Vigabatrin Oral powder

What is this medicine?

VIGABATRIN (vye GA ba trin) is used to control seizures caused by certain types of epilepsy.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• history of a drug or alcohol abuse problem

• kidney disease

• low red blood cell counts (anemia)

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• vision problems

• an unusual or allergic reaction to vigabatrin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on the advice of your doctor or health care professional.

This medicine may be given at the same time as food, but should not be mixed with food. Mix each dose immediately before administration. Follow the directions that come with the medicine for how to mix each dose. After the dose is measured, throw away any extra liquid.

A special MedGuide will be given to you with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 1 month for selected conditions, precautions do apply.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• clonazepam

• other medicines that may cause serious eye problems such as interferon-alpha, peg-interferon, prednisone, or methylprednisolone

• phenytoin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. This medicine needs careful monitoring.

It is important to get regular vision tests while taking this medicine. Report any changes in your vision to your health care professional right away.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.

This medicine may cause changes to MRI test results; ask your healthcare provider for more information.

Women who become pregnant while using this medicine may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic drug use during pregnancy.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision such as blurred vision, double vision or eye movements you cannot control

• fever or infection

• joint pain

• memory problems

• numbness or tingling in feet or toes

• seizures

• suicidal thoughts or other mood changes

• tremors

• unusually weak or tired

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• constipation

• diarrhea

• dizziness

• drowsiness

• headache

• nausea

• tiredness

• weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

This medicine may cause accidental overdose and death if it taken by other adults, children, or pets. Mix any unused medicine with a substance like cat litter or coffee grounds. Then throw the medicine away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medicine after the expiration date.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Store in the original container.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Vigabatrin Oral tablet

What is this medicine?

VIGABATRIN (vye GA ba trin) is used to control seizures caused by certain types of epilepsy.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• history of a drug or alcohol abuse problem

• kidney disease

• low red blood cell counts (anemia)

• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member

• vision problems

• an unusual or allergic reaction to vigabatrin, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. This medicine may be taken with or without food. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on the advice of your doctor or health care professional.

A special MedGuide will be given to you with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• clonazepam

• other medicines that may cause serious eye problems such as interferon-alpha, peg-interferon, prednisone, or methylprednisolone

• phenytoin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. This medicine needs careful monitoring.

It is important to get regular vision tests while taking this medicine. Report any changes in your vision to your health care professional right away.

Wear a medical ID bracelet or chain, and carry a card that describes your disease and details of your medicine and dosage times.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

The use of this medicine may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medicine. Any worsening of mood, or thoughts of suicide or dying should be reported to your health care professional right away.

Women who become pregnant while using this medicine may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic drug use during pregnancy.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision such as blurred vision, double vision or eye movements you cannot control

• fever or infection

• joint pain

• memory problems

• numbness or tingling in feet or toes

• seizures

• suicidal thoughts or other mood changes

• tremors

• unusually weak or tired

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• constipation

• diarrhea

• dizziness

• drowsiness

• headache

• nausea

• tiredness

• weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

This medicine may cause accidental overdose and death if it taken by other adults, children, or pets. Mix any unused medicine with a substance like cat litter or coffee grounds. Then throw the medicine away in a sealed container like a sealed bag or a coffee can with a lid. Do not use the medicine after the expiration date.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F).

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.