TERBINAFINE HYDROCHLORIDE- terbinafine hydrochloride tablet 
Wockhardt USA LLC.



Terbinafine (ter-BIN-ah-fin)

hydrochloride tablets

What is the most important information I should know about terbinafine hydrochloride tablets?

Terbinafine hydrochloride tablets may cause serious side effects, including:

o nausea
o upper right stomach-area (abdomen) pain
o poor appetite
o yellowing of your skin or eyes (jaundice)
o tiredness
o dark (tea-colored) urine
o vomiting
o pale or light colored stools

Your doctor should do a blood test to check you for liver problems before you start treatment with terbinafine hydrochloride tablets. Your doctor may also check you for liver problems during treatment, and tell you to stop taking terbinafine hydrochloride tablets if you develop liver problems.

What are terbinafine hydrochloride tablets?

Terbinafine hydrochloride tablet is a prescription medicine used to treat fungal infections of the fingernails and toenails (onychomycosis).

Your doctor should do tests to check you for fungal infection of your nails before you start terbinafine hydrochloride tablets.

It is not known if terbinafine hydrochloride tablets are safe and effective in children for the treatment of onychomycosis.

Who should not take terbinafine hydrochloride tablets?

Do not take terbinafine hydrochloride tablets if you:

What should I tell my doctor before taking terbinafine hydrochloride tablets?

Before taking terbinafine hydrochloride tablets, tell your doctor about all of your medical conditions, including if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Terbinafine hydrochloride tablets may affect the way other medicines work and other medicines may affect how terbinafine hydrochloride tablets work.

How should I take terbinafine hydrochloride tablets?

      o 1 time each day for 6 weeks to treat fungal infections of your fingernail, or

      o 1 time each day for 12 weeks to treat fungal infections of your toenail

o nausea
o rash
o vomiting
o stomach-area (abdomen) pain
o headache
o dizziness
o frequent urination

What should I avoid while taking terbinafine hydrochloride tablets?

Avoid sunlight. Terbinafine hydrochloride tablets 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 terbinafine hydrochloride tablets?

Terbinafine hydrochloride tablets may cause serious side effects, including:

o change in your sense of taste or loss of taste
o weight loss
o poor appetite
o anxiousness
o change in your mood or depressive symptoms. See the list of depressive symptoms below.
o feel sad or worthless
o loss of energy or interest in daily activities
o change in sleep pattern
o restlessness
o mood changes

o skin rash

o hives

o sores in your mouth, or your skin blisters and peels

o swelling of your face, eyes, lips, tongue or throat

o trouble swallowing or breathing

o fever

o swollen lymph glands

Also tell your doctor about any new symptoms, such as cough, chest pain, fast heartbeat, or blood in your urine.

o a skin rash that gets worse (progresses), is scaly, red, shows scarring, or loss of skin color

o unusual sensitivity to the sun that can cause a rash

The most common side effects of terbinafine hydrochloride tablets include:

o headache
o upset stomach
o nausea
o diarrhea
o abnormal liver function tests
o stomach-area (abdomen) pain
o rash
o itching
o gas

These are not all of the possible side effects of terbinafine hydrochloride tablets.

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 terbinafine hydrochloride tablets?

Keep terbinafine hydrochloride tablets and all medicines out of the reach of children.

General information about the safe and effective use of terbinafine hydrochloride tablets.

Medicines are sometimes prescribed for purposes other than those listed in Medication Guide. Do not use terbinafine hydrochloride tablets for a condition for which it was not prescribed. Do not give terbinafine hydrochloride tablets 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 terbinafine hydrochloride tablets that is written for health professionals.

What are the ingredients in terbinafine hydrochloride tablets?

Active ingredient: terbinafine hydrochloride

Inactive ingredients: microcrystalline cellulose, NF; hypromellose 6 cps, USP; sodium starch glycolate, NF; colloidal silicon dioxide, NF; magnesium stearate, NF.

This Medication Guide has been approved by the U.S. Food and Drug Administration

Manufactured by:

Wockhardt Limited

H-14/2, M.I.D.C. Area, Waluj,

Aurangabad, Maharashtra,


Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054



Revised: 11/2019
Wockhardt USA LLC.