Label: information for the user

Terbinafine Viatris 250 mg tablets EFG

Read this label carefully before starting to take this medication,because it contains important information for you.

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

Terbinafine belongs to a group of medications called antifungals and works by preventing the development of fungi.

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

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

• Onychomycosis (nail fungus).

Do not take TerbinafineViatris:

• If you are allergicto 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

Consult your doctor or pharmacist before starting to takeTerbinafine 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 fatigue, if your skin or the white of your eyes turns yellow, if your urine has an unusual dark color or if your stools have an unusual light color (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, bruises, or frequent infections (signs of blood abnormalities).
• If you have psoriasis or lupus erythematosus, in very rare cases, the disease may worsen. If a skin rash progresses, discontinue treatment.
• In very rare cases, blood disorders (neutropenia, agranulocytosis, thrombocytopenia, pancytopenia) have occurred.

Children and adolescents

The 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. If there is a pre-existing kidney problem, you may be prescribed a lower dose than usual. Terbinafine is not recommended for patients with or who have had liver problems in the past.

Other medicines and Terbinafine Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including oral contraceptives, herbal medicines, and over-the-counter medicines.

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)), antiarrhythmics (including classes 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 medicinesused to treat cough (e.g., dextromethorphan).
• Some medicines used to treat fungal infections (infections caused by fungi) (e.g., fluconazole, ketoconazole).

Pregnancy, breastfeedingand fertility

Pregnancy

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

Unless your doctor considers it necessary, do not administer terbinafine during pregnancy.

Breastfeeding

Terbinafine (a small amount) is transferred to breast milk. If you are breastfeeding, consult your doctor before using this medicine.

Fertility

Different studies have not shown that it should affect fertility.

Driving and operating machinery

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 mmolof sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

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

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

Terbinafina tablets are for oral administration.

The groove should not be used to break the tablet.

How Long to Take Terbinafina Viatris

Your doctor will tell you the duration of treatment. Do not stop treatment beforehand, as this could worsen your condition.

It is possible that the complete resolution of symptoms from the infection will not occur until several weeks (skin and scalp) or months (nails) after the disappearance of the fungus causing the infection.

If You Take More Terbinafina ViatrisThan You Should

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

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

If You Forget to Take Terbinafina Viatris

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

Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine can have side effects, although not everyone will experience them.

The side effects are generally mild or moderate and temporary.

Some rare or very rare side effects that can be severe:

Rarely, terbinafine can cause liver problems, and in very rare cases, these problems can be severe. The 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, inflammation of the pancreas 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 fatigue or weakness, or if you notice that your skin or the white of your eyes turns 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 more frequent infections or if you experience unusual bleeding or bruising (possible signs of diseases that affect the levels of certain blood cells).
• If you experience difficulty breathing, dizziness, swelling mainly of the face and throat, redness, abdominal pain like colic and loss of consciousness, or if you experience symptoms such as joint pain, stiffness, skin rash, fever or swelling/enlargement of lymph nodes (possible signs of severe allergic reactions).
• If you develop any skin problem such as skin rash, skin redness, blistering on the lips, eyes or mouth, skin peeling, fever.

Frequency not known(cannot be estimated from available data)

• If you experience symptoms such as skin rash, fever, itching, fatigue, or if you notice the appearance of red-purple spots under the skin surface (possible signs of inflammation of blood vessels).
• If you experience severe upper stomach pain radiating to the back (possible signs of pancreatitis inflammation).
• If you experience unexplained 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 severe, inform your doctor, pharmacist or nurse.

Most side effects are mild or moderate and generally 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.
• Postprandial discomfort (heartburn).
• Diarhea.
• Feeling of fullness in the stomach.
• Loss of appetite.
• Skin rash.
• Urticaria.
• Muscle or joint pain.

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.
• Abnormal mucous membrane or nail bed.
• Unusual fatigue 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.
• Ringing in the ears.
• Fever.
• Weight loss.
• Alteration of taste or loss of it, which generally recovers in a few weeks after treatment interruption**. This can lead, in very few patients, to a significant decrease in appetite and weight loss. Inform your doctor if the alteration of taste lasts for several days.

Rare(may affect more than 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.
• Intense weakness.
• Psoriasis-like skin eruptions (with silver-colored appearance).
• Worsening of psoriasis.
• Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, pustular exanthema).
• Decrease in white blood cells and platelets.
• Lupus erythematosus systemic and cutaneous (autoimmune disease characterized by general or skin alterations).
• Allergic reactions.
• Skin rash with peeling.
• Angioedema.
• Dizziness.
• Feeling of tingling and decreased sensitivity.

Frequency not known(cannot be estimated from available data)

• Anemia.
• Serum disease.
• Anxiety.
• Depression*.
• Alterations of smell, including permanent loss.
• Decreased ability to smell.
• Partial loss of hearing ability.
• Auditory problems.
• Tinnitus.
• Inflammation of blood vessels.
• Pancreatitis inflammation.
• Increased liver enzymes.
• Hepatitis.
• Yellow discoloration of skin and mucous membranes.
• Biliary tract obstruction.
• Photosensitivity reaction.
• Photodermatosis.
• Allergic reaction photosensitivity.
• Skin rash caused by elevated levels of a specific type of white blood cell.
• Muscle fiber decomposition.
• Pseudogripal syndrome (e.g., chills, sore throat, muscle or joint pain).
• Elevated body temperature.
• Increased creatine phosphokinase in the blood.
• Weight loss***.
• Blurred vision.

*Depression and anxiety symptoms following dysgeusia.

**The alteration of taste or loss of it, generally recovers in several weeks after treatment interruption. Isolated cases of prolonged alteration of taste have been reported.

***Weight loss due to hypogeusia.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of TerbinafineViatris

• The active ingredient 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 packaging

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 presented in packs of 14 and 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing:

McDermott Laboratories Ltd T/A Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublín 13

Ireland

or

Mylan Hungary Kft.

Mylan utca 1.

Komárom, 2900

Hungary

Last review date of this leaflet:December 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/