Patient leaflet included in the packaging: information for the patient

DERMOPANTEN, 50 mg/g, ointment
(Dexpanthenolum)
Please read this leaflet carefully before using the medicine, because it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist.

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

Table of contents:

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

1. What Dermopanten is and what it is used for

Dermopanten is an ointment containing the active substance dexpanthenol.
After topical application to the skin, dexpanthenol is metabolized to pantothenic acid.
Pantothenic acid is a component of coenzyme A, which is essential for the normal function of epithelium and skin, and contributes to skin regeneration.

Indications

Treatment of superficial wounds such as abrasions, cuts, skin fissures, burns, skin irritations (e.g. following excessive sun exposure, radiotherapy, or UV lamp irradiation), minor skin inflammations, and ulcers.
The product is particularly indicated for the treatment of dry skin.
For care of nipple areolas during breastfeeding – prevention and treatment of chafing and irritation of the nipple areolas.
For infant care – prevention and treatment of diaper rash and skin inflammations.

2. Information before using Dermopanten

When not to use Dermopanten

if the patient is allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6). If symptoms of hypersensitivity, including skin allergic reactions, occur, treatment should be discontinued and the patient should contact a doctor;
on large, deep and clearly infected wounds. In such cases, the patient should contact a doctor.

Warnings and precautions
Avoid contact of the medicine with the eyes.
Dermopanten and other medicines
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.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
When using this medicine in breastfeeding women, the nipples should be washed before each breastfeeding.
Driving and operating machinery
Dermopanten has no influence on the ability to drive vehicles or operate machinery.

3. How to use Dermopanten

The medicine is intended for use on the skin.
This medicine should always be used according to the instructions given by the doctor or pharmacist. In case of doubt,
you should consult your doctor or pharmacist.
Unless otherwise advised by a doctor, the medicine is usually applied as described below:

In the treatment of superficial wounds, apply the medicine once or several times daily, depending on the local condition.
For the care of nipples in breastfeeding women, apply a compress with the ointment to the nipples. Before each breastfeeding, the nipples should be washed.
For infant care, apply the medicine at every diaper change, after gently cleansing with water the areas exposed to irritation.

Discontinuation of Dermopanten use
You should discontinue using Dermopanten and consult your doctor if local allergic reactions occur.
If you have any further doubts regarding the use of this medicine, you should consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicinal product, this medicine may cause adverse reactions, although not in every case do they occur.
During treatment, local allergic reactions may occur.
Reporting of adverse reactions
If any adverse symptoms occur, including any 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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
{current address, telephone and fax number of the above-mentioned Department}
e-mail: [email protected]
By reporting adverse reactions, it is possible to gather more information on the safety of using this medicine.

5. How to store Dermopanten

Store below 25°C.
Store in the original packaging to protect from moisture.
Keep the medicine out of sight and reach of children.
Pay attention to the medicine's expiry date.
Do not use this medicine after the expiry date stated on the box and tube.
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 properly dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the package and other information

What Dermopanten contains

The active substance is dexpanthenol. 1 g of the ointment contains 50 mg of dexpanthenol.
The other ingredients are: white vaseline, white wax, liquid paraffin, polysorbate 80, fragrance-modifying substance Y66 (Chamomile), purified water.

What Dermopanten looks like and contents of the pack
Dermopanten is a homogeneous white or cream-colored ointment.
The medicinal product is available in an aluminum tube, placed in a cardboard box, containing 30 g of ointment.
For further detailed information, please contact the responsible party's representative.

Marketing Authorisation Holder and Manufacturer
CHEMA-ELEKTROMET Labour Cooperative
Przemysłowa Street 9
35-105 Rzeszów
Phone: 17 862 05 90
Email: [email protected]