Rufinamide Oral suspension

What is this medicine?

RUFINAMIDE (roo FIN a mide) is used to control seizures caused by a certain type of epilepsy called Lennox-Gastaut syndrome.

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:

• liver disease

• kidney disease requiring dialysis

• short QT syndrome

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

• an unusual or allergic reaction to rufinamide, 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. Shake well before using. Use the dosing syringe provided to measure your dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take this medicine with food. Take your doses at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist 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 year 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?

• alcohol

• carbamazepine

• chlorzoxazone

• divalproex

• female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections

• lamotrigine

• phenobarbital

• phenytoin

• primidone

• triazolam

• valproic acid

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.

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.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.

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

• blood in the urine

• changes in vision

• feeling faint or lightheaded, falls

• fever

• irregular heart beat

• pain in the lower back or side

• pain when urinating

• suicidal thoughts or other mood changes

• unusual bleeding or bruising

• unusually weak or tired

• yellowing of the eyes, skin

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

• decreased appetite

• drowsiness

• headache

• nausea, vomiting

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.

Store between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after 90 days of first opening the bottle or after the expiration date, whichever comes first. Keep tightly closed.

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.

Rufinamide Oral tablet

What is this medicine?

RUFINAMIDE (roo FIN a mide) is used to control seizures caused by a certain type of epilepsy called Lennox-Gastaut syndrome.

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:

• liver disease

• kidney disease requiring dialysis

• short QT syndrome

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

• an unusual or allergic reaction to Rufinamide, 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 with a glass of water. Take this medicine with 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 by the pharmacist 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 year for selected conditions, precautions do apply.

Overdosage: If you think you have 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?

• alcohol

• carbamazepine

• chlorzoxazone

• divalproex

• female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections

• lamotrigine

• phenobarbital

• phenytoin

• primidone

• triazolam

• valproic acid

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.

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.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.

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

• blood in the urine

• changes in vision

• feeling faint or lightheaded, falls

• fever

• irregular heart beat

• pain in the lower back or side

• pain when urinating

• suicidal thoughts or other mood changes

• unusual bleeding or bruising

• unusually weak or tired

• yellowing of the eyes, skin

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

• decreased appetite

• drowsiness

• headache

• nausea/vomiting

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.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date.