LaMICtal CD (Oral)

Lamotrigine is used alone or with other medicines to help control certain types of seizures (for example, partial seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome) in the treatment of epilepsy. This medicine cannot cure epilepsy and will only help control seizures for as long as you keep taking it. It can also be used to treat bipolar disorder (manic-depressive illness) in adults.

This medicine is available only with your doctor's prescription.

It is important for your doctor to check your or your child's progress at regular visits, especially during the first few months of treatment with lamotrigine. This will help your doctor adjust your dose if needed and reduce any unwanted effects.

You must tell your doctor if you become pregnant while taking this medicine. Your doctor may want you to join a pregnancy registry for patients using a seizure medicine.

You should not start or stop using birth control pills or other female hormonal products while taking this medicine until you have talked to your doctor.

Inform your doctor immediately if you experience unusual changes in your menstrual cycle, such as breakthrough bleeding, while taking lamotrigine and birth control pills or other female hormonal products.

This medicine may increase the effects of alcohol and other central nervous system (CNS) depressants (medications that can make you drowsy or less alert). Examples of CNS depressants include antihistamines or medications for allergies or colds, sedatives, tranquilizers, sleeping medicine, prescription pain medications or narcotics, seizure medications or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Consult your doctor before taking any of these while using this medicine.

Lamotrigine may cause blurred vision, double vision, clumsiness, unsteadiness, dizziness, or drowsiness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If these reactions are particularly bothersome, consult your doctor.

A skin rash may indicate a serious unwanted effect. Contact your doctor immediately if you or your child develop a rash, fever, flu-like symptoms, or swollen glands, or if your seizures worsen.

This medicine may cause hemophagocytic lymphohistiocytosis, a rare and life-threatening disorder where the body produces too many activated immune cells (macrophages and lymphocytes). Discuss any concerns with your doctor.

Lamotrigine may cause serious allergic reactions affecting multiple organs (for example, liver or kidney). Seek medical attention right away if you or your child experience the following symptoms: fever, dark urine, headache, hives, muscle pain or stiffness, stomach pain, unusual tiredness, or yellowing of the eyes or skin.

Some people may experience agitation, irritability, or other abnormal behaviors while taking this medicine. It may also lead to suicidal thoughts and tendencies or increased depression in some individuals. If you, your child, or your caregiver notice any of these side effects, inform your doctor or your child's doctor immediately.

Contact your doctor right away if you or your child experience a stiff neck, confusion, drowsiness, fever, chills, headache, nausea, vomiting, rash, or sensitivity to light. These could be signs of a rare and serious condition known as aseptic meningitis.

If you experience blurred vision, difficulty reading, or any other changes in vision during or after treatment, consult your doctor immediately. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).

Do not stop taking lamotrigine without first consulting your doctor. Stopping this medicine suddenly may cause your seizures to return or occur more frequently. Your doctor may want you to gradually reduce your dose before stopping completely.

Do not take any other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks of taking the medicine versus the benefits it may provide. Here are some important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your healthcare provider know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies so far have not shown any specific problems for children that would limit the use of lamotrigine chewable tablets, disintegrating tablets, tablets for suspension, or tablets for children aged 2 years and older with certain types of seizures. However, safety and effectiveness have not been established for children younger than 2 years old.

Studies have not been done to look at how age affects the use of lamotrigine extended-release tablets in children with partial seizures younger than 13 years old. Safety and effectiveness have not been established.

Studies have not been done on how age affects the use of lamotrigine chewable tablets, disintegrating tablets, tablets for suspension, or tablets in children with bipolar disorder. Safety and effectiveness have not been established.

Geriatric

While studies on how age affects the use of lamotrigine in older adults have not been conducted, there are no specific problems expected that would limit its use in the elderly. However, older patients are more likely to have age-related liver, kidney, or heart issues, which may require a dose adjustment for those taking lamotrigine.

Breast Feeding

There are not enough studies in women to know the risk to infants when using this medicine during breastfeeding. Consider the potential benefits against the potential risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines can be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare provider to know if you are taking any of the medicines listed below while using this medicine. The following interactions are notable and are not an exhaustive list.

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both medicines.

