OPTIDERM

OPTIDERM Cream

Important notes (mandatory information)

Optiderm Cream. Areas of application: for moisture regulation of the horny layer, for greasing and relieving itching as a supportive treatment for skin diseases with dry and/or itchy skin such as atopic eczema (neurodermatitis), exsiccation eczema (drying damage caused by detergents, etc.), as well as for the further and subsequent treatment of the aforementioned skin diseases.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Optiderm Cream for application to the skin
Active ingredients: urea, macrogol lauryl ether 6.5

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 directed by your doctor or pharmacist.

• 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 three weeks, you must see a doctor in any case.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.

What is in this package leaflet

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

1. WHAT IS OPTIDERM AND WHAT IS IT USED FOR?

Optiderm is a medicine for the supportive treatment of skin diseases with itching and dry skin. Optiderm is used for moisture regulation of the horny layer, for greasing and relieving itching as a supportive treatment for skin diseases with dry and/or itchy skin such as atopic eczema (neurodermatitis), exsiccation eczema (drying damage caused by detergents, etc.), as well as for the further and subsequent treatment of the aforementioned skin diseases.

2. WHAT SHOULD YOU CONSIDER BEFORE USING OPTIDERM?

Optiderm must not be used:

• if you are allergic to urea, macrogol lauryl ether 6.5 (polidocanol) or any of the other ingredients of this medicine listed in section 6.
• if you suffer from acute generalised, scaly skin redness (erythroderma). You must also not use Optiderm in the case of acutely inflamed, weeping and infected skin processes.

Warnings and precautions

Please talk to your doctor or pharmacist before using Optiderm. Special care must be taken when using Optiderm if you are using the medicine near the eyes and mucous membranes. You should not bring Optiderm into contact with the eyes and mucous membranes. Skin irritation such as redness or burning may occur when applied to damaged or inflamed skin.

Children

Please consult your doctor before using Optiderm on children.

Use of Optiderm together with other medicines

Tell your doctor or pharmacist if you are taking or using, have recently taken/used or intend to take/use any other medicines. The simultaneous use of Optiderm together with other medicines for external use (e.g. corticosteroids, dithranol, 5-fluorouracil) can increase their absorption through the skin. If Optiderm is used at the same time in the genital or anal area and latex products (e.g. condoms, diaphragms), the "liquid paraffin" contained in the product may reduce the functionality and thus impair the safety of these products.

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. Risks when using Optiderm during pregnancy and breast-feeding are not known. If you are breast-feeding, please do not use Optiderm in the breast area to prevent the product from getting into the infant's mouth or on the lips.

Driving and using machines
No special precautions are required.

3. HOW TO USE OPTIDERM?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor. Check with your doctor or pharmacist if you are not sure. For application to the skin. Unless otherwise prescribed by your doctor, you should apply Optiderm thinly and evenly to the skin twice a day. The duration of use depends on the clinical picture and is on average three weeks. If your skin remains dry, you can also use the product for a longer period of time after consulting your doctor.

Please talk to your doctor or pharmacist if you have the impression that the effect of Optiderm is too strong or too weak.

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. Occasionally (1 to 10 out of 1,000 people treated), burning or redness, itching or pustule formation may occur after application to the skin. Not known (frequency cannot be estimated from the available data): contact dermatitis, hives (urticaria), rash, rash with pustules (pustular rash). If side effects occur, you should stop using Optiderm and see a 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 provide more information on the safety of this medicine.

5. HOW TO STORE OPTIDERM?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the label and/or carton after "Use by". Do not store above 25°C. Optiderm has a shelf life of 6 months after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Optiderm contains

The active ingredients are: urea and macrogol lauryl ether 6.5 (polidocanol). 100 g cream contains 5.0 g urea and 3.0 g macrogol lauryl ether 6.5 (Ph.Eur.) (polidocanol). The other ingredients are: Purified water; octyldodecanol (Ph.Eur.); poly(methyl, phenyl siloxane); stearic acid 25; dimethicone; glycerol 85 %; liquid paraffin; hexadecyl palmitate; polysorbate 40; carbomer 940; benzyl alcohol; trometamol.

What Optiderm looks like and contents of the pack

Optiderm is a white cream. Optiderm is available in aluminium tubes with 50 g, 100 g and plastic dispensers with 200 g, 500 g cream.

Pharmaceutical entrepreneur and manufacturer

Almirall Hermal GmbH
Scholtzstraße 3
21465 Reinbek
Telephone: (040) 727 04-0
Fax: (040) 7229296
info@almirall.de
www.almirall.de

This package leaflet was last revised in July 2015.

Source: Information from the package leaflet
Status: 04/2018
Areas of application: for moisture regulation of the horny layer, for greasing and relieving itching as a supportive treatment for skin diseases with dry and/or itchy skin such as atopic eczema (neurodermatitis), exsiccation eczema (drying damage caused by detergents, etc.), as well as for the further and subsequent treatment of the aforementioned skin diseases.