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|Lamotrigine Chewable Dispersible Tablets

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Lamotrigine Chewable Dispersible Tablets

Generic Name: Lamotrigine Chewable Dispersible Tablets (la-MOE-tri-jeen)
Brand Name: Lamictal

Serious and sometimes fatal rashes have rarely occurred with the use of Lamotrigine Chewable Dispersible 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 Chewable Dispersible Tablets 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 Lamotrigine Chewable Dispersible Tablets developed within the first 2 to 8 weeks of treatment. However, serious rashes have also occurred in patients who have used Lamotrigine Chewable Dispersible 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 Chewable Dispersible Tablets should be stopped if rash occurs, unless it is clearly determined that the medicine did not cause the rash. Even if Lamotrigine Chewable Dispersible Tablets is stopped, a rash caused by Lamotrigine Chewable Dispersible Tablets may still become life-threatening or cause other serious side effects (eg, permanent scarring).

Lamotrigine Chewable Dispersible Tablets 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.

Lamotrigine Chewable Dispersible Tablets is an anticonvulsant. Exactly how it works is not known.

Do NOT use Lamotrigine Chewable Dispersible Tablets if:

you are allergic to any ingredient in Lamotrigine Chewable Dispersible Tablets

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

Before using Lamotrigine Chewable Dispersible Tablets:

Some medical conditions may interact with Lamotrigine Chewable Dispersible 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
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 Lamotrigine Chewable Dispersible Tablets
if you have a history of mental or mood problems or suicidal thoughts or attempts

Some MEDICINES MAY INTERACT with Lamotrigine Chewable Dispersible Tablets. 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 Lamotrigine Chewable Dispersible Tablets"s side effects
Carbamazepine because it may decrease Lamotrigine Chewable Dispersible Tablets"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 Lamotrigine Chewable Dispersible 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 Chewable Dispersible 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 Chewable Dispersible Tablets:

Use Lamotrigine Chewable Dispersible Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Lamotrigine Chewable Dispersible Tablets. Talk to your pharmacist if you have questions about this information.
Take Lamotrigine Chewable Dispersible Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Lamotrigine Chewable Dispersible Tablets may be swallowed whole or chewed. If you chew Lamotrigine Chewable Dispersible Tablets, drink a small amount of water or diluted fruit juice after swallowing.
Lamotrigine Chewable Dispersible Tablets may also be mixed in water or diluted fruit juice before swallowing. To mix, place Lamotrigine Chewable Dispersible Tablets in a glass or on a spoon. Add a small amount of liquid (about 1 teaspoonful/5 mL, or enough to cover the medicine). Allow the medicine to dissolve completely. After it is completely dissolved (about 1 minute), mix and drink the entire amount right away. Do not store the mixture for future use.
Keep taking Lamotrigine Chewable Dispersible Tablets even if you feel well. Do not miss any doses.
If you miss a dose of Lamotrigine Chewable Dispersible Tablets, take it as soon as possible. If it is almost time for your 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 Chewable Dispersible Tablets.

Important safety information:

Lamotrigine Chewable Dispersible Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Lamotrigine Chewable Dispersible Tablets 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 Lamotrigine Chewable Dispersible Tablets or change your dose without checking with your doctor. Doing so may increase seizure frequency. If you need to stop taking Lamotrigine Chewable Dispersible Tablets, your dose should be gradually reduced over a period of at least 2 weeks.
If you stop taking Lamotrigine Chewable Dispersible Tablets 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 Lamotrigine Chewable Dispersible Tablets 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 Lamotrigine Chewable Dispersible Tablets in your blood. Talk to your doctor before you start or stop taking hormonal birth control while you are taking Lamotrigine Chewable Dispersible Tablets. 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 Lamotrigine Chewable Dispersible Tablets. 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 Lamotrigine Chewable Dispersible 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 Chewable Dispersible Tablets. 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 Lamotrigine Chewable Dispersible Tablets in CHILDREN; they may be more sensitive to its effects, especially the risk of serious rash.
Lamotrigine Chewable Dispersible Tablets 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.
Lamotrigine Chewable Dispersible Tablets 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: Lamotrigine Chewable Dispersible 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 Chewable Dispersible Tablets while you are pregnant. Lamotrigine Chewable Dispersible Tablets is found in breast milk. Do not breast-feed while taking Lamotrigine Chewable Dispersible Tablets.

Possible side effects of Lamotrigine Chewable Dispersible 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; 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 Lamotrigine Chewable Dispersible Tablets:

Store Lamotrigine Chewable Dispersible 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 Chewable Dispersible Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Lamotrigine Chewable Dispersible Tablets, please talk with your doctor, pharmacist, or other health care provider.
Lamotrigine Chewable Dispersible 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.

This information is a summary only. It does not contain all information about Lamotrigine Chewable Dispersible Tablets. 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

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