Pigmentum castellani

Patient Information Leaflet

PIGMENTUM CASTELLANI, (40 mg + 80 mg + 8 mg)/g, topical solution
Phenolum + Resorcinolum + Acidum boricum
Please read all of this leaflet carefully 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
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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if your condition worsens, consult your doctor.

Table of Contents

1. What Pigmentum Castellani is and what it is 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 pack and other information

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

Pigmentum Castellani is a liquid for topical application to the skin.
It is a combination medicine exhibiting the combined action of its active ingredients – phenol,
resorcinol and boric acid. The medicine has antiseptic, including fungicidal, anti-inflammatory, and keratolytic properties.
Phenol contained in the medicine exerts fungicidal and bactericidal effects, boric acid has weak bacteriostatic (inhibits bacterial growth) and fungistatic (inhibits fungal growth) activity, while resorcinol has mild antiseptic and keratolytic effects.
Indications
Pigmentum Castellani is indicated for the local treatment of superficial fungal infections and superficial bacterial skin infections.

2. 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, discuss this with a doctor or pharmacist.
Do not use this medicine on large areas of skin, on skin lacking epidermis, or on skin with inflammatory lesions, as boric acid contained in the medicine may be absorbed through the skin and may have toxic effects on the body.
Do not use the medicine for longer than 7 days.
Do not apply occlusive (sealed) dressings or bandages to skin treated with Pigmentum Castellani due to the presence of phenol and the associated risk of significant skin irritation.
Do not use the medicine if cloudiness or precipitate is visible, due to the risk of methemoglobinemia (blood disorders).
Note: The medicine strongly stains the skin.
Children and adolescents
Exercise particular caution when using Pigmentum Castellani in children.
Do not use in children under 3 years of age.
Pigmentum Castellani with 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 use.
There are no data available regarding interactions with other medicines.
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.
Pigmentum Castellani should not be used during pregnancy unless, in the opinion of the doctor, the benefits of using the medicine outweigh the risks to the fetus.
Do not use this medicine during breastfeeding.
Driving and operating machinery
Pigmentum Castellani has no effect or has a negligible effect on the ability to drive and operate machinery.
Pigmentum Castellani contains ethanol.
This medicine contains 59.8 mg of alcohol (ethanol) per gram of liquid. It may cause a burning sensation on damaged skin.
The medicine is flammable. Do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).

3. How to use Pigmentum Castellani

This medicine should always be used exactly as directed by a doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
This medicine is for external use on the skin only.
Adults
Unless otherwise advised by a doctor, affected areas should be coated or brushed 2 or 3 times daily.
Use in children and adolescents
In children over 3 years of age and adolescents, apply the medicine to the affected skin areas once daily.
Do not use in children under 3 years of age.
The duration of treatment should not exceed 7 days.
In case of doubt, consult your doctor.
Use of a higher than recommended dose of Pigmentum Castellani
If more than the recommended amount of medicine is used, contact your doctor immediately.
Stopping the use of Pigmentum Castellani
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of the adverse reactions listed below is defined as follows:
very common (affects more than 1 in 10 patients);
common (affects 1 to 10 in 100 patients);
uncommon (affects 1 to 10 in 1,000 patients);
rare (affects 1 to 10 in 10,000 patients);
very rare (affects less than 1 in 10,000 patients);
unknown (frequency cannot be estimated from available data).
Skin irritation may rarely occur.
If skin irritation worsens or any adverse symptoms not listed in this leaflet occur, inform your doctor.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Pigmentum Castellani

Store below 25°C.
Protect from light.
The medicinal product is flammable. For additional information, see section 2.
Keep the medicine out of sight and reach of children.
Take care to observe the expiry date of the medicinal product. Do not use this medicine after the expiry date stated on the packaging has passed. The expiry date refers to the last day of the specified month.
Do not use this medicine if cloudiness of the liquid or precipitation occurs.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Pigmentum Castellani contains

• The active substances in the medicinal product are phenol, resorcinol, and boric acid. 1 g of the topical solution 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 contents of the pack
Pigmentum Castellani is a liquid with an intense cherry-red colour and a phenol odour.
Packaging
A brown glass bottle containing 50 g or 125 g of topical solution, placed in a cardboard box.
For further information, please contact the local representative of the Marketing Authorisation Holder.
Marketing Authorisation Holder and Manufacturer
CHEMA-ELEKTROMET
Labour Cooperative
Przemysłowa Street 9
35-105 Rzeszów
Phone: +48 17 862 05 90
e-mail: [email protected]