LAMISIL- terbinafine hydrochloride granule 
Novartis Pharmaceuticals Corporation

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This Medication Guide has been approved by the U.S. Food and Drug AdministrationRevised: March 2019
MEDICATION GUIDE
LAMISIL® (lam-i-sil)
(terbinafine hydrochloride) Oral Granules
What is the most important information I should know about LAMISIL Oral Granules?
LAMISIL Oral Granules may cause serious side effects, including:
  • Liver problems that can lead to the need for a liver transplant, or death. This can happen in people who have liver problems and in people who have never had liver problems. Tell your doctor right away if you get any of these symptoms of a liver problem:
  • nausea
  • poor appetite
  • tiredness
  • vomiting
  • upper right stomach-area (abdomen) pain
  • yellowing of your skin or eyes (jaundice)
  • dark (tea-colored) urine
  • pale or light colored stools
Your doctor should do a blood test to check you for liver problems before you start treatment with LAMISIL Oral Granules. Your doctor may also check you for liver problems during treatment, and tell you to stop taking LAMISIL Oral Granules if you develop liver problems.
What is LAMISIL Oral Granules?
LAMISIL Oral Granules is a prescription medicine used to treat a fungal infection of the scalp (tinea capitis) in people 4 years of age and older.
It is not known if LAMISIL Oral Granules are safe and effective in children under 4 years of age for the treatment of tinea capitis.
Who should not take LAMISIL Oral Granules?
Do not take LAMISIL Oral Granules if you:
  • have had a severe allergic reaction to terbinafine hydrochloride when taken by mouth.
  • have had liver disease for a long time (chronic) or have active liver disease.
What should I tell my doctor before taking LAMISIL Oral Granules?
Before taking LAMISIL Oral Granules, tell your doctor about all of your medical conditions, including if you:
  • have or had liver problems
  • have a weakened immune system (immunocompromised)
  • have lupus (an autoimmune disease)
  • are pregnant or plan to become pregnant. It is not known if LAMISIL Oral Granules may harm your unborn baby.
Tell your doctor right away if you become pregnant during treatment with LAMISIL.
  • are breastfeeding or plan to breastfeed. LAMISIL passes into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take LAMISIL Oral Granules.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
LAMISIL Oral Granules may affect the way other medicines work and other medicines may affect how LAMISIL Oral Granules works.
How should I take LAMISIL Oral Granules?
  • LAMISIL comes as oral granules that you sprinkle on food and take by mouth.
  • See the Instructions for Use that come with LAMISIL Oral Granules for information about the correct way to prepare and take or give a dose.
  • Take LAMISIL Oral Granules exactly as your doctor tells you to take it.
  • Your doctor will tell you how much LAMISIL Oral Granules to take and when to take it.
  • Take LAMISIL Oral Granules 1 time each day with pudding or other soft, non-acidic food such as mashed potatoes. Do not use applesauce or a fruit-based food.
  • If you take too much LAMISIL Oral Granules call your doctor. You may have the following symptoms:
  • nausea
  • stomach-area (abdomen) pain
  • frequent urination
  • rash
  • headache
  • vomiting
  • dizziness
What should I avoid while taking LAMISIL Oral Granules?
Avoid sunlight. LAMISIL Oral Granules can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You can get a severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your doctor if you get sunburn.
What are the possible side effects of LAMISIL Oral Granules?
LAMISIL Oral Granules may cause serious side effects, including:
  • See “What is the most important information I should know about LAMISIL Oral Granules?”
  • Change in your sense of taste or loss of taste may happen with LAMISIL Oral Granules, but can also be severe. This may improve within several weeks after you stop taking LAMISIL Oral Granules, but may last for a long time or may become permanent. Tell your doctor if you develop any of the following:
  • change in your sense of taste or loss of taste
  • poor appetite
  • change in your mood or depressive symptoms.
    See the list of depressive symptoms below.
  • weight loss
  • anxiousness
  • Change in your sense of smell or loss of smell may happen with LAMISIL Oral Granules. This may improve after you stop taking LAMISIL Oral Granules, but may last for a long time or may become permanent. Tell your doctor if you have a change in your sense of smell or loss of smell.
  • Depressive symptoms. Tell your doctor right away if you develop any of these signs or symptoms:
  • feel sad or worthless
  • change in sleep pattern
  • mood changes
  • loss of energy or interest in daily activities
  • restlessness
  • Low white blood cell count. LAMISIL Oral Granules may decrease your white blood cells, especially neutrophils. You may have a higher risk of getting an infection when your white blood cell count is low.
  • Serious skin or allergic reactions, which may include problems with some of your body organs. Tell your doctor right away or get emergency medical help if you get any of these symptoms:
    • skin rash
    • hives
    • sores in your mouth, or your skin blisters and peels
    • swelling of your face, eyes, lips, tongue or throat
    • trouble swallowing or breathing
    • fever
    • swollen lymph nodes
Also tell your doctor about any new symptoms, such as cough, chest pain, fast heartbeat, or blood in your urine.
  • New or worsening lupus. Stop taking LAMISIL Oral Granules and tell your doctor if you get any of the following:
    • a skin rash that gets worse (progresses), is scaly, red, shows scarring, or loss of skin color
    • unusual sensitivity to the sun that can cause a rash
  • Blood clotting problems. When taking LAMISIL Oral Granules, you may develop a blood clotting problem, that can sometimes cause death. Tell your doctor, if you get any unexplained bleeding or bruising.
The most common side effects of LAMISIL Oral Granules include:
  • nasal congestion
  • headache
  • fever
  • cough
  • vomiting
  • upper respiratory infection
  • upper stomach-area (abdomen) pain
  • diarrhea
These are not all of the possible side effects of LAMISIL Oral Granules.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store LAMISIL Oral Granules?
  • Store LAMISIL Oral Granules at room temperature between 68°F to 77°F (20°C to 25°C).

Keep LAMISIL Oral Granules and all medicines out of the reach of children.

General information about the safe and effective use of LAMISIL Oral Granules
Medicines are sometimes prescribed for purposes other than those listed in Medication Guide. Do not use LAMISIL Oral Granules for a condition for which it was not prescribed. Do not give LAMISIL Oral Granules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about LAMISIL Oral Granules that is written for health professionals.
What are the ingredients in LAMISIL Oral Granules?
Active ingredient: terbinafine hydrochloride
Inactive ingredients: basic butylated methacrylate copolymer, colloidal silicon dioxide NF, dibutyl sebacate NF, hypromellose USP, magnesium stearate NF, microcrystalline cellulose NF, nitrogen NF (filling gas), polyethylene glycol NF, sodium lauryl sulfate NF, and sodium starch glycolate NF

Distributed by:
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

© Novartis

T2019-48
Revised: 3/2019
Document Id: 69d6f28c-5491-4f68-a5b6-d810fe2d485e
Set id: bc7d43f0-8a4a-4d40-b0fd-70a37dc5faad
Version: 17
Effective Time: 20190329
Novartis Pharmaceuticals Corporation