|Packaging Size||100 Tablets|
|Type Of Medicines||Allopathic|
SABRIL (vigabatrin 500mg) is a prescription medicine used with other treatments in adults and children 2 years of age and older with refractory complex partial seizures (CPS) who have not responded well enough to several other treatments and if the possible benefits outweigh the risk of vision loss. SABRIL should not be the first medicine used to treat CPS. Because SABRIL might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. Your healthcare provider will explain the details of this Program to you. SABRIL can damage the vision of anyone who takes it. Some people can have severe loss particularly to their ability to see to the side when looking straight ahead (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. If this happens, it will not get better. Tell your healthcare provider right away if you (or your child): might not be seeing as well as before starting SABRIL; start to trip, bump into things, or are more clumsy than usual; are surprised by people or things coming in front of you that seem to come out of nowhere; or if your baby is acting differently than normal. These changes can mean that vision damage has occurred. It is recommended that your healthcare provider test your (or your child’s) vision before or within 4 weeks after starting SABRIL, and at least every 3 months during treatment until SABRIL is stopped. It is also recommended that vision be tested about 3 to 6 months after SABRIL is stopped. Your vision loss may get worse after you stop taking SABRIL. It is difficult to test vision in babies, but to the extent possible, all babies should have their vision tested. Your healthcare provider will determine if testing can be done. Regular vision testing is important because damage can happen before any changes are noticed. Vision tests cannot prevent the vision damage that can happen with SABRIL, but they do allow SABRIL to be stopped if vision has gotten worse. Even these regular vision tests may not show vision damage before it is severe and permanent. Parents, caregivers, and healthcare providers may not recognize the symptoms, or find vision loss in babies, until it is severe. If vision tests are not done regularly, your healthcare provider may stop prescribing SABRIL for you (or your child). Some people are not able to complete vision testing. If vision testing cannot be done, your healthcare provider may continue prescribing SABRIL, but will not be able to watch for any vision loss. 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. A type of swelling in the brain called Intramyelinic Edema (IME) has been seen in autopsy examination of babies treated with vigabatrin. Like other antiepileptic drugs, SABRIL may cause suicidal thoughts and actions in some people. Call a healthcare provider right away if you (or your child) 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 seizures that will not stop. SABRIL can cause serious side effects such as low red blood cell counts (anemia), sleepiness and tiredness, nerve problems, weight gain, and swelling. Because SABRIL causes sleepiness and tiredness, do not drive, operate machinery, or perform any hazardous task, unless it is decided that these things can be done safely. SABRIL may make certain types of seizures worse. Tell your healthcare provider right away if seizures get worse.