Lamisilatt

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Lamisilatt (Lamisil)

10 mg/g (1%), cream
Terbinafine hydrochloride
Lamisilatt and Lamisil are different trade names for the same medicine.

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 or nurse.
• 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, tell your doctor, pharmacist, or nurse. See section 4.
• If after 14 days there is no improvement or the patient feels worse, consult a 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 cream containing the active substance: terbinafine hydrochloride. This medicine has antifungal properties, acting on various species of fungi that cause skin diseases. The terbinafine in Lamisilatt cream acts fungicidally (causing the death of fungal cells) on dermatophytes and molds. On yeasts, depending on the species, it acts fungicidally or fungistatically (inhibiting fungal growth).
An antifungal medicine for topical use.
Treatment of fungal infections:

• athlete's foot,
• foot infection between the toes (interdigital foot infection),
• fungal infection 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 infection, 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 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 changes occur in the nails, consult a doctor, as Lamisilatt cream is NOT effective in treating nail fungus. It is then necessary to take medicines available at the pharmacy on a doctor's prescription.
Fungal infection 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 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 appear on the skin in these areas cause redness, itching, and peeling of the epidermis.

Fungal infection of smooth skin- may occur on the entire body, most often found on the smooth skin of the head, neck, face, and arms. Characteristic are ring-shaped foci with a pink to red color. They are covered with crusts 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 usually appears 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 the patient feels worse, consult a doctor.

2. Important information before using Lamisilatt

When NOT to use Lamisilatt:

Warnings and precautions

Before starting to use Lamisilatt, 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, consult a doctor.
• Infants should not have access to the treated skin, including the breasts.

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, consult your doctor or pharmacist before using this medicine.
In pregnancy, Lamisilatt can be used 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 breasts.

Driving and using machines

Lamisilatt has no influence 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 as directed by your doctor or pharmacist. If you are unsure, consult 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 change in the structure of the nail (thickening, peeling), consult a doctor, as Lamisilatt is NOT effective in treating this type of infection. In such a case, 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 in the cream,
• after each application of the medicine, wash your hands thoroughly,
• in the case of 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 infection (including the soles and lateral surfaces of the foot): apply twice a day for 2 weeks.
• Fungal infection of skin folds: apply once a day for 1 week.
• Fungal infection 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 fungicidal activity in the skin. Therefore, even after completing the treatment, improvement should continue.

If there is no improvement after 2 weeks of treatment, consult a doctor.

How to proceed during treatment with Lamisilatt

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, consult a doctor.

Using more than the recommended dose of Lamisilatt

In case of using more than the recommended dose of the medicine, consult a doctor.

Missing a dose of Lamisilatt

In case of missing a dose, 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. 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, STOP using Lamisilatt and consult a doctor immediately:

• difficulty breathing or swallowing,
• swelling of the face, lips, tongue, or throat,
• persistent itching with 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, change 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.
In case of contact of Lamisilatt with the eyes, irritation may occur.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. 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
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 given month.
The closed tube should be stored in a cardboard box.
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 that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Lamisilatt contains

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

What Lamisilatt looks like and contents of the pack

Lamisilatt is a white cream, placed in aluminum or laminated tubes with a screw cap, in a cardboard box.
The medicine is available in packs containing 15 g of cream.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Greece, the country of export:

Karo Healthcare AB
P.O. Box 16184
103 24 Stockholm
Sweden

Manufacturer:

Karo Healthcare AB
Klara Norra Kyrkogata 33
111 22 Stockholm
Sweden

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
License number in Greece, the country of export: 71463/04/15-11-2005
88114/25-11-2016

Parallel import license number: 308/09

Date of leaflet approval: 19.12.2024

[Information about the trademark]