Tersilat

Leaflet attached to the packaging: information for the user

Tersilat, 10 mg/g, cream

Terbinafine hydrochloride

Read 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 the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 14 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Tersilat and what is it used for

Tersilat is a white cream that contains 10 mg/g of the active substance - terbinafine hydrochloride.
Tersilat is used externally to treat fungal or yeast infections of the skin, such as athlete's foot.

2. Important information before using Tersilat

When not to use Tersilat

• If the patient is allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may manifest, for example, as red spots or skin swelling and (or) itching.

Warnings and precautions

Before starting to use Tersilat, the patient should discuss it with their doctor or pharmacist.

• Tersilat is intended for external use only.
• The medicine should not be used in the mouth or swallowed.
• If it is necessary to apply the medicine to the face, the patient should avoid contact with the eyes. The medicine may cause eye irritation. If the medicine accidentally gets into the eyes, they should be wiped and rinsed thoroughly with running water.
• Infants should not have access to the skin treated with this medicine, including breast skin.
• Tersilat should be kept out of the reach and sight of children.

Children

Tersilat is not recommended for children under 12 years of age. The data on the use of the medicine in children are limited.

Tersilat and other medicines

There is no data indicating that Tersilat cream has a negative effect on other medicines.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Pregnancy and breastfeeding

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
Tersilat cream should not be used during pregnancy unless it is absolutely necessary.
Breastfeeding
Tersilat should not be used during breastfeeding, as terbinafine passes into human milk. Infants should not have access to the skin treated with this medicine, including breast skin.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines.

Tersilat contains cetyl alcohol.

Cetyl alcohol may cause local skin reactions (e.g., contact dermatitis).

Tersilat contains benzyl alcohol.

This medicine contains 15 mg of benzyl alcohol in 1 g of cream.
Benzyl alcohol may cause mild local irritation. Benzyl alcohol may cause allergic reactions.

Tersilat contains polysorbate 60 (E435).

Polysorbate may cause allergic reactions.

3. How to use Tersilat

Method of administration

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The tube is tightly closed with an aluminum cap. The cap can be broken by lightly pressing the inverted cap.
It is essential to use Tersilat correctly. The instructions should be followed carefully.
In the case of fungal nail infection (fungal infection inside the nail plate or under the nail), which occurs with discoloration and (or) change in the structure of the nail (thickening, brittleness, fragility), the patient should consult their doctor. Tersilat is not effective in treating this type of infection.
For use on the skin only.

• Before applying, the patient should wash and dry the affected areas of the skin and their hands thoroughly.
• The patient should take a small amount of cream on their finger and screw the tube.
• The patient should apply a thin layer of cream to the infected areas of the skin and surrounding areas and gently rub it in.
• After touching the infected area of the skin, the patient should wash their hands thoroughly to prevent the infection from spreading. When using the medicine in skin folds (e.g., in the breast area, between the fingers, between the buttocks, between the thighs), these areas should be covered with gauze, especially at night. A new, clean gauze should be used each time.

Before applying Tersilat cream to large areas of the skin (larger than 10% of the body surface, which corresponds to the surface of about 10 hands), the patient should consult their doctor.

Adults and children over 12 years of age:

Duration of treatment and frequency of application

• Athlete's foot (between the toes): Once a day for a week.
• Athlete's foot (moccasin-type): Twice a day for 2 weeks.
• Fungal infections caused by dermatophytes (skin fold infections, smooth skin infections): Once a day for a week.
• Fungal skin infections (cutaneous candidiasis): Once or twice a day for 1 to 2 weeks.
• Pityriasis versicolor: Once or twice a day for 2 weeks.

Fungal infections (cutaneous candidiasis) may manifest as fungal or skin lesions, but occur in older patients or patients with overweight - in a humid environment in skin folds or in patients with other diseases, such as diabetes. In the treatment of cutaneous candidiasis, a longer treatment period (2 weeks) may be required.
The patient should continue treatment for the recommended duration, even if symptoms have disappeared after a few days. Symptoms usually disappear after a few days, but may return if the cream is not used regularly or if treatment is stopped too early.
After applying Tersilat cream, the skin condition should improve within a few days. However, complete healing of the damaged skin after the disease has disappeared may take up to four weeks. Tersilat cream will continue to work after treatment has stopped, so the skin condition should continue to improve.
If there is no improvement in symptoms within two weeks of starting treatment, the patient should consult their doctor or pharmacist for advice.

