Lamotrigine Extended-Release Tablets

What is this medication?

LAMOTRIGINE (la MOE tri jeen) prevents and controls seizures in people with epilepsy. It works by calming overactive nerves in your body.

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

COMMON BRAND NAME(S): Lamictal XR

What should I tell my care team before I take this medication?

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

• Heart disease
• History of irregular heartbeat
• Immune system problems
• Kidney disease
• Liver disease
• Low levels of folic acid in the blood
• Lupus
• Mental illness
• Suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• An unusual or allergic reaction to lamotrigine or other seizure medications, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Swallow these tablets whole. Do not chew, crush, or divide them. If this medication upsets your stomach, take it with food or milk. Take your doses at regular intervals. Do not take your medication more often than directed.

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

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 13 years of age, 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 medication?

• Atazanavir
• Birth control pills
• Certain medications for irregular heartbeat
• Certain medications for seizures like carbamazepine, phenobarbital, phenytoin, primidone, valproic acid
• Lopinavir
• Rifampin
• Ritonavir

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 medication?

Visit your care team for regular checks on your progress. Wear a Medic Alert bracelet or necklace. Carry an identification card with information about your condition, medications, and care team.

It is important to take this medication exactly as directed. When first starting treatment, your dose will need to be adjusted slowly. It may take weeks or months before your dose is stable. You should contact your care team if your seizures get worse or if you have any new types of seizures. Do not stop taking this medication unless instructed by your care team. Stopping your medication suddenly can increase your seizures or their severity.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness and dizziness. Avoid alcoholic drinks.

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

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

Women who become pregnant while using this medication 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 medication use during pregnancy.

This medication may cause a decrease in folic acid. You should make sure that you get enough folic acid while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Change in vision
• Fever, neck pain or stiffness, sensitivity to light, headache, nausea, vomiting, confusion
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Infection—fever, chills, cough, or sore throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low red blood cell count—unusual weakness or fatigue, dizziness, headache, trouble breathing
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling or loosening of the skin, including inside the mouth
• Thoughts of suicide or self-harm, worsening mood, or feelings of depression
• Unusual bruising or bleeding

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

• Diarrhea
• Dizziness
• Drowsiness
• Headache
• Nausea
• Stomach pain
• Tremors or shaking

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 medication?

Keep out of the reach of children and pets.

Store at 25 degrees C (77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.