ELACUTAN

ELACUTAN Cream

Important notes (mandatory information)

Elacutan Cream, 10%. Active ingredient: Urea. Areas of application: for the relief of dry skin conditions (exsiccation), which can also lead to pathological changes, such as in the case of neurodermatitis (atopic dermatitis), ageing skin or ichthyosis [congenital cornification disorders (fish scale disease)] and for basic treatment during symptom-free intervals in neurodermatitis (atopic eczema).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Elacutan Cream, 10%
Active ingredient: Urea

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Elacutan Cream must be used as directed in order to achieve the best possible treatment results.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 3 weeks, you must consult a doctor.
• If any of the side effects listed occur or if you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist. See section 4.

This package leaflet contains

1. WHAT IS ELACUTAN CREAM AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING ELACUTAN CREAM?
3. HOW TO USE ELACUTAN CREAM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ELACUTAN CREAM?
6. FURTHER INFORMATION

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

Elacutan Cream is a keratolytic and moisturising cream. Elacutan Cream is used: for the relief of dry skin conditions (exsiccation), which can also lead to pathological changes, such as in the case of neurodermatitis (atopic dermatitis), ageing skin or ichthyosis [congenital cornification disorders (fish scale disease)] and for basic treatment during symptom-free intervals in neurodermatitis (atopic eczema).

2. WHAT DO YOU NEED TO KNOW BEFORE USING ELACUTAN CREAM?

Elacutan Cream must not be used:

• if you are hypersensitive (allergic) to urea or any of the other ingredients of Elacutan Cream,
• for the treatment of acutely weeping or inflammatory skin conditions.

Elacutan Cream should not be used to treat abraded, acute skin inflammations. In the case of renal insufficiency, Elacutan Cream should not be used over large areas.

Special care must be taken when using Elacutan Cream

Do not bring Elacutan Cream into contact with the eyes and mucous membranes.

When using Elacutan Cream with other medicines

Please tell your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. The urea contained in Elacutan Cream can increase the release of active ingredients from other externally applied medicines and their penetration into the skin. This is particularly known for corticosteroids, dithranol and 5-fluorouracil.

When using Elacutan Cream with food and drink

Not applicable.

Pregnancy and breast-feeding

Risks during pregnancy and breast-feeding are not known. Elacutan Cream should not be used in the breast area during breast-feeding. Ask your doctor or pharmacist for advice before taking/using any medicines.

Driving and using machines

No special precautions are necessary.

Important information about certain other ingredients of Elacutan Cream

Cetyl stearyl alcohol (hexadecan-1-ol-octadecan-1-ol) can cause localised skin irritation (e.g. contact dermatitis).

3. HOW TO USE ELACUTAN CREAM?

Always use Elacutan Cream exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: The cream is applied 1-3 times a day.

Method of application

For application to the skin

Duration of use

The duration of treatment depends on the clinical findings and the duration of use is determined by the attending physician. There is no clinical data available for a duration of use of Elacutan Cream of more than 3 weeks.

If you forget to use Elacutan Cream

Do not use double the dose to make up for the forgotten previous application.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Elacutan Cream can cause side effects, although not everybody gets them. Skin irritation is possible if acutely inflammatory skin conditions are not treated properly with Elacutan Cream.

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 provide more information on the safety of this medicine.

5. HOW TO STORE ELACUTAN CREAM?

Keep out of the reach of children. Do not use the medicine after the expiry date which is stated on the folding box and the tube after "Use by:". The expiry date refers to the last day of the month. Note on shelf life after opening: The shelf life after opening the tube is 12 months, but not longer than the stated expiry date. Storage conditions: Do not store above 25°C.

6. FURTHER INFORMATION

What Elacutan Cream contains

The active ingredient is: Urea. 1 g o/w cream contains 100 mg urea. The other ingredients are: Glycerol 85%, hexadecan-1-ol-hexadecyl-D-glucopyranoside-octadecan-1-ol-octadecyl-D-glucopyranoside (contains cetyl stearyl alcohol), medium-chain triglycerides, liquid paraffin, stearic acid (Ph. Eur.), citric acid, sodium hydroxide, purified water.

What Elacutan Cream looks like and contents of the pack

White, homogeneous cream. Original packs with 50 g, 100 g and 150 g cream.

Pharmaceutical entrepreneur and manufacturer

Pharmaceutical entrepreneur

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 April 2014.

Source: Information from the package leaflet
Status: 02/2017
Active ingredient: Urea. Areas of application: for the relief of dry skin conditions (exsiccation), which can also lead to pathological changes, such as in the case of neurodermatitis (atopic dermatitis), ageing skin or ichthyosis [congenital cornification disorders (fish scale disease)] and for basic treatment during symptom-free intervals in neurodermatitis (atopic eczema).