TIAGABINE HYDROCHLORIDE- tiagabine hydrochloride tablet 
CIMA Laboratories, Inc.

----------

Medication Guide

Tiagabine Hydrochloride Tablets

Read this Medication Guide before you start taking tiagabine hydrochloride tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. 

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

Do not stop taking tiagabine hydrochloride without first talking to your healthcare provider.

Stopping tiagabine hydrochloride suddenly can cause serious problems.

Tiagabine hydrochloride can cause serious side effects, including:

1. Tiagabine hydrochloride may cause seizures in people who do not have epilepsy. If you do not have a seizure disorder and you take tiagabine hydrochloride, you may have a seizure or seizures that do not stop (status epilepticus). Call your healthcare provider right away if you have a seizure and you are not taking tiagabine hydrochloride for epilepsy.

2. Like other antiepileptic drugs, tiagabine hydrochloride may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

 

 

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

Do not stop tiagabine hydrochloride without first talking to a healthcare provider.

Stopping tiagabine hydrochloride suddenly can cause serious problems. If you have epilepsy and stop a seizure medicine suddenly, you may have more frequent seizures or seizures that will not stop (status epilepticus).

What is tiagabine hydrochloride?

 Tiagabine hydrochloride is a prescription medicine used with other medicines to treat partial seizures in adults and children age 12 and older.

Who should not take tiagabine hydrochloride?

Do not take tiagabine hydrochloride if you are allergic to tiagabine hydrochloride or any of the other ingredients in tiagabine hydrochloride. See the end of this Medication Guide for a complete list of ingredients in tiagabine hydrochloride.

What should I tell my healthcare provider before taking tiagabine hydrochloride?

Before taking tiagabine hydrochloride, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking tiagabine hydrochloride with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. Always tell your healthcare provider if there are any changes in any other medicines that you take.

How should I take tiagabine hydrochloride?

If you take too much tiagabine hydrochloride, call your healthcare provider or local Poison Control Center right away.

What should I avoid while taking tiagabine hydrochloride?

What are possible side effects of tiagabine hydrochloride?

See “What is the most important information I should know about tiagabine hydrochloride?”

Tiagabine hydrochloride may cause other serious side effects including:

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of tiagabine hydrochloride include:

These are not all the possible side effects of tiagabine hydrochloride. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

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 tiagabine hydrochloride?

Keep tiagabine hydrochloride and all medicines out of the reach of children.

General Information about tiagabine hydrochloride

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use tiagabine hydrochloride for a condition for which it was not prescribed. Do not give tiagabine hydrochloride to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about tiagabine hydrochloride. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about tiagabine hydrochloride that is written for health professionals.

What are the ingredients in tiagabine hydrochloride?

Active Ingredient: tiagabine hydrochloride

Inactive Ingredients: ascorbic acid, colloidal silicon dioxide, crospovidone, hydrogenated vegetable oil wax, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, stearic acid and titanium dioxide.

In addition:

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

TIAMG-001

June 2011

Rx only

Distributed by:

Cephalon, Inc.

Frazer, PA 19355

Revised: 12/2012
 
CIMA Laboratories, Inc.