Tersilat

Package Leaflet: Information for the User

Tersilat

10 mg/g, skin spray, solution

Terbinafine hydrochloride

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

• Keep this package leaflet, you may need to read it again.
• Ask your pharmacist if you need advice or further information.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days of treatment, there is no improvement or you feel worse, you should contact your doctor.

Package Leaflet Contents:

• 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. Package contents and other information

1. What is Tersilat and what is it used for

Tersilat is an antifungal medicine for use on the skin, containing terbinafine hydrochloride as the active substance. The medicine works on various fungal species that cause skin diseases. The terbinafine in the medicine has a fungicidal effect (causes the death of fungal cells) on dermatophytes and molds. On yeast, it has either a fungicidal or fungistatic effect (inhibits fungal growth), depending on the species. Tersilat is indicated for local treatment of:

• athlete's foot,
• fungal infections of skin folds,
• fungal infections of smooth skin,
• pityriasis versicolor.

Athlete's foot occurs on one or both feet, most often between the toes. It also appears on the sole or sides of the feet. Fungal changes between the toes are characterized by maceration, peeling, and may have a vesicular or blister-like appearance. Sudden exacerbations with numerous vesicles and blisters usually occur during heatwaves. Itching, pain, inflammation, and vesicles may be mild or severe. In the case of long-standing athlete's foot, nail infection (fungal infection on the surface or under the nail plate) may occur. The nails become thickened, dull, and there is an accumulation of keratinous masses under the free edge of the nail. The nail plate becomes layered, and the nail may be destroyed. If the above-mentioned changes occur in the nails, you should consult a doctor, as Tersilat is not effective in treating nail fungus. In such cases, it is necessary to take medications available at the pharmacy on a doctor's prescription. Fungal infections of skin folds may appear in areas of the skin that are folded and moist, i.e.,

• in the groin,
• on the inner surface of the thighs (bilateral changes, but often more severe on one side; these changes may spread to the buttocks or up the abdomen),
• under the breasts,
• in the armpits. Fungal changes that occur on the skin in these areas cause redness, itching, and peeling of the epidermis.

Fungal infections of smooth skin may occur on the entire body, most often on the non-hairy skin of the head, neck, face, and arms. Characteristic are ring-shaped foci with a pink to red color. They are covered with grains and scales, spreading peripherally and tend to regress in the central part. Pityriasis versicolor occurs on the skin in the form of peeling, patchy foci. These changes may only become visible in the summer, as the fungal foci do not tan under the influence of sunbathing, they become visible as spots of different sizes. Pityriasis versicolor occurs mainly on the torso, neck, arms, especially during heatwaves, with increased skin sweating.

2. Important information before using Tersilat

When not to use Tersilat

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

Tell your doctor or pharmacist if you are sensitive to these substances, as you should not use Tersilat in such cases.

Warnings and precautions

Before starting to use Tersilat, discuss it with your doctor or pharmacist. The medicine is intended for external use only. Avoid contact with the face and eyes, as well as damaged skin, as the alcohol in the medicine may cause irritation. If the medicine accidentally gets into your eyes, rinse them with running water. Do not inhale the medicine. If, after accidental inhalation of the medicine, you experience any worrying symptoms, contact your doctor. Tersilat should be kept out of the reach of children. Do not use the medicine in the mouth or swallow it. Do not use the medicine on the face. Additionally, infants should not have access to the treated skin, including breast skin.

Tersilat and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take. Do not use other medicines or products on areas of the skin treated with Tersilat (including over-the-counter medicines).

Children and adolescents

The medicine should not be used in children due to the lack of data on safety and efficacy in this age group.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine. Do not use the medicine during pregnancy, unless your doctor considers it absolutely necessary. During breastfeeding, the medicine can only be used on a doctor's advice. Infants should not have access to the skin treated with this medicine, including breast skin.

Driving and using machines

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

Tersilat contains propylene glycol

Tersilat contains 350 mg of propylene glycol in each gram of solution. Propylene glycol may cause skin irritation.

Tersilat contains ethanol

This medicine contains 235 mg of alcohol (ethanol) in each gram of solution. The medicine may cause burning of damaged skin. The medicine is flammable. Keep 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 package leaflet or as directed by a doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Recommended dosage

Unless your doctor advises otherwise, use Tersilat on the affected areas of the skin as described below. Do not use Tersilat for nail fungus. Adultsathlete's foot - once a day for 1 week, fungal infections of skin folds - once a day for 1 week, fungal infections of smooth skin - once a day for 1 week, pityriasis versicolor - twice a day for 1 week. Use the medicine in the recommended doses for the recommended period, even if the symptoms of the infection disappear after a few days of using the medicine. This will prevent the recurrence of the disease, which may occur if the medicine is not used regularly or is used for a shorter period than recommended. If after 7 days of treatment, there is no improvement, you should contact your doctor. ChildrenThe medicine should not be used in children. If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Method of administration

For use on the skin only. Follow the instructions below exactly:

• Wash and dry your hands and the affected areas of the skin and the surrounding areas.
• Spray the aerosol on the affected areas of the skin and their surroundings, using the appropriate amount of medicine to gently moisten these areas and cover them completely.
• After each use of the medicine, wipe the excess solution remaining on the nozzle with a clean, dry cloth.
• After applying the aerosol, wash your hands.

If you are using the medicine in skin folds (in the breast area, between the toes, between the buttocks, between the thighs), these areas should be covered with gauze, especially at night. Use a new, clean gauze each time. How to proceed during treatment with Tersilat to support its effectDuring treatment, the affected skin should be:

• kept clean by regular washing,
• wiped gently, not rubbed,
• avoid scratching the treated areas, as this may slow down the healing process or spread the infection. The basis for the prevention of fungal skin diseases is the use of your own towel, personal clothes, and frequent washing.

Using more than the recommended dose of Tersilat

If you use more than the recommended dose or accidentally swallow the medicine, contact your doctor.

Missing a dose of Tersilat

If you miss a dose of Tersilat, use it as soon as possible and then continue treatment according to the previously established schedule. Do not use a double dose to make up for the missed dose. The medicine should be used regularly, as using it according to the recommendations is the basis for the success of the treatment and reduces the risk of recurrence of the infection. If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tersilat can cause side effects, although not everybody gets them. At the site of application, side effects may occur, such as itching, peeling of the skin, pain at the application site, irritation at the application site, changes in skin color, burning sensation of the skin, severe redness of the skin, formation of scabs. Do not confuse these symptoms with allergic reactions. STOP USING Tersilat and contact your doctor immediatelyif you experience any of the following severe symptoms of an allergic reaction:

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

Common side effects (may affect up to 1 in 10 people): Peeling of the skin, itching. Uncommon side effects (may affect up to 1 in 100 people): Skin changes, scabs, skin disorders, changes in skin color, severe redness, burning, pain, pain at the application site, irritation at the application site. Rare side effects (may affect up to 1 in 1,000 people): Dryness of the skin, rash, eye irritation, contact dermatitis, exacerbation of symptoms at the application site. Unknown frequency (frequency cannot be estimated from the available data): Allergic reactions, rash. If the medicine accidentally comes into contact with the eyes, eye irritation may occur.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this 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 packaging. The expiry date refers to the last day of the month stated. Shelf life after first opening the bottle: 6 months. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tersilat contains

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

What Tersilat looks like and contents of the package

Tersilat, skin spray, is a colorless, clear solution. PackagingA brown glass bottle with a dosing pump and a polypropylene cap, containing 15 ml or 30 ml of the medicine, placed in a cardboard box. Not all pack sizes may be marketed.

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 package leaflet: