TERSILAT

Package leaflet: Information for the user

Tersilat
10 mg/g, cutaneous aerosol, solution
Terbinafini hydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• Speak to your pharmacist if you need advice or further information.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement within 7 days after completing treatment, or if you feel worse, consult your doctor.

Contents of the leaflet:

1. What Tersilat is and what it is 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 package and other information

1. What Tersilat is and what it is used for

Tersilat is a topical antifungal medicine containing terbinafine hydrochloride as the active substance. The medicine acts against various species of fungi causing skin diseases. Terbinafine contained in the medicine exerts a fungicidal effect (causing fungal cell death) against dermatophytes and moulds. Against yeasts, depending on the species, it acts either fungicidally or fungistatically (inhibiting fungal growth).

Tersilat is indicated for the topical treatment of:

• athlete's foot (tinea pedis),
• cutaneous candidiasis (fungal infection of skin folds),
• tinea of smooth skin (tinea corporis),
• pityriasis versicolor.

Athlete's foot – occurs on one or both feet, most commonly between the toes. It may also appear on the sole or the sides of the feet. Fungal lesions between the toes are characterized by maceration and desquamation, and may also present with vesicular lesions. Acute flare-ups with numerous vesicles and blisters typically occur during hot weather. Itching, pain, inflammation, and vesicle formation may be mild or severe. In long-standing athlete's foot, nail infection (onychomycosis) may develop, affecting the nail surface or the area beneath the nail plate. Nails become thickened, dull, and subungual hyperkeratosis develops. Nail plate layering occurs, and the nail may become destroyed. If nail changes as described above occur, medical advice should be sought, as Tersilat is not effective in treating onychomycosis. In such cases, prescription oral antifungal medicines are required.

Fungal infection of skin folds – may appear in folded, moist areas of the skin, such as:

• groin,
• inner surfaces of the thighs (lesions may be bilateral, but often more pronounced on one side; these lesions may spread to the buttocks or upwards towards the abdomen),
• under the breasts,
• in the armpits.

Fungal lesions in these areas cause redness, itching, and epidermal scaling.

Tinea of smooth skin – may occur anywhere on the body, but is most commonly seen on the non-hairy skin of the head, neck, face, and arms. Characteristic lesions are ring-shaped, pink to red in color, covered with papules and scales. They spread peripherally and tend to clear centrally.

Pityriasis versicolor – appears on the skin as scaly, patchy lesions. These lesions may be visible only during summer, as fungal areas do not tan under sunlight and become apparent as differently sized light spots. Pityriasis versicolor mainly affects the trunk, neck, and arms, especially during hot weather and increased sweating.

2. Important information before using Tersilat

When not to use Tersilat

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

You should inform your doctor or pharmacist if you have hypersensitivity to these substances, as
Tersilat must not be used in such cases.
Warnings and precautions
Before starting to use Tersilat, discuss it with your doctor or pharmacist.
This medicine is for external use only.
Avoid contact of the medicine with the face and eyes, as well as with damaged skin, because the
alcohol contained in the medicine may cause irritation. If the medicine accidentally gets into the eyes, rinse them
thoroughly with running water.
Do not inhale the medicine. If any disturbing symptoms occur after accidental inhalation, contact your doctor.
Tersilat should be stored out of reach of children.
Do not use the medicine in the mouth or swallow it.
Do not apply the medicine to the face.
In addition, infants should not have access to treated skin areas, including the skin of the breasts.
Tersilat and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or
plan to use.
Do not use other medicines or other products on the areas of skin being treated with Tersilat (including
medicines available without a prescription).
Children and adolescents
This medicine should not be used in children due to lack of data on safety and efficacy in this age group.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a
child, you should consult your doctor or pharmacist before using this medicine.
Do not use the medicine during pregnancy unless absolutely necessary, as determined by your doctor.
During breastfeeding, this medicine should only be used on the advice of a doctor.
Infants should not have access to skin treated with this medicine, including the skin of the breasts.
Driving and operating machinery
This medicine has no effect on the ability to drive or operate machinery.
Tersilat contains propylene glycol
Tersilat contains 350 mg of propylene glycol in each g of solution. Propylene glycol may cause
skin irritation.
Tersilat contains ethanol
This medicine contains 235 mg of alcohol (ethanol) in each g of solution. The medicine may cause
a burning sensation on damaged skin.
Flammable medicine. Store away from fire. Do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).

