LAMICTAL (Page 13 of 13)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Rash

Prior to initiation of treatment with LAMICTAL, inform patients that a rash or other signs or symptoms of hypersensitivity (e.g., fever, lymphadenopathy) may herald a serious medical event and instruct them to report any such occurrence to their healthcare providers immediately.

Hemophagocytic Lymphohistiocytosis

Prior to initiation of treatment with LAMICTAL, inform patients that excessive immune activation may occur with LAMICTAL and that they should report signs or symptoms such as fever, rash, or lymphadenopathy to a healthcare provider immediately.

Multiorgan Hypersensitivity Reactions, Blood Dyscrasias, and Organ Failure

Inform patients that multiorgan hypersensitivity reactions and acute multiorgan failure may occur with LAMICTAL. Isolated organ failure or isolated blood dyscrasias without evidence of multiorgan hypersensitivity may also occur. Instruct patients to contact their healthcare providers immediately if they experience any signs or symptoms of these conditions [see Warnings and Precautions (5.3, 5.5)].

Cardiac Rhythm and Conduction Abnormalities

Inform patients that, due to its mechanism of action, LAMICTAL could lead to irregular or slowed heart rhythm. This risk is increased in patients with underlying cardiac disease or heart conduction problems or who are taking other medications that affect heart conduction. Patients should be made aware of and report cardiac signs or symptoms to their healthcare provider right away. Patients who develop syncope should lie down with raised legs and contact their healthcare provider [see Warnings and Precautions (5.4)].

Suicidal Thinking and Behavior

Inform patients, their caregivers, and families that AEDs, including LAMICTAL, may increase the risk of suicidal thoughts and behavior. Instruct them to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts or behavior or thoughts about self-harm. Instruct them to immediately report behaviors of concern to their healthcare providers.

Worsening of Seizures

Instruct patients to notify their healthcare providers if worsening of seizure control occurs.

Central Nervous System Adverse Effects

Inform patients that LAMICTAL may cause dizziness, somnolence, and other symptoms and signs of central nervous system depression. Accordingly, instruct them neither to drive a car nor to operate other complex machinery until they have gained sufficient experience on LAMICTAL to gauge whether or not it adversely affects their mental and/or motor performance.

Pregnancy and Nursing

Instruct patients to notify their healthcare providers if they become pregnant or intend to become pregnant during therapy and if they intend to breastfeed or are breastfeeding an infant.

Encourage patients to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334 [see Use in Specific Populations (8.1)].

Inform patients who intend to breastfeed that LAMICTAL is present in breast milk and advise them to monitor their child for potential adverse effects of this drug. Discuss the benefits and risks of continuing breastfeeding.

Oral Contraceptive Use

Instruct women to notify their healthcare providers if they plan to start or stop use of oral contraceptives or other female hormonal preparations. Starting estrogen-containing oral contraceptives may significantly decrease lamotrigine plasma levels and stopping estrogen-containing oral contraceptives (including the pill-free week) may significantly increase lamotrigine plasma levels [see Warnings and Precautions (5.9), Clinical Pharmacology (12.3)]. Also instruct women to promptly notify their healthcare providers if they experience adverse reactions or changes in menstrual pattern (e.g., break-through bleeding) while receiving LAMICTAL in combination with these medications.

Discontinuing LAMICTAL

Instruct patients to notify their healthcare providers if they stop taking LAMICTAL for any reason and not to resume LAMICTAL without consulting their healthcare providers.

Aseptic Meningitis

Inform patients that LAMICTAL may cause aseptic meningitis. Instruct them to notify their healthcare providers immediately if they develop signs and symptoms of meningitis such as headache, fever, nausea, vomiting, stiff neck, rash, abnormal sensitivity to light, myalgia, chills, confusion, or drowsiness while taking LAMICTAL.

Potential Medication Errors

To avoid a medication error of using the wrong drug or formulation, strongly advise patients to visually inspect their tablets to verify that they are LAMICTAL, as well as the correct formulation of LAMICTAL, each time they fill their prescription [see Dosage Forms and Strengths (3.1, 3.2, 3.3), How Supplied/Storage and Handling (16)]. Refer the patient to the Medication Guide that provides depictions of the LAMICTAL tablets, tablets for oral suspension, and orally disintegrating tablets.

LAMICTAL and LAMICTAL ODT are trademarks owned by or licensed to the GSK group of companies. The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.

Distributed by

GlaxoSmithKline

Research Triangle Park, NC 27709

©2021 GSK group of companies or its licensor.

