Sabril contains the active ingredient vigabatrin, available in a film-coated 500 mg tablet form. It is an oral antiepileptic drug. Key inactive ingredients include magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. It is intended to help with epilepsy by managing seizures.

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, pour the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Change in vision such as blurry vision, seeing halos around lights, vision loss
• Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Pain, tingling, or numbness in the hands or feet
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Dizziness
• Drowsiness
• Fatigue
• Loss of balance or coordination
• Swelling of the ankles, hands, or feet
• Tremors or shaking
• Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• History of substance use disorder
• Kidney disease
• Low red blood cell levels
• Suicidal thoughts, plans, or attempt by you or a family member
• Vision problems
• An unusual or allergic reaction to vigabatrin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

• Clonazepam
• Other medications that may cause serious eye problems, such as interferon-alpha, peg-interferon, prednisone, or methylprednisolone
• Phenytoin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

Your vision may be tested before and during use of this medication. Tell your care team right away if you have any change in your eyesight.

Do not suddenly stop taking this medication. You may develop a severe reaction. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose may be slowly lowered over time to avoid any side effects.

This medication may cause thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression.

Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card.

What are the most serious risks of this medication?

This medicine should only be given by a healthcare provider who has special training and experience in using it.

This medicine can damage your vision. It causes loss of seeing to the side when you look straight ahead (peripheral vision). Any loss in vision will never get better. It may be severe, where you only see things straight in front of you (called tunnel vision). You may also have blurry vision. There is a risk of vision loss with any amount of this medicine. The risk may be higher with a higher dose and with longer treatment. Vision loss can happen at any time during or after treatment. Vision will be carefully monitored during and after treatment.