Polfungicid

Leaflet attached to the packaging: patient information

Polfungicid (50 mg + 10 mg)/ml, solution for the skin

Chloramidazole hydrochloride+ Salicylic acid

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used in accordance with the description in the patient leaflet or as directed by a doctor,
or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• Consult a pharmacist if you need advice or additional information.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist.
• If there is no improvement after 14 days or if you feel worse, contact your doctor.

Table of contents of the leaflet:

• 1. What is Polfungicid and what is it used for
• 2. Important information before using Polfungicid
• 3. How to use Polfungicid
• 4. Possible side effects
• 5. How to store Polfungicid
• 6. Package contents and other information

1. What is Polfungicid and what is it used for

Polfungicid is a medicine with antifungal and antibacterial action.
It is used to treat fungal and bacterial infections of the nails and skin – fungal
infections between the toes, and especially around the nails.

2. Important information before using Polfungicid

When not to use Polfungicid

Warnings and precautions

• If redness, burning, or itching of the skin occurs after applying the medicine, discontinue use and consult a doctor.
• Avoid contact of the medicine with the eyes and mucous membranes. If the medicine comes into contact with an eye or mucous membrane, rinse with plenty of water and consult a doctor.
• The medicine contains propylene glycol and may cause skin irritation.

Other medicines and Polfungicid

Tell your doctor about all the medicines you have taken recently, including those that
are available without a prescription.
Salicylic acid (one of the ingredients of the medicine) may change the permeability of the skin to other substances applied at the same time, so avoid applying other medicines, cosmetics, etc. to the treated skin.

Polfungicid with food and drink

Polfungicid is applied to the skin - it can be used independently of meals.

Pregnancy and breastfeeding

Before using any medicine, consult a doctor or pharmacist.

Driving and operating machinery

Polfungicid does not affect the ability to drive vehicles or operate machinery.

3. How to use Polfungicid

Usual dose of Polfungicid:
2 or 3 times a day, brush the changed, diseased area with the solution.
Patient with liver and kidney function disorders and elderly patients:
no need to change the dosage.

Using a higher dose of Polfungicid than recommended

No cases of overdose with Polfungicid have been reported.
In case of accidental or mistaken oral ingestion of the medicine, consult a doctor immediately.
Procedure in case of oral ingestion of the medicine:

• removal from the body (inducing vomiting, stomach lavage);
• monitoring the state of water and electrolyte balance;
• symptomatic treatment (if necessary).

Missing a dose of Polfungicid

If a dose of the medicine is missed at the scheduled time, use it as soon as possible. However, if it is close to the time for the next dose, skip the missed dose. Do not use a double dose to make up for the missed dose.

Stopping the use of Polfungicid

If the use of Polfungicid is stopped, the symptoms of the disease for which it is being used may worsen.
In case of doubts about the use of the medicine, consult a doctor or pharmacist.

4. Possible side effects

Every medicine can cause side effects, although not everybody gets them.
Disorders of the skin and subcutaneous tissue: local signs of skin irritation - redness,
burning, or itching of the skin (frequency not known - cannot be determined based on available data); if they occur, discontinue use of the medicine.
If any of the side effects worsen or if you experience any side effects not listed in the leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Polfungicid

Store at a temperature below 25°C. Store in the original packaging.
Store in a place inaccessible and invisible to children.
Do not use the medicine Polfungicid after the expiry date stated on the label after EXP.

6. Package contents and other information

What Polfungicid contains

The active substances of the medicine are chloramidazole hydrochloride and salicylic acid.
Other ingredients of the medicine are: isopropyl alcohol, disodium edetate, propylene glycol, purified water.

What Polfungicid looks like and what the package contains

Transparent, colorless or slightly brown liquid.
A cardboard box contains a brown glass bottle with a screw cap and dropper, containing 10 ml of the medicine, and an informational leaflet.

Responsible entity:

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-959 Rzeszów
To obtain more detailed information, please contact the representative of the responsible entity:
Valeant Pharma Poland sp. z o.o.
Przemysłowa 2 Street
35-959, Rzeszów
Phone: +48 17 865 51 00
Fax: +48 17 862 46 18
Date of leaflet approval: August 2020