Uses of Terbinafine Oral Granules:

• It is used to treat fungal infections of the scalp.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Terbinafine Oral Granules?

• If you are allergic to this medicine (terbinafine oral granules); any part of this medicine (terbinafine oral granules); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have liver disease.

This is not a list of all drugs or health problems that interact with this medicine (terbinafine oral granules).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (terbinafine oral granules) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Terbinafine Oral Granules?

• Tell all of your health care providers that you take this medicine (terbinafine oral granules). This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• It may take several weeks to see the full effects.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with this medicine (terbinafine oral granules) may cause nervousness, shakiness, and a fast heartbeat.
• Low white blood cell counts have rarely happened with this medicine (terbinafine oral granules). This may lead to a higher chance of getting an infection. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.
• Liver problems have happened with this medicine (terbinafine oral granules). Sometimes these problems have been severe, leading to liver transplant or death. Liver problems may happen in people with or without liver disease. Talk with the doctor.
• Very bad and sometimes deadly blood problems like thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS) have happened with this medicine (terbinafine oral granules) in some people. Call your doctor right away if you feel very tired or weak or have any bruising or bleeding; dark urine or yellow skin or eyes; pale skin; change in the amount of urine passed; change in eyesight; change in strength on 1 side is greater than the other, trouble speaking or thinking, or change in balance; or fever.
• A severe and sometimes deadly reaction has happened. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have questions, talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Terbinafine Oral Granules) best taken?

Use this medicine (terbinafine oral granules) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• Sprinkle granules on soft food. Do not use applesauce or fruit-based foods. Do not crush or chew granules.
• After mixing, take your dose right away. Do not store for future use.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If the next dose is less than 4 hours away, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Low mood (depression).
• Swollen gland.
• Cough.
• Chest pain or pressure or a fast heartbeat.
• Blood in the urine.
• Lupus has happened with this medicine (terbinafine oral granules), as well as lupus that has gotten worse in people who already have it. Tell your doctor if you have lupus. Call your doctor right away if you have signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• Changes in taste or smell like loss of taste or smell have happened with this medicine (terbinafine oral granules). This most often goes back to normal after this medicine (terbinafine oral granules) is stopped but may last for a long time or may never go back to normal. Call your doctor right away if you have a change in taste or loss of taste, weight loss without trying, change in mood like low mood (depression), or are not hungry.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Terbinafine Oral Granules?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Stomach pain or diarrhea.
• Gas.
• Upset stomach or throwing up.
• Signs of a common cold.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Terbinafine Oral Granules?

• Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (terbinafine oral granules) is refilled. If you have any questions about this medicine (terbinafine oral granules), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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