TERBINAFINE VIATRIS 250 mg TABLETS

Introduction

Package Leaflet: Information for the User

Terbinafine Viatris 250 mg Tablets EFG

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 is Terbinafine Viatris and what is it used for
2. What you need to know before you take Terbinafine Viatris
3. How to take Terbinafine Viatris
4. Possible side effects
5. Storage of Terbinafine Viatris
6. Contents of the pack and other information

1. What is Terbinafine Viatris and what is it used for

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

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

• Tinea corporis(ringworm of the body).
• Tinea cruris(jock itch or ringworm of the groin).
• Tinea pedis(athlete's foot or ringworm of the foot).
• Tinea capitis(ringworm of the scalp).

• Onychomycosis (fungal infection of the nails).

2. What you need to know before you take Terbinafine Viatris

Do not take Terbinafine Viatris:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Terbinafine Viatris

• 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, 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 disorders).
• If you have psoriasis or lupus erythematosus, in very rare cases, the disease has worsened. If a progressive skin rash occurs, treatment should be discontinued.
• In very rare cases, blood disorders (neutropenia, agranulocytosis, thrombocytopenia, pancytopenia) have occurred.

Children and adolescents

Experience with terbinafine in children is limited, therefore, it is not recommended for use in this type of patient.

Use in elderly patients

Terbinafine can be administered to patients over 65 years of age. In case of pre-existing kidney problems, a lower dose than usual may be prescribed. Terbinafine is not recommended in patients who have or have had liver problems in the past.

Other medicines and Terbinafine Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including oral contraceptives, herbal medicines, and those obtained without a prescription.

There are other medicines that may affect the effect of terbinafine, 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)), 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 prevent organ rejection in transplant patients (e.g., cyclosporine).
• Some medicines used to treat cough (e.g., dextromethorphan).
• Some medicines used to treat fungal infections (infections caused by fungi) (e.g., fluconazole, ketoconazole).

Pregnancy, breastfeeding and fertility

Pregnancy

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.

Unless your doctor considers it necessary, terbinafine should not be taken during pregnancy.

Breastfeeding

Terbinafine (a small amount) is transferred to breast milk. If you are breastfeeding, ask your doctor for advice before taking this medicine.

Fertility

Studies have shown that terbinafine does not affect fertility.

Driving and using machines

Patients who experience dizziness as an adverse reaction should avoid driving vehicles or using machines.

Terbinafine Viatris contains sodium

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

3. How to take Terbinafine Viatris

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Follow these instructions unless your doctor has given you other instructions.

The recommended dose in adults is one tablet (250 mg) once a day.

Terbinafine is for oral administration.

The score line is not intended for breaking the tablet.

How long to take Terbinafine Viatris

Your doctor will tell you how long to take the treatment. Do not stop treatment before, as it may worsen your illness.

It is possible that the complete resolution of the symptoms of the infection will 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 Terbinafine Viatris than you should

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

The main symptoms of acute poisoning can be gastrointestinal, such as nausea, abdominal pain, or vomiting, but headache or dizziness may also occur. If you experience any of these effects or any other unusual effect, consult your doctor.

If you forget to take Terbinafine Viatris

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.

Side effects are generally mild or moderate and transient.

Some side effects that appear rarely or very rarely can be serious:

Rarely, terbinafine can cause liver problems, and in very rare cases, these problems can be serious. Very rare side effects include a decrease in certain blood cells, lupus (an autoimmune disease), or severe skin reactions, including 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 tiredness or weakness, or if you notice that your skin or the whites of your eyes turn yellow, or if your urine is unusually dark or if 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 more frequent infections, or if you experience unusual bleeding or bruising (possible signs of blood disorders).
• 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, skin peeling, 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 inflammation of blood vessels).
• 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 necrosis).

Other side effects:

Other side effects include the following listed below. If they become serious, 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)

• Nausea.
• Mild abdominal pain.
• Discomfort after eating (heartburn).
• Diarrhea.
• Feeling of fullness in the stomach.
• Lack of appetite.
• Skin rash.
• Hives.
• Pain in the joints or muscles.

Common(may affect up to 1 in 10 people)

• Mood disorder (depression).
• Disturbance or loss of taste.
• Dizziness.
• Visual disturbances.
• Headache.

Uncommon(may affect up to 1 in 100 people)

• Pale skin color.
• Abnormal mucous membrane or nail bed.
• Unusual tiredness or weakness.
• Difficulty breathing during exercise (possible signs of a disease that affects red blood cell levels).
• Anxiety.
• Feeling of tingling or numbness.
• Decreased skin sensitivity.
• Increased skin sensitivity to the sun.
• Noises (e.g., ringing) in the ears.
• Fever.
• Weight loss.
• Alteration of taste or loss of taste, which usually recovers a few weeks after treatment is discontinued**. This can lead, in very few patients, to a decrease in appetite and significant weight loss. Inform your doctor if the alteration of taste lasts several days.

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

• Yellow eyes or skin (liver problems).
• Abnormal liver function test results.

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

• Hair loss.
• Severe weakness.
• Skin rash like psoriasis (with a silvery appearance).
• Worsening of psoriasis.
• Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, generalized pustular psoriasis).
• Decrease in white blood cells and platelets.
• Systemic and cutaneous lupus erythematosus (an autoimmune disease characterized by general or skin disorders).
• Allergic reactions.
• Skin rash with peeling.
• Angioedema.
• Dizziness.
• Feeling of tingling and decreased sensitivity.

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

• Anemia.
• Serum sickness.
• Anxiety.
• Depression*.
• Alterations of smell, including permanent loss of smell.
• Decreased ability to smell.
• Partial loss of hearing.
• Hearing problems.
• Tinnitus.
• Inflammation of blood vessels.
• Pancreatitis.
• Increased liver enzymes.
• Hepatitis.
• Yellowing of the skin and mucous membranes.
• Bile duct obstruction.
• Photosensitivity reaction.
• Photodermatosis.
• Photosensitivity allergic reaction.
• Skin rash caused by high levels of a specific type of white blood cells.
• Muscle fiber breakdown.
• Pseudogrippal syndrome (e.g., chills, sore throat, muscle or joint pain).
• High temperature.
• Increased creatine phosphokinase in the blood.
• Weight loss***.
• Blurred vision.

• Anxiety and depressive symptoms following dysgeusia.

** Alteration of taste or loss of taste usually recovers a few weeks after treatment is discontinued. Isolated cases of prolonged alteration of taste have been reported.

*** Weight loss due to hypogeusia.

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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Terbinafine Viatris

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

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 Terbinafine Viatris

• The active substance is terbinafine hydrochloride. Each tablet contains 250 mg of terbinafine (as terbinafine hydrochloride).
• The other ingredients (excipients) are: microcrystalline cellulose, sodium croscarmellose, talc, magnesium stearate, povidone, anhydrous colloidal silica.

Appearance of the product and pack contents

Terbinafine Viatris are white or almost white, biconvex, round, scored tablets with the inscription "TF/250" on one side and "G" on the other. They are available in packs of 14 and 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

Mylan Hungary Kft.

Mylan utca 1.

Komárom, 2900

Hungary

Date of last revision of this leaflet:December 2024

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