Fungotac

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Fungotac ,10 mg/ml, ear drops, solution
Clotrimazole

Please read the contents of the 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 information leaflet or as directed by your doctor or pharmacist.

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after a few days, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Fungotac and what is it used for

Fungotac is an ear drop solution. The active substance of Fungotac is clotrimazole, which belongs to the group of imidazole medicines. Fungotac has antifungal properties and combats the cause of fungal ear infections.

Indications for use

Fungal infections of the outer and middle ear caused by yeast (of the genus Candida), mold (of the genus Aspergillus), and other fungi.
In case of doubt whether the symptoms in the patient indicate a fungal ear infection, a doctor should be consulted.

2. Important information before using Fungotac

When not to use Fungotac

If the patient is allergic to clotrimazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Fungotac, the patient should discuss it with their doctor, pharmacist, or nurse.
The medicine is intended for topical use in the ear only.
The eyes should be protected from contact with the medicine.

Fungotac 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.
No data available.

Pregnancy, breastfeeding, and fertility

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.
Pregnancy
The use of the medicine during pregnancy is possible only on the doctor's prescription and under their supervision.
Breastfeeding
The use of the medicine in breastfeeding women is possible only on the doctor's prescription and under their supervision.
Fertility
No studies have been conducted on the effect of clotrimazole on human fertility; however, animal studies have not shown any effect of clotrimazole on fertility.

Driving and using machines

The medicine does not affect the ability to drive or use machines.

3. How to use Fungotac

This medicine should always be used exactly as described in this patient information leaflet or as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The medicine is intended for topical use in the ear.
In the case of a fungal ear infection, 2 or 3 drops of Fungotac should be applied to the ear canal 2 to 3 times a day.
After the acute symptoms of the disease have subsided, treatment should be continued for at least 2 more weeks, until all symptoms have disappeared.
If there is no improvement or the patient feels worse, they should consult their doctor.

Using more Fungotac than recommended

There are no reports of clotrimazole overdose when used topically.
If the medicine is swallowed, the patient should immediately consult their doctor.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

Missing a dose of Fungotac

• If a dose of the medicine is missed, it should be taken as soon as possible after remembering.
• A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, Fungotac can cause side effects, although not everybody gets them.
If an allergic reaction occurs after using Fungotac, the patient should stop using the medicine and immediately consult their doctor. The symptoms of an allergic reaction may include fainting, weakness, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue, rash (hives).
Frequency not known - cannot be estimated from the available data
After using Fungotac, the patient may experience blisters, discomfort, pain, swelling, redness, irritation, flaking, itching, rash, stinging, or burning sensation.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they 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 181 C, 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 Fungotac

The medicine should be stored out of sight and reach of children.
There are no special recommendations for the storage temperature of the medicine.
Store in the original packaging to protect from light.
Shelf life after first opening the bottle: 6 months.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. 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 Fungotac contains

The active substance of the medicine is clotrimazole. 1 ml of the solution contains 10 mg of clotrimazole.
The other ingredients are: macrogol 400; hydrochloric acid diluted (to adjust the pH to 4.5-7.0), sodium hydroxide (to adjust the pH to 4.5-7.0).

What Fungotac looks like and what the packaging contains

The medicine is a clear, colorless to slightly yellowish solution.

Packaging size

The packaging of the medicine is an HDPE bottle with an HDPE cap, with a tamper-evident seal, containing 20 ml of the solution, with a dropper made of LDPE, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tactica Pharmaceuticals Sp. z o.o.
ul. Królowej Jadwigi 148a/1a
30-212 Kraków
phone: +48 889 388 538
(logo of the marketing authorization holder)

Manufacturer

Laboratórios Basi –Indústria Farmacêutica S.A.
Parque Industrial Manuel Lourenco Ferriera, Lotes 8, 15 e 16
3450-232 Mortágua
Portugal
Date of last update of the leaflet:11/2024