LAMISILATT 10 mg /G Cream

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Lamisilatt
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Lamisilatt and what is it used for
4. Important information before using Lamisilatt
   1. When NOT to use Lamisilatt
   2. Warnings and precautions
   3. Children and adolescents
   4. Lamisilatt and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Lamisilatt contains benzyl alcohol, cetyl alcohol, and stearyl alcohol
5. How to use Lamisilatt
   1. Method of use
   2. Recommended dosage regimen:
   3. If there is no improvement after 2 weeks of treatment, you should contact your doctor.
   4. How to proceed during treatment with Lamisilatt cream
   5. Using a higher dose of Lamisilatt than recommended
   6. Missing a dose of Lamisilatt
6. Possible side effects
   1. Common side effects (may affect up to 1 in 10 people)
   2. Uncommon side effects (may affect up to 1 in 100 people)
   3. Rare side effects (may affect up to 1 in 1000 people)
   4. Reporting side effects
7. How to store Lamisilatt
8. Contents of the pack and other information
   1. What Lamisilatt contains
   2. What Lamisilatt looks like and contents of the pack
   3. Marketing authorization holder:
   4. Importer:
   5. Date of last revision of the leaflet: December 2023

Package Leaflet: Information for the User

Lamisilatt

Terbinafine hydrochloride
10 mg/g, cream

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 the package leaflet for the patient or as directed by a doctor or pharmacist or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist or nurse. See section 4.
• If after 14 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet:

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

1. What is Lamisilatt and what is it used for

Lamisilatt is a white, homogeneous, and shiny cream containing the active substance terbinafine hydrochloride. This medicine has antifungal properties, acting on various species of fungi that cause skin diseases. The terbinafine contained in Lamisilatt cream has a fungicidal effect (causes the death of fungal cells) on dermatophytes and molds. On yeasts, depending on the species, it has a fungicidal or fungistatic effect (inhibits the growth of fungi).
An antifungal medicine for topical use.
Treatment of fungal infections:

• athlete's foot,
• foot fungus (moccasin type),
• fungal infections of skin folds and smooth skin,
• pityriasis versicolor,
• cutaneous candidiasis.

Athlete's foot- occurs on one or both feet, most often between the toes. In the case of foot fungus, it also appears on the sole, heel, or other parts of the foot.
The fungal changes between the toes are characterized by maceration, peeling, and may also have a vesicular character. Sudden exacerbations with the eruption of numerous vesicles and blisters usually occur during heatwaves. Itching, pain, inflammation, and the eruption of vesicles may be mild or severe. In the case of long-standing athlete's foot, there may be an infection of the nails (fungal infection on the surface or under the nail plate). The nails become thickened, dull, and there is an accumulation of horny masses under the free edge. 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 Lamisilatt cream 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 on skin areas that are folded and moist, i.e.,

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

Fungal infections of smooth skin– may occur on the entire body, most often found 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, spread peripherally, and tend to regress in the central part.
Pityriasis versicolor– occurs on the skin in the form of peeling, plaque-like foci. These changes may be visible only in the summer, as the fungal infection 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, and arms, especially during heatwaves, with increased skin sweating.
Cutaneous candidiasis– occurs mainly in skin folds, in moist areas prone to sweating, e.g., under the breasts and in the armpits, especially in obese or diabetic individuals. These changes cause redness, itching, and peeling of the skin.
If after 14 days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before using Lamisilatt

When NOT to use Lamisilatt

• if you are allergic to terbinafine hydrochloride or any of the other ingredients of this medicine (listed in section 6 and at the end of section 2).

Warnings and precautions

Before starting to use Lamisilatt, you should discuss it with your doctor or pharmacist or nurse.

• The medicine is intended for use on the skin only.
• Do not use the medicine in the mouth, do not swallow.
• Avoid contact of the medicine with the eyes. If the medicine accidentally gets into the eyes, rinse them with running water. If discomfort persists in the eyes, contact your doctor.
• Infants should not have access to the treated skin, including the breast.

Children and adolescents

Do not use in children under 12 years of age.

