Emoliumlek
Poland
Table of Contents
Package leaflet: Information for the user
emoliumLEK, (20 mg + 200 mg)/g, cream
urea + glycerol
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor, pharmacist, or nurse.
- Keep this leaflet so that you can read it again if necessary.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement or if you feel worse, contact your doctor.
Leaflet contents
- What emoliumLEK is and what it is used for
- Important information before using emoliumLEK
- How to use emoliumLEK
- Possible side effects
- How to store emoliumLEK
- Contents of the pack and other information
1. What emoliumLEK is and what it is used for
emoliumLEK is a moisturizing cream that hydrates the skin, soothes itching, and provides protective action, containing urea and glycerol.
emoliumLEK is used to moisturize dry skin in adults, adolescents, and children of all ages.
2. 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 may be used during pregnancy and breastfeeding.
Driving and operating machinery
emoliumLEK has no influence on the ability to drive or operate machinery.
emoliumLEK contains cetostearyl alcohol
This medicine may cause local skin reactions (e.g. contact dermatitis).
3. How to use emoliumLEK
This medicine should always be used exactly as described in this patient leaflet, or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
Adults, adolescents and children
Apply the cream to the skin at least twice daily, preferably after contact with water. Apply an amount sufficient for the skin to absorb without leaving a sticky feeling.
There is no known risk of overdose with use of more than the recommended amount of emoliumLEK.
If you have any further doubts concerning the use of this medicine, consult your doctor, pharmacist, or nurse.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Common (may occur in up to 1 in 10 patients): Transient burning, itching, stinging and redness of the skin.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse reactions, more information on the safety of this medicine can be collected.
5. How to store emoliumLEK
Keep this medicine out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
6. Contents of the pack and other information
What emoliumLEK contains
- The active substances are glycerol and urea. One gram of cream contains 20 mg of urea and 200 mg of glycerol.
- The other ingredients are butylene glycol 1,3, hydrogenated rapeseed oil, dexpanthenol, medium-chain triglycerides, cetostearyl alcohol, dimethicone, white paraffin, glycerol monostearate, polyoxyl stearate, triacetin, carbomer 50 000 mPas and purified water.
What emoliumLEK looks like and contents of the pack
emoliumLEK is a white cream.
Pack sizes:
Plastic tube with a 100 g capacity with a flip-top closure in a cardboard box.
Plastic container with a 500 g capacity with a plastic-metal pump dispenser in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Perrigo Poland Sp. z o.o.
ul. Domaniewska 48
02-672 Warsaw
Tel.: +48 (22) 852 55 51
Manufacturer
Medgenix Benelux NV
Vliegveld 21
B-8560 Wevelgem
Belgium