Supporting treatment

To support treatment, the patient should maintain good hygiene by regularly washing the affected area. The area should be dried carefully - gently, without rubbing. The patient should avoid scratching the skin during itching, as this can cause further skin damage and delay the healing process or cause the infection to spread.
The patient should regularly change towels, clothes, and socks that come into contact with the affected skin area and wash them at a temperature of at least 60 ° C. If this is not possible, the patient should at least use a disinfectant. The patient should choose natural materials, such as cotton. This can help prevent the infection from spreading to other parts of the body and to other people.
Elderly patients
There is no data indicating that dose adjustment is necessary in elderly patients or that adverse reactions other than those observed in younger patients may occur.
Use in children
Due to the limited amount of available data on the use of Tersilat cream in children under 12 years of age, the use of this medicine is not recommended in this age group.

Using more than the recommended dose of Tersilat

There are no known cases of overdose with Tersilat when used externally.
In case of any doubts about use, the patient should contact their doctor or pharmacist.
In case of accidental ingestion of Tersilat cream, for example by a child, the expected adverse reactions will be similar to those that occur with overdose of terbinafine tablets (such symptoms may include headache, nausea, dizziness, and abdominal pain).
In this case, the patient should contact their doctor or go to the hospital emergency room.
In case of accidental contact of the cream with the eyes, they should be rinsed thoroughly with clean, running water.

Missing a dose of Tersilat

If a dose of the medicine is missed, it should be applied as soon as possible and then the medicine should be used according to the dosing schedule. If the patient does not remember to apply a missed dose until the next use, they should apply the usual amount of the medicine and then continue treatment as usual. The patient should not apply a double dose to make up for a missed dose.
The cream should be used according to the leaflet. This is especially important because if the medicine is missed several times, there is a risk of the infection returning.

Stopping use of Tersilat

If the use of Tersilat cream is stopped before the end of the treatment period, the initial symptoms may return.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient should stop using the cream and contact their doctor immediately if they experience any of the following symptoms of an allergic reaction:

• persistent itching with red rash or bumps, hives, or blisters,
• difficulty breathing or swelling of the mouth, face, lips, tongue, or throat. The frequency of these allergic reactions is unknown (cannot be estimated from the available data).

The following side effects have also been reported:
Common (may affect up to 1 in 10 people): skin peeling, itching.
Uncommon (may affect up to 1 in 100 people): skin changes, crusts, skin disorders, pigmentation disorders, redness, burning sensation, pain, pain at the application site, irritation at the application site.
Rare (may affect up to 1 in 1000 people): dry skin, contact dermatitis, rash, exacerbation of fungal infection.
Frequency not known (frequency cannot be estimated from the available data):
hypersensitivity, rash.
In case of contact of Tersilat cream with the eyes, eye irritation may rarely occur.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Tersilat

The medicine should be stored in a place that is out of sight and reach of children.
The medicine should not be used after the expiry date stated on the tube and carton after: "EXP".
The expiry date refers to the last day of the month.
There are no special precautions for storage.
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.

Instructions for the shelf life after opening

Shelf life after first opening the tube: 6 months.

6. Contents of the pack and other information

What Tersilat contains

The active substance of the medicine is terbinafine hydrochloride.
1 g of cream contains 10 mg of terbinafine hydrochloride.
The other ingredients are:
purified water, cetyl alcohol, isopropyl myristate, cetyl palmitate, sorbitan stearate, benzyl alcohol, polysorbate 60, sodium hydroxide.

What Tersilat looks like and contents of the pack

Tersilat is a white cream.
The medicine is available in tubes of 15 g and 30 g.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
Date of last revision of the leaflet:04.2025