Medication Guide

MEDICATION GUIDE

Lamotrigine Tablets, USP

(la moe'tri jeen)

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

1. Lamotrigine tablets, USP 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 tablets, USP but is more likely to happen within the first 2 to 8 weeks of treatment. Children and teenagers between 2 and 17 years have a higher chance of getting this serious skin rash while taking lamotrigine tablets, USP.

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

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

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 tablets 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 tablets, USP without first talking to a healthcare provider.

Stopping lamotrigine tablets, USP 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 in myself or a family member?

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 tablets, USP may 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 tablets, USP.

Lamotrigine tablets, USP can cause 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 tablets, USP?"

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

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

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, USP. Immediately call your pharmacist if you receive a lamotrigine tablet, USP that does not look like one of the tablets shown below, as you may have received the wrong medication.

[tablet]

What is lamotrigine tablets, USP?

Lamotrigine tablets, USP 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 who have been treated for mood episodes with other medicine.

It is not known if lamotrigine tablets, USP is safe or effective in people younger than 18 years with mood episodes such as bipolar disorder or depression.

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

It is not known if lamotrigine tablets, USP is safe or effective for people with mood episodes who have not already been treated with other medicines.

Lamotrigine tablets, USP should not be used for acute treatment of manic or mixed mood episodes.

Who should not take lamotrigine tablets, USP?

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

What should I tell my healthcare provider before taking lamotrigine tablets, USP?

Before taking lamotrigine tablets USP, 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 tablets, USP.
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 while you are taking lamotrigine tablets, USP may cause side effects (such as dizziness, lack of coordination, or double vision). Starting these medicines may lessen how well lamotrigine tablets, USP works.
are pregnant or plan to become pregnant. It is not known if lamotrigine tablets, USP will harm your unborn baby. If you become pregnant while taking lamotrigine tablets USP, 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 tablets,USP 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 tablets, USP.

Tell your healthcare provider about all the medicines you take or if you are planning to take a new medicine, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

If you use lamotrigine tablets, USP with certain other medicines, they can affect each other, causing side effects.

How should I take lamotrigine tablets, USP?

Take lamotrigine tablets, USP 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 tablets, USP without talking to your healthcare provider. Stopping lamotrigine tablets, USP suddenly may cause serious problems. For example, if you have epilepsy and you stop taking lamotrigine tablets, USP suddenly, you may have seizures that do not stop. Talk with your healthcare provider about how to stop lamotrigine tablets, USP slowly.
If you miss a dose of lamotrigine tablets, USP 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 tablets USP, 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 tablets, USP 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, USP whole.
If you have trouble swallowing lamotrigine tablets, USP tell your healthcare provider because there may be another form of lamotrigine you can take.
If you receive lamotrigine tablets, USP in a blisterpack, examine the blisterpack before use. Do not use if blisters are torn, broken, or missing.

What should I avoid while taking lamotrigine tablets, USP?

Do not drive, operate machinery, or do other dangerous activities until you know how lamotrigine tablet, USP affects you.

What are possible side effects of lamotrigine tablets, USP?

Lamotrigine tablets, USP can cause serious side effects.

See "What is the most important information I should know about lamotrigine Tablets, USP?"

Common side effects of lamotrigine tablets, USP include:

dizziness
tremor
headache
rash
blurred or double vision
fever
lack of coordination
abdominal pain
infections, including seasonal flu
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 tablets, USP. 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 tablets, USP?

Store lamotrigine tablets, USP at room temperature between 680F to770F (200C to 250C).
Keep lamotrigine tablets, USP and all medicines out of the reach of children.

General information about the safe and effective use of lamotrigine tablets, USP

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lamotrigine tablets, USP for a condition for which it was not prescribed. Do not give lamotrigine tablets, USP 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 tablets, USP.

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

What are the ingredients in lamotrigine tablets, USP?

Active ingredient: lamotrigine.

Inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, povidone, sodium starch glycolate, black iron oxide, iron oxide red and yellow iron oxide.

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

Disclaimer: Other Brands listed are the registered trademarks of their respective owners and are not trademarks of Cipla Limited.

Manufactured by:

Cipla Ltd.,

Verna Goa, INDIA.

Manufactured for:

Cipla USA, Inc.

9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156

Revised: 6/2015