LMT:24PI

MEDICATION GUIDE LAMICTAL (la-MIK-tal) (lamotrigine) tablets LAMICTAL (lamotrigine) tablets for oral suspension LAMICTAL ODT (lamotrigine) orally disintegrating tablets
What is the most important information I should know about LAMICTAL? 1. LAMICTAL 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 LAMICTAL, 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 LAMICTAL.The risk of getting a serious skin rash is higher if you: 1. take LAMICTAL while taking valproate [DEPAKENE (valproic acid) or DEPAKOTE (divalproex sodium)]. 2. take a higher starting dose of LAMICTAL than your healthcare provider prescribed. 3. increase your dose of LAMICTAL faster than prescribed. Call your healthcare provider right away if you have any of the following: 4. a skin rash 5. blistering or peeling of your skin 6. hives 7. 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 LAMICTAL. 2. Other serious reactions, including serious blood problems or liver problems. LAMICTAL 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: 8. fever 9. frequent infections 10. severe muscle pain 11. swelling of your face, eyes, lips, or tongue 12. swollen lymph glands 13. unusual bruising or bleeding, looking pale 14. weakness, fatigue 15. yellowing of your skin or the white part of your eyes 16. trouble walking or seeing 17. seizures for the first time or happening more often 18. 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 LAMICTAL may lead to a fast heart beat. Call your healthcare provider right away if you: 4. have a fast, slow, or pounding heart beat. 5. feel your heart skip a beat. 6. have shortness of breath. 7. have chest pain. 8. feel lightheaded. 9. Like other antiepileptic drugs, LAMICTAL 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: 19. thoughts about suicide or dying 20. attempt to commit suicide 21. new or worse depression 22. new or worse anxiety 23. feeling agitated or restless 24. panic attacks 25. trouble sleeping (insomnia) 26. new or worse irritability 27. acting aggressive, being angry, or violent 28. acting on dangerous impulses 29. an extreme increase in activity and talking (mania) 30. other unusual changes in behavior or mood Do not stop LAMICTAL without first talking to a healthcare provider. 31. Stopping LAMICTAL suddenly can cause serious problems. 32. 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? 33. Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. 34. Keep all follow-up visits with your healthcare provider as scheduled. 35. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. 10. LAMICTAL 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: 36. headache 37. fever 38. nausea 39. vomiting 40. stiff neck 41. rash 42. unusual sensitivity to light 43. muscle pains 44. chills 45. confusion 46. drowsiness Meningitis has many causes other than LAMICTAL, which your doctor would check for if you developed meningitis while taking LAMICTAL.LAMICTAL 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 LAMICTAL?” 11. People prescribed LAMICTAL have sometimes been given the wrong medicine because many medicines have names similar to LAMICTAL, so always check that you receive LAMICTAL. Taking the wrong medication can cause serious health problems. When your healthcare provider gives you a prescription for LAMICTAL: 47. Make sure you can read it clearly. 48. Talk to your pharmacist to check that you are given the correct medicine. 49. 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 LAMICTAL tablets, tablets for oral suspension, and orally disintegrating tablets. Immediately call your pharmacist if you receive a LAMICTAL tablet that does not look like one of the tablets shown below, as you may have received the wrong medication. LAMICTAL (lamotrigine) tablets
25 mg, white Imprinted with LAMICTAL 25	100 mg, peach Imprinted with LAMICTAL 100	150 mg, cream Imprinted with LAMICTAL 150	200 mg, blue Imprinted with LAMICTAL 200
LAMICTAL (lamotrigine) tablets for oral suspension
2 mg, white Imprinted with LTG 2	5 mg, white Imprinted with GX CL2	25 mg, white Imprinted with GX CL5
LAMICTAL ODT (lamotrigine) orally disintegrating tablets
25 mg, white to off-white Imprinted with LMT on one side 25 on the other	50 mg, white to off-white Imprinted with LMT on one side 50 on the other	100 mg, white to off-white Imprinted with LAMICTAL on one side 100 on the other	200 mg, white to off-white Imprinted with LAMICTAL on one side 200 on the other
What is LAMICTAL? • LAMICTAL 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 LAMICTAL is safe or effective in people younger than 18 years with mood episodes such as bipolar disorder or depression. • It is not known if LAMICTAL is safe or effective when used alone as the first treatment of seizures. • It is not known if LAMICTAL is safe or effective for people with mood episodes who have not already been treated with other medicines. • LAMICTAL should not be used for acute treatment of manic or mixed mood episodes.
