Lamisilatt

Patient Information Leaflet

Lamisilatt
Terbinafini hydrochloridum
10 mg/g, cream
Please read this leaflet carefully before using this medicine, as 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, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any possible side 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.

Leaflet Contents:

1. What Lamisilatt is and what it is 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 Lamisilatt is and what it is used for

Lamisilatt is a white, homogeneous, and glossy cream containing the active substance terbinafine hydrochloride. This medicine has antifungal properties and acts against various species of fungi causing skin diseases. The terbinafine in Lamisilatt cream exerts a fungicidal effect (causing fungal cell death) against dermatophytes and moulds. Against yeasts, it may be either fungicidal or fungistatic (inhibiting fungal growth), depending on the species.
This is an antifungal medicine for topical use.
Treatment of fungal infections such as:

• Athlete's foot (tinea pedis),
• Moccasin-type tinea pedis (plantar 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, lesions also appear on 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 typically 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, affecting the nail surface or the area beneath the nail plate. Nails become thickened, dull, and subungual accumulation of keratinous material occurs. Nail plate layering may develop, and the nail may become destroyed. If the above-described changes in the nails appear, medical advice should be sought, as Lamisilatt cream is NOT effective in treating fungal nail infections. In such cases, prescription medicines taken orally are required.

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

• Groin area,
• Inner 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,
• Armpits.
  Fungal lesions in these areas cause redness, itching, and peeling of the skin.

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 lesions, pink to red in color, covered with papules and scales, spreading peripherally and tending to clear centrally.

Pityriasis versicolor – appears on the skin as scaly, plaque-like lesions. These lesions may become visible only in summer, as the affected areas do not tan when exposed to sunlight, appearing as light or differently pigmented patches. Pityriasis versicolor mainly affects 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 use in the mouth; do not swallow.
• Avoid contact with the eyes. If the medicine accidentally gets into the eyes, rinse thoroughly with running water. If discomfort persists in the eyes, contact your 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.
Lamisilatt and other medicines
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 or 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 or operate machinery.
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, this medicine may cause local skin reactions (e.g. contact dermatitis).

3. How to use Lamisilatt medicine

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

• Open the hermetically sealed tube.
• Wash and dry your 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 your hands thoroughly.
• When applying the medicine to skin folds, cover the area with fresh, clean gauze, especially when using the cream at night.

The following dosing regimen is recommended:

• Athlete's foot (excluding soles and sides of the feet): once daily for 1 week.
• Athlete's foot affecting soles and sides of the feet (moccasin-type athlete's foot): twice daily for 2 weeks.
• Fungal infection of skin folds: once daily for 1 week.
• Cutaneous fungal infection (fungal infection of smooth skin): once daily for 1 week.
• Cutaneous candidiasis (yeast infection of the skin): once daily for 1 week.
• Pityriasis versicolor: once daily for 2 weeks.

The medicine should be used at the recommended dose for the recommended duration, even if symptoms
of infection 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 recommended.
After using Lamisilatt, improvement should be noticeable within a few days. After completing
a 7-day treatment course, 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.
How to care for affected skin during treatment with Lamisilatt cream
During treatment, affected skin areas should be:

• Kept clean by regular washing.
• Gently patted dry—do not rub.
• Avoid scratching treated areas, as this may slow healing or spread the infection.

The basis of 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.
Use of a higher than recommended dose of Lamisilatt
If more than the recommended dose is used, contact a doctor.
Missed dose of Lamisilatt
If a dose is missed, apply the medicine as soon as possible, then continue treatment according to the recommended 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 experiences 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 accompanied by red rash or lumps.

Common adverse reactions (may occur in 1 in 10 people)
Skin peeling, itching
Uncommon adverse reactions (may occur in 1 in 100 people)
Skin lesions, crusts, skin disorders, skin discoloration, redness, burning, pain, pain at application site, irritation at application site.
Rare adverse reactions (may occur in 1 in 1000 people)
Dry skin, eczema

Irritation may occur if Lamisilatt comes into contact with the eyes.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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, 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 .
Adverse reactions can also be reported directly to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Lamisilatt

Keep this medicine out of 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 closed tube in the cardboard box.
Do not store above 30°C.
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 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 supplied in aluminium or laminated tubes with a screw cap.
The medicine is a white, smooth, shiny cream.
Lamisilatt is available in pack sizes containing 7.5 g, 15 g or 30 g of cream. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Karo Healthcare AB
Box 16184
103 24 Stockholm
Sweden
Importer:
Karo Healthcare AB
Klara Norra Kyrkogata 33
111 22 Stockholm
Sweden