Lamisil

Leaflet accompanying the packaging: patient information

Lamisil, 125 mg, tablets
Lamisil, 250 mg, tablets
Terbinafine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Lamisil and what is it used for

Lamisil tablets contain terbinafine, an active substance belonging to the group of antifungal medicines.
The medicine is used to treat fungal infections of the skin, hair, and nails caused by, among others,
dermatophytes of the genus Trichophyton (e.g., T. rubrum, T. mentagrophytes, T. verrucosum, T.
tonsurans, T. violaceum), Microsporum (e.g., M. canis), Epidermophyton floccosumand yeast of the genus Candida(e.g., C. albicans) and Pityrosporum.
The medicine has a fungicidal effect on dermatophytes, molds, and some dimorphic fungi. On yeast, depending on the species, it has a fungicidal or fungistatic effect (inhibiting fungal growth).
After oral administration, terbinafine accumulates in the infection sites at concentrations that ensure fungicidal or fungistatic effects.

Indications

• Fungal infection of the nails caused by dermatophytes.
• Fungal infection of the hairy scalp caused by dermatophytes.
• Fungal skin infections (caused by dermatophytes), such as trunk fungus, groin ringworm, foot fungus, and skin infections caused by yeast of the genus Candida (e.g., Candida albicans). Indications for oral treatment in these cases usually depend on the location, severity, and extent of the infection.

Warning:

Lamisil tablets, unlike topical terbinafine preparations, are not effective in treating pityriasis versicolor.

2. Important information before taking Lamisil

When not to take Lamisil

Warnings and precautions
Before starting treatment with Lamisil, the patient should discuss it with their doctor or pharmacist.
Taking Lamisil in patients with chronic or active liver disease is contraindicated.
The patient should inform their doctor:

• about taking other medicines (see "Lamisil and other medicines").
• if they have had or currently have thickened skin areas with red or silvery discoloration (psoriasis) or facial rash, joint pain, muscle weakness, or fever (symptoms of cutaneous and systemic lupus erythematosus).

Elderly patients (65 years and older)
Patient aged 65 and older may take the same dose of Lamisil as younger patients.
Elderly patients should inform their doctor if they have had liver or kidney function disorders in the past.
Children and adolescents (2 to 17 years old)
Lamisil is not recommended for children under 2 years old due to the lack of available data on its use in this age group.
Lamisil and other medicines
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, especially:

• certain medicines used to treat stomach ulcers (e.g., cimetidine),
• certain medicines used to treat fungal infections (e.g., fluconazole, ketoconazole),
• certain antibiotics used to treat infectious diseases (e.g., rifampicin),
• certain medicines used to treat mood swings (certain antidepressants, such as tricyclic antidepressants, selective serotonin reuptake inhibitors, monoamine oxidase inhibitors, or desipramine),
• medicines used to treat high blood pressure (beta-adrenergic blockers, such as metoprolol),
• medicines used to treat irregular heartbeat (certain antiarrhythmic medicines, such as propafenone or amiodarone),
• oral contraceptives,
• medicines used to treat cough (e.g., dextromethorphan),
• caffeine,
• cyclosporine, a medicine used to control the immune system (e.g., a medicine used to prevent transplant rejection).

In case of concomitant use of Lamisil with medicines that induce metabolism (e.g., rifampicin, an antibiotic) or medicines that inhibit cytochrome P450 activity (e.g., cimetidine, a medicine used to treat stomach ulcers), the doctor may decide to change the dosage.
The patient should tell their doctor about all concomitantly used medicines.
Lamisil with food and drink
Lamisil should be taken on an empty stomach or after a meal.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The doctor will discuss the potential risks associated with the use of Lamisil during pregnancy.
Lamisil should not be used during pregnancy unless, in the doctor's opinion, the patient's health condition requires treatment, or the potential benefits of treatment outweigh the risks to the fetus. If the patient becomes pregnant while taking Lamisil, they should stop taking the medicine and inform their doctor.
Terbinafine passes into breast milk. If the patient is breastfeeding, they should consult their doctor before taking Lamisil.
Driving and using machines
Patient who experience dizziness after taking Lamisil should not drive or operate machinery.
Lamisil 125 mg, tablets contain lactose monohydrate and sodium.
If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking Lamisil, 125 mg.
Lamisil, 125 mg contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".
Lamisil, 250 mg, tablets contain sodium.
Lamisil, 250 mg contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Lamisil

The medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor again.
The medicine is intended for oral use.