Do not take LAMICTAL: • if you have had an allergic reaction to lamotrigine or to any of the inactive ingredients in LAMICTAL. See the end of this leaflet for a complete list of ingredients in LAMICTAL.
Before taking LAMICTAL, tell your healthcare provider about all of your health 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 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 LAMICTAL or LAMICTAL XR (lamotrigine). • 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 LAMICTAL may cause side effects (such as dizziness, lack of coordination, or double vision). Starting these medicines may lessen how well LAMICTAL works. • are pregnant or plan to become pregnant. It is not known if LAMICTAL may harm your unborn baby. If you become pregnant while taking LAMICTAL, 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. LAMICTAL passes into breast milk and may cause side effects in a breastfed baby. If you breastfeed while taking LAMICTAL, 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 LAMICTAL. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LAMICTAL 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 LAMICTAL? • Take LAMICTAL 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 LAMICTAL without talking to your healthcare provider. Stopping LAMICTAL suddenly may cause serious problems. For example, if you have epilepsy and you stop taking LAMICTAL suddenly, you may have seizures that do not stop. Talk with your healthcare provider about how to stop LAMICTAL slowly. • If you miss a dose of LAMICTAL, 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 LAMICTAL, 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 LAMICTAL 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 LAMICTAL Tablets whole. • If you have trouble swallowing LAMICTAL Tablets, tell your healthcare provider because there may be another form of LAMICTAL you can take. • LAMICTAL ODT should be placed on the tongue and moved around the mouth. The tablet will rapidly disintegrate, can be swallowed with or without water, and can be taken with or without food. • LAMICTAL tablets for oral suspension may be swallowed whole, chewed, or mixed in water or fruit juice mixed with water. If the tablets are chewed, drink a small amount of water or fruit juice mixed with water to help in swallowing. To break up LAMICTAL tablets for oral suspension, add the tablets to a small amount of liquid (1 teaspoon, or enough to cover the medicine) in a glass or spoon. Wait at least 1 minute or until the tablets are completely broken up, mix the solution together, and take the whole amount right away. • If you receive LAMICTAL 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 LAMICTAL? Do not drive, operate machinery, or do other dangerous activities until you know how LAMICTAL affects you.
What are the possible side effects of LAMICTAL? LAMICTAL can cause serious side effects. See “What is the most important information I should know about LAMICTAL?” Common side effects of LAMICTAL include: • dizziness • sleepiness • tremor • back pain • headache • nausea, vomiting • rash • diarrhea • blurred or double vision • tiredness • fever • insomnia • lack of coordination • dry mouth • abdominal pain • stuffy nose • infections, including seasonal flu • sore throat
These are not all the possible side effects of LAMICTAL. 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 LAMICTAL? • Store LAMICTAL at room temperature between 68°F and 77°F (20°C and 25°C). Keep LAMICTAL and all medicines out of the reach of children.
General information about the safe and effective use of LAMICTAL. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use LAMICTAL for a condition for which it was not prescribed. Do not give LAMICTAL 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, LAMICTAL 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 LAMICTAL. You can ask your healthcare provider or pharmacist for information about LAMICTAL that is written for health professionals.
What are the ingredients in LAMICTAL? LAMICTAL tablets Active ingredient: lamotrigine. Inactive ingredients: lactose; magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, FD&C Yellow No. 6 Lake (100-mg tablet only), ferric oxide, yellow (150-mg tablet only), and FD&C Blue No. 2 Lake (200-mg tablet only). LAMICTAL tablets for oral suspension Active ingredient: lamotrigine. Inactive ingredients: blackcurrant flavor, calcium carbonate, low-substituted hydroxypropylcellulose, magnesium aluminum silicate, magnesium stearate, povidone, saccharin sodium, and sodium starch glycolate. LAMICTAL ODT orally disintegrating tablets Active ingredient: lamotrigine. Inactive ingredients: artificial cherry flavor, crospovidone, ethylcellulose, magnesium stearate, mannitol, polyethylene, and sucralose. For more information about LAMICTAL, call 1-888-825-5249. LAMICTAL and LAMICTAL ODT are trademarks owned by or licensed to the GSK group of companies. The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709 ©2020 GSK group of companies or its licensor. LMT:18MG

