Terbinafine is an antifungal medication that fights infections caused by fungus.

Terbinafine tablets are used to treat infections caused by fungus that affect the fingernails or toenails.

Terbinafine oral granules are used to treat a fungal infection of scalp hair follicles in children who are at least 4 years old.

Terbinafine may also be used for purposes not listed in this medication guide.

Some people taking terbinafine have developed severe liver damage leading to liver transplant or death.

Call your doctor at once if you have symptoms of liver damage, such as nausea, upper stomach pain, vomiting, loss of appetite, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.

Terbinafine comes as granules and as a tablet to take by mouth. Terbinafine granules are usually taken with a soft food once a day for 6 weeks. Terbinafine tablets are usually taken with or without food once a day for 6 weeks for fingernail infections and once a day for 12 weeks for toenail infections. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take terbinafine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

To prepare a dose of terbinafine granules, sprinkle the entire packet of granules onto a spoonful of soft food such as pudding or mashed potatoes. Do not sprinkle the granules onto a fruit-based soft food, such as applesauce. If your doctor has told you to take 2 packets of terbinafine granules, you may sprinkle the contents of both packets onto one spoonful, or you may sprinkle each packet onto a separate spoonful of soft food.

Swallow the spoonful of granules and soft food without chewing.

Your fungus may not be completely cured until a few months after you finish taking terbinafine. This is because it takes time for a healthy nail to grow in.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with terbinafine and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take the terbinafine tablet with or without food.

Terbinafine granules should be sprinkled into a spoonful of pudding or mashed potatoes (do not mix with applesauce, fruit juice, or other fruit-based or acidic foods). Swallow this mixture right away without chewing. Do not save the mixture for later use.

Terbinafine is usually taken for 6 weeks to treat scalp or fingernail infections, and for 12 weeks to treat a toenail infection.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medicine. Terbinafine will not treat a viral infection such as the flu or a common cold.

While using terbinafine, you may need frequent blood tests.

It may take several months for your nails to return to their normal appearance after your treatment with terbinafine.

Store at room temperature away from moisture, heat, and light. Keep the terbinafine oral granules in their sealed packet until you are ready to use.

You should not use terbinafine if you are allergic to it, or if you have:

• liver disease.

To make sure terbinafine is safe for you, tell your doctor if you have ever had:

• liver problems;

• weak immune system (caused by disease or by using certain medicine); or

• lupus.

It is not known whether terbinafine will harm an unborn baby. You should wait until after your pregnancy to start treating your nail or scalp infection with terbinafine. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Terbinafine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include headache, dizziness, vomiting, stomach pain, rash, and increased urination.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Store terbinafine tablets away from light.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid coffee, tea, cola, energy drinks or other sources of caffeine while taking terbinafine.

Avoid exposure to sunlight or tanning beds. Terbinafine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using terbinafine.

Some people taking terbinafine have developed severe liver damage leading to liver transplant or death. It is not clear whether terbinafine actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking terbinafine.

Call your doctor at once if you have symptoms of liver damage, such as nausea, upper stomach pain, vomiting, loss of appetite, tiredness, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.

Also call your doctor if you have:

• changes in your sense of taste or smell;

• depressed mood, sleep problems, lack of interest in daily activity, feeling anxious or restless;

• pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• swelling, rapid weight gain, little or no urinating;

• blood in your urine or stools;

• weight loss due to taste changes or loss of appetite; or

• skin sores, butterfly-shaped skin rash on your cheeks and nose (worsens in sunlight).

Common side effects of terbinafine may include:

• diarrhea, nausea, gas, stomach pain or upset;

• rash;

• headache;

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with terbinafine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before you begin treatment and during your treatment.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.