Dosage of Lamisil Children

There is no experience with the use of Lamisil in children under 2 years old (usually under 12 kg).
Dosage in children over 2 years old, depending on body weight:
Children with body weight <20 kg
62.5 mg (half a 125 mg tablet) once a day.
Children with body weight from 20 to 40 kg 125 mg (1 tablet of 125 mg) once a day.
Children with body weight > 40 kg
250 mg (2 tablets of 125 mg) once a day.
Adults
250 mg once a day.

When to take Lamisil

Taking Lamisil at the same time every day will help remember to take the medicine.
Lamisil tablets should be taken on an empty stomach or after a meal.

How to take Lamisil

Lamisil tablets should be taken orally with water.

How long to take Lamisil

The treatment duration depends on the type and severity of the infection and the part of the body affected.
The doctor will precisely determine how long to take the tablets.
Skin infections
Recommended treatment period:

• Fungal infection of the feet, interdigital type, and (or) moccasin-type: 2 to 6 weeks
• Fungal infection of the trunk, groin ringworm: 2 to 4 weeks
• Cutaneous candidiasis: 2 to 4 weeks.

It is essential to take the medicine every day and continue it for as long as the doctor recommends. This will ensure that the infection is cured and reduce the chance of its recurrence after stopping treatment.
It may happen that complete disappearance of infection symptoms occurs only a few weeks after the fungal infection has been cured.
Fungal infections of the hairy scalp
Recommended treatment duration:
Fungal infection of the hairy scalp: 4 weeks.
Fungal infection of the hairy scalp occurs mainly in children.
Onychomycosis
Treatment of onychomycosis usually lasts longer than treatment of skin infections. In most patients, complete cure is achieved after 6-12 weeks of treatment.
Onychomycosis of the hands
A 6-week treatment period is sufficient in most cases of hand onychomycosis.
Onychomycosis of the feet
A 12-week treatment period is sufficient in most cases of foot onychomycosis.
Patient with slow nail growth may require a longer treatment period, which will be decided by the doctor.
To facilitate treatment and prevent recurrence, it is essential to keep the treated areas dry, not overheated, and to change clothes that come into direct contact with them daily.
Using more than the recommended dose of Lamisil
In case of accidental use of a larger number of tablets than recommended by the doctor, the patient should immediately inform their doctor or go to the hospital for advice. The patient may need medical help. This also applies to other people who have accidentally taken the patient's medicine.
Symptoms of Lamisil overdose are headache, nausea, abdominal pain, and dizziness.
Missing a dose of Lamisil
If a dose is missed, the medicine should be taken as soon as possible, unless there are less than 4 hours left before the next dose. In this case, the patient should wait and take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Lamisil can cause side effects, although not everybody gets them.

Some side effects may be serious:

In rare cases, Lamisil may cause liver disease, and in very rare cases, this may be severe. Other serious side effects include a decrease in the number of certain types of blood cells, lupus (an autoimmune disease), severe skin reactions, severe allergic reactions, vasculitis, pancreatitis, and muscle necrosis.

The patient should immediately inform their doctor:

• If they experience symptoms such as persistent nausea of unknown origin, gastrointestinal disorders, loss of appetite, unusual fatigue, or weakness, or if they notice yellowing of the skin or whites of the eyes, unusually dark urine, or pale stools (symptoms that may indicate liver dysfunction).
• If they experience fever, chills, sore throat, or mouth ulcers caused by infections or weakness, more frequent infections, or unusual bleeding and bruising (possible symptoms of blood disorders).
• If they experience difficulty breathing, dizziness, swelling, mainly of the face and throat, sudden redness of the face, crampy abdominal pain, and loss of consciousness, or if they experience symptoms such as joint pain, stiffness, rash, fever, or swelling (enlargement) of lymph nodes (possible symptoms of severe allergic reactions).
• If they experience rash, fever, itching, fatigue, or the appearance of purple-red blisters under the skin (possible symptoms of vasculitis).
• If they experience any skin changes, such as rash, redness of the skin, blisters on the lips, eyelids, or in the mouth, peeling of the skin, fever.
• If they experience abdominal pain radiating to the back (possible symptoms of pancreatitis).
• If they experience unexplained weakness or muscle pain, or dark (red-brown) urine (possible symptoms of muscle necrosis).

