Package leaflet: Information for the patient

Lamisil, 125 mg, tablets
Lamisil, 250 mg, tablets
Terbinafine
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed specifically for a certain individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

What Lamisil is and what it is used for
Important information before taking Lamisil
How to take Lamisil
Possible side effects
How to store Lamisil
Contents of the pack and other information

1. What Lamisil is and what it is used for

Lamisil tablets contain terbinafine, an active substance belonging to a group of antifungal medicines.
The medicine is used to treat fungal infections of the skin, hair, and nails caused, among others, by dermatophytes of the genus Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. tonsurans, T. violaceum), Microsporum (e.g. M. canis), Epidermophyton floccosum, as well as yeasts of the genus Candida (e.g. C. albicans) and Pityrosporum.
Terbinafine exerts a fungicidal effect against dermatophytes and moulds, as well as against some dimorphic fungi. Against yeasts, depending on the species, it acts either fungicidally or fungistatically (inhibiting fungal growth).
After oral administration, terbinafine accumulates at the site of infection in concentrations ensuring fungicidal or fungistatic activity.

Indications

Fungal infection of the nails (onychomycosis) caused by dermatophytes.
Fungal infection of the scalp and hair (tinea capitis) caused by dermatophytes.
Fungal infections of the skin (caused by dermatophytes), such as tinea corporis (ringworm of the body), tinea cruris (jock itch), tinea pedis (athlete's foot), and skin infections caused by yeasts of the genus Candida (e.g. Candida albicans). Oral treatment in these cases is usually indicated depending on the location, severity, and extent of the infection.

Note:
Lamisil tablets, unlike topical terbinafine preparations, are not effective in the treatment of pityriasis versicolor.

2. Important information before using Lamisil

When not to use Lamisil

if the patient is allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6),
if the patient has had or currently has liver disease,
if the patient has kidney disease.
If any of the above points apply to the patient, the use of the medicine should be discontinued and the doctor should be contacted. The doctor should be informed about any suspected allergic reaction to any of the ingredients of the medicine in the past.

Warnings and precautions
Before starting to use Lamisil, discuss this with your doctor or pharmacist.
The use of Lamisil is contraindicated in patients with chronic or active liver disease.
Inform your doctor:

about taking other medicines (see section "Lamisil with other medicines").
if symptoms indicating liver function disorders occur, such as persistent nausea of unknown origin, vomiting, abdominal pain, loss of appetite, or feeling tired, jaundice, dark urine, or pale stools. In such cases, stop taking the medicine and contact your doctor. Before and periodically after starting treatment with Lamisil, your doctor may perform blood tests to monitor liver function. If test results are abnormal, the use of the medicine should be discontinued.
if skin reactions occur, such as rash, redness of the skin, blisters on the lips or eyelids, skin peeling, fever (possible symptoms of severe skin reactions), or skin rash associated with a high number of certain types of white blood cells (eosinophilia). Contact your doctor immediately.
if there has been or currently is red or silvery thickened areas of skin (psoriasis) or facial rash, joint pain, muscle disorders, or fever (cutaneous and systemic lupus erythematosus).
if weakness, bleeding, bruising, or frequent infections occur (symptoms of blood disorders).

Elderly people (aged 65 years and older)
Patients aged 65 years and older may take the same dose of Lamisil as younger patients.
Elderly patients should inform their doctor about any previous liver or kidney function disorders.

Children and adolescents (aged 2 to 17 years)
The use of Lamisil is not recommended in children under 2 years of age due to lack of available data on use in this age group.

Lamisil with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, especially:

certain medicines used to treat stomach ulcers (e.g. cimetidine),
certain antifungal medicines (e.g. fluconazole, ketoconazole),
certain antibiotics used to treat infectious diseases (e.g. rifampicin),
certain medicines used to treat mood disorders (certain antidepressants such as tricyclic antidepressants, selective serotonin reuptake inhibitors of classes 1A, 1B and 1C, monoamine oxidase inhibitors type B, desipramine),
medicines used to treat high blood pressure (beta-blockers such as metoprolol),
medicines used to treat irregular heartbeat (certain antiarrhythmics such as propafenone, 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).

