LAMISIL 250 mg TABLETS

Introduction

Patient Information Leaflet

Lamisil 250 mg Tablets

Terbinafine Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Lamisil tablets are and what they are used for
2. What you need to know before you take Lamisil tablets
3. How to take Lamisil tablets
4. Possible side effects
5. Storage of Lamisil tablets
6. Contents of the pack and other information

1. What Lamisil tablets are and what they are used for

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

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

Tinea corporis(body ringworm).

Tinea cruris(jock itch or groin ringworm).

Tinea pedis(athlete's foot).

Tinea capitis(scalp ringworm).

Onychomycosis (fungal infection of the nails).

2. What you need to know before you take Lamisil tablets

Read the following information before you take Lamisil tablets.

Do not take Lamisil tablets

• If you are allergicto terbinafine or 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 you take Lamisil tablets.

If any of the following apply to you, tell 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 tiredness, or if your skin or the whites of your eyes turn yellow, if your urine is unusually dark or if your stools are pale (signs of liver problems).
• If you experience any skin problems such as rash, redness, blisters on the lips, eyes, or mouth, peeling of the skin (signs of severe skin reactions).
• If you experience weakness, unusual bleeding, bruising, or frequent infections (signs of blood disorders).
• If you have psoriasis or lupus erythematosus.

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

Use in children

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 given to patients over 65 years of age. If there is pre-existing kidney problems, a lower dose may be prescribed. Lamisil is not recommended in patients who have or have had liver problems.

Other medicines and Lamisil tablets

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, herbal remedies, and oral contraceptives. There are other medicines that may affect the action of Lamisil tablets, such as:

• 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)), anti-arrhythmics (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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You may use Lamisil tablets during pregnancy only if your doctor advises you to.

Terbinafine (a small amount) is transferred into breast milk. If you are breastfeeding, ask your doctor for advice before taking Lamisil tablets.

Driving and using machines

If you feel dizzy while taking Lamisil tablets, do not drive or use machines.

3. How to take Lamisil tablets

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

Remember to take your medicine.

How much to take

Take Lamisil tablets as your doctor has told you. Your doctor will decide the dose you need.

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

How to take Lamisil tablets

Lamisil tablets are for oral use. Swallow the tablets whole, without chewing, with a glass of water.

How long to take Lamisil tablets

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

It is possible that the complete resolution of the symptoms of the infection may not occur until a few weeks (skin and scalp) or months (nails) after the disappearance of the fungus that causes the infection.

If you take more Lamisil tablets than you should

Consult your doctor, pharmacist, or call the Toxicology Information Service (telephone 91 562 04 20) indicating the medicine and the amount used.

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

If you forget to take Lamisil tablets

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

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

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

Some side effects can be serious:

Rarely, Lamisil tablets can cause liver problems, and in very rare cases, these problems can be serious. Serious side effects also include a decrease in certain blood cells, lupus (an autoimmune disease), severe skin reactions, severe allergic reactions, blood vessel inflammation, pancreatitis, or muscle necrosis.

Stop taking this medicine and tell 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 tiredness or weakness, or if you notice that your skin or the whites of your eyes turn yellow, that your urine is unusually dark, or that you have pale stools (possible signs of liver problems).

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

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

Frequency not known: cannot be estimated from the available data

• If you experience symptoms such as skin rash, fever, itching, tiredness, or if you notice the appearance of reddish-purple spots under the skin surface (possible signs of blood vessel inflammation).
• If you experience severe pain in the upper abdomen with radiation to the back (possible signs of pancreatitis).
• If you experience muscle pain and weakness or dark-colored urine (possible signs of muscle disorder).

Other side effects

Other side effects include the following listed below. If they become severe, tell 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, stomach upset after meals (heartburn), diarrhea, bloating or abdominal distension (feeling of fullness in the stomach), loss of appetite, skin rash (with itching), hives, joint or muscle pain.

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

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

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

Pale skin, mucous membrane, or nail bed that is not normal, unusual tiredness or weakness, or difficulty breathing during exercise (possible signs of a disease that affects red blood cell levels), anxiety, sensation of tingling or numbness, and decreased sensitivity of the skin, increased sensitivity of the skin to sunlight, ringing in the ears (e.g., whistling), fever, and weight 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):

Skin rashes like psoriasis (skin rash with a silvery appearance), worsening of psoriasis, and skin rash with peeling and hair loss.

Frequency not known(cannot be estimated from the available data):

Alterations of 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 cells, flu-like symptoms (e.g., tiredness, 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, please tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lamisil tablets

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

Store in the original package.

Do not store this medicine in a warm place.

Keep the tablets protected from light.

Do not use this medicine after the expiry date stated on the package.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Lamisil tablets

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

Appearance of the product and pack contents

Lamisil tablets are scored, circular, biconvex, white to off-white tablets with the inscription LAMISIL 250, in circular, 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 cutaneous solution. Pack with 30 ml.

Lamisil 10 mg/g cutaneous spray solution. Pack with 30 ml.

Marketing authorization holder

Novartis Farmacéutica, S.A.

Gran Vía de les Corts Catalanes, 764

08013 – Barcelona

Spain

Manufacturer

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

Date of last revision of this leaflet:March 2024

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