• Atazanavir
• Calcifediol
• Carbamazepine
• Cenobamate
• Desmopressin
• Dofetilide
• Ezogabine
• Fosphenytoin
• Levoketoconazole
• Lopinavir
• Methotrexate
• Orlistat
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• Valproic Acid

Using this medicine with any of the following medicines may increase the risk of certain side effects, but taking both may be the best option for you. If both medicines are prescribed together, your doctor may change the dose or frequency of use for one or both medicines.

• Desogestrel
• Dienogest
• Drospirenone
• Escitalopram
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Gestodene
• Ginkgo
• Ginseng
• Levonorgestrel
• Mestranol
• Methsuximide
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel
• Oxcarbazepine
• Risperidone
• Ritonavir
• Rufinamide
• Sertraline

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken close to mealtime or with certain foods due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare provider how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Blood or bone marrow problems or
• Depression or
• Heart disease (such as heart attack or heart failure) or
• Heart rhythm problems—these may worsen these conditions.

• Kidney disease or
• Liver disease—use with caution, as the effects may be stronger due to slower elimination of the medicine from the body.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects occur:

More common

• Blurred vision
• changes in vision
• chest pain, discomfort, or tightness
• clumsiness or unsteadiness
• decreased urine output
• dilated neck veins
• double vision
• irregular breathing
• irregular heartbeat
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• poor coordination
• seizure that will not stop
• skin rash
• sweating
• swelling of the face, fingers, feet, or lower legs
• trouble breathing
• unusual tiredness or weakness
• vomiting
• weight gain

Less common

• Anxiety
• chest pain
• confusion
• continuous, uncontrolled back and forth or rolling eye movements
• depression
• increase in seizures
• infection
• irritability

Rare

• Blistering, peeling, or loosening of the skin
• chills
• cough
• dark urine
• diarrhea
• fever
• general feeling of discomfort or illness
• headache
• itching
• joint pain
• loss of appetite
• memory loss
• muscle cramps, pain, or weakness
• red or irritated eyes
• runny nose
• shivering
• small red or purple spots on the skin
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the face, mouth, hands, or feet
• swollen lymph nodes
• trouble sleeping
• unusual bleeding or bruising
• yellow eyes or skin

Incidence not known

• Back, leg, or stomach pains
• bleeding gums
• bloating
• blood in the urine
• bloody, black or tarry stools
• bluish lips or skin
• constipation
• cough
• coughing or vomiting blood
• difficulty with swallowing
• fainting
• fast heartbeat
• general body swelling
• heartburn
• high fever
• hoarseness
• lightheadedness
• loss of balance control
• lower back or side pain
• mask-like face
• muscle spasms
• nosebleeds
• not breathing
• pain or burning in the throat
• painful or difficult urination
• pains in the stomach or side, possibly radiating to the back
• pale skin
• persistent bleeding or oozing from puncture sites, mouth, or nose
• rapid, shallow breathing
• redness, soreness, or itching skin
• shuffling walk
• slowed movement
• slurred speech
• sores, welting, or blisters
• stiffness of the arms and legs
• swollen or painful glands
• tic-like (jerky) movements

Get emergency help right away if any of the following symptoms of overdose occur:

Symptoms of overdose

• Clumsiness or unsteadiness (severe)
• continuous, uncontrolled back and forth or rolling eye movements (severe)
• dizziness (severe)
• drowsiness (severe)
• dryness of the mouth (severe)
• headache (severe)
• increased heart rate
• loss of consciousness
• slurred speech (severe)

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to suggest ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Dizziness
• drowsiness

Less common

• Indigestion
• loss of strength
• menstrual pain
• pain
• trembling or shaking
• trouble with sleeping
• unusual weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• LaMICtal
• LaMICtal CD
• LaMICtal ODT
• LaMICtal XR

In Canada

• lamoTRIgine
• lamoTRIgine-100
• lamoTRIgine-150
• lamoTRIgine-25
• Mylan-lamoTRIgine
• Teva-lamoTRIgine

Available Dosage Forms:

• Tablet
• Tablet, Extended Release
• Tablet, Chewable
• Tablet, Disintegrating

Therapeutic Class: Anticonvulsant

Chemical Class: Phenyltriazine

Take this medicine only as directed by your doctor to help your condition as much as possible and to decrease the chance of unwanted effects. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Lamotrigine may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed.

