Terbinafine (By mouth)

When This Medicine Should Not Be Used

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Brand Name(s)

Lamisil, Terbinex

How to Use This Medicine

Packet, Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• Terbinafine tablets may be taken with food or on an empty stomach. However, it is best to take terbinafine oral granules with food.
• Sprinkle the oral granules on a spoonful of pudding or other soft, non-acidic food such as mashed potatoes. This mixture must be swallowed immediately without chewing. Do not use applesauce or fruit-based foods. If you will need two packets of oral granules with each dose, you may sprinkle the content of both packets on one spoonful or two spoonfuls of non-acidic food.
• This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at the same times every day. If you need help in planning the best time to take your medicine, check with your doctor.
• Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
• It may take several months for your infection to clear up completely and for healthy nails to grow out and replace the infected nails.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.
• If you miss a dose of terbinafine tablets, take it as soon as you can. If your next regular dose is less than 4 hours away, wait until then to use the medicine and skip the missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using cimetidine (Tagamet®), cyclosporine (such as Gengraf®, Neoral®, Sandimmune®), dextromethorphan (Benylin®), fluconazole (Diflucan®), ketoconazole (Nizoral®), rifampin (such as Rfifadin®, Rifamate®, Rifater®, or Rimactane®), blood pressure medicine (such as atenolol, carvedilol, metoprolol, propranolol, timolol, Blocadren®, Coreg®, or Toprol®), medicine for heart rhythm problems (such as amiodarone, flecainide, propafenone, Cordarone®, Tambocor®, or Rythmol®), medicine for depression (such as amitriptyline, clomipramine, desipramine, fluoxetine, fluvoxamine, imipramine, nortriptyline, paroxetine, venlafaxine, Anafranil®, Aventyl®, Effexor®, Luvox®, Norpramin®, Pamelor®, Paxil®, Prozac®, or Tofranil®), or an MAO inhibitor (such as selegiline or Eldepryl®).
• Avoid caffeine (coffee, soda, chocolate) while you are using this medicine. Terbinafine may cause caffeine to stay in your body longer than usual.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant, or if you have kidney disease, liver disease, blood problems, lupus, or a weak immune system (such as HIV infection or AIDS).
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have a skin rash, itching, hives, trouble with breathing or swallowing, or any swelling of your hands, face, or mouth while you or your child are using this medicine.
• This medicine may cause serious liver problems, including liver failure. Stop taking this medicine and check with your doctor right away if you start having nausea or vomiting, dark urine, light-colored stools, stomach pain, or yellow eyes or skin while you or your child are using this medicine.
• This medicine may cause problems with your sense of taste or smell. Stop taking this medicine and tell your doctor if you or your child have change or loss of sense of smell, change in taste or loss of taste, poor appetite, or weight loss.
• You may become depressed when taking this medicine. Tell your doctor right away if you think this medicine is causing changes in your mood or behavior. Other symptoms include feeling very sad or empty, irritable, lack of appetite, loss of interest or pleasure, restlessness, trouble concentrating, or trouble sleeping.
• Serious skin reactions have occurred rarely in patients receiving this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you or your child are using this medicine.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• Stop taking this medicine and tell your doctor right away if you or your child have a red, scaly, skin rash or unusual sensitivity of the skin to the sun that can lead to a rash.
• If your symptoms do not improve or if they get worse, call your doctor.You may need to take this medicine for several weeks or months before your infection gets better.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

Introduction

Terbinafine (TER-bin-a-feen)

Treats fungal infections of the scalp, toenails, or fingernails.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Dark-colored urine or pale stools.
• Fever, chills, cough, sore throat, and body aches.
• Nausea, vomiting, loss of appetite, or pain in the upper stomach.
• Red, scaly, skin rash.
• Unusual bleeding, bruising, or weakness.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, stomach pain, or upset stomach.
• Feeling very sad, irritable, or restless.
• Headache.
• Loss of sense of smell.
• Mild skin rash or itching.
• Stuffy or runny nose, headache, and vomiting (in children).
• Toothache.
• Unusual or bad taste in your mouth.