LAMOTRIGINE- lamotrigine tablet 
Glenmark Pharmaceuticals Inc., USA

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MEDICATION GUIDE

Lamotrigine Tablets USP
(la moe' tri jeen)

Read this Medication Guide before you start taking lamotrigine and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment. If you have questions about lamotrigine, ask your healthcare provider or pharmacist.

What is the most important information I should know about lamotrigine?

1. Lamotrigine may cause a serious skin rash that may cause you to be hospitalized or even cause death.

There is no way to tell if a mild rash will become more serious. A serious skin rash can happen at any time during your treatment with lamotrigine, but is more likely to happen within the first 2 to 8 weeks of treatment. Children aged between 2 and 16 years have a higher chance of getting this serious skin rash while taking lamotrigine.

The risk of getting a serious skin rash is higher if you:

take lamotrigine while taking valproate [DEPAKENE ® (valproic acid) or DEPAKOTE ® (divalproex sodium)].
take a higher starting dose of lamotrigine than your healthcare provider prescribed
increase your dose of lamotrigine faster than prescribed.

Call your healthcare provider right away if you have any of the following:

a skin rash
blistering or peeling of your skin
hives
painful sores in the mouth or around your eyes

These symptoms may be the first signs of a serious skin reaction. A healthcare provider should examine you to decide if you should continue taking lamotrigine.

2. Other serious reactions, including serious blood problems or liver problems. Lamotrigine can also cause other types of allergic reactions or serious problems that may affect organs and other parts of your body like your liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away if you have any of these symptoms:

fever
frequent infections
severe muscle pain
swelling of your face, eyes, lips, or tongue
swollen lymph glands
unusual bruising or bleeding
weakness, fatigue
yellowing of your skin or the white part of your eyes

3. Like other antiepileptic drugs, lamotrigine may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

thoughts about suicide or dying
attempt to commit suicide
new or worse depression
new or worse anxiety
feeling agitated or restless
panic attacks
trouble sleeping (insomnia)
new or worse irritability
acting aggressive, being angry, or violent
acting on dangerous impulses
an extreme increase in activity and talking (mania)
other unusual changes in behavior or mood

Do not stop lamotrigine without first talking to a healthcare provider.

Stopping lamotrigine suddenly can cause serious problems.
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

4. Lamotrigine may rarely cause aseptic meningitis, a serious inflammation of the protective membrane that covers the brain and spinal cord.

Call your healthcare provider right away if you have any of the following symptoms:

headache
fever
nausea
vomiting
stiff neck
rash
unusual sensitivity to light
muscle pains
chills
confusion
drowsiness

Meningitis has many causes other than lamotrigine, which your doctor would check for if you developed meningitis while taking lamotrigine.

Lamotrigine can have other serious side effects. For more information ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you. Be sure to read the section below entitled “What are the possible side effects of lamotrigine?”

5. Patients prescribed lamotrigine have sometimes been given the wrong medicine because many medicines have names similar to lamotrigine, so always check that you receive lamotrigine.

Taking the wrong medication can cause serious health problems. When your healthcare provider gives you a prescription for lamotrigine:

Make sure you can read it clearly.
Talk to your pharmacist to check that you are given the correct medicine.
Each time you fill your prescription, check the tablets you receive against the pictures of the tablets below.

These pictures show the distinct wording, colors, and shapes of the tablets that help to identify the right strength of lamotrigine tablets. Immediately call your pharmacist if you receive a lamotrigine tablet that does not look like one of the tablets shown below, as you may have received the wrong medication.

tablet-images

Lamotrigine Tablets USP

What is lamotrigine?

Lamotrigine is a prescription medicine used:

together with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, generalized seizures of Lennox-Gastaut syndrome) in people aged 2 years and older.
alone when changing from 1 other medicine used to treat partial-onset seizures in people aged 16 years and older.
for the long-term treatment of bipolar I disorder to lengthen the time between mood episodes in people aged 18 years and older who have been treated for mood episodes with other medicine.

It is not known if lamotrigine is safe or effective in children or teenagers younger than 18 years with mood disorders such as bipolar disorder or depression.

It is not known if lamotrigine is safe or effective when used alone as the first treatment of seizures.

Who should not take lamotrigine?

You should not take lamotrigine if you have had an allergic reaction to lamotrigine or to any of the inactive ingredients in lamotrigine tablets. See the end of this leaflet for a complete list of ingredients in lamotrigine tablets.

