Package leaflet: Information for the patient

Polfungicid (50 mg + 10 mg)/ml, solution for skin use
Chlormidazoli hydrochloridum + Acidum salicylicum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used according to the instructions in this patient leaflet or as directed by a doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
Consult your pharmacist if you need advice or further information.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
If there is no improvement after 14 days of treatment, or if the patient feels worse, contact a doctor.

Table of contents of the leaflet:

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

1. What Polfungicid is and what it is used for

Polfungicid is a medicine with antifungal and antibacterial properties.
It is used in the treatment of fungal and bacterial infections of the nails and skin – interdigital fungal infections, particularly infections around the nails.

2. Important information before using Polfungicid

When not to use Polfungicid

if the patient has been diagnosed with hypersensitivity (allergy) to chlorimidazole hydrochloride, salicylic acid, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If redness, burning, or itching of the skin occurs at the site of application, discontinue use and consult a doctor.
Avoid contact of the medicine with eyes and mucous membranes. If contact occurs, rinse thoroughly with plenty of water and consult a doctor.
The medicine contains propylene glycol and may cause skin irritation.

Other medicines and Polfungicid
Inform your doctor about all medicines you are currently taking, including those available without a prescription.
Salicylic acid (one of the components of the medicine) may alter the skin's permeability to other substances applied simultaneously; therefore, avoid applying other medicines, cosmetics, etc., to the treated area of skin.
Polfungicid with food and drink
Polfungicid is for topical use – it can be used regardless 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 or operate machinery.
3. How to use Polfungicid
Usual dose of Polfungicid:
Apply the solution with a brush to the affected area 2 or 3 times daily.
Patients with liver or kidney function disorders and elderly patients:
no dose adjustment is required.
Use of more than the recommended dose of Polfungicid
No cases of overdose with Polfungicid have been reported.
In case of accidental or unintentional oral ingestion of the medicine, seek immediate medical advice.
Management in case of oral ingestion:

removal from the body (inducing vomiting, gastric lavage);
monitoring of fluid and electrolyte balance;
symptomatic treatment (if necessary).

Missed dose of Polfungicid
If a dose is missed, apply it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not use a double dose to make up for the missed dose.
Stopping Polfungicid
If treatment with Polfungicid is discontinued, symptoms of the underlying condition may worsen.
If in doubt about the use of the medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Any medicine can cause adverse reactions, although not everybody experiences them.
Skin and subcutaneous tissue disorders: local skin irritation symptoms – redness,
burning or itching of the skin (frequency unknown – cannot be determined from available
data); if any of these occur, treatment should be discontinued.
If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur,
a doctor or pharmacist should be consulted.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl By reporting adverse reactions, additional information regarding the safety of the medicine can be collected.
5. How to store Polfungicid
Store below 25°C. Keep in the original packaging.
Store out of the reach and sight of children.
Do not use Polfungicid after the expiry date stated on the label following EXP.

6. Contents of the packaging and other information

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

What Polfungicid looks like and contents of the pack
A clear, colourless or slightly brown liquid.
The cardboard box contains an amber glass bottle with a cap and a dropper, containing 10 ml of the medicine, and a patient information leaflet.

Marketing Authorisation Holder:
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
Poland

For further information, please contact the representative of the Marketing Authorisation Holder:
Valeant Pharma Poland sp. z o.o.
Przemysłowa 2 Street
35-959 Rzeszów
Poland
Tel.: +48 17 865 51 00
Fax: +48 17 862 46 18