Lamictal XR 300 mg Tablets

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

LAMOTRIGINE EXTENDED-RELEASE - ORAL

(lam-OH-try-jeen)

COMMON BRAND NAME(S): Lamictal XR

WARNING: Rarely, serious (sometimes fatal) skin rashes have occurred while taking this medication. These rashes are more common in children under 16 than in adults. Rashes may be more likely if you start at too high a dose, if you increase your dose too quickly, or if you take this medication with certain other anti-seizure medications (valproic acid, divalproex). These rashes may occur anytime during use, but most serious rashes have occurred within 2 to 8 weeks of starting lamotrigine. Seek immediate medical attention if you develop any type of skin rash while taking this medication, or if you have hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, or swelling of the lips or tongue. Your doctor will tell you if you should stop taking lamotrigine. Even after you stop taking this medication, it is still possible for the rash to become life-threatening or cause permanent scars or other problems.

USES: This product is used to prevent or control seizures (epilepsy).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This medication may also be used to help prevent the extreme mood swings of bipolar disorder in adults.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking lamotrigine and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. Take this medication with or without food, usually once daily or as directed by your doctor. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. Dosage is based on your medical condition, response to treatment, and use of certain interacting drugs. (See also Drug Interactions section.) If you are being switched from the immediate release form of this medication, your doctor will usually start you on a dose similar to what you were taking with the immediate release form. It is very important to follow your doctor\'s dosing instructions exactly. The dose must be increased slowly. It may take several weeks or months to reach the best dose for you and to get the full benefit from this medication. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. Also, if you have stopped taking this medication, do not restart lamotrigine without consulting your doctor. Tell your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: See also Warning section. Dizziness, drowsiness, headache, blurred/double vision, lack of coordination, shaking (tremor), nausea, vomiting, diarrhea, or hot flushes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she 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. 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. Tell your doctor right away if any of these rare but very serious side effects occur: fainting, easy bruising/bleeding, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, signs of infection (such as fever, stiff neck, persistent sore throat), muscle pain/tenderness, change in the amount of urine, unusual tiredness, fast heartbeat. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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.

PRECAUTIONS: See also Warning section. Before taking lamotrigine, 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: kidney disease, liver disease. This drug may make you dizzy, drowsy, or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages. Older adults may be more sensitive to the side effects of this drug, especially dizziness, loss of coordination, or fainting. These side effects can increase the risk of falling. During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor. This drug passes into breast milk and may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Other medications can affect the removal of lamotrigine from your body, which may affect how lamotrigine works. Examples include hormonal birth control (such as pills, patches), estrogens, other medications to treat seizures (such as carbamazepine, phenobarbital, phenytoin, primidone, valproic acid), certain HIV protease inhibitors (such as lopinavir/ritonavir, atazanavir/ritonavir), and rifampin, among others. Your doctor may need to adjust your dose of lamotrigine if you are on these medications or if you stop these medications. If you are using hormonal birth control or estrogens, tell your doctor right away of any changes in your menstrual pattern (such as breakthrough bleeding). This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. Tell your doctor or pharmacist if you are taking other products that cause drowsiness, including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. This medication may interfere with certain laboratory tests (including urine drug screening tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, unusual eye movements (nystagmus), loss of consciousness.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as liver/kidney function, complete blood count) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. There are different types of this medication available. Some do not have the same effects. There are also some medications that sound the same as this product. Make sure you have the right product before taking it.

MISSED DOSE: It is important to take each dose at the scheduled time. If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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).

Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.