Tiagabine Hydrochloride Tiagabine

Brand Name: Tiagabine Hydrochloride

Generic Name: TIAGABINE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET

Packager: Amneal Pharmaceuticals NY LLC

Data Current As Of: 2021-02-11

Tiagabine hydrochloride tablets are indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.

Tiagabine HCl tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.

The abuse and dependence potential of tiagabine HCl have not been evaluated in human studies.

Tiagabine (tye-AG-a-been) Hydrochloride Tablets

Read this Medication Guide before you start taking tiagabine HCl 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 HCl?

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

Stopping tiagabine HCl suddenly can cause serious problems.

Tiagabine HCl can cause serious side effects, including:

• Tiagabine HCl may cause seizures in people who do not have epilepsy. If you do not have a seizure disorder and you take tiagabine HCl, 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 HCl for epilepsy.

   

• Like other antiepileptic drugs, tiagabine HCl 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:

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?   

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.
• Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

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

• Stopping tiagabine HCl 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 HCl?

Tiagabine HCl 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 HCl tablets?

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

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

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

• have or have had depression, mood problems, or suicidal thoughts or behavior
• have liver problems
• have a history of seizures that do not stop (status epilepticus)
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if tiagabine HCl can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking tiagabine HCl. You and your healthcare provider will decide if you should take tiagabine HCl while you are pregnant.
  • If you become pregnant while taking tiagabine HCl, 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.
• are breastfeeding or plan to breastfeed. It is not known if tiagabine HCl 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 HCl.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking tiagabine HCl 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 HCl?

Take tiagabine HCl exactly as your healthcare provider tells you.

• Your healthcare provider may change your dose.
• Tiagabine HCl should be taken with food.
• Do not stop taking tiagabine HCl without talking to your healthcare provider. Stopping tiagabine HCl suddenly can increase your chances of having a seizure or cause seizures that will not stop.
• If you miss a dose of tiagabine HCl, do not take 2 doses of tiagabine HCl at the same time. Contact your healthcare provider if you miss more than one dose.

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

What should I avoid while taking tiagabine HCl?

• Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking tiagabine HCl without first talking to your healthcare provider. Taking tiagabine HCl with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how tiagabine HCl affects you. Tiagabine HCl can slow your thinking and motor skills.

What are possible side effects of tiagabine HCl?   

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

Tiagabine HCl may cause other serious side effects including:

• seizures that can happen more often or become worse
• trouble concentrating, problems with speech and language, feeling confused, feeling sleepy and tired, and problems thinking
• weakness all over your body
• eye and vision problems
• 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 HCl include:

• dizziness
• lack of energy
• drowsiness
• nausea
• nervousness
• tremor
• stomach pain
• abnormal thinking
• difficulty with concentration or attention

These are not all the possible side effects of tiagabine HCl. 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 HCl tablets?

• Store tiagabine HCl tablets between 68°F to 77°F (20°C to 25°C)
• Keep tiagabine HCl tablets out of light
• Keep tiagabine HCl tablets dry

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

General Information about Tiagabine HCl

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use tiagabine HCl for a condition for which it was not prescribed. Do not give tiagabine HCl 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 HCl. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about tiagabine HCl that is written for health professionals.

For more information, go to www.amneal.com or call 1-877-835-5472.

What are the ingredients in tiagabine HCl tablets?

Active Ingredient: tiagabine hydrochloride, USP

Inactive Ingredients: anhydrous lactose, ascorbic acid, colloidal silicon dioxide, crospovidone Type A, hydrogenated vegetable oil Type 1 (cottonseed oil), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, stearic acid and titanium dioxide.

In addition:

• the 2 mg tablets contain FD&C Yellow No. 6 aluminum lake
• the 4 mg tablets contain D&C Yellow No. 10 aluminum lake
• the 12 mg tablets contain D&C Yellow No. 10 aluminum lake and FD&C Blue No. 1 aluminum lake
• the 16 mg tablets contain FD&C Blue No. 2 aluminum lake and talc

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

*Trademarks are the property of their respective owners.

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Oral Solid Dosage Unit
Ahmedabad 382213, INDIA

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 12-2017-01