Package leaflet: Information for the patient

HASCERAL
(100 mg + 50 mg)/g, ointment
Urea + Acidum salicylicum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician, pharmacist, or nurse.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your physician, pharmacist, or nurse. See section 4.
If your condition does not improve or worsens, consult your physician.

Table of contents

What Hasceral is and what it is used for
Important information before using Hasceral
How to use Hasceral
Possible side effects
How to store Hasceral
Contents of the pack and other information

1. What Hasceral is and what it is used for

Hasceral ointment contains 10% urea and 5% salicylic acid.
10% urea exerts a keratolytic effect, leading to desquamation of the stratum corneum.
It also softens excessively keratinized layers of the epidermis and helps restore the skin's protective barrier, significantly reducing transepidermal water loss.
5% salicylic acid causes exfoliation of epidermal cells. Its action is twofold: it reduces cell adhesion by dissolving intercellular substances and lowers the pH in the stratum corneum, promoting skin hydration and softening. As a result, intercellular cohesion is weakened, leading to separation and desquamation of skin cells.
Salicylic acid and urea, by altering the skin surface pH, also exert antibacterial and antifungal effects.
Hasceral is indicated in conditions associated with abnormal keratinization of the epidermis, such as ichthyosis, psoriasis, discoid lupus erythematosus, excessive keratosis of the palms and soles, follicular keratosis, as well as allergic and non-allergic hand eczema, neurodermatitis, atopic dermatitis, and various etiologies of excessive skin dryness.

2. 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 treatment with Hasceral, consult your doctor, pharmacist, or nurse.
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Do not apply on damaged skin or in the eye area and on mucous membranes.
Do not apply the ointment over large areas of skin; use only locally.

Hasceral and other medicines
You must tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
There are no data available on drug interactions.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Due to absorption through the skin, salicylic acid-containing preparations should not be used on large skin surfaces in pregnant and breastfeeding women.

Driving and operating machinery
There are no data regarding the influence of the medicine on the ability to drive or operate machinery.

3. How to use Hasceral

This medicine should always be used exactly as described in the patient leaflet or according to the instructions given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

This is a topical medicine for skin application.

Apply the ointment by gently rubbing it into the affected skin areas 1 to 2 times daily.

Use for several days or a few weeks; if longer treatment is needed, introduce treatment breaks.

Hasceral ointment may be washed off by warm water; therefore, reapply the ointment after washing.

Use of more than the recommended dose of Hasceral

Overdose is unlikely with topical application.

Missed dose of Hasceral

Do not apply a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this product may cause adverse reactions, although not everyone experiences them.
When used according to the recommended dosage and indications, there is no significant risk of
adverse reactions occurring. Occasionally, local skin irritation may occur.
Reporting of adverse reactions
If any adverse effects occur, including any possible adverse effects not listed in this leaflet,
inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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: [email protected]
Adverse reactions may also be reported to the marketing authorization holder.
Reporting of adverse reactions helps to provide more information on the safety of using this medicine.

5. Storage of Hasceral medicine
Keep in the original packaging, below 25°C.
Store the medicine in a place inaccessible and out of sight 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What the medicine Hasceral contains

The active substances are urea and salicylic acid. 1 g of the cream contains 100 mg of urea and 50 mg of salicylic acid.
The other ingredients (excipients) are: Polysorbate 40, sorbitan tristearate, glycerol monostearate self-emulsifying, glycerol, white soft paraffin.

What Hasceral looks like and contents of the pack
The medicine is a white or slightly creamy cream.
One pack of the medicine (aluminium tube) contains 50 g of cream.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine Information
tel.: (22) 742 00 22
e-mail: [email protected]
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