MEDICATION GUIDE

Lamotrigine Tablets, USP 

Rx Only

Read this Medication Guide before you start taking Lamotrigine Tablets 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 Tablets, ask your healthcare provider or pharmacist.

What is the most important information I should know about Lamotrigine Tablets?

1. Lamotrigine Tablets may cause a serious skin rash that may cause you to be hospitalized or to stop Lamotrigine Tablets; it may rarely cause death.

There is no way to tell if a mild rash will develop into a more serious reaction. These serious skin reactions are more likely to happen when you begin taking Lamotrigine Tablets, within the first  2 to 8 weeks of treatment.  But it can happen in people who have taken Lamotrigine Tablets for any period of time.  Children between 2 to 16 years of age have a higher chance of getting this serious skin reaction while taking Lamotrigine Tablets.

The risk of getting a rash is higher if you:

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

Lamotrigine Tablets can also cause other types of allergic reactions or serious problems which may affect organs and other parts of your body like the 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 the following:

• a skin rash
• hives
• fever
• swollen lymph glands
• painful sores in the mouth or around your eyes
• swelling of your lips or tongue
• yellowing or your skin or eyes
• unusual bruising or bleeding
• severe fatigue or weakness
• severe muscle pain
• frequent infections 

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

2.  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 without first talking to a healthcare provider.

• Stopping Lamotrigine Tablets 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.

3. Lamotrigine Tablets 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 Tablets.

Lamotrigine Tablets 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 Tablets?”

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

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

• 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 information about the tablets below.

The wording describes the actual tablet shape, size, color and printing that is on each strength of Lamotrigine Tablets. Immediately call your pharmacist if you receive a Lamotrigine tablet that does not look like one of the tablets described below, as you may have received the wrong medication.

25 mg -  Round, white to off white tablets, debossed with ‘J’ and ‘245’ on one side and scoreline on the other side

100 mg -  Round, white to off white tablets, debossed with ‘J’ and ‘246’ on one side and scoreline on the other side

150 mg - Round, white to off white tablets, debossed with ‘J’ and ‘247’ on one   side  and scoreline on the other side

200 mg -  Round, white to off white tablets, debossed with ‘J’ and ‘248’ on one side  and scoreline on the other side

What are Lamotrigine Tablets?

Lamotrigine tablets are a prescription medicine used:

• together with other medicines to treat certain types of seizures (partial seizures, primary generalized tonic-clonic seizures, generalized seizures of Lennox-Gastaut syndrome) in people 2 years or older.
• alone when changing from other medicines used to treat partial seizures in people 16 years or older.

• for the long-term treatment of Bipolar I Disorder to lengthen the time between mood episodes in people 18 years or older who have been treated for mood episodes with other medicine.

It is not known if Lamotrigine Tablets are safe or effective in children or teenagers under the age of 18 with mood disorders such as bipolar disorder or depression.

It is not known if Lamotrigine Tablets are safe or effective when used alone as the first treatment of seizures in adults.

Who should not take Lamotrigine Tablets?

You should not take Lamotrigine Tablets 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 Tablets?

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

• have had a rash or allergic reaction to another anti seizure medicine.
• have or have had depression, mood problems or suicidal thoughts or behavior.
• 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 or starting these medicines may cause side effects (such as dizziness, lack of coordination, or double vision), or lessen how well Lamotrigine Tablet works.
• are pregnant or plan to become pregnant. It is not known if Lamotrigine Tablets will harm your unborn baby. If you become pregnant while taking Lamotrigine Tablets, 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, 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.

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.  Using Lamotrigine Tablets with certain other medicines can affect each other, causing side effects.

How should I take Lamotrigine Tablets?

• Take Lamotrigine Tablets 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 without talking to your healthcare provider. Stopping Lamotrigine Tablets suddenly may cause serious problems. For example, if you have epilepsy and you stop taking Lamotrigine Tablets suddenly, you may get seizures that do not stop. Talk with your healthcare provider about how to stop Lamotrigine Tablets slowly.
• If you miss a dose of Lamotrigine Tablets, 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 two doses at the same time.
• You may not feel the full effect of Lamotrigine Tablets 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, there may be another form of Lamotrigine you can take.

What should I avoid while taking Lamotrigine Tablets?

• Do not drive a car or operate complex, hazardous machinery until you know how Lamotrigine Tablets affect you. 

What are possible side effects of Lamotrigine Tablets?

• See “What is the most important information I should know about Lamotrigine Tablets?” 

Common side effects of Lamotrigine Tablets include:

• dizziness
• headache
• blurred or double vision
• lack of coordination
• sleepiness
• nausea, vomiting
• insomnia
• tremor
• rash
• fever
• abdominal pain
• back pain
• tiredness
• dry mouth

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. 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?

• Store Lamotrigine Tablets at  room temperature between 68oF to 77oF (20oC to 25oC); excursions permitted to 15oC to 30oC (59oF to 86oF) in a dry place and protect from light.
• Keep Lamotrigine Tablets and all medicines out of the reach of children.

General information about Lamotrigine Tablets

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

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

For more information, call 1-800-313-4623

What are the ingredients in Lamotrigine Tablets?

Active ingredient: Lamotrigine, USP.

Inactive ingredients: lactose monohydrate; magnesium stearate, microcrystalline cellulose, sodium starch glycolate.

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:
Jubilant Cadista Pharmaceuticals Inc.                                    
Salisbury, MD 21801, USA

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

0245/MG
Rev. # 08/2013