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: October 2020

PRINCIPAL DISPLAY PANEL

NDC 0173-0642-55

LAM ICTAL^®

(LAMOTRIGINE)

TABLETS

100 mg

CAUTION: Verify Product Dispensed

100 Tablets

Dispense the accompanying Medication Guide to each patient.

Each scored tablet contains 100 mg of lamotrigine.

See Prescribing Information for dosage information.

Store at 25^o C (77^o F); excursions 15 to 30^o C (59 to 86^o F) [see USP Controlled Room Temperature] in a dry place and protect from light.

Do not accept if printed seal under cap is missing or broken.

Dispense in a tight, light-resistant container as defined in the USP.

Distributed by

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in India

R_x only

10000000146191 Rev. 5/17

PRINCIPAL DISPLAY PANEL

NDC 0173-0643-60

LAM ICTAL^®

(LAMOTRIGINE)

TABLETS

150 mg

CAUTION: Verify Product Dispensed

60 Tablets

Dispense the accompanying Medication Guide to each patient.

Each scored tablet contains 150 mg of lamotrigine.

See Prescribing Information for dosage information.

Store at 25^o C (77^o F); excursions 15-30^o C (59-86^o F) [see USP Controlled Room Temperature] in a dry place and protect from light.

Do not accept if printed seal under cap is missing or broken.

Dispense in a tight, light-resistant container as defined in the USP.

Distributed by

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in India

R_x only

10000000143541 Rev. 9/16

PRINCIPAL DISPLAY PANEL

NDC 0173-0644-60

LAM ICTAL^®

(LAMOTRIGINE)

TABLETS

200 mg

CAUTION: Verify Product Dispensed

60 Tablets

Dispense the accompanying Medication Guide to each patient.

Each scored tablet contains 200 mg of lamotrigine.

See Prescribing Information for dosage information.

Store at 25^o C (77^o F); excursions 15 to 30^o C (59 to 86^o F) [see USP Controlled Room Temperature] in a dry place and protect from light.

Do not accept if printed seal under cap is missing or broken.

Dispense in a tight, light-resistant container as defined in the USP.

Distributed by

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in India

R_x only

10000000146195 Rev. 4/17

PRINCIPAL DISPLAY PANEL

NDC 0173-0633-10

LAMICTAL^®

(LAMOTRIGINE)

TABLETS

R_X ONLY

For patients TAKING valproate*

*See prescribing information for other drugs that may affect dosing of LAMICTAL.

STARTER KIT

Contains: 35 25-mg Tablets

Weeks	Tablets per day
1&2	Take 1 (25 mg) tablet every OTHER day
3&4	Take 1 (25 mg) tablets once a day
5	Take 2 (25 mg) tablet once a day

Please check with your physician about proper maintenance dose before week 5.

Dispense the enclosed Medication Guide to each patient.

Each LAMICTAL 25 tablet contains 25 mg of lamotrigine

CAUTION: Verify Product Dispensed

Do not use if blisters are torn, broken, or missing.

Made in India

©2017 the GSK group of companies

546716-01 Rev.11/17

PRINCIPAL DISPLAY PANEL

NDC 0173-0817-28

LAMICTAL^®

(LAMOTRIGINE)

TABLETS

R_X ONLY

For patients TAKING carbamazepine, phenytoin, phenobarbital, or primidone and NOT TAKING valproate*

*See prescribing information for other drugs that may affect dosing of LAMICTAL.

STARTER KIT

Contains: 84 25-mg Tablets

14 100-mg Tablets

Weeks	Tablets per day
1&2	Take 2 (25 mg) tablets once a day
3&4	Take 2 (25 mg) tablets twice a day
5	Take 1 (100 mg) tablet twice a day

Please check with your physician about proper maintenance dose before week 5.

Dispense the enclosed Medication Guide to each patient.

Each LAMICTAL 25 tablet contains 25 mg of lamotrigine

Each LAMICTAL 100 tablet contains 100 mg of lamotrigine

CAUTION: Verify Product Dispensed

Do not use if blisters are torn, broken, or missing.

Made in India

©2017 the GSK group of companies

546714-01 Rev. 11/17

PRINCIPAL DISPLAY PANEL

NDC 0173-0594-02

LAMICTAL^®

(LAMOTRIGINE)

TABLETS

R_X ONLY

For patients NOT TAKING carbamazepine, phenytoin, phenobarbital, primidone, or valproate*

*See prescribing information for other drugs that may affect dosing of LAMICTAL.

