WIDMER Carbamid Cream

Package size:100 g

Dosage form:creamarbamid Cream Widmer 12% Urea. Active ingredient: Urea. Indications: for excessive keratinization, mild forms of ichthyosis, as relapse prevention and long-term treatment of ichthyosis, follicular keratinization disorders, dry, brittle, reddened skin.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Carbamid Cream Widmer 12% Urea
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 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 even feel worse after 4 days, consult your doctor.

What this package leaflet contains

1. WHAT IS CARBAMID CREME WIDMER AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING CARBAMID CREME WIDMER?
3. HOW IS CARBAMID CREME WIDMER TO BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD CARBAMID CREME WIDMER BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

1. WHAT IS CARBAMID CREAM WIDMER AND WHAT IS IT USED FOR?

Carbamid Cream Widmer is a topical skin medication. It is used for excessive keratinization, mild forms of ichthyosis, as relapse prevention and long-term treatment for ichthyosis, follicular hyperkeratosis, and dry, brittle, reddened skin.

2. WHAT SHOULD YOU KNOW BEFORE USING CARBAMID CREAM WIDMER?

Carbamid Cream Widmer must not be used:

• if you are allergic to urea, propylene glycol or any of the other ingredients of this medicine listed in section 6.
• For the treatment of acute inflammatory skin conditions and not for large areas in patients with impaired kidney function (renal insufficiency).

Warnings and precautions:
Please talk to your doctor or pharmacist before using Carbamid Cream Widmer. Avoid contact of Carbamid Cream Widmer with the mucous membranes of the eyes, nose, and mouth.

Using Carbamid Cream Widmer with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The possibility of increased absorption of other topically applied substances (e.g., corticosteroids) should be considered when the skin is treated with urea.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines:
No special precautions are necessary.

Carbamid Cream Widmer contains butylhydroxyanisole, butylhydroxytoluene, and propylene glycol.
Butylhydroxyanisole and butylhydroxytoluene can cause localized skin irritation (e.g., contact dermatitis), eye irritation, and irritation of the mucous membranes. Propylene glycol can cause skin irritation.

3. HOW TO USE CARBAMID CREAM WIDMER?

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the recommended dose is: Apply to the affected areas of skin once or twice daily and rub in gently. The duration of treatment depends on the clinical findings and will be determined individually by your doctor.

If you have used more Carbamid Cream Widmer than you should:
There are no risks associated with using more Carbamid Cream Widmer than you should.

If you stop using Carbamid Cream Widmer:
Interrupting or stopping treatment may lead to dry skin. The original skin condition may return.

Please talk to your doctor or pharmacist if you feel that the effect of Carbamid Cream Widmer is too strong or too weak. If you have any further questions about 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. In rare cases (1 to 10 users in 10,000), skin irritation such as burning, redness, itching, or peeling may occur.

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

5. HOW TO STORE CARBAMID CREAM WIDMER?

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and tube. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Carbamid Cream Widmer contains:
The active ingredient is: urea. 1 g of cream contains 120 mg of urea.

The other ingredients are: retinyl palmitate, dexpanthenol, POE-(1)-glycerol, sorbitan isostearate, polyoxyethylene-(30)-sorbitol, white petrolatum, hard paraffin, cetyl PEG/PPG-10/1 dimethicone, liquid paraffin, mineral wax, hydrogenated castor oil, glyceryl isostearate, polyglyceryl-3 oleate, decyl oleate, dibutyl adipate, isopropyl myristate (Ph.Eur.), propylene glycol, butane-1,3-diol, sorbitol (Ph.Eur.), citric acid, all-rac-alpha tocopherol acetate, butylhydroxyanisole (Ph.Eur.), butylhydroxytoluene (Ph.Eur.), phenoxyethanol (Ph.Eur.), magnesium sulfate heptahydrate, purified water.

What Carbamid Cream Widmer looks like and contents of the pack:
Carbamid Cream Widmer is a white cream and is available in 100g and 50g tubes.

Marketing Authorisation Holder:
Louis Widmer GmbH
P.O. Box 12 66
79602 Rheinfelden/Baden Germany


Manufacturer:
Louis Widmer AG
Rietbachstrasse 5
CH-8952 Schlieren Switzerland


This leaflet was last revised in June 2014.

Source: Package insert information,
as of May 2017

Active ingredient: Urea. Indications: for excessive keratinization, mild forms of ichthyosis, as relapse prevention and long-term treatment of ichthyosis, follicular keratinization disorders, dry, brittle, reddened skin.

WIDMER Carbamid Cream