ELACUTAN

ELACUTAN Fat Cream

Important notes (mandatory information)

Elacutan Fettcreme 10 %. Active ingredient: Urea. Areas of application: for the treatment of dry skin, e.g. in the case of neurodermatitis or ageing skin, exsiccation dermatoses (dry, pathological skin changes), for the supportive treatment of ichthyosis (congenital cornification 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 Fettcreme 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 package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 3 weeks, talk to your doctor.

What is in this package leaflet

1. WHAT IS ELACUTAN FETTCREME AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING ELACUTAN FETTCREME?
3. HOW TO USE ELACUTAN FETTCREME?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ELACUTAN FETTCREME?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS ELACUTAN FETTCREME AND WHAT IS IT USED FOR?

Elacutan Fettcreme is a medicine for regulating skin moisture. Areas of application: For the treatment of dry skin, e.g. in the case of neurodermatitis or ageing skin, exsiccation dermatoses (dry, pathological skin changes), for the supportive treatment of ichthyosis (congenital cornification disorders [fish scale disease]).

2. WHAT SHOULD YOU CONSIDER BEFORE USING ELACUTAN FETTCREME?

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

Warnings and precautions

Please talk to your doctor or pharmacist before using Elacutan Fettcreme. Do not bring Elacutan Fettcreme into contact with the eyes and mucous membranes. Due to the irritant potential of the 10% urea content, application to acutely inflamed skin (characterised e.g. by burning, redness, blisters/weeping) should be avoided in order to prevent possible worsening of the skin condition. When using latex products (e.g. condoms, diaphragms) at the same time, the functional capacity may be reduced and thus the safety of the products may be impaired due to the auxiliary substances (vaseline, paraffin) contained.

Children

Elacutan Fettcreme should not be used for the treatment of children, as there is insufficient experience with the use in this age group.

Use of Elacutan Fettcreme together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. The release of other active ingredients from externally applied medicines and their permeability for the skin can be increased by Elacutan Fettcreme. This is particularly known for corticosteroids, dithranol and 5-fluorouracil.

Use of Elacutan Fettcreme together with food and drink

Not applicable.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. No risks are known during pregnancy and breast-feeding when used externally.

Driving and using machines

No special precautions are required.

3. HOW TO USE ELACUTAN FETTCREME?

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

Type of use

For use on the skin.

Duration of use

The duration of use depends on the clinical findings. This will be decided by the doctor. As a rule, a period of use of 3 weeks is considered sufficient. It should not be exceeded, as there is no clinical experience with a longer period of use.

If you forget to use Elacutan Fettcreme

Do not use twice the amount if you have forgotten the previous application.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. When used externally, skin irritation is possible if acute inflammatory skin conditions are treated (see section 2: »Warnings and precautions"). If the side effect listed occurs for the first time or if your symptoms worsen, do not continue to use Elacutan Fettcreme and please consult your doctor.

Reporting of side effects

If you get any side effects, talk to 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, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW TO STORE ELACUTAN FETTCREME?

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Elacutan Fettcreme contains

The active ingredient is: Urea. 100 g w/o cream contain 10 g urea. The other ingredients are: white vaseline, liquid paraffin, hard paraffin, pregelatinised starch (corn starch), sorbitan oleate, bleached wax, sorbitol (Ph. Eur.), adipic acid, purified water.

What Elacutan Fettcreme looks like and contents of the pack

Almost white, soft cream. Original pack with 50 g cream, original pack with 100 g cream and original pack with 150 g cream.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

RIEMSER Pharma GmbH
An der Wiek 7
17493 Greifswald - Insel Riems
phone +49 30 338427-0
fax +49 38351 308
e-mail info@RIEMSER.com

Manufacturer

L-A-W Services GmbH Leipziger Arzneimittelwerk
Elisabeth-Schumacher-Straße 54/56
04328 Leipzig

This package leaflet was last revised in July 2014.

Source: Information from the package leaflet
Status: 01/2017
Active ingredient: Urea. Areas of application: for the treatment of dry skin, e.g. in the case of neurodermatitis or ageing skin, exsiccation dermatoses (dry, pathological skin changes), for the supportive treatment of ichthyosis (congenital cornification disorders [fish scale disease]).