Terbinafine Viatris 250 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Terbinafine Viatris 250 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Terbinafina Viatris is and what it is 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 groin ringworm).

• Tinea pedis (athlete's foot).

• Tinea capitis (scalp ringworm).

• Onychomycosis (fungal infection of the nails).

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

Do not take Terbinafine Viatris:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take 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, yellowing of the skin or whites of the eyes, unusually dark urine, or unusually pale stools (signs of liver problems).
• If you develop any skin problems such as rash, red skin, blisters on lips, eyes or mouth, or skin peeling (signs of serious skin reactions).
• If you experience weakness, unusual bleeding, bruising, or frequent infections (signs of blood disorders).
• If you suffer from psoriasis or systemic lupus erythematosus, in very rare cases worsening of the disease has occurred. If progressive skin rash develops, treatment should be discontinued.
• Very rarely, blood disorders (neutropenia, agranulocytosis, thrombocytopenia, pancytopenia) have been reported.

Children and adolescents

Experience with terbinafine in children is limited; therefore, its use is not recommended in this patient group.

Use in elderly patients

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

Other medicines and Terbinafine Viatris

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

There are other medicines that may alter 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)), 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 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 (e.g., fluconazole, ketoconazole).

Pregnancy, breastfeeding, and fertility

Pregnancy

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

Unless considered necessary by your doctor, terbinafine should not be used during pregnancy.

Breastfeeding

Terbinafine (in small amounts) is transferred into breast milk. If you are breastfeeding, consult your doctor before using this medicine.

Fertility

Various studies conducted do not show that it should affect fertility.

Driving and use of machines

Patients who experience dizziness as an adverse reaction should avoid driving vehicles or operating machinery.

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 for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Follow these instructions unless your doctor has given you different advice.

The recommended dose for adults is one tablet (250 mg) once daily.

Terbinafine are tablets for oral administration.

The score line should not be used to split the tablet.

How long to take Terbinafina Viatris

Your doctor will advise you on the duration of treatment. Do not stop treatment early, as this could worsen your condition.

Complete resolution of infection symptoms may not occur until several weeks (skin and scalp) or months (nails) after the causative fungus has been eliminated.

If you take more Terbinafina Viatris than you should

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and amount taken.

Main symptoms of acute overdose may be gastrointestinal, for example, nausea, abdominal pain, or vomiting; headache or dizziness (sensation of instability) may also occur. If you experience any of these effects or any other unusual effects, consult your doctor.

If you forget to take Terbinafina Viatris

Take the missed dose as soon as you remember, unless it is less than 6 hours until your next scheduled dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects are generally mild or moderate and transient.

Some adverse effects that occur rarely or very rarely can be serious:

Terbinafine may rarely cause liver problems, and in very rare cases, these problems may be severe. Very rare adverse effects include a decrease in certain blood cells, lupus (an autoimmune disease), or severe skin reactions, including severe allergic reactions, inflammation of blood vessels, inflammation of the pancreas, or muscle necrosis.

Stop taking this medicine and contact your doctor immediately if:

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

• 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, your urine becomes unusually dark, or you have pale stools (possible signs of liver problems).

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

• You have fever, chills, sore throat, or mouth ulcers due to infections, weakness, or if you get infections more frequently or experience unusual bleeding or bruising (possible signs of conditions affecting levels of certain blood cells).
• You experience difficulty breathing, dizziness, swelling (mainly of the face and throat), redness, cramp-like abdominal pain, or loss of consciousness, or if you have symptoms such as joint pain, stiffness, skin rash, fever, or swelling/thickening of the lymph nodes (possible signs of severe allergic reactions).
• You develop any skin problems such as rash, redness of the skin, blistering of the lips, eyes, or mouth, skin peeling, or fever.

Frequency not known (cannot be estimated from available data)

• You experience symptoms such as rash, fever, itching, tiredness, or notice the appearance of red-purple spots under the skin surface (possible signs of inflammation of blood vessels).
• You experience severe pain in the upper abdomen radiating to the back (possible signs of inflammation of the pancreas).
• You experience unexplained muscle pain and weakness or dark (brown-red) urine (possible signs of muscle necrosis).

Other adverse effects:

Other adverse effects include the following listed below. If any of these become severe, inform your doctor, pharmacist, or nurse.

Most adverse effects are mild or moderate and usually resolve after a few days to several weeks of treatment.

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

• Nausea.
• Mild abdominal pain.
• Stomach discomfort after meals (indigestion).
• Diarrhea.
• Feeling of fullness in the stomach.
• Loss of appetite.
• Skin rash.
• Urticaria (hives).
• Joint or muscle pain.

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Pale skin.
• Abnormal mucous membranes or nail beds.
• Unusual tiredness or weakness.
• Difficulty breathing during exercise (possible signs of a condition affecting red blood cell levels).
• Anxiety.
• Tingling or numbness sensation.
• Decreased skin sensitivity.
• Increased skin sensitivity to sunlight.
• Ringing in the ears (e.g., buzzing sounds).
• Fever.
• Weight loss.
• Taste disturbance or loss of taste, which usually recovers within a few weeks after stopping treatment**. In very few patients, this may lead to decreased appetite and significant weight loss. Inform your doctor if taste disturbance lasts for several days.

Rare (may affect more than 1 in 1,000 people)

• Yellowing of the 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.
• Psoriasis-like skin eruptions (with silvery appearance).
• Worsening of psoriasis.
• Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, exanthematous pustulosis).
• Decrease in white blood cells and platelets in the blood.
• Systemic and cutaneous lupus erythematosus (autoimmune disease characterized by general and/or skin disorders).
• Allergic reactions.
• Skin rash with peeling.
• Angioedema.
• Dizziness.
• Tingling sensation and reduced sensitivity.

Frequency not known (cannot be estimated from available data)

• Anaemia.

• Serum sickness.

• Anxiety.

• Depression*.

• Olfactory disturbances, including permanent loss of smell.

• Reduced ability to smell.

• Partial hearing loss.

• Hearing problems.

• Tinnitus.

• Inflammation of blood vessels.

• Inflammation of the pancreas.

• Increased liver enzymes.

• Hepatitis.

• Yellowish discoloration of the skin and mucous membranes.

• Bile duct obstruction.

• Photosensitivity reaction.

• Photodermatosis.

• Allergic photosensitivity reaction.

• Skin rash caused by elevated levels of a specific type of white blood cells.

• Breakdown of muscle fibers.

• Pseudoinfluenza syndrome (e.g., chills, sore throat, muscle or joint pain).

• Elevated temperature.

• Increased creatine phosphokinase in the blood.

• Weight loss***.

• Blurred vision.

• Anxiety and depressive symptoms secondary to dysgeusia.

** Taste disturbance or loss of taste generally recovers within several weeks after discontinuation of treatment. Isolated cases of prolonged taste disturbance have been reported.

*** Weight loss secondary to hypogeusia.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Terbinafine Viatris

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of TerbinafinaViatris

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

Appearance of the product and contents of the pack

TerbinafinaViatris are white or almost white, round, biconvex, scored tablets, with the imprint “TF/250” on one side and “G” on the other. They are available in packs of 14 and 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

Mylan Hungary Kft.

Mylan utca 1.

Komárom, 2900

Hungary

Date of the most recent revision of this leaflet: December 2024

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