When Lamisil is used concomitantly with medicines that induce metabolism (e.g. rifampicin - an antibiotic) or medicines that inhibit cytochrome P450 activity (e.g. cimetidine - a medicine used in ulcer disease), the doctor may decide to adjust the dosage.
Tell your doctor about all medicines taken simultaneously.

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, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The doctor will discuss the potential risks associated with using 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, she should stop taking the medicine and inform the doctor.
Terbinafine passes into breast milk. If the patient is breastfeeding, she should consult her doctor before using Lamisil.

Driving and operating machinery
Patients 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 previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking Lamisil 125 mg.
Lamisil 125 mg contains less than 1 mmol (23 mg) of sodium per tablet, meaning 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, meaning the medicine is considered "sodium-free".

3. How to take Lamisil

Always take this medicine exactly as your doctor has told you. If you are unsure, you should contact your doctor again.
This medicine is for oral use.
Dosage of Lamisil
Children
There is no experience with the use of Lamisil in children under 2 years of age (usually with body weight < 12 kg).
Dosage for children over 2 years of age according to body weight:
Children with body weight < 20 kg: 62.5 mg (half a 125 mg tablet) once daily.
Children with body weight from 20 to 40 kg: 125 mg (1 tablet of 125 mg) once daily.
Children with body weight > 40 kg: 250 mg (2 tablets of 125 mg) once daily.
Adults
250 mg once daily.
When to take Lamisil
Taking Lamisil at the same time each day will help you remember to take your dose.
Lamisil tablets may be taken on an empty stomach or after food.
How to take Lamisil
Lamisil tablets should be taken orally with water.
How long to take Lamisil
The duration of treatment depends on the type and severity of the infection and the part of the body affected.
Your doctor will clearly indicate how long you should take the tablets.
Skin infections
Recommended treatment duration:

Interdigital, moccasin-type and/or plantar tinea pedis: 2 to 6 weeks
Tinea corporis, tinea cruris: 2 to 4 weeks
Cutaneous candidiasis: 2 to 4 weeks

It is important to take the medicine every day and continue treatment for as long as your doctor has instructed. This will ensure the infection is eradicated and reduce the risk of recurrence after stopping treatment.
It may take several weeks after the fungal infection has been cured before symptoms completely disappear.
Scalp infections
Recommended treatment duration:
Tinea capitis: 4 weeks.
Tinea capitis occurs mainly in children.
Onychomycosis (fungal nail infection)
Treatment of fungal nail infections usually takes longer than treatment of skin infections. In most patients, complete cure is achieved after 6–12 weeks of treatment.
Fungal nail infections of the hands
A 6-week treatment period is sufficient in most cases of fingernail infections.
Fungal nail infections of the feet
A 12-week treatment period is sufficient in most cases of toenail infections.
Patients with slow nail growth may require a longer treatment period, as decided by the doctor.
To facilitate treatment and prevent recurrence, care should be taken to keep treated areas dry, not overheated, and clothing in direct contact with the skin should be changed daily.
Taking more Lamisil than recommended
If you take more tablets than prescribed, contact your doctor or go to hospital immediately for advice. Medical help may be needed. This also applies to other people who have accidentally taken the patient's medicine.
Symptoms of overdose with Lamisil include headache, nausea, abdominal pain and dizziness.
If you miss a dose of Lamisil
If you miss a dose, take it as soon as possible, unless there are less than 4 hours until the next dose. In that case, wait and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious:
In rare cases, Lamisil may cause liver disorders, and in very rare cases these disorders may be severe. Severe adverse reactions also include: reduced numbers of certain types of blood cells, lupus (an autoimmune disease), severe skin reactions, severe allergic reactions, vasculitis (inflammation of blood vessels), pancreatitis, and rhabdomyolysis (muscle necrosis).
You should immediately contact a doctor if:

