Terbisil

Package Leaflet: Information for the Patient

Terbisil, 250 mg, Tablets

Terbinafine

Read the package leaflet carefully before taking the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Terbisil and what is it used for

Terbisil tablets contain terbinafine, an active substance belonging to the group of antifungal medicines.
Terbisil 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 floccosum, and yeasts of the genus Candida(e.g., C. albicans) and Pityrosporum.
The medicine has a fungicidal effect on dermatophytes, molds, and some dimorphic fungi. On yeasts, depending on the species, it has a fungicidal or fungistatic effect (inhibiting fungal growth). After oral administration, terbinafine accumulates in the infected areas 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 tinea corporis, tinea cruris, tinea pedis, and skin infections caused by yeasts 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.

Note: Terbisil tablets, unlike terbinafine preparations for topical use, are not effective in treating pityriasis versicolor.

2. Important information before taking Terbisil

When not to take Terbisil:

• if you are allergic to terbinafine or any of the other ingredients of this medicine (listed in section 6),
• if you have had or currently have liver disease,
• if you have kidney disease.

If any of the above points apply to you, stop taking this medicine and consult a doctor.
Tell your doctor if you have ever had an allergic reaction to any of the ingredients of the medicine.

Warnings and precautions

Before taking Terbisil, discuss it with your doctor or pharmacist.
Taking Terbisil is contraindicated in patients with chronic or active liver disease.
Tell your doctor:

• about other medicines you are taking (see "Terbisil and other medicines"),
• if you experience symptoms suggesting liver dysfunction, such as persistent nausea of unknown origin, vomiting, abdominal pain, loss of appetite, or fatigue, jaundice, dark urine, light-colored stools, stop taking the medicine and consult a doctor immediately. Before and periodically after starting treatment with Terbisil, your doctor may perform blood tests to monitor liver function. If the test results are abnormal, stop taking the medicine,
• if you experience skin reactions, such as rash, redness of the skin, blisters on the lips or eyelids, peeling of the skin, fever (possible symptoms of severe skin reactions), skin rash caused by an increased number of certain types of white blood cells (eosinophilia). Consult a doctor immediately,
• if you have had or currently have thickened skin areas with red or silvery discoloration (psoriasis) or facial rash, joint pain, muscle weakness, fever (lupus erythematosus),
• if you experience weakness, bleeding, bruising, or frequent infections (symptoms of blood disorders).

Elderly patients (65 years and older)

Patient aged 65 and older may take the same dose of Terbisil as younger patients.
Elderly patients should tell their doctor if they have had liver or kidney dysfunction in the past.

Children and adolescents

Do not give Terbisil 250 mg tablets to children with a body weight below 40 kg.

Terbisil and other medicines

Tell your doctor or pharmacist about all medicines you are taking or plan to take, especially:

• certain medicines for stomach ulcers (e.g., cimetidine),
• certain medicines for fungal infections (e.g., fluconazole, ketoconazole),
• certain antibiotics (e.g., rifampicin),
• certain medicines for mood swings (certain antidepressants, such as tricyclic antidepressants, selective serotonin reuptake inhibitors, monoamine oxidase inhibitors type B, desipramine),
• medicines for high blood pressure (beta-blockers, such as metoprolol),
• certain antiarrhythmic medicines (e.g., propafenone, amiodarone),

oral contraceptives,

• cough medicines (e.g., dextromethorphan),
• caffeine,
• cyclosporine, a medicine used to control the immune system (e.g., to prevent transplant rejection).

If you are taking Terbisil with medicines that induce metabolism (e.g., rifampicin, an antibiotic) or inhibit cytochrome P450 activity (e.g., cimetidine, a medicine for stomach ulcers), your doctor may decide to change the dosage.
Tell your doctor about all medicines you are taking.

Terbisil with food and drink

Take Terbisil on an empty stomach or after a meal.

Pregnancy, breastfeeding, and fertility.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medicine.
Your doctor will discuss the potential risks associated with taking Terbisil during pregnancy. Do not take the medicine during pregnancy unless your doctor considers it necessary. If you become pregnant while taking Terbisil, stop taking the medicine and consult a doctor.
Do not breastfeed while taking Terbisil, as terbinafine passes into breast milk.

Driving and using machines

If you experience dizziness after taking Terbisil, do not drive or operate machinery.

Terbisil contains sodium

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

3. How to take Terbisil

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist again.
The medicine is for oral use.
The recommended dose of Terbisil is:
Adults
250 mg once a day.
Use in children and adolescents
For children with a body weight over 40 kg, the recommended dose is 250 mg (1 tablet) once a day.
Do not give Terbisil to children with a body weight below 40 kg.
When to take Terbisil
Taking Terbisil at the same time every day will help you remember to take the medicine.
Take Terbisil tablets on an empty stomach or after a meal.

