TERBINAFINE HYDROCHLORIDE- terbinafine hydrochloride tablet 
PD-Rx Pharmaceuticals, Inc.


TERBINAFINE (ter' bin a feen) Tablets, USP

Dispense with Medication Guide available at: www.bpirx.com/products/patientinformation

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

Terbinafine tablets may cause serious side effects, including:

  • 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 Terbinafine tablets. Your doctor may also check you for liver problems during treatment, and tell you to stop taking Terbinafine tablets if you develop liver problems.

What are Terbinafine tablets?

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

Who should not take Terbinafine tablets?

Do not take Terbinafine tablets if you:

What should I tell my doctor before taking Terbinafine tablets?

Before taking Terbinafine 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 tablets may affect the way other medicines work and other medicines may affect how Terbinafine tablets work.

How should I take Terbinafine tablets?

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

What should I avoid while taking Terbinafine tablets?

Avoid sunlight. Terbinafine 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 tablets?

Terbinafine tablets may cause serious side effects, including:

  • feel sad or worthless
  • change in sleep pattern
  • mood changes
  • loss of energy or interest in daily activities
  • restlessness

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

The most common side effects of Terbinafine tablets include:

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

These are not all of the possible side effects of Terbinafine 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 tablets?

Keep Terbinafine tablets and all medicines out of the reach of children.

General information about the safe and effective use of Terbinafine tablets.

Medicines are sometimes prescribed for purposes other than those listed in Medication Guide. Do not use Terbinafine tablets for a condition for which it was not prescribed. Do not give Terbinafine 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 tablets that is written for health professionals. For more information, call 1-800-367-3395 or go to www.bpirx.com.

What are the ingredients in Terbinafine tablets?

Active ingredient: terbinafine hydrochloride

Inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Distributed by:
Breckenridge Pharmaceutical, Inc.
Berlin, CT 06037

Manufactured by:
Guadalajara, Spain
Made in Spain

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

Revised: April 2023

Revised: 7/2023
PD-Rx Pharmaceuticals, Inc.