Zelefion

Leaflet attached to the packaging: patient information

ZELEFION, 250 mg, tablets

Terbinafine

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• 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 as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Zelefion and what is it used for

Zelefion is a tablet. The active substance of Zelefion is terbinafine, which has antifungal properties.
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.
violaceum), Microsporum(e.g., M. canis), Epidermophyton floccosum, and yeasts of the genus Candida(e.g., C. albicans) and Pityrosporum.

Indications:

Fungal infections of the skin, such as:

• body ringworm, groin ringworm, foot ringworm, ringworm of the hairy scalp, nail ringworm caused by dermatophytes,
• skin fungal infections caused by yeasts of the genus Candida(e.g., Candida albicans).

In the case of body ringworm, groin ringworm, and foot ringworm, oral treatment with terbinafine depends on the location, severity, and extent of the infection.
Zelefion tablets are not effective in treating pityriasis versicolor and vaginal candidiasis.

2. Important information before taking Zelefion

When not to take Zelefion:

• 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 liver disease in the past or currently has liver disease,
• if the patient has severe kidney disease.

If any of the above points apply to the patient, they should stop taking the medicine and consult a doctor.
The patient should inform their doctor if they suspect they have had an allergic reaction to any of the ingredients of the medicine in the past.

Warnings and precautions

Before starting treatment with Zelefion, the patient should discuss it with their doctor or pharmacist.
The patient should inform their doctor about liver disease, as Zelefion is not recommended for patients with liver disease.
If symptoms indicating liver function disorders occur, such as persistent nausea of unknown origin, vomiting, abdominal pain, loss of appetite, or fatigue,
fever, sore throat, or other infections, jaundice, dark urine, or light-colored stools

• the patient should stop taking the medicine and consult a doctor. The doctor will decide whether to discontinue treatment with Zelefion. Before and periodically after starting treatment with Zelefion, the doctor may order a blood test to monitor liver function. If the test results are abnormal, the patient should stop taking the medicine.

The patient should inform their doctor about kidney disease, as this medicine should not be taken by patients with kidney disease.
If skin reactions occur, such as a rash, redness of the skin, blisters on the mouth or eyelids, peeling of the skin, fever (possible symptoms of severe skin reactions),
a skin rash caused by a high number of certain types of white blood cells (eosinophilia), the patient should immediately consult a doctor.
The patient should immediately consult a doctor if they experience a red, scaly rash with thickening under the skin and pus-filled blisters, usually on the face and in skin folds, on the torso and upper limbs, with fever at the beginning of treatment (acute generalized pustular psoriasis).
The patient should inform their doctor if they have had a history of or currently have thickened skin areas with red or silvery discoloration (psoriasis), facial rash, joint pain, muscle weakness, fever (lupus erythematosus), or if they experience weakness, bleeding, bruising, or frequent infections (symptoms of blood disorders).
This medicine may cause a change or loss of taste (taste returns after discontinuing treatment). It is not recommended to take this medicine if the patient uses their sense of taste for professional purposes.

Elderly patients (65 years and older)

Patient aged 65 and over may take the same dose of Zelefion as younger patients.
Elderly patients should inform their doctor if they have had liver or kidney function disorders in the past.

Children

This medicine should not be taken by children with a body weight below 20 kg.

Zelefion 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 insomnia (e.g., triazolam),
• certain medicines used to lower blood sugar levels (e.g., tolbutamide),
• oral contraceptives,
• medicines used to treat cough (e.g., dextromethorphan, codeine),
• medicines used to treat irregular heart rhythm (certain antiarrhythmic medicines, such as propafenone, amiodarone, flecainide),
• certain medicines used to treat allergies (e.g., mequitazine, terfenadine),
• certain medicines used to treat pain (e.g., tramadol),
• certain medicines used to treat Huntington's disease (e.g., tetrabenazine),
• cyclosporine, a medicine used to control the immune system (e.g., a medicine used to prevent transplant rejection),
• medicines used to treat high blood pressure (beta blockers, such as metoprolol),
• certain medicines used to treat cancer (e.g., tamoxifen).

If Zelefion is taken with medicines that stimulate metabolism (e.g., rifampicin, an antibiotic) or medicines that inhibit cytochrome P450 activity (e.g., cimetidine used to treat stomach ulcers), the doctor may decide to change the dosage.
The patient should tell their doctor about all medicines they are taking at the same time.

Zelefion with food and drink

The medicine can be taken regardless of meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor before taking this medicine.
Pregnancy
Zelefion should not be taken during pregnancy unless the doctor considers it necessary.
The doctor will discuss the potential risks associated with taking Zelefion during pregnancy.
If the patient becomes pregnant while taking Zelefion, they should stop taking the medicine and inform their doctor.
Breastfeeding
Zelefion should not be taken during breastfeeding, as terbinafine passes into breast milk. The patient should inform their doctor if they are breastfeeding.

Driving and using machines

Patient who experience dizziness after taking Zelefion should not drive or operate machines.

