Side Effects in Adults

SABRIL^® (vigabatrin) Tablets
SABRIL^® (vigabatrin) for Oral Solution

Use

SABRIL Tablets is a prescription medicine used along with other treatments to treat adults with complex partial seizures (CPS) if the CPS does not respond well enough to several other treatments, and if you and your doctor decide the possible benefit of taking SABRIL is more important than the risk of vision loss. SABRIL should not be the first medicine used to treat your CPS.

SABRIL for Oral Solution is a prescription medicine used to treat babies, 1 month to 2 years old who have infantile spasms (IS), if you and your doctor decide that the possible benefits of SABRIL are more important than the possible risk of vision loss.

Important Safety Information

SABRIL can permanently damage the vision of anyone who takes it. The most noticeable loss is in the ability to see to the side when looking 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.

Because of the risk of vision loss in adults, SABRIL is used to treat CPS only in people who do not respond well enough to several other medications. Tell your doctor right away if you think you are not seeing as well as before you started taking SABRIL; start to trip, bump into things, or are more clumsy than usual; or are surprised by people or things coming in front of you that seem to come out of nowhere.

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.

Because of the risk of vision loss, SABRIL is used in babies with IS only when you and your doctor decide that the possible benefits of SABRIL are more important than the risks. Parents or caregivers are not likely to recognize the symptoms of vision loss in babies until it is severe. Doctors may not find vision loss in babies until it is severe. It is difficult to test vision in babies, but all babies should have their vision tested before starting SABRIL or within 4 weeks after starting SABRIL, and every 3 months after that until SABRIL is stopped. Your baby should have a vision test after SABRIL is stopped. Your baby may not be able to be tested in certain situations. Your doctor will determine if your baby can be tested.

Tell your doctor right away if you think that your baby is not seeing as well as before taking SABRIL or is acting differently than normal. 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 tests 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.

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.

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 symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings, and especially if they are new, worse, or worry you.

Do not stop SABRIL without first talking to a healthcare provider. Stopping SABRIL suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus) in people who are being treated for seizures.

If you are an adult with CPS, tell your doctor about all of your medical conditions including depression, mood problems, suicidal thoughts or behavior, an allergic reaction to SABRIL, any vision problems, any kidney problems, low red blood cell counts and any nervous or mental illness. If you are breastfeeding or plan to breastfeed, SABRIL can pass into breast milk and may harm your baby. If you are pregnant or plan to become pregnant, it is not known if SABRIL will harm your unborn baby. You and your healthcare provider will have to decide if you should take SABRIL while you are pregnant.

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 an allergic reaction to SABRIL, or any vision or kidney problems.

Tell your doctor about all the medicines you or your baby take.

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. SABRIL can cause serious side effects in adults such as low red blood cell counts, sleepiness and tiredness, nerve problems, weight gain that happens without swelling, and swelling. It is not known if these side effects also happen in babies who take SABRIL. SABRIL may make certain types of seizures worse. You should tell your or your baby's doctor right away if the seizures get worse.

The most common side effects of SABRIL in adults include: problems walking or feeling uncoordinated, feeling dizzy, shaking, joint pain, memory problems and not thinking clearly, and eye problems such as blurry vision, double vision, and eye movements you cannot control. The most common side effects of SABRIL in babies and young children include: sleepiness—some babies may have a harder time suckling and feeding or may be irritable, ear infection, and irritability. Tell your doctor if you or your baby has any side effect that bothers you or that does not go away. These are not all of the possible side effects of SABRIL. For more information, ask your doctor or pharmacist.

Please see SABRIL Medication Guide and full Prescribing Information including Boxed Warning and dosing instructions for SABRIL for Oral Solution on this website or call toll-free 1-888-45-SHARE (1-888-457-4273).

Oral Solution: For more information, please see the full Prescribing Information including Boxed Warning, Medication Guide and Dosing Instructions.

Solución oral: Para más información, vea por favor la información que prescribe completa incluyendo la advertencia encajonada, guía de la medicación y las instrucciones de la dosificación.

Tablets: For more information, please see the full Prescribing Information including Boxed Warning and Medication Guide.

Tabletas: Para más información, vea por favor la información que prescribe completa incluyendo la advertencia encajonada y guía de la medicación.