STARTER KIT

Contains: 42 25-mg Tablets

7 100-mg Tablets

Weeks	Tablets per day
1&2	Take 1 (25 mg) tablet once a day
3&4	Take 2 (25 mg) tablets once a day
5	Take 1 (100 mg) tablet once a day

Please check with your physician about proper maintenance dose before week 5.

Dispense the enclosed Medication Guide to each patient.

Each LAMICTAL 25 tablet contains 25 mg of lamotrigine

Each LAMICTAL 100 tablet contains 100 mg of lamotrigine

CAUTION: Verify Product Dispensed

Do not use if blisters are torn, broken, or missing.

Made in India

©2017 the GSK group of companies

546718-01 Rev. 11/17

PRINCIPAL DISPLAY PANEL

NDC 0173-0699-00

LAMICTAL

(LAMOTRIGINE)

TABLETS FOR ORAL SUSPENSION

2 mg

CAUTION: Verify Product Dispensed

30 Tablets

Dispense the accompanying Medication Guide to each patient.

Each tablet contains 2 mg of lamotrigine. Tablets may be swallowed whole, chewed, or dispersed in water or diluted fruit juice.

See Prescribing Information for dosage information.

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place.

Do not accept if printed seal under cap is missing or broken.

Dispense in a tight, light-resistant container as defined in the USP.

Distributed by

GlaxoSmithKline, RTP, NC 27709

Made in India

R_x only

62000000058470 Rev. 11/20

PRINCIPAL DISPLAY PANEL

NDC 0173-0526-00

LAMICTAL

(LAMOTRIGINE)

TABLETS FOR ORAL SUSPENSION

5 mg

CAUTION: Verify Product Dispensed

100 Tablets

Dispense the accompanying Medication Guide to each patient.

Each tablet contains 5 mg of lamotrigine. Tablets may be swallowed whole, chewed, or dispersed in water or diluted fruit juice.

See Prescribing Information for dosage information.

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place.

Do not accept if printed seal under cap is missing or broken.

Dispense in a tight, light-resistant container as defined in the USP.

Distributed by

GlaxoSmithKline, RTP, NC 27709

Made in India

R_x only

62000000058469 Rev. 11/20

PRINCIPAL DISPLAY PANEL

NDC 0173-0527-00

LAMICTAL

(LAMOTRIGINE)

TABLETS FOR ORAL SUSPENSION

25 mg

CAUTION: Verify Product Dispensed

100 Tablets

Dispense the accompanying Medication Guide to each patient.

Each tablet contains 25 mg of lamotrigine. Tablets may be swallowed whole, chewed, or dispersed in water or diluted fruit juice.

See Prescribing Information for dosage information.

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in a dry place.

Do not accept if printed seal under cap is missing or broken.

Dispense in a tight, light-resistant container as defined in the USP.

Distributed by

GlaxoSmithKline, RTP, NC 27709

Made in India

R_x only

62000000058472 Rev. 11/20

PRINCIPAL DISPLAY PANEL

NDC 0173-0772-02

LAMICTAL ODT ^®

(LAMOTRIGINE)

ORALLY DISINTEGRATING TABLETS

R_x only

Maintenance Pack

25 mg

30 Tablets

This Maintenance Pack is intended for patients already taking LAMICTAL.

NOT for initial titration.

Dispense the accompanying Medication Guide to each patient.

CAUTION: Verify Product Dispensed

Made in India

©2017 the GSK group of companies

10000000146533 Rev. 7/17

PRINCIPAL DISPLAY PANEL

NDC 0173-0774-02

LAMICTAL ODT ^®

(LAMOTRIGINE)

ORALLY DISINTEGRATING TABLETS

R_x only

Maintenance Pack

50 mg

30 Tablets

This Maintenance Pack is intended for patients already taking LAMICTAL.

NOT for initial titration.

Dispense the accompanying Medication Guide to each patient.

CAUTION: Verify Product Dispensed

Made in India

©2017 the GSK group of companies

10000000146531 Rev. 7/17

PRINCIPAL DISPLAY PANEL

NDC 0173-0776-02

LAMICTAL ODT ^®

(LAMOTRIGINE)

ORALLY DISINTEGRATING TABLETS

R_x only

Maintenance Pack

100 mg

30 Tablets

This Maintenance Pack is intended for patients already taking LAMICTAL.

NOT for initial titration.

Dispense the accompanying Medication Guide to each patient.

