Package Insert: Information for the Patient

Lamisil 250 mg Tablets

TerbinafineHydrochloride

Terbinafine belongs to a group of medicines called antifungals and works by preventing the development of fungi.

Lamisil is used to treat the following fungal skin, scalp, and nail infections:

Tinea corporis(body ringworm).

Tinea cruris(inguinal ringworm or jock itch).

Tinea pedis(athlete's foot).

Tinea capitis(scalp ringworm).

Onychomycosis (nail ringworm).

Read the following information before taking Lamisil tablets.

Do not take Lamisil tablets

• If you are allergicto terbinafine or to any of the other ingredients of this medicine (listed in section 6).
• If you have or have had liver problems.
• If you have kidney problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lamisil tablets.

If any of these conditions affect you, inform your doctor before taking Lamisil.

• If you have kidney problems, consult your doctor before taking this medicine.
• If you experience symptoms such as persistent and unexplained nausea, vomiting, stomach pain, loss of appetite, unusual fatigue, if your skin or the white of your eyes turns yellow, if your urine has an unusual dark color or if your stools have an unusual light color (signs of liver problems).
• If you experience any skin problems such as rash, red skin, blisters on lips, eyes, or mouth, skin peeling (signs of severe skin reactions).
• If you experience weakness, unusual bleeding, bruising, or frequent infections (signs of blood abnormalities).
• If you suffer from psoriasis or lupus erythematosus.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Use in children

The experience with Lamisil tablets in children is limited, therefore, it is not recommended for use in this type of patient.

Use in elderly patients

Lamisil tablets can be administered to patients over 65 years of age. If there is a pre-existing renal problem, you may be prescribed a lower than usual dose.Lamisil is not recommended for patients who have or have had liver problems.

Other medicines and Lamisil tablets

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine, including oral contraceptives, herbal medicines, and those obtained without a prescription. There are other medicines that may modify the effect of Lamisil tablets, for example:

• some antibiotics (e.g. rifampicin),
• caffeine,
• some medicines used to treat mood disorders (some antidepressants such as tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs)), antiarrhythmics (including class 1A, 1B, and 1C), monoamine oxidase inhibitors (MAOIs) type B,
• some medicines used to treat heart problems (e.g. propafenone, amiodarone),
• some medicines used to treat high blood pressure (e.g. metoprolol),
• some medicines used to treat stomach ulcers (e.g. cimetidine),
• some medicines used to treat fungal infections (e.g. fluconazole, ketoconazole),
• some medicines used to treat cough (e.g. dextromethorphan),
• some medicines used to prevent organ rejection in transplant patients (e.g. cyclosporine).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

You can use Lamisil tablets during pregnancy only if your doctor tells you to.

A small amount of terbinafine is transferred to breast milk. If you are breastfeeding, consult your doctor before using Lamisil tablets.

Driving and operating machinery

If you feel dizzy while taking Lamisil tablets, do not drive or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

How much to take

Take Lamisil tablets as directed by your doctor. He will determine the dose you need.

The usual dosein adults is one tablet (250 mg) once a day.

How to take Lamisil tablets

Lamisil tabletsare oral tablets. Swallow the tablets whole, without chewing, with a glass of water.

For how long to take Lamisil tablets

The duration of treatment will be established by your doctor. Do not stop treatment before, as it may worsen your condition.

It is possible that the complete resolution of symptoms of the infection will not occur until several weeks (skin and scalp) or months (nails) after the disappearance of the fungus causing the infection.

If you take more Lamisil tablets than you should

Consult your doctor, pharmacist, or callthe Toxicological Information Service (phone 91 562 04 20)indicating the medication and the amount used.

The main symptoms of acute poisoning may be gastrointestinal, e.g. nausea, abdominal pain, or vomiting, but may also present with headache or a sense of instability (dizziness). If you experience any of these effects or any other unusual effect, consult your doctor.

If you forgot to take Lamisil tablets

Take another one as soon as you remember, unless it is less than 6 hours before the next dose.

Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some side effects can be severe:

Rarely, Lamisil tablets may cause problems in the liver and in very rare cases these problems can be severe. Severe adverse reactions also include a decrease in certain blood cells, lupus (an autoimmune disease), severe skin reactions, severe allergic reactions, inflammation of blood vessels, pancreatitis or muscle necrosis.