What should I tell my healthcare provider before taking lamotrigine?

Before taking lamotrigine, tell your healthcare provider about all of your medical conditions, including if you:

have had a rash or allergic reaction to another antiseizure medicine.
have or have had depression, mood problems, or suicidal thoughts or behavior.
have had aseptic meningitis after taking lamotrigine.
are taking oral contraceptives (birth control pills) or other female hormonal medicines. Do not start or stop taking birth control pills or other female hormonal medicine until you have talked with your healthcare provider. Tell your healthcare provider if you have any changes in your menstrual pattern such as breakthrough bleeding. Stopping these medicines may cause side effects (such as dizziness, lack of coordination, or double vision). Starting these medicines may lessen how well lamotrigine works.
are pregnant or plan to become pregnant. It is not known if lamotrigine will harm your unborn baby. If you become pregnant while taking lamotrigine, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
are breastfeeding. Lamotrigine passes into breast milk and may cause side effects in a breastfed baby. If you breastfeed while taking lamotrigine, watch your baby closely for trouble breathing, episodes of temporarily stopping breathing, sleepiness, or poor sucking. Call your baby’s healthcare provider right away if you see any of these problems. Talk to your healthcare provider about the best way to feed your baby if you take lamotrigine.

Tell your healthcare provider about all the medicines you take or if you are planning to take a new medicine, including prescription and non-prescription medicines, vitamins, and herbal supplements. If you use lamotrigine with certain other medicines, they can affect each other, causing side effects.

How should I take lamotrigine?

Take lamotrigine exactly as prescribed.
Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
Do not stop taking lamotrigine without talking to your healthcare provider. Stopping lamotrigine suddenly may cause serious problems. For example, if you have epilepsy and you stop taking lamotrigine suddenly, you may have seizures that do not stop. Talk with your healthcare provider about how to stop lamotrigine slowly.
If you miss a dose of lamotrigine, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time.
If you take too much lamotrigine, call your healthcare provider or your local Poison Control Center or go to the nearest hospital emergency room right away.
You may not feel the full effect of lamotrigine for several weeks.
If you have epilepsy, tell your healthcare provider if your seizures get worse or if you have any new types of seizures.
Swallow lamotrigine tablets whole.
If you have trouble swallowing lamotrigine tablets, tell your healthcare provider because there may be another form of lamotrigine you can take.

What should I avoid while taking lamotrigine?

Do not drive a car or operate complex, hazardous machinery until you know how lamotrigine affects you.

What are the possible side effects of lamotrigine?

See “What is the most important information I should know about lamotrigine?”

Common side effects of lamotrigine include:

 
dizziness
 
tremor
 
headache
 
rash
 
blurred or double vision
 
fever
 
lack of coordination
 
abdominal pain
 
sleepiness
 
back pain
 
nausea, vomiting, diarrhea
 
tiredness
 
insomnia
 
dry mouth
 
stuffy nose
 
sore throat

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of lamotrigine. For more information, ask your healthcare provider or pharmacist.

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

How should I store lamotrigine?

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Keep lamotrigine and all medicines out of the reach of children.

General information about lamotrigine

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lamotrigine for a condition for which it was not prescribed. Do not give lamotrigine to other people, even if they have the same symptoms you have. It may harm them.

If you take a urine drug screening test, lamotrigine may make the test result positive for another drug. If you require a urine drug screening test, tell the healthcare professional administering the test that you are taking lamotrigine.

This Medication Guide summarizes the most important information about lamotrigine. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about lamotrigine that is written for healthcare professionals.

For more information, call 1 (888)721-7115.

What are the ingredients in lamotrigine?

Lamotrigine tablets USP

Active ingredient: lamotrigine USP

Inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, FD&C Yellow No. 6 (100 mg tablet only), ferric oxide yellow (150 mg tablet only) and FD&C Blue No. 2 (200 mg tablet only).

This Medication Guide has been approved by the U.S. Food and Drug Administration.

DEPAKENE and DEPAKOTE are registered trademarks of Abbott Laboratories.

Manufactured by:

Glenmark Pharmaceuticals Ltd.
Colvale-Bardez, Goa 403 513, India

Manufactured for:
Glenmark logo

Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430

Questions? 1 (888)721-7115
www.glenmarkpharma.com/usa

April 2015

Revised: 6/2015
Glenmark Pharmaceuticals Inc., USA