Lamisilatt and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently and about medicines you plan to take.
No interactions of Lamisilatt with other medicines are known.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Lamisilatt can be used during pregnancy only in justified cases.
Do not use Lamisilatt during breastfeeding.
Infants and young children should not have access to the skin treated with this medicine, including the breast.

Driving and using machines

Lamisilatt has no effect on the ability to drive and use machines.

Lamisilatt contains benzyl alcohol, cetyl alcohol, and stearyl alcohol

Lamisilatt contains 10 mg of benzyl alcohol in each gram of cream.
Benzyl alcohol may cause allergic reactions or mild local irritation.
Due to the presence of cetyl alcohol and stearyl alcohol, the medicine may cause a local skin reaction (e.g., contact dermatitis).

3. How to use Lamisilatt

This medicine should always be used exactly as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
In the case of fungal nail infection(fungal infection inside the nail plate or under the nail), which occurs with discoloration and changes in the nail structure (thickening, peeling), you should consult a doctor, as Lamisilatt is NOT effective in treating this type of infection. In such cases, oral products available at the pharmacy on a doctor's prescription should be used.
The medicine is intended for use on the skin.

Method of use

Adults and children over 12 years of age:

• open the hermetically sealed tube,
• wash and dry your hands and the affected areas of the skin,
• apply a small amount of cream to the affected areas of the skin, gently rubbing it in,
• after each application of the medicine, wash your hands thoroughly,
• when using the medicine in skin folds, these areas should be covered with fresh and clean gauze, especially when using the cream at night.

Recommended dosage regimen:

• Athlete's foot (excluding the sole and lateral surfaces of the foot): apply once a day for 1 week.
• Foot fungus (moccasin type) (including the soles and lateral surfaces of the foot): apply twice a day for 2 weeks.
• Fungal infections of skin folds: apply once a day for 1 week.
• Fungal infections of smooth skin: apply once a day for 1 week.
• Cutaneous candidiasis: apply once a day for 1 week.
• Pityriasis versicolor: apply once a day for 2 weeks.

The medicine should be used in the recommended doses for the recommended period, even if the symptoms of the infection disappear after a few days of using the cream. 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.
After using Lamisilatt, improvement should occur within a few days. After completing the 7-day therapy, the medicine still shows a fungicidal effect in the skin. Therefore, even after completing the treatment, there should still be an improvement.

If there is no improvement after 2 weeks of treatment, you should contact your doctor.

How to proceed during treatment with Lamisilatt cream

During 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.
If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor.

Using a higher dose of Lamisilatt than recommended

If you use a higher dose of the medicine than recommended, you should contact your doctor.

Missing a dose of Lamisilatt

If you miss a dose of the medicine, use it as soon as possible and then use the medicine according to the dosage regimen. Do not use a double dose to make up for the missed dose. You should use Lamisilatt 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, which may indicate an allergic reaction, you should STOP using Lamisilatt and contact your doctor immediately:

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

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, crusts, skin disorders, changes in skin color, redness, burning, pain, pain at the application site, irritation at the application site.

Rare side effects (may affect up to 1 in 1000 people)

Dryness of the skin, eczema
If Lamisilatt comes into contact with the eyes, irritation may occur.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 Lamisilatt

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The sealed tube should be stored in the carton.
Do not store above 30°C.
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. Contents of the pack and other information

What Lamisilatt contains

• The active substance is terbinafine hydrochloride.
• The other ingredients are: sodium hydroxide, benzyl alcohol, sorbitan monostearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water.

What Lamisilatt looks like and contents of the pack

Lamisilatt is placed in aluminum or laminated tubes with a screw cap.
The medicine is a white, smooth, shiny cream.
The medicine is available in packs containing 7.5 g, 15 g, or 30 g of the preparation. Not all pack sizes may be marketed.

Marketing authorization holder:

Karo Healthcare AB
Box 16184
103 24 Stockholm
Sweden

Importer:

Karo Healthcare AB
Klara Norra Kyrkogata 33
111 22 Stockholm
Sweden

Date of last revision of the leaflet: December 2023