emoliumlek

Package Leaflet: Information for the User

emoliumLEK, (20 mg + 200 mg)/g, cream
urea + glycerol

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient, or according to the doctor's, pharmacist's, or nurse's instructions.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What is emoliumLEK and what is it used for
• 2. Important information before using emoliumLEK
• 3. How to use emoliumLEK
• 4. Possible side effects
• 5. How to store emoliumLEK
• 6. Package contents and other information

1. What is emoliumLEK and what is it used for

emoliumLEK is a cream with a moisturizing, anti-itching, and protective effect, containing urea and glycerol.
emoliumLEK is used for moisturizing dry skin in adults, adolescents, and children of all ages.

2. Important information before using emoliumLEK

When not to use emoliumLEK

• if the patient is allergic to urea, glycerol, or any of the other ingredients of this medicine (listed in section 6).

Pregnancy and breastfeeding

emoliumLEK can be used during pregnancy and breastfeeding.

Driving and using machines

emoliumLEK has no effect on the ability to drive and use machines.

emoliumLEK contains cetearyl alcohol

The medicine may cause a local skin reaction (e.g., contact dermatitis).

3. How to use emoliumLEK

This medicine should always be used exactly as described in this package leaflet for the patient, or according to the doctor's, pharmacist's, or nurse's instructions. In case of doubt, consult a doctor, pharmacist, or nurse.
Adults, adolescents, and children
The cream should be applied to the skin at least twice a day, preferably after contact with water. Apply an amount that the skin can absorb without feeling sticky.
There is no known risk of overdose in case of using a larger amount of emoliumLEK than recommended.
In case of any further doubts about the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):Transient burning, itching, stinging, and redness of the skin.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store emoliumLEK

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
After opening, the cream should be used within 6 months.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What emoliumLEK contains

• The active substances are glycerol and urea. 1 gram of cream contains 20 mg of urea and 200 mg of glycerol.
• The other ingredients are 1,3-butylene glycol, hydrogenated rapeseed oil, dexpanthenol, medium-chain triglycerides, cetearyl alcohol, dimethicone, white petrolatum, glycerol monostearate, macrogol stearate, triacetin, carbomer 50,000 mPa·s, and purified water.

What emoliumLEK looks like and what the package contains

emoliumLEK is a white cream.
Package sizes:
A 100 g plastic tube with a flip-top cap in a cardboard box.
A 500 g plastic container with a plastic-metal pump in a cardboard box.
Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
Phone: +48 (22) 852 55 51

Manufacturer

Medgenix Benelux NV
Vliegveld 21
B-8560 Wevelgem
Belgium

Date of last revision of the package leaflet: August 2024