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Generic Name: Lamotrigine Tablets (la-MOE-tri-jeen)
Brand Name: Lamictal
Serious and sometimes fatal rashes have rarely occurred with the use of Lamictal . 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 Lamictal at a higher than recommended dose, 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 Lamictal developed within the first 2 to 8 weeks of treatment. However, serious rashes have also occurred in patients who have used Lamictal 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
Lamictal should be stopped if rash occurs, unless it is clearly determined that the medicine did not cause the rash. Even if Lamictal is stopped, a rash caused by Lamictal may still become life-threatening or cause other serious side effects (eg, permanent scarring).
Lamictal is used for:
Treating certain types of seizures. It may be used alone or with other medicines. It may also be used to delay the occurrence of mood problems in certain patients with bipolar disorder. It may also be used for other conditions as determined by your doctor.
Lamictal is an anticonvulsant. Exactly how it works is not known.
Do NOT use Lamictal if:
- you are allergic to any ingredient in Lamictal
Contact your doctor or health care provider right away if any of these apply to you.
Before using Lamictal :
Some medical conditions may interact with Lamictal . 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
- if you have liver or kidney problems, heart problems, certain blood problems (eg, thalassemia), or Parkinson disease, or if you receive dialysis treatments
- if you have a skin rash or if you have ever developed a skin rash from taking Lamictal
- if you have a history of mental or mood problems or suicidal thoughts or attempts
Some MEDICINES MAY INTERACT with Lamictal . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Valproate (eg, valproic acid, divalproex sodium)
because it may increase the risk of Lamictal "s side effects
- Carbamazepine because it may decrease Lamictal "s effectiveness;
the risk of side effects, such as dizziness, double vision, blurred vision, and decreased coordination, may be increased
- Oxcarbazepine because the risk of side effects, such as headache, dizziness, nausea, and drowsiness, may be increased
- Estrogens, phenobarbital, phenytoin, primidone, rifampin, or succinimides
(eg, methsuximide) because they may decrease Lamictal "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 Lamictal 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 Lamictal :
Use Lamictal as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Lamictal . Talk to your pharmacist if you have questions about this information.
- Take Lamictal by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Swallow Lamictal whole. Do not break, crush, or chew before swallowing;
Lamictal has a bitter taste.
- Continue to take Lamictal even if you feel well. Do not miss any doses.
- Do not miss any doses. If you miss a dose of Lamictal , 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 Lamictal .
Important safety information:
medicine may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Lamictal with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Do not suddenly stop taking Lamictal or change your dose without checking with your doctor. Doing so may increase seizure frequency. If you need to stop taking Lamictal , your dose should be gradually reduced over a period of at least 2 weeks.
- If you stop taking Lamictal for any reason, contact your doctor right away. Do not start taking it again unless your doctor tells you to do so. Discuss any questions or concerns with your doctor.
- If you develop new or worsening seizures, contact your doctor right away.
- Patients with bipolar disorder may be at risk for
suicidal thoughts or actions. It is unknown if patients who take Lamictal may be at increased risk. The risk of suicidal thoughts or actions may be greater in children and teenagers. It may also be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who have bipolar disorder 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 your doctor right away if any signs of suicidal thoughts or actions occur.
- Hormonal birth control (eg, birth control pills) may change the amount of Lamictal in your blood. Talk to your doctor before you start or stop taking hormonal birth control while you are taking Lamictal . Women who take hormonal birth control may be at greater risk for 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 Lamictal . To prevent pregnancy, use an extra form of birth control (eg, condoms). Contact your doctor right away if you notice any unusual vaginal bleeding or spotting.
- Tell your doctor or dentist that you take Lamictal 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 Lamictal . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Caution is advised when using Lamictal in CHILDREN; they may be more sensitive to its effects, especially the risk of serious rash.
- Lamictal should be used with extreme
caution in CHILDREN younger than 18 years old with bipolar disorder; safety and effectiveness in these children have not been confirmed.
- Lamictal should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Lamictal 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 Lamictal while you are pregnant. Lamictal is found in breast milk. Do not breast-feed while taking Lamictal .
Possible side effects of Lamictal :
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:
Seek medical attention right away if any of these SEVERE side effects occur:
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.
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; 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 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 or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088
(1-800-332-1088) or at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include coma; involuntary eye movements; loss of consciousness or coordination; new or worsening seizures.
Proper storage of Lamictal :
Store Lamictal 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 Lamictal out of the reach of children and away from pets.
- If you have any questions about Lamictal , please talk with your doctor, pharmacist, or other health care provider.
- Lamictal 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.
This information is a summary only. It does not contain all information about Lamictal . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.
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