Balneum Plus cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Urea; Lauromacrogols

Available from:

Almirall Ltd

ATC code:

D02AE51

INN (International Name):

Urea; Lauromacrogols

Dosage:

50mg/1gram ; 30mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13020100; GTIN: 4042762037159 5000167032598

Patient Information leaflet

ARTWORK INFORMATION PANEL
DESCRIPTION:
PRINTING COLOURS
NON PRINTING COLOURS
INLINE CONTROL CODE
COLOUR REFERENCE IN PMS BRIDGE
EQUATE WITH CMYK
PROOF:
REGULATORY TEXT:
ITEM NUMBER:
MATERIAL SIZE:
DESIGNER: Laura Garcia - LuDesign
FONTS:
DATE:
MANUFACTURER’S TECHNICAL CHECK:
Manufacturer confirms the printability and
technical compliance of this packaging material
for correct use during packaging process.
Date and Signature
LAETUS
PIL Balneum Medicinal Bath Oil 500 ml GB Mock Up.ai
uk-pl-tracked-asp-mht.doc
Mock Up
148 x 210 mm
22.08.2019
3
Die cut
P 293
Ocean Sans MT Book, BOLD y SEMIBOLD
000
PACKAGE LEAFLET: INFORMATION FOR THE USER
BALNEUM PLUS CREAM
Active Substances: Urea 5,0 %, Lauromacrogols 3,0 %
Cream
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.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Balneum Plus Cream is and what it is used for
2.
What you need to know before you use Balneum Plus Cream
3.
How to use Balneum Plus Cream
4.
Possible side effects
5.
How to store Balneum Plus Cream
6.
Content of the pack and other information
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 Balne

Summary of Product characteristics

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