Unguentum undecilenicum

Leaflet included in the packaging: patient information

UNGUENTUM UNDECYLENICUM, (50 mg + 200 mg)/g, ointment

(Acidum undecylenicum + Zinci undecylenas)
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 or pharmacist.

• 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 any undesirable symptoms occur in the patient, including any possible undesirable symptoms not mentioned in the leaflet, you should tell the doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, you should contact a doctor.

Table of contents of the leaflet

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

1. What is Unguentum undecylenicum and what is it used for

Unguentum undecylenicum is an ointment intended exclusively for local use on the skin.
The medicine contains the active substances undecylenic acid and zinc undecylenate, with a fungicidal
effect on dermatophytes (types of Epidermophyton floccosum, Trichophytonand Microsporum). The medicine acts not
only on the fungal mycelium but also on the spores of the fungi.
Indications
The medicine is used for local treatment of:
fungal infections of the skin of the groin, feet, hands, head;
superficial forms of ringworm;
pityriasis versicolor.
The medicine is used both preventively and therapeutically.
Fungal infection of the skin of the groin – usually starts in the depths of the groin fold and spreads
outwardly, occupying the area up to the thighs, sometimes moving to the pubic mound and in the direction of the groin.
Fungal infection of the feet and hands – occurs most often between the toes. Fungal changes between the toes
are characterized by maceration, peeling, and may also have a vesicular character. This fungal infection also appears
on the plantar surface of the foot (sole). Itching, pain, inflammation, and vesicular eruptions may be mild or severe. In the case of long-standing fungal infection of the feet, nail infection may occur.
Fungal infection of the skin of the head – superficial fungal infection of the hairy skin mainly affects children,
manifested by foci of the disease, in which the hair breaks off, looking as if it has been cut,
and the skin in this area is red, peeling, and itchy.
Ringworm of the smooth skin – may occur on the entire body, most often on the uncovered skin (face, hands, neck). On the smooth skin, annular-vesicular foci may appear. The foci are clearly delineated from the surroundings, with nodular, vesicular, and pustular eruptions on the edge. Itching is variably severe, sometimes significant.
Pityriasis versicolor – occurs most often on the skin of the chest and arms, where small patches initially appear
with a pinkish-yellow color, taking on darker shades, spreading and merging into larger foci, with sharply defined, irregular borders. Under the influence of sunlight, discoloration occurs in the areas of the fungal infection, with hyperpigmentation of the surrounding skin.

2. Important information before using Unguentum undecylenicum

When not to use Unguentum undecylenicum:

if the patient is allergic to undecylenic acid, zinc undecylenate, or any of the other components of this medicine (listed in section 6);
on skin lesions with significant inflammatory reactions;
on mucous membranes;
in the eye area;
on large skin surfaces;
in children under 11 years of age.

Warnings and precautions

Particular caution should be exercised:
if the medicine is used in patients with kidney diseases;
if the medicine is used in elderly patients; in elderly patients, the medicine should be used on small skin surfaces.

Unguentum undecylenicum and other medicines

You should tell the doctor or pharmacist about all medicines currently used by the patient
or recently used, as well as medicines that the patient plans to use.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Unguentum undecylenicum should not be used in pregnant or breastfeeding women.
Use in pregnant or breastfeeding women – only on the doctor's instructions.

Driving and operating machinery

Unguentum undecylenicum has no effect on the ability to drive vehicles and operate machinery.

Unguentum undecylenicum contains ethyl parahydroxybenzoate and methyl

parahydroxybenzoate.The medicine may cause allergic reactions (possible reactions of the delayed type).

3. How to use Unguentum undecylenicum

This medicine should always be used exactly as described in the patient leaflet or according to the
recommendations of a doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist.
The medicine is intended for use on the skin.
Unless the doctor recommends otherwise, the affected areas should be covered with a thin layer of ointment 2 times a day. Treatment should be continued, despite the disappearance of symptoms, for at least 2 to 3
weeks.
After using the medicine, you should wash your hands.

Using a higher dose of Unguentum undecylenicum than recommended

No symptoms of overdose of the medicinal product are known when used in accordance with the indications and recommended method of use.
The medicine accidentally ingested may cause nausea, vomiting, diarrhea, headache, respiratory disorders, swelling of the joints and lymph nodes.
In case of ingestion of the medicine, you should contact a doctor.

Missing a dose of Unguentum undecylenicum

You should not use a double dose to make up for a missed dose.

Stopping the use of Unguentum undecylenicum

In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, this medicine can cause undesirable effects, although not everybody gets them.
The frequency of occurrence of undesirable effects listed below is defined as follows:
very common (occurring more often than 1 in 10 patients);
common (occurring in 1 to 10 in 100 patients);
uncommon (occurring in 1 to 10 in 1000 patients);
rare (occurring in 1 to 10 in 10,000 patients);
very rare (occurring in less than 1 in 10,000 patients);
unknown (frequency cannot be estimated from available data).
Rare:
Local skin irritation symptoms, burning, rash may occur.
The medicine may irritate mucous membranes.
Unknown frequency:
Due to the presence of ethyl parahydroxybenzoate (E 214) and methyl parahydroxybenzoate (E

• 218), the medicine may cause hives and allergic reactions (possible reactions of the delayed type). Sometimes, immediate allergic reactions with hives and bronchospasm may occur. In such a case, treatment should be discontinued and a doctor should be consulted immediately.

Reporting undesirable effects

If any undesirable symptoms occur, including any undesirable symptoms not mentioned in the leaflet, you should tell the doctor or pharmacist, or nurse. Undesirable effects can be reported directly to the Department of Monitoring of Undesirable Effects of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: + 48 22 49-21-301
Fax: + 48 22 49-21-309
e-mail: [email protected]
Undesirable effects can also be reported to the marketing authorization holder.
Thanks to the reporting of undesirable effects, more information can be collected on the safety of the use of the medicine.

5. How to store Unguentum undecylenicum

Store at a temperature below 25°C.
Store the tube tightly closed.
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 Unguentum undecylenicum contains

The active substances of the medicine are undecylenic acid and zinc undecylenate.
1 g of ointment contains 50 mg of undecylenic acid and 200 mg of zinc undecylenate.
The other ingredients are: white petrolatum, anhydrous lanolin, methyl parahydroxybenzoate (E 218), ethyl parahydroxybenzoate (E 214).

What Unguentum undecylenicum looks like and what the packaging contains

Unguentum undecylenicum is a creamy, homogeneous ointment with a characteristic smell.
The packaging of the medicine is an aluminum tube with a polyethylene or polypropylene cap, containing 30 g
of ointment, placed in a cardboard box.

Marketing authorization holder and manufacturer

CHEMA-ELEKTROMET
Cooperative
ul. Przemysłowa 9
35-105 Rzeszów
phone: 17 862 05 90
e-mail: [email protected]

Date of the last update of the leaflet: