SABRIL- vigabatrin tablet, film coated 
Lundbeck LLC

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Medication Guide

Sabril® (SAY-bril) 
(vigabatrin)
tablets

Sabril® (SAY-bril) 
(vigabatrin)
powder for oral solution

Read the Medication Guide that comes with SABRIL before you or your child starts taking SABRIL and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your or your child’s medical condition or treatment.

What is the most important information I should know about SABRIL?

SABRIL can cause serious side effects, including:

  1. Permanent vision damage
  2. Magnetic resonance imaging (MRI) changes in babies with infantile spasms (IS)
  3. Risk of suicidal thoughts or actions

1. Permanent vision damage:  

SABRIL can damage the vision of anyone who takes it. The most noticeable loss is in your ability to see to the side when you look straight ahead (peripheral vision). If this happens, it will not get better. People who take SABRIL do not lose all of their vision, but some people can have severe loss particularly to their peripheral vision. With severe vision loss, you may only be able to see things straight in front of you (sometimes called “tunnel vision”). You may also have blurry vision.

Tell your healthcare provider right away if you (or your child):

Tell your healthcare provider right away if you think that your baby is:

   In all people who take SABRIL:
  • You are at risk for vision loss with any amount of SABRIL.
  • Your risk of vision loss may be higher the more SABRIL you take daily and the longer you take it.
  • It is not possible for your healthcare provider to know when vision loss will happen. It could happen soon after starting SABRIL or any time during treatment. It may even happen after treatment has stopped.

2. Magnetic resonance imaging (MRI) changes in babies with infantile spasms:

Brain pictures taken by magnetic resonance imaging (MRI) show changes in some babies after they are given SABRIL. It is not known if these changes are harmful.

3. Risk of suicidal thoughts or actions:  

Like other antiepileptic drugs, SABRIL may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it. Call a healthcare provider right away if you or your child 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 or your child 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 SABRIL without first talking to a healthcare provider.

SABRIL can be prescribed only to people who are enrolled in a program called SHARE. Before you or your child can begin taking SABRIL, you must read and agree to all of the instructions in the SHARE program. 

What is SABRIL?

If you or your child has CPS, you must sign an agreement form before you or your child can receive SABRIL.

If you are the parent or caregiver of a baby with IS, you must sign an agreement form before your baby can receive SABRIL.

What should I tell my healthcare provider before starting SABRIL?

If you or your child has CPS, before taking SABRIL tell your healthcare provider if you or your child have or had:

Pregnancy Registry:

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

Before giving SABRIL to your baby, tell the healthcare provider about all of your baby’s medical conditions, including if your baby has or ever had:

Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SABRIL and other medicines may affect each other causing side effects.

How should I take SABRIL?

What should I avoid while taking SABRIL?

SABRIL causes sleepiness and tiredness. Adults taking SABRIL should not drive, operate machinery, or perform any hazardous task, unless you and your healthcare provider have decided that you can do these things safely.

What are the possible side effects of SABRIL?

SABRIL can cause serious side effects, including:  

The following serious side effects happen in adults. It is not known if these side effects also happen in babies who take SABRIL. 

If you or your child has CPS, SABRIL may make certain types of seizures worse. Tell your healthcare provider right away if your (or your child's) seizures get worse. 

The most common side effects of SABRIL in adults include:

The most common side effects of SABRIL in children 10 to 16 years of age include:

If you are giving SABRIL to your baby for IS:

SABRIL may make certain types of seizures worse. You should tell your baby’s healthcare provider right away if your baby’s seizures get worse. Tell your baby’s healthcare provider if you see any changes in your baby’s behavior.

The most common side effects of SABRIL in babies include:

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

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 SABRIL?

Keep SABRIL and all medicines out of the reach of children.

General information about the safe and effective use of SABRIL.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SABRIL for a condition for which it was not prescribed. Do not give SABRIL 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 SABRIL. If you would like more information about SABRIL, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about SABRIL that is written for health professionals. For more information, go to www.SABRIL.net or call 1-800-455-1141.

What are the ingredients in SABRIL?
Active Ingredient: vigabatrin
Inactive Ingredients:

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

Marketed by: Lundbeck, Deerfield, IL 60015, U.S.A.

SABRIL is a registered trademark of Lundbeck 
Revised: October 2013                  

Revised: 10/2013
 
Lundbeck LLC