Terbinafine Hydrochloride Oral granules

What is this medicine?

TERBINAFINE (TER bin a feen) is an antifungal medicine. It is used to treat certain kinds of fungal or yeast infections.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• drink alcoholic beverages
• kidney disease
• liver disease
• an unusual or allergic reaction to Terbinafine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Hold packet with cut line on top. Shake packet gently to settle contents. Tear packet open along cut line, or use scissors to cut across line. Carefully pour the entire contents of packet onto a spoonful of a soft food, such as pudding or other soft, non-acidic food such as mashed potatoes (do NOT use applesauce or a fruit-based food). If two packets are required for each dose, you may either sprinkle the content of both packets on one spoonful of non-acidic food, or sprinkle the contents of both packets on two spoonfuls of non-acidic food. Make sure that no granules remain in the packet. Swallow the mxiture of the food and granules without chewing. Take your medicine at regular intervals. Do not take it more often than directed. Take all of your medicine as directed even if you think you are better. Do not skip doses or stop your medicine early.

Contact your pediatrician or health care professional regarding the use of this medicine in children. While this medicine may be prescribed for children as young as 4 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• thioridazine

This medicine may also interact with the following medications:

• beta-blockers
• caffeine
• cimetidine
• cyclosporine
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• medicines for fungal infections like fluconazole and ketoconazole
• medicines for irregular heartbeat like amiodarone, flecainide and propafenone
• rifampin
• SSRIs like citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline
• tricyclic antidepressants like amitriptyline, clomipramine, desipramine, imipramine, nortriptyline, and others
• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your doctor may monitor your liver function. Tell your doctor right away if you have nausea or vomiting, loss of appetite, stomach pain on your right upper side, yellow skin, dark urine, light stools, or are over tired.

You need to take this medicine for 6 weeks or longer to cure the fungal infection. Take your medicine regularly for as long as your doctor or health care professional tells you to.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash or hives, swelling of the face, lips, or tongue
• change in vision
• dark urine
• fever or infection
• general ill feeling or flu-like symptoms
• light-colored stools
• loss of appetite, nausea
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• right upper belly pain
• unusually weak or tired
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• changes in taste
• diarrhea
• hair loss
• muscle or joint pain
• stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.