Zelefion contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Zelefion

This medicine should always be taken according to the doctor's recommendations. If the patient has any doubts, they should consult a doctor.

Dosage of Zelefion

Adults

1 tablet (250 mg) once a day.

Use in children and adolescents

This medicine should not be taken by children with a body weight below 20 kg.

• Children with a body weight between 20 kg and 40 kg - half a tablet (125 mg) once a day,
• Children with a body weight over 40 kg - 1 tablet (250 mg) once a day.

How long to take Zelefion:

The treatment duration depends on the type and severity of the infection and the part of the body affected.
The doctor will recommend how long to take Zelefion.
It may happen that complete disappearance of infection symptoms occurs only after several weeks (skin) or several months (nails) after the fungus has been eliminated.
The patient should follow the doctor's recommendations. This will ensure that the infection is cured and reduce the risk of its recurrence after treatment is discontinued.

• Fungal skin infectionsAthlete's foot, interdigital type/vesicular type: usually 2 to 6 weeks. Body ringworm: usually 2 to 4 weeks. Groin ringworm: usually 2 to 4 weeks. Cutaneous candidiasis: usually 2 to 4 weeks. It may happen that complete disappearance of infection symptoms occurs only after several weeks after the fungal infection has been cured.
• Infections of the hairy scalpRingworm of the hairy scalp: usually 4 weeks.
• Nail fungal infectionsIn most patients, complete cure is achieved after 6-12 weeks of treatment. Fingernail fungal infections: in most cases of fingernail infections, a 6-week treatment period is sufficient. Toenail fungal infections: in most cases of toenail infections, a 12-week treatment period is sufficient. Patients with slow nail growth may require a longer treatment period, which will be decided by the doctor.

To facilitate treatment and prevent recurrence, the patient should ensure that the treated areas are dry, not overheated, and that clothing in direct contact with them is changed daily.

How to take Zelefion

Zelefion tablets should be taken orally with water.

Taking more than the recommended dose of Zelefion

If the patient takes more than the recommended dose of the medicine, they should immediately consult a doctor or go to the hospital for advice. The patient may need medical attention. This also applies to people who have accidentally taken the patient's medicine.
The most important symptoms of overdose are: nausea, abdominal pain, vomiting, abdominal pain, and dizziness.

Missing a dose of Zelefion

If the patient misses a dose, they should take the medicine 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 a doctor or pharmacist.

4. Possible side effects

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

Some side effects may be serious

In rare cases, Zelefion may cause liver disease, and in very rare cases, this may be severe. Other serious side effects include: decreased 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, decreased appetite, unusual fatigue or weakness, or if they notice yellowing of the skin or whites of the eyes, unusually dark urine, or unusually light-colored stools (symptoms that may indicate liver function disorders).
• 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 symptoms such as 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 mouth, 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).

Side effects reported during treatment with Zelefion:

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

Headache, nausea, 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):

Fatigue, vision disturbances, depression, taste disturbances, including loss of taste, dizziness.

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

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

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

Yellowing of the whites of the eyes and skin (symptoms of liver disease) and abnormal liver function test results.

Very rare side effects (occurring in less than 1 in 10,000 patients):

Lupus (an autoimmune disease), severe skin reactions, allergic reactions, appearance of skin lesions similar to psoriasis (psoriasis-like rash, worsening of psoriasis, skin rash with peeling, hair loss).

Side effects with unknown frequency (frequency cannot be estimated from the available data):

Severe allergic reactions or infections, vasculitis, disturbances of smell, including permanent loss of smell, decreased ability to smell, blurred vision, decreased visual acuity, hearing impairment, hearing disturbances, pancreatitis, skin rash caused by a high number of certain types of white blood cells, muscle breakdown, flu-like symptoms (fatigue, chills, sore throat, joint pain, muscle pain), decreased number of certain types of blood cells, 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 function disorders, blood disorders, or skin disorders.
If the patient experiences a worsening skin rash, they should stop taking Zelefion and immediately consult a doctor.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Zelefion

Do not take this medicine after the expiry date stated on the packaging.
The medicine should be stored out of sight and reach of children.
The medicine should be stored in its original packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Zelefion contains

• The active substance of Zelefion is terbinafine in the form of terbinafine hydrochloride. One tablet contains 250 mg of terbinafine.
• The other ingredients are: sodium carboxymethylcellulose (type A), microcrystalline cellulose, hypromellose, colloidal anhydrous silica, magnesium stearate.

What Zelefion looks like and contents of the pack

The pack contains 14 tablets or 28 tablets in PVC/Aluminum blisters, placed in a cardboard box.

Marketing authorization holder

Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland, Tel: +48 17 865 51 00

Manufacturer

Laboratorios Liconsa S.A., Avda. Miralcampo, No. 7, Poligono Industrial Miralcampo, 19200 Azuqueca de Henares (Guadalajara), Spain, Bausch Health Poland sp. z o.o., ul. Przemysłowa 2, 35-959 Rzeszów

Date of last revision of the leaflet: