EUCERIN INTENSIVE 10% W/W UREA TREATMENT LOTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

UREA

Available from:

Beiersdorf UK Limited

ATC code:

D02AX

INN (International Name):

UREA

Dosage:

10 %w/w

Pharmaceutical form:

Cutaneous Emulsion

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other emollients and protectives

Authorization status:

Marketed

Authorization date:

2005-04-15

Patient Information leaflet

April 2018
Common PIL UK/IE
Page 1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EUCERIN
INTENSIVE LOTION 10% W/W
CUTANEOUS EMULSION
UREA
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 or pharmacist 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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
The name of your medicine is
EUCERIN
INTENSIVE LOTION 10% W/W CUTANEOUS EMULSION.
In the rest of this leaflet it is called
EUCERIN
.
WHAT IS IN THIS LEAFLET
1.
What
EUCERIN
is and what it is used for
2.
What you need to know before you use
EUCERIN
3.
How to use
EUCERIN
4.
Possible side effects
5.
How to store
EUCERIN
6.
Contents of the pack and other information
1.
WHAT EUCERIN
IS AND WHAT IT IS USED FOR
EUCERIN
IS A HYDRATING AGENT. IT IS USED FOR THE TREATMENT OF:
•
ichthyosis (an inherited condition in which the skin is dry, rough and
scaly because of a defect
in cornification),
•
xeroderma, especially in the elderly (a mild form of ichthyosis in
which the skin develops slight
dryness and forms scales) and hyperkeratosis (thickening of the outer
layer of the skin)
•
other chronic dry skin conditions such as atopic eczema (dermatitis).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EUCERIN
DO NOT USE EUCERIN:
•
if you are allergic to urea or any of the other ingredients of this
medicine (listed in section 6)
•
on broken, inflamed skin
•
on large areas of skin if you have kidney trouble
OTHER MEDICINES AND EUCERIN
Consult your doctor or pharmacist if you are using any other medicines
on your skin, including those
obtained without a prescription.
EUCERIN
may increase the penetration of some substances into the
skin e.g.:
•
medicines known as corticosteroids
•
dithranol
•
fluorouracil

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eucerin Intensive Lotion 10% w/w Cutaneous Emulsion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Urea 10% w/w
Contains castor oil, polyoxyl hydrogenated.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous emulsion.
A white, shiny smooth viscous emulsion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For
the treatment
of
ichthyosis,
xeroderma (especially in the elderly),
hyperkeratosis and other
chronic dry skin
conditions such as atopic eczema (dermatitis).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Eucerin Intensive Lotion 10% w/w Cutaneous Emulsion should be applied
twice daily or as directed by a doctor to the
affected areas and gently massaged into the skin.
It should not be allowed to come into contact with the eyes.
It should
not be applied on large areas in patients with renal insufficiency.
The duration of use depends on the particular condition of the skin
and should be established on an individual basis.
4.3 CONTRAINDICATIONS
Eucerin Intensive Lotion 10% w/w Cutaneous Emulsion should not be used
in patients with a known hypersensitivity
to any of the ingredients.
It should not be used to treat excoriated acute inflammation of the
skin.
It should not be used
on large areas in patients with renal insufficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
A doctor should be consulted if symptoms persist.
Application of the product to broken skin should be avoided.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Urea may potentiate the release of active substances from topical
preparations and their penetration into the skin.
This
is known in particular for corticosteroids, dithranol and
fluorouracil.
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