CAUTION: Verify Product Dispensed

Made in India

©2017 the GSK group of companies

10000000146532 Rev. 7/17

PRINCIPAL DISPLAY PANEL

NDC 0173-0777-02

LAMICTAL ODT ^®

(LAMOTRIGINE)

ORALLY DISINTEGRATING TABLETS

R_x only

Maintenance Pack

200 mg

30 Tablets

This Maintenance Pack is intended for patients already taking LAMICTAL.

NOT for initial titration.

Dispense the accompanying Medication Guide to each patient.

CAUTION: Verify Product Dispensed

Made in India

©2017 the GSK group of companies

10000000146534 Rev. 7/17

PRINCIPAL DISPLAY PANEL

NDC 0173-0779-00

LAMICTAL ODT ^®

(LAMOTRIGINE)

ORALLY DISINTEGRATING TABLETS

R_X only

Patient Titration Kit

For patients TAKING valproate*

*See prescribing information for other drugs that may affect dosing of LAMICTAL ODT.

KIT CONTAINS:

21	25 mg Tablets
7	50 mg Tablets

WEEKS	TABLETS PER DAY
1&2	Take 1 (25 mg) tablet every OTHER day
3&4	Take 1 (25 mg) tablet ONCE a day
5	Take 1 (50 mg) tablet ONCE a day

Dispense the accompanying Medication Guide to each patient.

CAUTION: Verify Product Dispensed

Do not use if blisters are torn, broken, or missing.

©2017 the GSK group of companies

Rev. 7/17

10000000146500

PRINCIPAL DISPLAY PANEL

NDC 0173-0780-00

LAMICTAL ODT ^®

(LAMOTRIGINE)

ORALLY DISINTEGRATING TABLETS

R_X only

Patient Titration Kit

For patients TAKING carbamazepine, phenytoin, phenobarbital, or primidone, and NOT TAKING valproate*

*See prescribing information for other drugs that may affect dosing of LAMICTAL ODT.

KIT CONTAINS:

42	50 mg Tablets
14	100 mg Tablets

WEEKS	TABLETS PER DAY
1&2	Take 1 (50 mg) tablet ONCE a day
3&4	Take 1 (50 mg) tablet TWICE a day
5	Take 1 (100 mg) tablet TWICE a day

Dispense the accompanying Medication Guide to each patient.

CAUTION: Verify Product Dispensed

Do not use if blisters are torn, broken, or missing.

©2017 the GSK group of companies

Rev. 7/17

10000000146535

PRINCIPAL DISPLAY PANEL

NDC 0173-0778-00

LAMICTAL ODT ^®

(LAMOTRIGINE)

ORALLY DISINTEGRATING TABLETS

R_X ONLY

Patient Titration Kit

For patients NOT TAKING carbamazepine, phenytoin, phenobarbital, primidone, or valproate*

*See prescribing information for other drugs that may affect dosing of LAMICTAL ODT.

KIT CONTAINS:

14	25 mg Tablets
14	50 mg Tablets
7	100 mg Tablets

WEEKS	TABLETS PER DAY
1&2	Take 1 (25 mg) tablet ONCE a day
3&4	Take 1 (50 mg) tablet ONCE a day
5	Take 1 (100 mg) tablet ONCE a day

Dispense the accompanying Medication Guide to each patient.

CAUTION: Verify Product Dispensed

Do not use if blisters are torn, broken, or missing.

©2017 the GSK group of companies

Rev. 7/17

10000000146499

LAMICTAL lamotrigine tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0633 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 25 mg

Inactive Ingredients Ingredient Name Strength LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color WHITE Score 2 pieces Shape HEXAGON (6 sided) Size 6mm Flavor Imprint Code LAMICTAL;25 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0633-02 100 TABLET in 1 BOTTLE None 2 NDC:0173-0633-10 35 TABLET in 1 DOSE PACK None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020241 08/15/1996

LAMICTAL lamotrigine tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0642 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 100 mg

Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color ORANGE (peach) Score 2 pieces Shape HEXAGON (6 sided) Size 11mm Flavor Imprint Code LAMICTAL;100 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0642-55 100 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020241 01/17/1995

LAMICTAL lamotrigine tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0643 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 150 mg

Inactive Ingredients Ingredient Name Strength FERRIC OXIDE YELLOW LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color WHITE (cream) Score 2 pieces Shape HEXAGON (6 sided) Size 12mm Flavor Imprint Code LAMICTAL;150 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0643-60 60 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020241 01/17/1995

LAMICTAL lamotrigine tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0644 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 200 mg

Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 2 LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color BLUE Score 2 pieces Shape HEXAGON (6 sided) Size 12mm Flavor Imprint Code LAMICTAL;200 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0644-60 60 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020241 01/18/1995

LAMICTAL lamotrigine tablet, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0699 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 2 mg

Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM STEARATE POVIDONE, UNSPECIFIED SACCHARIN SODIUM SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM ALUMINUM SILICATE

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND Size 5mm Flavor BLACKBERRY (blackcurrant) Imprint Code LTG;2 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0699-02 30 TABLET, FOR SUSPENSION in 1 BOTTLE None 2 NDC:0173-0699-00 30 TABLET, FOR SUSPENSION in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020764 10/12/2000

LAMICTAL lamotrigine tablet, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0526 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 5 mg

Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM STEARATE POVIDONE, UNSPECIFIED SACCHARIN SODIUM MAGNESIUM ALUMINUM SILICATE SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL (caplet-shaped) Size 8mm Flavor BLACKBERRY (blackcurrant) Imprint Code GX;CL2 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0526-00 100 TABLET, FOR SUSPENSION in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020764 09/04/1998

LAMICTAL lamotrigine tablet, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0527 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 25 mg

Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MAGNESIUM STEARATE POVIDONE, UNSPECIFIED SACCHARIN SODIUM SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM ALUMINUM SILICATE

Product Characteristics Color WHITE Score no score Shape OVAL (super elliptical-shaped) Size 5mm Flavor BLACKBERRY (blackcurrant) Imprint Code GX;CL5 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0527-00 100 TABLET, FOR SUSPENSION in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020764 09/03/1998

LAMICTAL ODT lamotrigine tablet, orally disintegrating

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0772 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 25 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) MANNITOL SUCRALOSE ETHYLCELLULOSE (100 MPA.S)

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (flat-faced, radius edge) Size 7mm Flavor CHERRY Imprint Code LMT;25 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0772-02 1 DOSE PACK in 1 CARTON contains a DOSE PACK 1 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK This package is contained within the CARTON (0173-0772-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022251 06/05/2009

LAMICTAL ODT lamotrigine tablet, orally disintegrating

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0774 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 50 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) MANNITOL SUCRALOSE ETHYLCELLULOSE (100 MPA.S)

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (flat-faced, radius edge) Size 9mm Flavor CHERRY Imprint Code LMT;50 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0774-02 1 DOSE PACK in 1 CARTON contains a DOSE PACK 1 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK This package is contained within the CARTON (0173-0774-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022251 06/05/2009

LAMICTAL ODT lamotrigine tablet, orally disintegrating

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0776 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 100 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) MANNITOL SUCRALOSE ETHYLCELLULOSE (100 MPA.S)

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (flat-faced, radius edge) Size 11mm Flavor CHERRY Imprint Code LAMICTAL;100 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0776-02 1 DOSE PACK in 1 CARTON contains a DOSE PACK 1 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK This package is contained within the CARTON (0173-0776-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022251 06/05/2009

LAMICTAL ODT lamotrigine tablet, orally disintegrating

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0777 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 200 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) MANNITOL SUCRALOSE ETHYLCELLULOSE (100 MPA.S)

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (flat-faced, radius edge) Size 14mm Flavor CHERRY Imprint Code LAMICTAL;200 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0777-02 1 DOSE PACK in 1 CARTON contains a DOSE PACK 1 30 TABLET, ORALLY DISINTEGRATING in 1 DOSE PACK This package is contained within the CARTON (0173-0777-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022251 06/05/2009

LAMICTAL lamotrigine kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0594

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0594-02 1 BLISTER PACK in 1 PACKAGE, COMBINATION contains a BLISTER PACK 1 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE, COMBINATION (0173-0594-02)

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 7 Part 2 42

Part 1 of 2 LAMICTAL lamotrigine tablet

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 100 mg

Inactive Ingredients Ingredient Name Strength LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED FD&C YELLOW NO. 6 SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color ORANGE (peach) Score 2 pieces Shape HEXAGON (6 sided) Size 11mm Flavor Imprint Code LAMICTAL;100 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020241 01/17/1995

Part 2 of 2 LAMICTAL lamotrigine tablet

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 25 mg

Inactive Ingredients Ingredient Name Strength LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color WHITE Score 2 pieces Shape HEXAGON (6 sided) Size 6mm Flavor Imprint Code LAMICTAL;25 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020241 08/15/1996

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020241 09/29/2003

LAMICTAL ODT lamotrigine kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0779

