LAMOTRIGINE- lamotrigine tablet, extended release
NorthStar Rx LLC
Lamotrigine Extended-Release Tablets, USP
What is the most important information I should know about lamotrigine extended-release tablets?
1. Lamotrigine extended-release tablets 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 extended-release tablets, 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 extended-release tablets. Lamotrigine extended-release tablets are not approved for use in children younger than 13 years.
The risk of getting a serious skin rash is higher if you:
• take lamotrigine extended-release tablets while taking valproate [DEPAKENE (valproic acid) or DEPAKOTE (divalproex sodium)].
• take a higher starting dose of lamotrigine extended-release tablets than your healthcare provider prescribed.
• increase your dose of lamotrigine extended-release tablets 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
• 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 extended-release tablets.
2. Other serious reactions, including serious blood problems or liver problems. Lamotrigine extended-release tablets 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:
• 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 extended-release 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 extended-release tablets without first talking to a healthcare provider.
• Stopping lamotrigine extended-release 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 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 extended-release tablets 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:
Meningitis has many causes other than lamotrigine extended-release tablets, which your doctor would check for if you developed meningitis while taking lamotrigine extended-release tablets.
Lamotrigine extended-release tablets 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 extended-release tablets?”
5. People prescribed lamotrigine extended-release tablets have sometimes been given the wrong medicine because many medicines have names similar to lamotrigine extended-release tablets, so always check that you receive lamotrigine extended-release tablets.
Taking the wrong medication can cause serious health problems. When your healthcare provider gives you a prescription for lamotrigine extended-release 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 description of the tablets below.
The below wording describes the color and imprinting that is on each strength of lamotrigine extended-release tablets that help to identify the right strength of lamotrigine extended-release tablets. Immediately call your pharmacist if you receive a lamotrigine extended-release tablet that does not match with the description of the tablets below, as you may have received the wrong medication.
Lamotrigine extended-release tablets
What are lamotrigine extended-release tablets?
Do not take lamotrigine extended-release tablets?
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Lamotrigine extended-release tablets and certain other medicines may interact with each other. This may cause serious side effects.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take lamotrigine extended-release tablets?
• Take lamotrigine extended-release 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 extended-release tablets without talking to your healthcare provider. Stopping lamotrigine extended-release tablets suddenly may cause serious problems. For example, if you have epilepsy and you stop taking lamotrigine extended-release tablets suddenly, you may have seizures that do not stop. Talk with your healthcare provider about how to stop lamotrigine extended-release tablets slowly.
• If you miss a dose of lamotrigine extended-release 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 2 doses at the same time.
• If you take too much lamotrigine extended-release tablets, call your healthcare provider or you local Poison Control Center or go to the nearest hospital emergency room right away.
• You may not feel the full effect of lamotrigine extended-release 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.
• Lamotrigine extended-release tablets can be taken with or without food.
• Do not chew, crush, or divide lamotrigine extended-release tablets.
• Swallow lamotrigine extended-release tablets whole.
• If you have trouble swallowing lamotrigine extended-release tablets, tell your healthcare provider because there may be another form of lamotrigine you can take.
What should I avoid while taking lamotrigine extended-release tablets?
Do not drive, operate machinery, or do other dangerous activities until you know how lamotrigine extended-release tablets affects you.
What are possible side effects of lamotrigine extended-release tablets?
Lamotrigine extended-release tablets can cause serious side effects.
• See “What is the most important information I should know about lamotrigine extended-release tablets?”
Common side effects of lamotrigine extended-release tablets include:
• double vision
• Trouble with balance and coordination
Other common side effects that have been reported with another form of lamotrigine include headache, sleepiness, blurred vision, runny nose, and rash.
These are not all the possible side effects of lamotrigine extended-release tablets.
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 extended-release tablets?
• Store lamotrigine extended-release tablets at room temperature between 20oC to 25oC (68oF to 77oF).
• Keep lamotrigine extended-release tablets and all medicines out of the reach of children.
General information about the safe and effective use of lamotrigine extended-release tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lamotrigine extended-release tablets for a condition for which it was not prescribed. Do not give lamotrigine extended-release tablets 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 extended-release tablets 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 extended-release tablets.
You can ask your healthcare provider or pharmacist for information about lamotrigine extended-release tablets that is written for health professionals.
What are the ingredients in lamotrigine extended-release tablets?
Active ingredient: Lamotrigine USP.
Inactive ingredients: D&C Red # 27 (250 mg), FD&C BLUE No. 2 (200 mg and 250 mg), hypromellose, iron oxide black (50 mg and 300 mg), iron oxide yellow (25 mg, 50 mg and 100 mg), iron oxide red (100 mg), lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polyethylene glycol 400, talc, titanium dioxide and triethyl citrate. Tablets are printed with edible black ink which contains iron oxide black and shellac glaze.
For more information about lamotrigine extended-release tablets, call 1-844-375-6847.
The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the Dr. Reddy's Laboratories Limited. The makers of these brands are not affiliated with and do not endorse the Dr. Reddy's Laboratories Limited or its products.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Medication Guides available at www.northstarrxllc.com/products or call 1-844-375-6847.
NorthStar Rx LLC
Memphis, TN 38141
Dr. Reddy’s Laboratories Limited
Bachupally – 500 090 INDIA