SUBVENITE- lamotrigine tablet
SUBVENITE- lamotrigine
OWP Pharmaceuticals, Inc.
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What is the most important information I should know about SUBVENITE?
1. SUBVENITE 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 SUBVENITE, but is more likely to happen within the first 2 to 8 weeks of treatment. Children and teenagers aged between 2 and 17 years have a higher chance of getting this serious skin rash while taking SUBVENITE.
The risk of getting a serious skin rash is higher if you:
Call your healthcare provider right away if you have any of the following:
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 SUBVENITE.
2. Other serious reactions, including serious blood problems or liver problems. SUBVENITE 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:
3. In patients with known heart problems, the use of SUBVENITE may lead to a fast heart beat. Call your healthcare provider right away if you:• have a fast, slow, or pounding heart beat.
• feel your heart skip a beat.
• have shortness of breath.
• have chest pain.
• feel lightheaded.
4. Like other antiepileptic drugs, SUBVENITE 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:
Do not stop SUBVENITE without first talking to a healthcare provider.
How can I watch for early symptoms of suicidal thoughts and actions in myself or a family member?
5. SUBVENITE 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 SUBVENITE, which your doctor would check for if you developed meningitis while taking SUBVENITE.
SUBVENITE 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 SUBVENITE?"
6. People prescribed SUBVENITE have sometimes been given the wrong medicine because many medicines have names similar to SUBVENITE, so always check that you receive SUBVENITE.
Taking the wrong medication can cause serious health problems. When your healthcare provider gives you a prescription for SUBVENITE:
These pictures show the distinct wording, colors, and shapes of the tablets that help to identify the right strength of SUBVENITE tablets. Immediately call your pharmacist if you receive a SUBVENITE tablet that does not look like one of the tablets shown below, as you may have received the wrong medication.
What is SUBVENITE?
• SUBVENITE is a prescription medicine used:
o 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.
o alone when changing from 1 other medicine used to treat partial-onset seizures in people aged 16 years and older.
o 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 SUBVENITE is safe or effective in people younger than 18 years with mood episodes such as bipolar disorder or depression.
• It is not known if SUBVENITE is safe or effective when used alone as the first treatment of seizures.
• It is not known if SUBVENITE is safe or effective for people with mood episodes who have not already been treated with other medicines.
SUBVENITE should not be used for acute treatment of manic or mixed mood episodes.
Do not take SUBVENITE:
Before taking SUBVENITE, tell your healthcare provider about all of your health conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. SUBVENITE 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 SUBVENITE?
What should I avoid while taking SUBVENITE?
Do not drive, operate machinery, or do other dangerous activities until you know how SUBVENITE affects you.
What are the possible side effects of SUBVENITE?
SUBVENITE can cause serious side effects.
See "What is the most important information I should know about SUBVENITE?"
Common side effects of SUBVENITE include:
These are not all the possible side effects of SUBVENITE.
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 SUBVENITE?
General information about the safe and effective use of SUBVENITE.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SUBVENITE for a condition for which it was not prescribed. Do not give SUBVENITE to other people, even if they have the same symptoms that you have. It may harm them.
If you take a urine drug screening test, SUBVENITE 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 SUBVENITE.
You can ask your healthcare provider or pharmacist for information about SUBVENITE that is written for health professionals.
For more information, call 1-800-273-6729.
What are the ingredients in SUBVENITE? SUBVENITE (lamotrigine)tablets, USP
Active ingredient: lamotrigine, USP.
Inactive ingredients: lactose monohydrate; magnesium stearate; microcrystalline cellulose; povidone; and sodium starch glycolate.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Trademarks are the property of their respective owners.
Manufactured by:
TORRENT PHARMACEUTICALS LTD., INDIA.
Manufactured for:
OWP Pharmaceuticals, Inc., 400 E. Diehl Road, Suite 400, Naperville, IL 60563.
8082161 OWOSSUBMGI0321 Revised May 2021