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0779-00 1 BLISTER PACK in 1 PACKAGE, COMBINATION contains a BLISTER PACK 1 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE, COMBINATION (0173-0779-00)

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 7 Part 2 21

Part 1 of 2 LAMICTAL ODT lamotrigine tablet, orally disintegrating

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 50 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) MANNITOL SUCRALOSE ETHYLCELLULOSE (100 MPA.S)

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (flat-faced, radius edge) Size 9mm Flavor CHERRY Imprint Code LMT;50 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022251 06/05/2009

Part 2 of 2 LAMICTAL ODT lamotrigine tablet, orally disintegrating

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 25 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) MANNITOL SUCRALOSE ETHYLCELLULOSE (100 MPA.S)

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (flat-faced, radius edge) Size 7mm Flavor CHERRY Imprint Code LMT;25 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022251 06/05/2009

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022251 06/05/2009

LAMICTAL ODT lamotrigine kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0780

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0780-00 1 BLISTER PACK in 1 PACKAGE, COMBINATION contains a BLISTER PACK 1 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE, COMBINATION (0173-0780-00)

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 42 Part 2 14

Part 1 of 2 LAMICTAL ODT lamotrigine tablet, orally disintegrating

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 50 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) MANNITOL SUCRALOSE ETHYLCELLULOSE (100 MPA.S)

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (flat-faced, radius edge) Size 9mm Flavor CHERRY Imprint Code LMT;50 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022251 06/05/2009

Part 2 of 2 LAMICTAL ODT lamotrigine tablet, orally disintegrating

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 100 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) MANNITOL SUCRALOSE ETHYLCELLULOSE (100 MPA.S)

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (flat-faced, radius edge) Size 11mm Flavor CHERRY Imprint Code LAMICTAL;100 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022251 06/05/2009

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022251 06/05/2009

LAMICTAL ODT lamotrigine kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0778

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0778-00 1 BLISTER PACK in 1 PACKAGE, COMBINATION contains a BLISTER PACK 1 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE, COMBINATION (0173-0778-00)

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 14 Part 2 14 Part 3 7

Part 1 of 3 LAMICTAL ODT lamotrigine tablet, orally disintegrating

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 25 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) MANNITOL SUCRALOSE ETHYLCELLULOSE (100 MPA.S)

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (flat-faced, radius edge) Size 7mm Flavor CHERRY Imprint Code LMT;25 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022251 06/05/2009

Part 2 of 3 LAMICTAL ODT lamotrigine tablet, orally disintegrating

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 50 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) MANNITOL SUCRALOSE ETHYLCELLULOSE (100 MPA.S)

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (flat-faced, radius edge) Size 9mm Flavor CHERRY Imprint Code LMT;50 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022251 06/05/2009

Part 3 of 3 LAMICTAL ODT lamotrigine tablet, orally disintegrating

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 100 mg

Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (15 MPA.S AT 5%) MANNITOL SUCRALOSE ETHYLCELLULOSE (100 MPA.S)

Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND (flat-faced, radius edge) Size 11mm Flavor CHERRY Imprint Code LAMICTAL;100 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022251 06/05/2009

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022251 06/05/2009

LAMICTAL lamotrigine kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0817

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0173-0817-28 1 BLISTER PACK in 1 PACKAGE, COMBINATION contains a BLISTER PACK 1 1 KIT in 1 BLISTER PACK This package is contained within the PACKAGE, COMBINATION (0173-0817-28)

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 14 Part 2 84

Part 1 of 2 LAMICTAL lamotrigine tablet

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 100 mg

Inactive Ingredients Ingredient Name Strength LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED FD&C YELLOW NO. 6 SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color ORANGE (peach) Score 2 pieces Shape HEXAGON (6 sided) Size 11mm Flavor Imprint Code LAMICTAL;100 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020241 01/17/1995

Part 2 of 2 LAMICTAL lamotrigine tablet

Product Information Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMOTRIGINE (LAMOTRIGINE) LAMOTRIGINE 25 mg

Inactive Ingredients Ingredient Name Strength LACTOSE, UNSPECIFIED FORM MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color WHITE Score 2 pieces Shape HEXAGON (6 sided) Size 6mm Flavor Imprint Code LAMICTAL;25 Contains

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020241 08/15/1996

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020241 09/29/2003

Labeler — GlaxoSmithKline LLC (167380711)

Revised: 03/2021 GlaxoSmithKline LLC