Hasceral

Leaflet included in the packaging: patient information

HASCERAL

(100 mg + 50 mg)/g, ointment
Urea + Salicylic acid
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or according to the
recommendations of a doctor, pharmacist, or nurse.

• You should keep this leaflet, so that you can read it again if necessary.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any undesirable effects, including any possible undesirable effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Hasceral and what is it used for
• 2. Important information before using Hasceral
• 3. How to use Hasceral
• 4. Possible side effects
• 5. How to store Hasceral
• 6. Contents of the packaging and other information

1. What is Hasceral and what is it used for

Hasceral ointment contains 10% urea and 5% salicylic acid.
10% urea has a keratolytic effect, which leads to the shedding of the stratum corneum of the skin.
It also affects the hydration of excessively keratinized skin layers, as well as the renewal of the skin's protective barrier, which significantly reduces water loss through the skin layers.
Salicylic acid at a concentration of 5% causes the shedding of skin cells. The effect of its action is twofold. It involves reducing cell adhesion by dissolving intercellular substances and reducing the pH in the stratum corneum, which promotes hydration and softening of the skin.
As a result, there is a loss of cohesion between cells, their separation, and shedding.
Salicylic acid and urea also have antibacterial and antifungal effects through the change in skin surface pH.
The indications for the use of Hasceral are diseases characterized by skin keratinization disorders, such as ichthyosis, psoriasis, red lichen, excessive keratinization of the hands and feet, keratosis, as well as allergic and non-allergic hand eczema, neurodermatitis, atopic dermatitis, and conditions of excessive skin dryness of various etiologies.

2. Important information before using Hasceral

When not to use Hasceral

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

Warnings and precautions

Before starting to use Hasceral, you should discuss it with your doctor, pharmacist, or nurse.
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Do not use on damaged skin and in the eye and mucous membrane areas.
Do not use the ointment on larger skin surfaces, only locally.

Hasceral and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
There is no data on interactions.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Due to skin absorption, preparations containing salicylic acid should not be used on large skin surfaces in pregnant and breastfeeding women.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive and use machines.

3. How to use Hasceral

This medicine should always be used exactly as described in the patient leaflet or according to the recommendations of a doctor, pharmacist, or nurse. In case of doubt, you should consult a doctor, pharmacist, or nurse.
The medicine is for use on the skin.
The ointment should be rubbed into the affected areas of the skin 1 to 2 times a day.
Use for several or several dozen days, with breaks during longer use.
The medicine is washed off with warm water, so after washing, the ointment should be reapplied.

Using a higher dose of Hasceral than recommended

When used topically, overdose of the medicine is unlikely.

Missing a dose of Hasceral

You should not use a double dose to make up for a missed dose.
In case of any further doubts related to the use of this medicine, you should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Using the medicine according to the recommended dosage and indications does not involve a significant risk of side effects. Sometimes, local skin irritation may occur.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. Storing Hasceral

Store in the original packaging, at a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Hasceral contains

• The active substances of the medicine are urea and salicylic acid. 1 g of ointment contains 100 mg of urea and 50 mg of salicylic acid.
• The other ingredients (excipients) are: Polysorbate 40, sorbitan trioleate, self-emulsifying glycerol monostearate, glycerol, white petrolatum.

What Hasceral looks like and what the packaging contains

The medicine is a white or slightly creamy ointment.
One packaging of the medicine (aluminum tube) contains 50 g of ointment.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

tel.: (22) 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of the last update of the leaflet:

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