PACKAGE LEAFLET: INFORMATION FOR THE USER

Fungotac, 10 mg/ml, ear drops, solution
Clotrimazolum
Please read all of this leaflet carefully before using this 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 the
doctor 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 a few days, or if you feel worse, contact your doctor.

Contents of the leaflet:

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

1. What Fungotac is and what it is used for

Fungotac is an ear drop solution. The active substance in Fungotac is clotrimazole,
which belongs to a group of medicines called imidazoles. Fungotac has antifungal activity and combats the cause
of fungal ear infections.
Indications
Fungal infections of the external and middle ear caused by yeasts (of the genus
Candida), molds (of the genus Aspergillus), and other fungi.
If you are unsure whether your symptoms indicate a fungal ear infection,
consult your doctor.

2. Important information before using Fungotac

When not to use Fungotac
If the patient is allergic to clotrimazole or to any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Before starting treatment with Fungotac, consult your doctor, pharmacist, or nurse.
This medicine is intended for topical use in the ear only.
Protect the eyes from contact with the medicine.

Fungotac and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
No data available.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Fungotac may be used during pregnancy only on the advice and under the supervision of a doctor.

Breastfeeding
In women who are breastfeeding, Fungotac should be used only on the advice and under the supervision of a doctor.

Fertility
No studies have been conducted on the effect of clotrimazole on fertility in humans; however, animal studies have not shown any effect of clotrimazole on fertility.

Driving and operating machinery
This medicine has no effect on the ability to drive or operate machinery.

3. How to use Fungotac

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The medicine is intended for topical use in the ear.
In case of fungal ear infection, apply 2 or 3 drops of Fungotac into the ear twice or three times daily.
After acute symptoms have subsided, treatment should be continued for at least 2 more weeks, until symptoms have completely resolved.
If there is no improvement or if the patient feels worse, consult a doctor.

Use of more Fungotac than recommended
There are no reports of overdose with topical clotrimazole.
In case of accidental ingestion, seek medical advice immediately.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

Missing a dose of Fungotac

If a dose is missed, take it as soon as you remember.
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If an allergic reaction occurs after using Fungotac, stop using the medicine and contact your doctor immediately.
Symptoms of an allergic reaction may include fainting, weakness, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue, rash (urticaria).
Frequency unknown – cannot be estimated based on available data
After using Fungotac, blistering, discomfort and pain, swelling, redness (erythema), irritation, peeling/flaking, itching, rash, stinging and burning sensations may occur.
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 for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel. +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 Fungotac

Keep this medicine out of sight and reach of children.
There are no special requirements regarding storage temperature.
Store in the original packaging to protect from light.
Usable for 6 months after first opening the bottle.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Fungotac contains
The active substance is clotrimazole. 1 ml of solution contains 10 mg of clotrimazole.
The other components are: macrogol 400; diluted hydrochloric acid (for adjustment of pH to 4.5–7.0), sodium hydroxide (for adjustment of pH to 4.5–7.0).

What Fungotac looks like and contents of the pack
Fungotac is a clear, colourless to slightly yellow solution.

Pack size
The medicinal product is supplied in an HDPE bottle closed with an HDPE screw cap and a tamper-evident seal, containing 20 ml of solution, with an LDPE dropper provided, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Tactica Pharmaceuticals Sp. z o.o.
ul. Królowej Jadwigi 148a/1a
30-212 Kraków
tel.: +48 889 388 538
(logo of the Marketing Authorisation Holder)

Manufacturer
Laboratórios Basi – Indústria Farmacêutica S.A.
Parque Industrial Manuel Lourenco Ferriera, Lotes 8, 15 e 16
3450-232 Mortágua
Portugal