The patient experiences symptoms such as persistent nausea of unknown origin, gastrointestinal disturbances, loss of appetite, unusual fatigue or weakness, or notices yellowing of the skin or whites of the eyes, unusually dark urine, or unusually pale stools (symptoms which may indicate liver function disorders).
The patient experiences fever, chills, sore throat, or oral ulcers caused by infections or immune suppression, frequent infections, or unusual bleeding and bruising (possible symptoms of diseases causing disturbances in the number of certain types of blood cells).
The patient experiences difficulty breathing, dizziness, swelling (especially of the face and throat), sudden facial flushing, cramping abdominal pain, loss of consciousness, or symptoms such as joint pain, stiffness, rash, fever, or swelling (enlargement) of lymph nodes (possible symptoms of severe allergic reactions).
The patient experiences symptoms such as rash, fever, itching, fatigue, or the appearance of purple-red blisters under the skin (possible symptoms of vasculitis).
The patient develops any skin changes, such as rash, redness of the skin, formation of blisters on the lips, eyelids, or inside the mouth, skin peeling, or fever.
The patient experiences upper abdominal pain radiating to the back (possible symptoms of pancreatitis).
The patient experiences unexplained muscle weakness or pain, or dark (reddish-brown) urine (possible symptoms of rhabdomyolysis).

The following adverse reactions have been reported during treatment with Lamisil:
Very common adverse reactions (occur in more than 1 in 10 patients):
Headache, nausea, mild abdominal pain, discomfort in the stomach after meals (dyspepsia), diarrhoea, abdominal swelling or bloating (feeling of fullness), loss of appetite, rash, urticaria, joint pain, muscle pain.
Common adverse reactions (occur in 1 to 10 in 100 patients):
Mood changes (depression), disturbances or loss of taste sensation, dizziness, eye disorders, and fatigue.
Uncommon adverse reactions (occur in 1 to 10 in 1,000 patients):
Unusual paleness of the skin, mucous membranes, or nail beds, unusual fatigue or weakness, and shortness of breath during exertion (possible symptoms of anaemia – a disease causing disturbances in the number of red blood cells), restlessness, numbness or tingling, and hypoesthesia, increased skin sensitivity to sunlight, tinnitus (e.g. ringing in the ears), fever, and weight loss.
Rare adverse reactions (occur 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.
Very rare adverse reactions (occur in fewer than 1 in 10,000 patients):
Reduced numbers of certain types of blood cells, lupus (an autoimmune disease), severe skin reactions, allergic reactions, development of psoriasis-like skin lesions (silver-looking rash, exacerbation of psoriasis, scaly skin rash), alopecia (hair loss).
The following adverse reactions have also been reported:
Severe allergic reactions or infections, vasculitis, disturbances of smell including permanent loss of smell, reduced ability to detect odours, blurred vision, decreased visual acuity, pancreatitis, skin rash caused by increased numbers of certain types of white blood cells, rhabdomyolysis (breakdown of striated muscle), influenza-like symptoms (fatigue, chills, sore throat, joint pain, muscle pain), and increased activity of muscle enzymes in the blood (creatine kinase).
Some adverse reactions occurring rarely or very rarely may be serious. You should immediately contact a doctor if symptoms indicating liver function disorders, blood disorders, or skin disorders occur.
If a worsening skin rash develops, treatment with Lamisil should be discontinued and medical advice sought immediately.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this 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 specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lamisil contains
The active substance in Lamisil is terbinafine. One tablet contains 125 mg or 250 mg of terbinafine hydrochloride.
The other ingredients are:
Lamisil 125 mg tablets:
magnesium stearate, hypromellose, lactose monohydrate, sodium carboxymethyl starch (type A), microcrystalline cellulose.
Lamisil 250 mg tablets:
magnesium stearate, hypromellose, colloidal anhydrous silica, sodium carboxymethyl starch (type A), microcrystalline cellulose.

What Lamisil looks like and contents of the pack
Lamisil is a tablet.
One pack of Lamisil 125 mg tablets or Lamisil 250 mg tablets contains 14 tablets.
125 mg tablets (with a score line): each tablet contains 125 mg of terbinafine as terbinafine hydrochloride.
250 mg tablets (with a score line): each tablet contains 250 mg of terbinafine as terbinafine hydrochloride.

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

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