10% carbamide ( urea ) and 5% lactic acid
Read this leaflet carefully. It contains information that is important to you.
Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist or nurse.
– Save this information, you may need to read it again.
– Contact the pharmacy staff if you need more information or advice.
– You must contact a doctor if the symptoms worsen or do not improve.
– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.
In this leaflet you will find information about:
1. What Calmuril is and what it is used for
2. Before you use Calmuril
3. How to use Calmuril
4. Possible side effects
5. How to store Calmuril
6. Other information
1. WHAT CALMURIL IS AND WHAT IT IS USED FOR
Calmuril is a white emollient cream that contains 10% urea and 5% lactic acid. Calmuril binds water and softens the skin’s stratum corneum. The moisture in the skin increases, thickened skin softens, and the tendency to peel decreases. Calmuril also has an antipruritic effect.
Calmuril is used for the treatment of dry and thickened skin and for emollient effect in connection with the treatment of certain types of eczema.
Urea and lactic acid found in Calmuril may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.
2. BEFORE YOU USE CALMURIL
Do not use Calmuril
if you are allergic to urea or lactic acid in Calmuril or any of the other ingredients of this medicine (listed in section 6).
Take special care with Calmuril
Avoid contact with eyes
Pregnancy and breastfeeding
Calmuril can be used during pregnancy and lactation.
Driving and using machines
Calmuril does not affect your ability to drive or use machines.
3. HOW TO USE CALMURIL
Adults and children: Cream one lubricates twice a day or after each contact with water.
In more severe cases with thickened skin, a thick layer is applied, which after 3-5 minutes is massaged into the skin. The treatment is repeated daily for 1-2 weeks and then if necessary, preferably 1-2 times a week. For thickened skin on hands and feet, take a hand or foot bath before application.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your 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): Cream one can cause a transient local irritation in the form of burning or heat sensation that may occur depending on the degree and type of skin disease.
Rare (may affect up to 1 in 1,000 people): Hives, eczema, dermatitis, redness, blisters, and itching.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. HOW TO STORE CALMURIL
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 after EXP.
Unopened packaging: Store in a refrigerator (2 – 8 ° C).
Opened packaging: To be consumed within 6 months and in the meantime, there are no special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
– The active substances are carbamide ( urea ) 100 mg / g and lactic acid 50 mg / g.
The other ingredients are glycerol monostearate, betaine monohydrate, macrogol-6-cetostearyl ether, macrogol-25-cetostearyl ether, isopropyl myristate, hard fat, cholesterol, sodium chloride, purified water.
Instructions for use and handling
For pump can: Completely remove the gray transport cover by pulling off the pin and collar. Press the pump completely several times during the first use to fill it.
What the medicine looks like and contents of the pack
What the medicine looks like White cream
50 grams, polypropylene tube with outer carton
100 grams, polypropylene tube with outer carton
400 grams, polypropylene pump can.
Not all packaging may be marketed.
Marketing Authorization Holder and Manufacturer
ACO Hud Nordic AB, Box 622, 194 26 Upplands Väsby.