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
Terbinafini hydrochloridum
Lamisilatt and Lamisil are different trade names for the same medicinal product.
Please read this 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 patient leaflet or as directed by the doctor, pharmacist, or nurse.
Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 14 days of treatment, or if you feel worse, consult your doctor.

Table of contents of the leaflet:

What Lamisilatt is and what it is used for
Important information before using Lamisilatt
How to use Lamisilatt
Possible side effects
How to store Lamisilatt
Contents of the pack and other information

1. What Lamisilatt is and what it is used for

Lamisilatt is a white cream containing the active substance: terbinafine hydrochloride. This medicine has antifungal properties and acts against various species of fungi causing skin diseases.
The terbinafine contained in Lamisilatt cream acts fungicidally (causing fungal cell death) against dermatophytes and moulds. Against yeasts, it acts either fungicidally or fungistatically (inhibiting fungal growth), depending on the species.
Antifungal medicine for topical use.
Treatment of fungal infections:

Athlete's foot (tinea pedis),
Moccasin-type tinea pedis,
Fungal infection of skin folds and smooth skin,
Pityriasis versicolor,
Cutaneous candidiasis.

Athlete's foot – occurs on one or both feet, most commonly between the toes. In moccasin-type tinea pedis, it also affects the heel, sole, or other parts of the foot. Fungal lesions between the toes are characterized by maceration and desquamation, and may also be vesicular. Acute flare-ups with numerous vesicles and blisters usually occur during hot weather. Itching, pain, inflammation, and vesicle formation may be mild or severe. In long-standing cases of athlete's foot, nail infection (onychomycosis) may develop. Nails become thickened, dull, and underneath the nail plate, accumulation of keratinous material occurs. Nail plate separation follows, and the nail may eventually be destroyed. If the nail changes described above occur, medical advice should be sought, as Lamisilatt cream is NOT effective in the treatment of nail fungal infections. In such cases, prescription medicines must be used.

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

Groin,
Inner thighs (lesions may be bilateral, but often more pronounced on one side; they may spread to the buttocks or upwards towards the abdomen),
Under the breasts,
Armpits. Fungal lesions in these areas cause redness, itching, and epidermal desquamation.

Fungal infection 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 features are ring-shaped, pink to red lesions covered with papules and scales. These lesions spread peripherally and tend to clear centrally.

Pityriasis versicolor – appears on the skin as scaly, plaque-like lesions. These changes may become visible only during summer, as the affected areas do not tan when exposed to sunlight and appear as differently sized light or dark patches. Pityriasis versicolor mainly occurs on the trunk, neck, and arms, especially during hot weather and increased sweating.

Cutaneous candidiasis – occurs mainly in skin folds and moist, sweat-prone areas, such as under the breasts and in the armpits, particularly in obese individuals or those with diabetes. These lesions cause redness, itching, and skin desquamation.

If there is no improvement after 14 days of treatment, or if you feel worse, consult your doctor.

2. Important information before using Lamisilatt

When NOT to use Lamisilatt:

if the patient is 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, discuss this with your doctor, pharmacist, or nurse.

This medicine is for external use on the skin only.
Do not apply inside the mouth; do not swallow.
Avoid contact with the eyes. If the medicine accidentally gets into the eyes, rinse thoroughly with running water. If eye discomfort persists, consult a doctor.
Infants must not have access to treated skin areas, including the breasts.

Children and adolescents
Do not use in children under 12 years of age.
Other medicines and Lamisilatt
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
No interactions between Lamisilatt and other medicines are known.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Lamisilatt should only be used during pregnancy if clearly needed.
Do not use Lamisilatt during breastfeeding.
Infants and young children must not have access to treated skin areas, including the breasts.
Driving and operating machinery
Lamisilatt has no influence on the ability to drive and operate machinery.
Lamisilatt contains benzyl alcohol, cetyl alcohol, and stearyl alcohol
Lamisilatt contains 10 mg of benzyl alcohol per 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 local skin reactions (e.g. contact dermatitis).

3. How to use Lamisilatt

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
In case of fungal nail infection (fungal infection within or under the nail plate) associated with
discoloration and changes in nail structure (thickening, flaking), consult a doctor, as Lamisilatt is NOT
effective in treating this type of infection. In such cases, oral prescription products available from a
pharmacy should be used.
This medicine is for topical use only.
Instructions for use
Adults and children over 12 years of age:

Open the hermetically sealed tube.
Wash and dry hands and the affected skin areas.
Apply a small amount of cream to the affected skin areas, gently rubbing it in.
After each application, wash hands thoroughly.
When applying the cream to skin folds, cover these areas with fresh, clean gauze, especially when using the cream overnight.

Recommended dosing regimen:

Athlete's foot (excluding soles and lateral surfaces of the feet): apply once daily for 1 week.
Tinea pedis of the soles (moccasin-type tinea pedis) (affecting soles and lateral surfaces of the feet): apply twice daily for 2 weeks.
Fungal infection of skin folds: apply once daily for 1 week.
Cutaneous fungal infection (tinea corporis): apply once daily for 1 week.
Cutaneous candidiasis: apply once daily for 1 week.
Pityriasis versicolor: apply once daily for 2 weeks.

The medicine should be used in the recommended doses 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 duration than advised.
After applying Lamisilatt, improvement should be observed within a few days. After completing
a 7-day treatment, the medicine continues to exert antifungal activity in the skin. Therefore,
improvement may continue even after treatment has ended.
If there is no improvement after 2 weeks of starting treatment, consult a doctor.
What to do during treatment with Lamisilatt
During treatment, affected skin areas should be:

Kept clean by regular washing,
Gently patted dry—do not rub,
Protected from scratching, as this may delay healing or spread the infection.

Prevention of fungal skin infections includes using personal towels and clothing, and frequent washing.
If you feel the effect of the medicine is too strong or too weak, consult a doctor.
Overdose of Lamisilatt
If more than the recommended dose is used, consult a doctor.
Missed dose of Lamisilatt
If a dose is missed, apply the medicine as soon as possible and then continue treatment according to
the dosing schedule. Do not use a double dose to make up for a missed dose. Regular use of
Lamisilatt is essential for successful treatment and reduces the risk of infection recurrence.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, which may indicate an allergic reaction, STOP using Lamisilatt and contact your doctor immediately:

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

Common adverse reactions (may occur in 1 out of 10 people)
Skin peeling, itching.
Uncommon adverse reactions (may occur in 1 out of 100 people)
Skin changes, crusts, skin disorders, change in skin color, redness, burning, pain, pain at application site, irritation at application site.
Rare adverse reactions (may occur in 1 out of 1000 people)
Dry skin, eczema.
Irritation may occur if Lamisilatt comes into contact with the eyes.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Lamisilatt

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store the tube in its cardboard box after closing.
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 packaging and other information

What Lamisilatt contains

The active substance 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 contained in aluminium or laminated tubes with a cap, packed in a cardboard box.
The medicine is available in packages containing 15 g of cream.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation 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 in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation number in Greece, the country of export: 71463/04/15-11-2005
88114/25-11-2016
Parallel Import Licence number: 308/09