Stop taking this medicine and inform your doctor immediately:

Rare:may affect up to 1 in 1,000 people

• If you experience symptoms such as persistent and unexplained nausea, stomach problems, loss of appetite or unusual fatigue or weakness, or if you notice that your skin or the white of your eyes turns yellow, that your urine is unusually dark or that you have pale stools (possible signs of liver problems).

Veryrar:may affect up to 1 in 10,000 people

• If you have fever, chills, sore throat or ulcers in the mouth caused by infections and weakness, or if you have more frequent infections or if you experience unusual bleeding or bruising (possible signs of diseases that affect the levels of certain blood cells).
• If you experience difficulty breathing, dizziness, swelling mainly of the face and throat, redness, abdominal pain like colic and loss of consciousness, or if you experience symptoms such as joint pain, stiffness, skin rash, fever or swelling/enlargement of lymph nodes (possible signs of severe allergic reactions).
• If you develop any skin problem such as skin rash, skin redness, blistering on the lips, eyes or mouth, skin peeling, fever.

Unknown frequency:cannot be estimated from available data

• If you experience symptoms such as skin rash, fever, itching, fatigue or if you notice the appearance of red-purple patches under the skin surface (possible signs of inflammation of blood vessels).
• If you experience severe upper abdominal pain radiating to the back (possible signs of pancreatitis).
• If you experience unexplained muscle pain and weakness or dark urine (possible signs of muscle disorder).

Otherside effects

Other side effects include the following listed below. If they become severe, inform your doctor, pharmacist or nurse.

Most side effects are mild or moderate and usually disappear after a few days to a few weeks of treatment.

Very common(may affect more than 1 in 10 people):

Headache, nausea, mild abdominal pain, postprandial gastric discomfort (heartburn), diarrhea, abdominal distension or bloating (feeling of fullness in the stomach), loss of appetite, skin rash (with itching), urticaria, joint or muscle pain.

Common(may affect up to 1 in 10 people):

Mood disorder (depression), taste disturbance or loss, dizziness, visual disturbances.

Uncommon(may affect up to 1 in 100 people):

Pale skin, abnormal mucous membrane or nail bed, unusual fatigue or weakness, or difficulty breathing during exercise (possible signs of a disease affecting red blood cell levels), anxiety, sensation of tingling or numbness and decreased skin sensitivity, increased skin sensitivity to the sun, ringing in the ears, fever andweight loss.

Rare(may affect up to 1 in 1,000 people):

Abnormal liver function test results.

Very rare(may affect up to 1 in 10,000 people):

Psoriasis-like skin eruptions (skin rash with silver appearance), worsening of psoriasis, and skin eruption with peeling and hair loss.

Unknown frequency(cannot be estimated from available data):

Changes in smell including permanent loss, decreased ability to smell, blurred vision, decreased visual acuity, hearing loss or difficulty hearing, skin rash caused by elevated levels of a specific type of white blood cell, pseudo-gripal symptoms (e.g. fatigue, chills, sore throat, muscle or joint pain), and increased blood levels of a muscle enzyme (creatine phosphokinase).

If you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store in the original packaging.

Do not store this medication in a warm place.

Store the tablets protected from light.

Do not use this medication after the expiration date that appears on the packaging.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lamisil tablets

• The active ingredient is terbinafine hydrochloride. Each tablet contains 250 mg of terbinafine (as hydrochloride).
• The other components (excipients) are: magnesium stearate, anhydrous colloidal silica, hypromellose, sodium carboxymethylcellulose (from potato, gluten-free), microcrystalline cellulose, and demineralized water.

Appearance of the product and contents of the packaging

Lamisil tablets are scored, circular, biconvex, white to light yellowish in color, and have the inscription LAMISIL 250 in a circular pattern on one face.They are available in packs of 14 and 28 tablets.

Other presentations:

Lamisil 10 mg/g cream. Pack with 30 g.

Lamisil 10 mg/g topical solution. Pack with 30 ml.

Lamisil 10 mg/g topical solution for skin spray. Pack with 30 ml.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Vía de les Corts Catalanes, 764

08013 – Barcelona

Spain

Responsible for manufacturing

Novartis Farmacéutica, S.A.

Gran Vía de les Corts Catalanes, 764

08013 – Barcelona

Spain

Lek d.d, PE PROIZVODNJA LENDAVA

Trimlini 2D

Lendava, 9220

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

Last review date of this leaflet:March 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/