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Vigabatrin

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Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Warning

Serious vision problems may occur while taking this medication and may be permanent even after you stop taking the medication. To prevent vision problems from getting worse, your doctor must find any eye problems as early as possible. Also, tell your doctor if you have a history of vision problems. It is very important that you have an eye exam before or within 4 weeks of starting this medication, then every 3 months thereafter while you are taking this medication. You should also have an eye exam 3 to 6 months after stopping this medication. Follow your doctor's directions carefully and keep all medical/eye/lab appointments. Tell your doctor right away if you have any changes in vision (such as loss of vision, blurred vision, double vision, sensitivity to light, eye pain).

To receive vigabatrin in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

Precautions

Before taking vigabatrin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (such as visual field defect, glaucoma, macular degeneration, optic nerve problem), mental/mood problems (such as depression, psychosis), kidney disease, low red blood cell count (anemia).

This drug may make you dizzy or drowsy or cause vision problems. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

MRI tests of the brain in infants have shown changes after they are given vigabatrin. It is not known if these changes are harmful. Consult your doctor for more details. If your infant is going to have an MRI test, notify testing personnel that your infant is using this medication.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be at greater risk for side effects (such as confusion) while using this drug. Confusion can increase the risk of falling.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using vigabatrin. Vigabatrin may harm an unborn baby. Ask about reliable forms of birth control while using this medication. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

This medication passes into breast milk in small amounts. Consult your doctor before breastfeeding.

Side Effects

See also Warning section.

Drowsiness, dizziness, and difficulty concentrating may occur, especially during the first few days as your body adjusts to the medication. Children may become restless or excited. Nausea, vomiting, stomach upset, diarrhea, headache, weight gain, and tiredness may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: shakiness (tremor), swelling ankles/feet, tingling/numbness, shortness of breath, fast heartbeat.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.