The following side effects have been reported during treatment with Lamisil:

Very common side effects (occurring in more than 1 in 10 patients):

Headache, nausea, mild abdominal pain, discomfort in the stomach after eating (heartburn),
diarrhea, abdominal swelling or bloating (feeling of fullness), loss of appetite, rash, hives, joint pain, muscle pain.

Common side effects (occurring in 1 to 10 in 100 patients):

Mood changes (depression), taste disturbances or loss of taste, dizziness, eye disorders, and fatigue.

Uncommon side effects (occurring in 1 to 10 in 1000 patients):

Non-typical pallor of the skin, mucous membranes, or nail matrix, non-typical fatigue or weakness, and shortness of breath during exertion (possible symptoms of anemia - a disease that disrupts the number of red blood cells), anxiety, numbness or tingling, and decreased sensitivity, increased sensitivity of the skin to sunlight, ringing (e.g., hissing) in the ears, fever, and weight loss.

Rare side effects (occurring in 1 to 10 in 10,000 patients):

Yellowing of the whites of the eyes and skin (symptoms indicating liver problems) and abnormal liver function test results.
Side effects that occur very rarely (occurring in less than 1 in 10,000 patients):
D decrease in the number of certain types of blood cells, lupus (an autoimmune disease), severe skin reactions, allergic reactions, appearance of skin lesions similar to psoriasis (rash with a silvery appearance, exacerbation of psoriasis, skin rash with peeling, hair loss.

The following side effects have also been reported:

Severe allergic reactions or infections, vasculitis, disorders of smell, including permanent loss of smell, decreased ability to perceive smells, blurred vision, decreased visual acuity, pancreatitis, skin rash caused by an increased number of certain types of white blood cells, breakdown of striated muscles, flu-like symptoms (fatigue, chills, sore throat, joint pain, muscle pain) and increased activity of the muscle enzyme in the blood (creatine kinase).
Some side effects that occur rarely or very rarely may be severe. The patient should immediately inform their doctor if they experience symptoms indicating liver dysfunction, blood disorders, or skin disorders.
In case of worsening skin rash, treatment with Lamisil should be stopped, and the doctor should be consulted immediately.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should tell their doctor or 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
Aleje 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.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Lamisil

Keep out of the reach and sight of children.
Protect from light.
Do not use Lamisil after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Lamisil contains

The active substance of Lamisil is terbinafine. One tablet contains 125 mg or 250 mg of terbinafine hydrochloride.
In addition, the medicine contains:
Lamisil 125 mg tablets:
magnesium stearate, hypromellose, lactose monohydrate, sodium carboxymethyl starch (type A),
microcrystalline cellulose.
Lamisil 250 mg tablets:
magnesium stearate, hypromellose, colloidal silica, sodium carboxymethyl starch (type A), microcrystalline cellulose.

What Lamisil looks like and contents of the pack

Lamisil is in the form of tablets.
One pack of Lamisil 125 mg tablets or Lamisil 250 mg tablets contains 14 tablets.
125 mg tablets (with a dividing line) for use in children: 1 tablet contains 125 mg of terbinafine,
in the form of terbinafine hydrochloride.
250 mg tablets (with a dividing line): 1 tablet contains 250 mg of terbinafine, in the form of terbinafine hydrochloride.

Marketing authorization holder

Novartis Poland Sp. z o.o.
Marynarska 15
02-674 Warsaw
Tel. + 48 22 375 48 88

Manufacturer/Importer

Novartis Pharma GmbH
Roonstrasse 25
90429 Nürnberg
Germany
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Poland Sp. z o.o.
Marynarska 15
02-674 Warsaw
(only for Lamisil, 250 mg, tablets)
Lek d.d., PE PROIZVODNJA LENDAVA
Trimlini 2D,
Lendava, 9220
Slovenia

Date of leaflet approval: 04/2022