Uses of Sabril:

• It is used to help control certain kinds of seizures.
• It is used to treat infantile spasms.

What do I need to tell my doctor BEFORE I take Sabril?

• If you have an allergy to vigabatrin or any other part of Sabril (vigabatrin oral solution).
• If you are allergic to Sabril (vigabatrin oral solution); any part of Sabril (vigabatrin oral solution); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are breast-feeding or plan to breast-feed.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Sabril (vigabatrin oral solution) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Sabril?

For all patients taking Sabril (vigabatrin oral solution):

• Tell all of your health care providers that you take Sabril (vigabatrin oral solution). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how Sabril (vigabatrin oral solution) affects you.
• Do not stop taking Sabril (vigabatrin oral solution) all of a sudden without calling your doctor. You may have a greater risk of seizures. If you need to stop this drug, you will want to slowly stop it as ordered by your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Sabril (vigabatrin oral solution).
• Nerve problems like burning, numbness, or tingling feelings that are not normal have happened with Sabril (vigabatrin oral solution). It is not known if these nerve problems will go away if Sabril (vigabatrin oral solution) is stopped. Talk with the doctor.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• If you are 65 or older, use Sabril (vigabatrin oral solution) with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Sabril (vigabatrin oral solution) while you are pregnant.

Children:

• If your child's weight changes, talk with the doctor. The dose of Sabril (vigabatrin oral solution) may need to be changed.
• This medicine may cause MRI changes that are not normal in infants. This has not been seen in older children or adults. It is not known if these changes are harmful. Talk with the doctor.

How is this medicine (Sabril) best taken?

Use Sabril (vigabatrin oral solution) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Ask your doctor what to do if you are not able to take the full dose. Ask your doctor what to do if you throw up after taking Sabril (vigabatrin oral solution).
• Keep taking Sabril (vigabatrin oral solution) as you have been told by your doctor or other health care provider, even if you feel well.
• Mix with water as told before you take Sabril (vigabatrin oral solution). Do not swallow the dry powder.
• Be sure you know how many packets to use.
• Dissolve each packet in 2 teaspoons (10 mL) of water.
• After mixing, measure the liquid dose carefully. Use the measuring device that comes with Sabril (vigabatrin oral solution).
• Swallow the mixture right away. Do not store for use at a later time.
• Do not use if the solution is cloudy or has particles.
• Do not use if solution changes color.
• Throw away any part left over after the dose is given.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• A burning, numbness, or tingling feeling that is not normal.
• Chest pain.
• Change in balance.
• Very bad dizziness or passing out.
• Feeling confused, not able to focus, or change in behavior.
• Fever.
• Ear pain.
• Feeling very tired or weak.
• If seizures are worse or not the same after starting Sabril (vigabatrin oral solution).
• Not able to control eye movements.
• Very bad muscle pain or weakness.
• Swelling.
• Memory problems or loss.
• Trouble walking.
• Not able to get or keep an erection.
• Painful periods.
• Like other drugs that may be used for seizures, Sabril (vigabatrin oral solution) may rarely raise the risk of suicidal thoughts or actions. The risk may be higher in people who have had suicidal thoughts or actions in the past. Call the doctor right away about any new or worse signs like depression; feeling nervous, restless, or grouchy; panic attacks; or other changes in mood or behavior. Call the doctor right away if any suicidal thoughts or actions occur.

What are some other side effects of Sabril?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
• Cough.
• Nose or throat irritation.
• Signs of a common cold.
• Headache.
• Trouble sleeping.
• Back, muscle, or joint pain.
• More hungry.
• Weight gain.
• Tooth pain.
• Twitching.
• Shakiness.
• Flu-like signs.
• Feeling nervous and excitable.
• Strange or odd dreams.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Sabril?

• Store in the original container at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Sabril (vigabatrin oral solution) is refilled. If you have any questions about Sabril (vigabatrin oral solution), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Frequently asked questions

• How long does vigabatrin (Sabril) take to work?
• What is the vigabatrin REMS Program?