LAMOTRIGINE- lamotrigine tablet
LAMOTRIGINE - lamotrigine
Torrent Pharmaceuticals Limited
| MEDICATION GUIDE
Lamotrigine (la-MOE-tri-jeen) Tablets, USP
What is the most important information I should know about lamotrigine?
• trouble walking or seeing
• seizures for the first time or happening more often
• pain and/or tenderness in the area towards the top of your stomach (enlarged liver and/or spleen)
3. In patients with known heart problems, the use of lamotrigine may lead to a fast heart beat. Call your healthcare provider right away if you:
4. Like other antiepileptic drugs, lamotrigine may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
| 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 who have been treated for mood episodes with other medicine.
● It is not known if lamotrigine 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 is safe or effective when used alone as the first treatment of seizures.
● It is not known if lamotrigine is safe or effective for people with mood episodes who have not already been treated with other medicines.
Lamotrigine should not be used for acute treatment of manic or mixed mood episodes.
| Do not take lamotrigine:
if you have had an allergic reaction to lamotrigine or to any of the inactive ingredients in lamotrigine. See the end of this leaflet for a complete list of ingredients in lamotrigine.
Before taking lamotrigine, tell your healthcare provider about all of your health conditions, including if you:
● have a history of heart problems or irregular heart beats or any of your family members have any heart problem, including genetic abnormalities.
● have had aseptic meningitis after taking lamotrigine.
| 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.
● If you receive lamotrigine in a blister pack, examine the blister pack before use. Do not use if blisters are torn, broken, or missing.
| What should I avoid while taking lamotrigine?
Do not drive, operate machinery, or do other dangerous activities until you know how lamotrigine affects you.
| What are the possible side effects of lamotrigine?
Lamotrigine can cause serious side effects.
See "What is the most important information I should know about lamotrigine?"
Common side effects of lamotrigine include:
● blurred or double vision
● lack of coordination
● abdominal pain
● infections, including seasonal flu
● back pain
● nausea, vomiting
● dry mouth
● stuffy nose
● sore throat
These are not all the possible side effects of lamotrigine.
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 lamotrigine 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 the safe and effective use of lamotrigine.
For more information, call 1-800-912-9561.
| What are the ingredients in lamotrigine? 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.
TORRENT PHARMACEUTICALS LTD., INDIA.
TORRENT PHARMA INC., Basking Ridge, NJ 07920.
8082049 Revised May 2021