Lamotrigine extended-release tablets

Pronunciation

Generic Name: lamotrigine (la-MOE-tri-jeen)
Brand Name: Lamictal XR

Serious and sometimes fatal rashes have rarely occurred with the use of lamotrigine extended-release tablets. The risk of serious rash may be greater in children younger than 16 years old than in adults. Although it has not been proven, the risk may also be greater if you start taking lamotrigine extended-release tablets at a higher dose than recommended, if you take more than the recommended dose during treatment, or if you also take a medicine called valproate (eg, valproic acid, divalproex sodium). Most of the serious rashes that have occurred with the use of lamotrigine extended-release tablets developed within the first 2 to 8 weeks of treatment. However, serious rashes have also occurred in patients who have used lamotrigine extended-release tablets for a longer period of time. Contact your doctor at once if you develop rash symptoms, including red, swollen, blistered, or peeling skin. Treatment with lamotrigine extended-release tablets should be stopped if rash occurs, unless it is clearly determined that the medicine did not cause the rash. Even if lamotrigine extended-release tablets is stopped, a rash caused by lamotrigine extended-release tablets may still become life-threatening or cause other serious side effects (eg, permanent scarring).


Lamotrigine extended-release tablets is used for:

Treating certain types of seizures in certain patients. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Lamotrigine extended-release tablets is an anticonvulsant. Exactly how it works is not known.

Do NOT use lamotrigine extended-release tablets if:

  • you are allergic to any ingredient in lamotrigine extended-release tablets

Contact your doctor or health care provider right away if any of these apply to you.

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Before using lamotrigine extended-release tablets:

Some medical conditions may interact with lamotrigine extended-release tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances (especially other anti-seizure medicines)
  • if you have liver, kidney, or heart problems; certain blood problems (eg, thalassemia); or if you receive dialysis treatment
  • if you have a skin rash or have ever developed a skin rash from taking lamotrigine extended-release tablets or any other medicines to treat seizures
  • if you have a history of mental or mood problems (eg, depression) or suicidal thoughts or attempts

Some MEDICINES MAY INTERACT with lamotrigine extended-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Carbamazepine because it may decrease lamotrigine extended-release tablets's effectiveness and increase the risk of side effects, such as dizziness, double vision, blurred vision, and decreased coordination
  • Valproate (eg, valproic acid, divalproex sodium) because it may increase the risk of lamotrigine extended-release tablets's side effects
  • Estrogens, phenobarbital, phenytoin, primidone, rifampin, or succinimides (eg, methsuximide) because they may decrease lamotrigine extended-release tablets's effectiveness
  • Hormonal contraceptives (eg, birth control pills) because the effectiveness of both medicines may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if lamotrigine extended-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use lamotrigine extended-release tablets:

Use lamotrigine extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Lamotrigine extended-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get lamotrigine extended-release tablets refilled.
  • Take lamotrigine extended-release tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Swallow lamotrigine extended-release tablets whole. Do not break, crush, or chew before swallowing. If you have difficulty swallowing lamotrigine extended-release tablets whole, tell your health care provider. There may be another form of lamotrigine extended-release tablets you can take.
  • Continue to take lamotrigine extended-release tablets even if you feel well. Do not miss any doses.
  • If you miss a dose of lamotrigine extended-release tablets, take it as soon as possible. If it is almost time for you next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use lamotrigine extended-release tablets.

Important safety information:

  • Lamotrigine extended-release tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use lamotrigine extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Several weeks may pass before you feel lamotrigine extended-release tablets's full effects. Do NOT take more than the recommended dose, change your dose, or use for longer than prescribed without checking with your doctor.
  • Do not suddenly stop taking lamotrigine extended-release tablets or change your dose without checking with your doctor. Doing so may increase seizure frequency. If you need to stop taking lamotrigine extended-release tablets, your dose should be gradually reduced over a period of at least 2 weeks. Discuss any questions or concerns with your doctor.
  • If you stop taking lamotrigine extended-release tablets for any reason, contact your doctor right away. Do not start taking it again unless your doctor tells you to. Discuss any questions or concerns with your doctor.
  • If you develop new or worsening seizures, contact your doctor right away.
  • Patients who take lamotrigine extended-release tablets may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take lamotrigine extended-release tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • Aseptic meningitis is a serious condition that may rarely occur with the use of lamotrigine extended-release tablets. Symptoms may include headache, fever, chills, nausea, vomiting, stiff neck, rash, sensitivity to light, drowsiness, or confusion. Contact your doctor right away if you experience any of these effects. Discuss any questions or concerns with your doctor.
  • Hormonal birth control (eg, birth control pills) may change the amount of lamotrigine extended-release tablets in your blood. Talk to your doctor before you start or stop taking hormonal birth control while you are taking lamotrigine extended-release tablets. Women who take hormonal birth control may be at greater risk of side effects during the week of inactive pills in their pack. Contact your doctor if side effects, such as dizziness, decreased coordination, or double vision, occur.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using lamotrigine extended-release tablets. Check with your doctor if you have questions about how lamotrigine extended-release tablets might affect your hormonal birth control. Contact your doctor right away if you notice any unusual vaginal bleeding or spotting. If you wish to avoid pregnancy, talk with your doctor about the use of effective birth control methods.
  • Tell your doctor or dentist that you take lamotrigine extended-release tablets before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including complete blood cell counts, may be performed while you use lamotrigine extended-release tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Different medicines may look like or have names similar to lamotrigine extended-release tablets. Always check your medicine to make sure it is correct. If you notice any change in the appearance of your medicine (eg, shape, color, size, wording), check with your pharmacist.
  • Caution is advised when using lamotrigine extended-release tablets in CHILDREN; they may be more sensitive to its effects, especially the risk of serious rash.
  • Increased sensitivity to the sun has been reported in some CHILDREN taking lamotrigine extended-release tablets. Use a sunscreen or protective clothing if your child will be exposed to the sun. Discuss any questions or concerns with your child's doctor.
  • Lamotrigine extended-release tablets should not be used in CHILDREN younger than 13 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Lamotrigine extended-release tablets may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using lamotrigine extended-release tablets while you are pregnant. Lamotrigine extended-release tablets is found in breast milk. Do not breast-feed while taking lamotrigine extended-release tablets.

Possible side effects of lamotrigine extended-release tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred or double vision; constipation; decreased coordination; diarrhea; dizziness; drowsiness; headache; nausea; painful menstrual periods; runny or stuffy nose; stomach upset or pain; tiredness; trouble sleeping; vomiting; weakness; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unexplained hoarseness); absent menstrual period or other menstrual changes; calf pain or tenderness; chest pain; dark urine; difficult or painful urination; fast or irregular heartbeat; fever, chills, or persistent sore throat; new or worsening mental or mood changes (eg, anxiety, depression, restlessness, irritability, panic attacks, behavior changes); new or worsening seizures; pale stools; reddened, blistered, swollen, or peeling skin; severe muscle pain or tenderness; severe or persistent dizziness or stomach pain; shortness of breath; sores in the mouth or around the eyes; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; swollen lymph glands; tremor; unusual bruising or bleeding; unusual weakness or tiredness; vaginal itching or discharge; vision changes; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; involuntary eye movements; loss of consciousness or coordination; new or worsening seizures.

Proper storage of lamotrigine extended-release tablets:

Store lamotrigine extended-release tablets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep lamotrigine extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about lamotrigine extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Lamotrigine extended-release tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take lamotrigine extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about lamotrigine extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to lamotrigine extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using lamotrigine extended-release tablets.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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