GABITRIL - tiagabine hydrochloride tablet
STAT RX USA LLC
Read this Medication Guide before you start taking GABITRIL 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 GABITRIL?
Do not stop taking GABITRIL without first talking to your healthcare provider.
Stopping GABITRIL suddenly can cause serious problems.
GABITRIL can cause serious side effects, including:
1. GABITRIL may cause seizures in people who do not have epilepsy. If you do not have a seizure disorder and you take GABITRIL, 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 GABITRIL for epilepsy.
2. Like other antiepileptic drugs, GABITRIL 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?
Do not stop GABITRIL without first talking to a healthcare provider.
Stopping GABITRIL 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 GABITRIL?
GABITRIL is a prescription medicine used with other medicines to treat partial seizures in adults and children age 12 and older.
Who should not take GABITRIL?
Do not take GABITRIL if you are allergic to tiagabine hydrochloride or any of the other ingredients in GABITRIL. See the end of this Medication Guide for a complete list of ingredients in GABITRIL.
What should I tell my healthcare provider before taking GABITRIL?
Before taking GABITRIL, 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 GABITRIL 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 GABITRIL?
If you take too much GABITRIL, call your healthcare provider or local Poison Control Center right away.
What should I avoid while taking GABITRIL?
What are possible side effects of GABITRIL?
See “What is the most important information I should know about GABITRIL?”
GABITRIL 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 GABITRIL include:
These are not all the possible side effects of GABITRIL. 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 GABITRIL?
Keep GABITRIL and all medicines out of the reach of children.
General Information about GABITRIL
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use GABITRIL for a condition for which it was not prescribed. Do not give GABITRIL 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 GABITRIL. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about GABITRIL that is written for health professionals.
For more information, go to www.GABITRIL.com or call 1-800-896-5855.
What are the ingredients in GABITRIL?
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.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Frazer, PA 19355
U.S. Patent Nos. 5,354,760; 5,866,590; 5,958,951
©2010 Cephalon, Inc., or its affiliates. All rights reserved.
Printed in U.S.A.
Label for 63459-402-30