ELACUTAN Fat Cream

Elacutan Fat Cream 10%. Active ingredient: urea. Indications: for the treatment of dry skin, e.g., in cases of neurodermatitis or aging skin, exsiccation dermatoses (dry, pathological skin changes), for the supportive treatment of ichthyosis (congenital keratinization disorders [fish scale disease]).

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Elacutan Fat Cream 10%
Active ingredient: urea

Read the entire package leaflet carefully before you start using this medicine because it contains important information. Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you.

• Keep this leaflet. You may want to read it again later.
• Ask your pharmacist if you need further information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse after 3 weeks, consult your doctor.

What is in this leaflet:

1. WHAT IS ELACUTAN OILY CREAM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING ELACUTAN OILY CREAM?
3. HOW SHOULD ELACUTAN OILY CREAM BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ELACUTAN OILY CREAM BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS ELACUTAN OILY CREAM AND WHAT IS IT USED FOR?

Elacutan OILY CREAM is a medicine for regulating skin moisture. Indications: For the treatment of dry skin, e.g., in cases of atopic dermatitis or aging skin, exsiccation dermatoses (dry, pathological skin changes), and for the supportive treatment of ichthyosis (congenital keratinization disorders [fish scale disease]).

2. WHAT SHOULD YOU CONSIDER BEFORE USE ELACUTAN OILY CREAM?

Elacutan OILY CREAM must not be used if you are allergic to urea or any of the other ingredients of this medicine listed in section 6. Elacutan OILY CREAM should not be used to treat acute inflammatory skin conditions. In cases of kidney disease, Elacutan OILY CREAM should not be applied over large areas.

Warnings and precautions:
Please talk to your doctor or pharmacist before using Elacutan OILY CREAM. Do not allow Elacutan Fat Cream to come into contact with the eyes or mucous membranes. Due to the irritating potential of the 10% urea content, application to acutely inflamed skin (characterized, for example, by burning, redness, blisters/oozing) should be avoided in order to prevent a possible worsening of the skin condition. Concomitant use with latex products (e.g. condoms, diaphragms) may result in a reduction in functionality and thus a compromise in the safety of the products due to the excipients they contain (petroleum jelly, paraffin).

Children:
Elacutan Fat Cream should not be used to treat children as there is insufficient experience with its use in this age group.

Use of Elacutan Fat Cream together with other medicines:
Inform your doctor or pharmacist if you are taking/using, have recently taken or intend to take/use any other medicines. The release of other active ingredients from externally applied medications and their permeability through the skin may be increased by Elacutan Fat Cream. This is particularly known for corticosteroids, dithranol, and 5-fluorouracil.

Use of Elacutan Fat Cream with food and drinks:
Not applicable.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. There are no known risks associated with external use during pregnancy and breastfeeding.

Driving and operating machinery:
No special precautions are necessary.

3. HOW SHOULD ELACUTAN FOAM CREAM BE USED?

Always use this medicine exactly as described in this package leaflet or as agreed with your doctor or pharmacist. Ask your doctor or pharmacist if you are not sure. The recommended dose is: Elacutan Fat Cream is applied to the affected areas of skin once or several times a day.

Method of application:
For application to the skin.

Duration of use:
The duration of use depends on the clinical findings. This will be decided by the doctor. A duration of use of 3 weeks is generally considered sufficient. This should not be exceeded, as there is no clinical experience with longer periods of use.

If you forget to use Elacutan Fat Cream:
Do not use a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. When used externally, skin irritation is possible when treating acute inflammatory skin conditions (see section 2: "Warnings and Precautions###). If the listed side effect occurs for the first time or if your symptoms worsen, stop using Elacutan Fat Cream and consult your doctor.

Reporting of side effects:
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Pharmacovigilance Department, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD ELACUTAN FAT CREAM BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date printed on the carton and tube after "Use by###". The expiry date refers to the last day of that month. Storage conditions: Do not store above 25°C. Shelf life after opening: The shelf life after opening the tube is 15 months, but not longer than the expiry date shown.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Elacutan Fat Cream contains:
The active ingredient is urea. 100 g of cream contains 10 g of urea. The other ingredients are: white petrolatum, liquid paraffin, hard paraffin, pregelatinized starch (corn starch), sorbitan oleate, bleached wax, sorbitol (Ph. Eur.), adipic acid, and purified water.

What Elacutan Fettcreme looks like and what it contains:
A nearly white, soft cream. Original packs contain 50 g of cream, 100 g of cream, and 150 g of cream.

Pharmaceutical entrepreneur and manufacturer:
Pharmaceutical entrepreneur:
RIEMSER Pharma GmbH
An der Wiek 7
17493 Greifswald - Insel Riems


Manufacturer:
LAW Services GmbH Leipziger Arzneimittelwerk
Elisabeth-Schumacher-Straße 54/56
04328 Leipzig

This package leaflet was last revised in July 2025.

Source: Information from the package leaflet
as of: 01/2025

Active ingredient: urea. Indications: for the treatment of dry skin, e.g., in cases of atopic dermatitis or aging skin, exsiccation dermatoses (dry, pathological skin changes), and for the supportive treatment of ichthyosis (congenital keratinization disorders [fish scale disease]).