SABRIL- vigabatrin tablet, film coated
Sabril® (SAY-bril) (vigabatrin) Tablet
Sabril® (SAY-bril) (vigabatrin) for Oral Solution
Read the Medication Guide that comes with SABRIL before you or your baby 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 doctor about your or your baby'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:
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 doctor right away if you:
These changes can mean that you have damage to your vision. Your doctor will test your visual fields (including peripheral vision) and visual acuity (ability to read an eye chart) before you start SABRIL or within 4 weeks after starting SABRIL, and at least every 3 months after that until SABRIL is stopped. You may not be able to be tested in certain situations. Your doctor will determine if you can be tested. Even if your vision seems fine, it is important that you get these regular vision tests because damage can happen to your vision before you notice any changes. These vision tests cannot prevent the vision damage that can happen with SABRIL, but they do allow you to stop SABRIL if vision has gotten worse, which usually will lessen further damage. If you do not have these vision tests regularly, your doctor may stop prescribing SABRIL for you. You should also have a vision test after SABRIL is stopped. Some people are not able to complete testing of vision for medical reasons. If you cannot complete vision testing, your doctor may continue prescribing SABRIL, but your doctor will not be able to watch for any vision loss you may get.
If you drive and your vision is damaged by SABRIL, driving might be more dangerous, or you may not be able to drive safely at all. You should discuss this with your doctor.
Tell your doctor right away if you think that your baby is:
Even if your baby's vision seems fine, it is important to get regular vision tests because damage can happen before your baby acts differently. Even these regular vision exams may not show the damage to your baby's vision before it is serious and permanent. If your baby does not have these vision tests regularly, your doctor may stop prescribing SABRIL for your baby. If your baby is not able to complete vision testing, your doctor may continue prescribing SABRIL for your baby. But, your doctor will not be able to watch for vision loss in your baby.
In all people who take SABRIL:
Because SABRIL might cause vision loss, it is available to doctors and patients only under a special program called SHARE. As part of the SHARE program, among other things, your doctor will have to test your or your baby's vision frequently while you or your baby are being treated with SABRIL, and even after you or your baby stops treatment. You also have to agree to be in the SHARE program, and agree to have your or your baby's vision tested regularly. Your doctor will explain the details of the SHARE program to you.
2. Magnetic resonance imaging (MRI) changes:
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 doctor 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 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 baby can begin taking SABRIL, you must read and agree to all of the instructions in the SHARE program.
What is SABRIL?
SABRIL Tablets is a prescription medicine used along with other treatments to treat adults with CPS if:
SABRIL should not be the first medicine used to treat your CPS.
SABRIL for Oral Solution is a prescription medicine used to treat babies, one month to two years old who have IS, if you and your doctor decide the possible benefits of taking SABRIL are more important than the possible risk of vision loss.
If you are an adult with CPS, you must sign an agreement form before you 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 doctor before starting SABRIL?
If you are an adult with CPS, before taking SABRIL tell your doctor if you have or had:
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 doctor about all of your baby's medical conditions, including if your baby has or ever had:
Tell your doctor about all the medicines you or your baby take, including prescription and non-prescription medicines, vitamins, and herbal supplements. SABRIL and other medicines may affect each other causing side effects.
How should I take SABRIL?
If you are an adult with CPS:
If you are giving SABRIL to your baby for IS:
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 doctor have decided that you can do these things safely.
What are the possible side effects of SABRIL?
SABRIL can cause serious side effects. See "What is the most important information I should know about SABRIL?"
These other serious side effects happen in adults. It is not known if these side effects also happen in babies who take SABRIL.
If you are an adult with CPS, SABRIL may make certain types of seizures worse. Tell your doctor right away if your seizures get worse.
The most common side effects of SABRIL in adults 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 doctor right away if your baby's seizures get worse. Tell your baby's doctor if you see any changes in your baby's behavior.
The most common side effects of SABRIL in babies and young children include:
Tell your doctor if you or your baby have any side effect that bother you or that does not go away. These are not all the possible side effects of SABRIL. For more information, ask your doctor 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?
Store SABRIL tablets and SABRIL packets at room temperature, between 68°F to 77°F (20°C to 25°C).
Keep SABRIL tablets and SABRIL powder in the container they come in.
Keep SABRIL and all medicines out of the reach of children.
General information about 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 doctor. You can ask your pharmacist or doctor 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 in SABRIL tablets: hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone, sodium starch glycolate, and titanium dioxide.
Inactive Ingredient in SABRIL powder: povidone.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Marketed by: Lundbeck, Deerfield, IL 60015, U.S.A.
® Trademark of Lundbeck
Revised: December 2012