If you are taking the chewable dispersible tablets or tablets for suspension, they may be swallowed whole, chewed, and swallowed, or dispersed in a small amount of liquid and swallowed. If the tablets are chewed, they should be followed with a small amount of water or diluted fruit juice to aid in swallowing. To break up these tablets, add them in enough water or diluted fruit juice to cover the tablets (about a teaspoonful). Wait until the tablets are completely dispersed (about 1 minute), then swirl the solution and swallow it immediately.

If you are taking the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet into your tongue and move it around in your mouth. It should melt quickly. After the tablet has melted, swallow or take a sip of water.

Swallow the extended-release tablets whole. Do not break, crush, or chew it.

Use only the brand of this medicine that your doctor prescribed. Different brands and dosage forms may not work the same way.

This medicine can be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you to stop.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (chewable dispersible tablets, disintegrating tablets, tablets for suspension, or tablets): For treatment of bipolar disorder: Adults not taking valproic acid (Depakote®) and not taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)—At first, 25 milligrams (mg) of lamotrigine once a day for 2 weeks, then 50 mg once a day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 200 mg a day. Adults taking valproic acid (Depakote®)—At first, 25 mg of lamotrigine once every other day for 2 weeks, then 25 mg once a day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 100 mg a day. Adults not taking valproic acid (Depakote®) but taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)—At first, 50 mg of lamotrigine once a day for 2 weeks, then a total of 100 mg divided into 2 smaller doses each day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 400 mg a day. Adults who are discontinuing valproic acid (Depakote®) or discontinuing carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)—Dose will be determined by your doctor. Children—Use and dose must be determined by your doctor. For treatment of epilepsy: Adults not taking valproic acid (Depakote®) but taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)—At first, 50 milligrams (mg) of lamotrigine once a day for 2 weeks, then a total of 100 mg divided into 2 smaller doses each day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 500 mg a day. Adults not taking valproic acid (Depakote®), carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)—At first, 25 mg of lamotrigine once a day for 2 weeks, then 50 mg once a day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 375 mg a day. Adults taking valproic acid (Depakote®)—At first, 25 mg of lamotrigine once every other day for 2 weeks, then 25 mg once a day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 400 mg a day. Adults who are discontinuing valproic acid (Depakote®) or discontinuing carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)—Dose will be determined by your doctor. Children 2 to 12 years of age: Children not taking valproic acid (Depakote®) but taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)— At first, 0.6 milligrams per kilogram (mg/kg) of body weight of lamotrigine divided into 2 smaller doses each day for 2 weeks, then 1.2 mg/kg of body weight divided into 2 smaller doses each day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 400 mg a day. Children not taking valproic acid (Depakote®), carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)— At first, 0.3 mg/kg of body weight of lamotrigine given in one dose or two smaller doses each day for 2 weeks, then 0.6 mg/kg of body weight divided into 2 smaller doses each day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 300 mg a day. Children taking valproic acid (Depakote®)— At first, 0.15 mg/kg of body weight of lamotrigine given in one dose or two smaller doses each day for 2 weeks, then 0.3 mg/kg of body weight given in one dose or two smaller doses each day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 200 mg a day. Children younger than 2 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (extended-release tablets):For seizures: Adults and children older than 13 years of age not taking valproic acid (Depakote®) but taking carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)—At first, 50 milligrams (mg) of lamotrigine once a day for 2 weeks, then 100 mg once a day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 600 mg a day. Adults and children older than 13 years of age not taking valproic acid (Depakote®), carbamazepine (Tegretol®), phenobarbital (Luminal®), phenytoin (Dilantin®), or primidone (Mysoline®)—At first, 25 mg of lamotrigine once a day for 2 weeks, then 50 mg once a day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 400 mg a day. Adults and children older than 13 years of age taking valproic acid (Depakote®)—At first, 25 mg of lamotrigine once every other day for 2 weeks, then 25 mg once a day for 2 weeks. After this, your doctor may gradually increase your dose as needed. However, the dose is usually not more than 250 mg a day. Children younger than 13 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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