3. How to use Tersilat

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dosage
Unless otherwise prescribed by a doctor, Tersilat should be applied to affected skin areas as described below.
Tersilat should not be used for fungal nail infections.
Adults
athlete's foot – once daily for 1 week,
skin fold fungal infection – once daily for 1 week,
fungal skin infection – once daily for 1 week,
pityriasis versicolor – twice daily for 1 week.
The medicine should be used at the recommended dose for the recommended duration, even if symptoms improve within a few days of starting treatment. This helps prevent recurrence of the infection, which may occur if the medicine is not used regularly or for a shorter period than recommended.
If there is no improvement within 7 days after completing treatment, consult your doctor.
Children
This medicine should not be used in children.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Method of administration
For external use only.
Follow the instructions below carefully:

• Wash and dry your hands and the affected skin areas and surrounding skin.
• Spray the aerosol onto the affected skin areas and surrounding regions, using an appropriate amount of medicine to gently moisten and completely cover these areas.
• After each application, wipe off any excess solution remaining at the outlet of the bottle with a clean, dry cloth.
• Wash your hands after applying the aerosol.

When using the medicine on skin folds (under the breasts, between fingers, between buttocks, between thighs), these areas should be covered with gauze, especially at night. Always use a new, clean gauze each time.
How to support the effectiveness of Tersilat during treatment
During treatment, the affected skin should be:

• kept clean by regular washing,
• gently patted dry, not rubbed,
• not scratched, as this may slow down the healing process or spread the infection. Basic prevention of fungal skin infections includes using personal towels and clothing, and frequent washing.

Use of a higher than recommended dose of Tersilat
If more medicine than recommended is used or if Tersilat is accidentally swallowed, contact your doctor.
Missed dose of Tersilat
If a dose of Tersilat is missed, apply it as soon as possible and then continue treatment according to the original schedule. Do not use a double dose to make up for the missed dose.
The medicine should be used regularly, as adherence to the recommended regimen is essential for successful treatment and reduces the risk of infection recurrence.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions at the site of application may include: itching, skin peeling,
pain at the application site, irritation at the application site, skin pigmentation disorders, burning sensation of the skin,
severe redness of the skin, and scab formation. These symptoms should not be confused with
allergic reactions.

You must DISCONTINUE use of Tersilat and immediately contact your doctor if any of the following severe allergic reaction symptoms occur:

• difficulty breathing or swallowing,
• swelling of the face, tongue, lips, or throat,
• severe skin itching with red rash or bumps.

Frequent adverse reactions (may occur in up to 1 in 10 people):
Skin peeling, itching.

Uncommon adverse reactions (may occur in up to 1 in 100 people):
Skin lesions, scabs, skin disorders, skin color changes, severe redness, burning, pain,
pain at the application site, irritation at the application site.

Rare adverse reactions (may occur in up to 1 in 1000 people):
Dry skin, rash, eye irritation, contact dermatitis, worsening of disease symptoms at the application site.

Frequency not known (frequency cannot be estimated from available data):
Allergic reactions, rash.

In case of accidental contact with eyes, eye irritation may occur.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your 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
Phone: +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 Tersilat
Keep the medicine out of sight and reach of children.
Store in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Shelf life after first opening of the bottle – 6 months.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Tersilat contains

• The active substance is terbinafine hydrochloride. 1 g of the medicinal product contains 10 mg of terbinafine hydrochloride.
• The other ingredients are: ethanol, propylene glycol, cetostearyl macrogol ether, purified water.

What Tersilat looks like and contents of the pack
Tersilat cutaneous aerosol is a colourless, clear solution.
Packaging
Amber glass bottle closed with a metered-dose pump and a polypropylene cap,
containing 15 ml or 30 ml of the medicinal product, placed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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