How to take Terbisil

Take Terbisil tablets orally with a glass of water.

How long to take Terbisil

The duration of treatment depends on the type and severity of the infection and the part of the body affected.
Your doctor will determine exactly how long you should take the tablets.
Skin infections

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

It is essential to take this medicine every day and continue it for as long as your doctor prescribes. This will ensure that the infection is fully treated and reduce the chance of it coming back after treatment is stopped.
It may take several weeks after the infection has been treated for the symptoms to disappear completely.
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.
Nail infections
Treatment of nail infections usually takes longer than treatment of skin infections. In most patients, complete cure is achieved after 6-12 weeks of treatment.
Fingernail infection
A 6-week treatment period is sufficient in most cases of fingernail infections.
Toenail infection
A 12-week treatment period is sufficient in most cases of toenail infections.
Patient with slow nail growth may require a longer treatment period, which will be decided by your doctor.
To facilitate treatment and prevent relapse, keep the treated areas dry, not overheated, and change clothes that come into direct contact with the treated areas daily.

Overdose of Terbisil

If you have taken more tablets than your doctor prescribed, tell your doctor or go to the hospital immediately. You may need medical attention. This also applies to others who have taken your medicine by mistake.
Symptoms of overdose include headache, nausea, stomach pain, and dizziness.

Missed dose of Terbisil

If you miss a dose, take it as soon as possible, unless it is less than 4 hours before your next dose. In this 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 doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Some side effects may be serious:

In rare cases, Terbisil 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 (inflammation of the pancreas), and muscle necrosis.

Tell your doctor immediately:

• If you experience symptoms such as persistent nausea of unknown origin, stomach disorders, decreased appetite, unusual fatigue or weakness, or if you notice yellowing of the skin or whites of the eyes, unusually dark urine, or light-colored stools (symptoms that may indicate liver dysfunction).
• If you have a 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 you 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 you have symptoms such as joint pain, stiffness, rash, fever, or swelling (enlargement) of lymph nodes (possible symptoms of severe allergic reactions).
• If you experience symptoms such as rash, fever, itching, fatigue, or the appearance of purple-red spots under the skin (possible symptoms of vasculitis).
• If you experience any skin changes, such as rash, redness of the skin, widespread rash with blisters, especially around the mouth, eyes, or mouth, peeling of the skin, fever.
• If you experience abdominal pain radiating to the back (possible symptoms of pancreatitis).
• If you 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 terbinafine:

Very common side effects (may affect more than 1 in 10 patients):
Headache, nausea, abdominal distension, and mild abdominal pain, digestive disorders after eating, diarrhea, abdominal swelling or feeling of bloating (feeling of fullness in the upper abdomen), loss of appetite, rash, urticaria, joint pain, muscle pain.
Common side effects (may affect up to 1 in 10 patients):
Mood changes (depression), changes or loss of taste, dizziness, vision disturbances, and fatigue.
Uncommon side effects (may affect up to 1 in 100 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 hypersensitivity to sunlight, ringing in the ears, fever, and weight loss.
Rare side effects (may affect up to 1 in 1,000 patients):

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, e-mail: ndl@urpl.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 this medicine.

5. How to store Terbisil

Keep the medicine out of sight and reach of children.
No special precautions for storage are necessary.
Store in the original package.
Do not take this medicine after the expiry date stated on the packaging after "Expiry date (EXP)". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Terbisil contains

The active substance of the medicine is 250 mg of terbinafine in the form of terbinafine hydrochloride in each tablet.
Other ingredients are:

• excipients: microcrystalline cellulose (type 101), hypromellose, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate.

What Terbisil looks like and contents of the pack

Round, biconvex, white or almost white tablets, with "250" embossed on one side and a dividing line on the other side.
One blister pack (14 tablets) or two blister packs (28 tablets) packaged in one cardboard box.

Marketing authorization holder

Gedeon Richter Polska Sp. z o.o., ul. ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki

Manufacturer

Gedeon Richter Polska Sp. z o.o., ul. ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Gedeon Richter Plc., Gyömrõi út 19-21, 1103 Budapest, Hungary.
For more detailed information, please contact: GEDEON RICHTER POLSKA Sp. z o.o., Medical Department, ul. ks. J. Poniatowskiego 5, 05-825 Grodzisk Mazowiecki, Tel. +48 22 755 96 48, lekalert@grodzisk.rgnet.org, fax: +48 22 755 96 24

Date of last revision of the leaflet: