Balneum Intensiv cream

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Disponibil de la:

Almirall Ltd

Forma farmaceutică:

Cream

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Never Valid To Prescribe As A VMP

Rezumat produs:

BNF: ; GTIN: 4042762060218 4042762060201

Prospect

80009175 / GB / 0415
Lot:
Exp:
500 G
For the treatment of itching and
dry skin associated with eczema,
dermatitis and scaling skin conditions
Urea 5,0 %,
Lauromacrogols 3,0 %
Balneum Plus
CREAM
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.
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: www.mhra.gov.uk/yellow

Caracteristicilor produsului

1.
NAME OF THE MEDICINAL PRODUCT
Balneum Plus Cream
Lauromacrogols 3.0% w/w and Urea 5.0% w/w, Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Percentage (w/w)
Lauromacrogols
3.0%
Urea
5.0%
3
PHARMACEUTICAL FORM
Cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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.
4.3
CONTRAINDICATIONS
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.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
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
4.6
FERTILITY, PREGNANCY AND LACTATION
For Balneum Plus Cream no clinical data on exposed pregnancies are
available.
Animal studies do not indicate direct o