipruritic and/or hydrating effect is required. It may also be used for the continued treatment and follow-up treatment of these skin diseases.
Adults, the elderly and children: Balneum Plus Cream should be applied to each affected area twice a day. The duration of treatment depends on the clinical response. For external use only.
Patients with known hypersensitivity to any of the ingredients. It should not be used to treat acute erythroderma, acute inflammatory, oozing or infected skin lesions.
Avoid contact to mucous membranes and eyes. Irritation (e.g. erythema, burning) may occur if applied to broken or inflamed skin. Benzyl alcohol may cause allergic reactions and mild local irritation. Children/Pediatric population: Reports from the literature suggest that the use of urea-containing products in children may lead to a usually brief burning sensation on the skin. 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
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
For Balneum Plus Cream no clinical data on exposed pregnancies are available.Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.There are no specific restrictions concerning its use during pregnancy, but it is not to be used on the breasts immediately prior to breast feeding during lactation.
None.
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 (frequency based on available data not assessable)Skin and subcutaneous tissue disorders: Uncommon: skin burning sensation, erythema, pruritus, application site pustulesNot known: contact dermatitis, urticaria, rash, rash pustular. 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
Not applicable
Ask anything about Balneum Plus Cream. 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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