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 HCl 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:

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thoughts about suicide or dying

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attempts to commit suicide

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new or worse depression

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new or worse anxiety

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feeling agitated or restless

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panic attacks

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trouble sleeping (insomnia)

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new or worse irritability

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acting aggressive, being angry, or violent

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acting on dangerous impulses

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an extreme increase in activity and talking (mania)

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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?

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Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.

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Keep all follow-up visits with your healthcare provider as scheduled.

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Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

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

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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:

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have or have had depression, mood problems, or suicidal thoughts or behavior

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have liver problems

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have a history of seizures that do not stop (status epilepticus)

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have any other medical conditions

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are pregnant or plan to become pregnant. It is not known if tiagabine hydrochloride can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking tiagabine hydrochloride. You and your healthcare provider will decide if you should take tiagabine hydrochloride while you are pregnant.

o

If you become pregnant while taking tiagabine hydrochloride, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicines during pregnancy. You can enroll in this registry by calling 1-888-233-2334.

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are breastfeeding or plan to breastfeed. It is not known if tiagabine hydrochloride passes into breast milk or if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take tiagabine hydrochloride.

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?

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Take tiagabine hydrochloride exactly as your healthcare provider tells you.

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Your healthcare provider may change your dose.

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tiagabine hydrochloride should be taken with food.

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

 

Stopping tiagabine hydrochloride suddenly can increase your chances of having a seizure or cause seizures that will not stop.

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If you miss a dose of tiagabine hydrochloride, do not take 2 doses of tiagabine hydrochloride at the same time. Contact your healthcare provider if you miss more than one dose.

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?

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Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking tiagabine hydrochloride without first talking to your healthcare provider. Taking tiagabine hydrochloride with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

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Do not drive, operate heavy machinery, or do other dangerous activities until you know how tiagabine hydrochloride affects you. tiagabine hydrochloride can slow your thinking and motor skills.

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:

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seizures that can happen more often or become worse

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trouble concentrating, problems with speech and language, feeling confused, feeling sleepy and tired, and problems thinking

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weakness all over your body

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eye and vision problems

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serious rash

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:

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dizziness

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lack of energy

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drowsiness

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nausea

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nervousness

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tremor

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stomach pain

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abnormal thinking

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difficulty with concentration or attention

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?

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Store tiagabine hydrochloride between 68°F to 77°F (20°C to 25°C)

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Keep tiagabine hydrochloride out of light

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Keep tiagabine hydrochloride dry

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:

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the 2 mg tablets contain FD&C Yellow No. 6

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the 4 mg tablets contain D&C Yellow No. 10

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

TIAMG-001A

November 2015

Rx only

Distributed by:

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454