Pigmentum Castellani

Leaflet attached to the packaging: patient information

PIGMENTUM CASTELLANI, (40 mg + 80 mg + 8 mg)/g, liquid for skin

Phenol + Resorcinol + Boric acid

Please read carefully 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 this patient leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Pigmentum Castellani and what is it used for

Pigmentum Castellani is a liquid for application to the skin.
It is a combination medicine that exhibits the combined action of active substances - phenol, resorcinol, and boric acid. The medicine has antiseptic, antifungal, anti-inflammatory, and keratolytic effects.
The phenol contained in the medicine has antifungal and antibacterial effects, boric acid has a weak bacteriostatic (inhibiting bacterial growth) and fungistatic (inhibiting fungal growth) effect, and resorcinol has a weak antiseptic and keratolytic effect.

Indications

Pigmentum Castellani is used for the local treatment of superficial fungal infections and superficial bacterial skin infections.

2. Important information before using Pigmentum Castellani

When not to use Pigmentum Castellani

• if the patient is allergic to phenol, resorcinol, boric acid, or any of the other ingredients of this medicine (listed in section 6);
• in newborns and infants;
• in children under 3 years of age.

Warnings and precautions

Before starting to use Pigmentum Castellani, the patient should discuss it with their doctor or pharmacist.
The medicine should not be used on large areas of skin, on skin without an epidermis, and with inflammatory changes, as the boric acid contained in the medicine may be absorbed through the skin and have a toxic effect on the body.
The medicine should not be used for more than 7 days.
Occlusive dressings and bandages should not be used on the skin treated with Pigmentum Castellani, due to the presence of phenol and the associated risk of significant skin irritation.
The medicine should not be used in case of visible turbidity and sediment formation, due to the risk of methemoglobinemia (blood disorders).
Warning:the medicine strongly stains the skin.

Children and adolescents

Particular caution should be exercised when using Pigmentum Castellani in children.
The medicine should not be used in children under 3 years of age.

Pigmentum Castellani and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
There are no data on interactions with other medicines.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pigmentum Castellani should not be used in pregnant women, unless the doctor considers that the benefits of using the medicine outweigh the risks to the fetus.
The medicine should not be used during breastfeeding.

Driving and using machines

Pigmentum Castellani has no influence or negligible influence on the ability to drive and use machines.

Pigmentum Castellani contains ethanol.

This medicine contains 59.8 mg of alcohol (ethanol) per gram of liquid. It may cause burning of damaged skin.
The medicine is flammable. It should not be used near an open flame, a lit cigarette, or certain devices (e.g., hair dryers).

3. How to use Pigmentum Castellani

This medicine should always be used as directed by a doctor or pharmacist. If there are any doubts, the patient should consult their doctor or pharmacist.
The medicine is intended for use on the skin.
Adults
Unless the doctor recommends otherwise, the affected areas should be smeared or brushed 2 or 3 times a day.

Use in children and adolescents

In children over 3 years of age and adolescents, the affected areas of skin should be smeared with the medicine once a day.
The medicine should not be used in children under 3 years of age.
Treatment should not last longer than 7 days.
In case of doubts, the patient should contact their doctor.

Using more than the recommended dose of Pigmentum Castellani

In case of using more than the recommended dose of the medicine, the patient should immediately contact their doctor.

Stopping the use of Pigmentum Castellani

In case of any further doubts about using the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Pigmentum Castellani can cause side effects, although not everybody gets them.
The frequency of side effects listed below is defined as follows:
very common (occurring in more than 1 in 10 patients);
common (occurring in 1 to 10 in 100 patients);
uncommon (occurring in 1 to 10 in 1,000 patients);
rare (occurring in 1 to 10 in 10,000 patients);
very rare (occurring in less than 1 in 10,000 patients);
not known (frequency cannot be estimated from the available data).
Rarely, skin irritation may occur.
If skin irritation worsens or any side effects not listed in this leaflet occur, the patient should inform their doctor.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Pigmentum Castellani

Store in a temperature below 25°C.
Protect from light.
The medicine is flammable. For additional information, see section 2.
The medicine should be stored out of sight and reach of children.
Attention should be paid to the expiration date of the medicine. The medicine should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
The medicine should not be used if turbidity of the liquid and sediment formation are observed.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their 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 Pigmentum Castellani contains

• The active substances in the medicine are phenol, resorcinol, and boric acid. 1 g of liquid for skin contains 40 mg of phenol, 80 mg of resorcinol, and 8 mg of boric acid.
• The other ingredients are: basic fuchsin, acetone, ethanol 96%, purified water.

What Pigmentum Castellani looks like and what the packaging contains

Pigmentum Castellani is a liquid with an intense cherry-red color and a phenol odor.
Medicine packaging
A brown glass bottle containing 50 g or 125 g of liquid for skin, placed in a cardboard box.
For more detailed information, the patient should contact the local representative of the marketing authorization holder.

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: