Memantine Hydrochloride: Package Insert and Label Information (Page 3 of 3)

16 HOW SUPPLIED/STORAGE AND HANDLING

7 mg Capsule

Size ‘4’ hard gelatin yellow capsule with yellow opaque cap and yellow opaque body, with black imprint “LU” on cap and “O61” on body.

Bottle of 30: NDC 68180-246-06

Bottle of 90: NDC 68180-246-09

Bottle of 500: NDC 68180-246-02

14 mg Capsule

Size ‘4’ hard gelatin capsule with yellow opaque cap and dark green opaque body, with black imprint “LU” on cap and “O62” on body.

Bottle of 30: NDC 68180-247-06

Bottle of 90: NDC 68180-247-09

Bottle of 500: NDC 68180-247-02

Blister of 10 X 10 Unit-Dose: NDC 68180-247-13

21 mg Capsule

Size ‘4’ hard gelatin capsule with white opaque cap and dark green opaque body, with black imprint “LU” on cap and “O63” on body.

Bottle of 30: NDC 68180-248-06

Bottle of 90: NDC 68180-248-09

Bottle of 500: NDC 68180-248-02

28 mg Capsule

Size ‘3’ hard gelatin dark green capsule with black imprint “LU” on cap and “O64” on body.

Bottle of 30: NDC 68180-249-06

Bottle of 90: NDC 68180-249-09

Bottle of 500: NDC 68180-249-02

Blister of 10 X 10 Unit-Dose: NDC 68180-249-13

Storage

Store memantine hydrochloride extended-release at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

• To assure safe and effective use of memantine hydrochloride extended-release, the information and instructions provided in the patient information section should be discussed with patients and caregivers.

• Instruct patients and caregivers to take memantine hydrochloride extended-release only once per day, as prescribed.

• Instruct patients and caregivers that memantine hydrochloride extended-release capsules be swallowed whole. Alternatively, memantine hydrochloride extended-release capsules may be opened and sprinkled on applesauce and the entire contents should be consumed. The capsules should not be divided, chewed or crushed.

• Warn patients not to use any capsules of memantine hydrochloride extended-release that are damaged or show signs of tampering.

• If a patient misses a single dose of memantine hydrochloride extended-release, that patient should not double up on the next dose. The next dose should be taken as scheduled. If a patient fails to take memantine hydrochloride extended-release for several days, dosing should not be resumed without consulting that patient’s healthcare professional.

• Advise patients and caregivers that memantine hydrochloride extended-release may cause headache, diarrhea, and dizziness.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) – 454 775

India

November 2020

Patient Information

Memantine Hydrochloride Extended-release Capsules

[me-MAN-teen HYE-droe-KLOR-ide]

Rx Only

Read this Patient Information that comes with memantine hydrochloride extended-release capsules before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What are memantine hydrochloride extended-release capsules?

Memantine hydrochloride extended-release capsule is a prescription medicine used for the treatment of moderate to severe dementia in people with Alzheimer’s disease. Memantine hydrochloride extended-release capsule belongs to a class of medicines called N-methyl-D-aspartate (NMDA) inhibitors.

It is not known if memantine hydrochloride extended-release capsule is safe and effective in children.

Who should not take memantine hydrochloride extended-release capsules?

Do not take memantine hydrochloride extended-release capsules if you are allergic to memantine or any of the other ingredients in memantine hydrochloride extended-release capsules. See the end of this leaflet for a complete list of ingredients in memantine hydrochloride extended-release capsules.

What should I tell my doctor before taking memantine hydrochloride extended-release capsules?

Before you take memantine hydrochloride extended-release capsules, tell your doctor if you:

• have or have had seizures
• have or have had problems passing urine
• have or have had bladder or kidney problems
• have liver problems
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if memantine hydrochloride extended-release will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if memantine passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take memantine hydrochloride extended-release.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Taking memantine hydrochloride extended-release capsules with certain other medicines may affect each other. Taking memantine hydrochloride extended-release capsules with other medicines can cause serious side effects.

Especially tell your doctor if you take:

• other NMDA antagonists such as amantadine, ketamine, and dextromethorphan

• medicines that make your urine alkaline such as carbonic anhydrase inhibitors and sodium bicarbonate

Ask your doctor or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take memantine hydrochloride extended-release capsules?

• Your doctor will tell you how much memantine hydrochloride extended-release capsules to take and when to take it.
• Your doctor may change your dose if needed.
• Memantine hydrochloride extended-release capsules may be taken with food or without food.
• Memantine hydrochloride extended-release capsules may be opened and sprinkled on applesauce before swallowing, but the contents of the entire capsule should be taken and the dose should not be divided. Except when opened and sprinkled on applesauce, memantine hydrochloride extended-release capsules must be swallowed whole and never crushed, divided or chewed.
• Do not use any capsules of memantine hydrochloride extended-release that are damaged or show signs of tampering.
• If you are currently taking another formulation of memantine, talk to your healthcare professional about how to switch to memantine hydrochloride extended-release capsules.
• If you forget to take one dose of memantine hydrochloride extended-release capsules, do not double up on the next dose. You should take only the next dose as scheduled.
• If you have forgotten to take memantine hydrochloride extended-release capsules for several days, you should not take the next dose until you talk to your doctor.
• If you take too much memantine hydrochloride extended-release capsules call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.

What are the possible side effects of memantine hydrochloride extended-release capsules?

Memantine hydrochloride extended-release capsules may cause side effects, including:

The most common side effects of memantine hydrochloride extended-release capsules include:

• headache

• diarrhea

• dizziness

These are not all the possible side effects of memantine hydrochloride extended-release capsules. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or visit our website at www.lupinpharmaceuticals.com.

How should I store memantine hydrochloride extended-release capsules?

Store memantine hydrochloride extended-release capsules at room temperature between 68 to 77°F (20 to 25°C).

Keep memantine hydrochloride extended-release capsules and all medicines out of the reach of children.

What are the ingredients in memantine hydrochloride extended-release capsules?

Active ingredient: memantine hydrochloride USP

Inactive ingredients: ethyl cellulose, gelatin, hypromellose, maize starch, sucrose, talc, titanium dioxide and triethyl citrate in hard gelatin capsules. Additionally, 7 mg strength capsules contain D&C Yellow #10 and FD&C Red #40; 14 mg strength capsules contain D&C Yellow #10, FD&C Blue #1, FD&C Red #40 and iron oxide yellow; 21 mg and 28 mg strength capsules contain FD&C Blue #1 and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol and shellac.

General information about the safe and effective use of memantine hydrochloride extended-release capsules:

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take memantine hydrochloride extended-release capsules for a condition for which it was not prescribed. Do not give memantine hydrochloride extended-release capsules to other people, even if they have the same condition. It may harm them.

This Patient Information leaflet summarizes the most important information about memantine hydrochloride extended-release capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about memantine hydrochloride extended-release capsules that was written for healthcare professionals.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) – 454 775

India

November 2020 ID#: 266044

Memantine Hydrochloride Extended-release Capsules, 7 mg

Rx Only

NDC 68180-246-06

30 Capsules

Memantine Hydrochloride Extended-release Capsules, 14 mg

Rx Only

NDC 68180-247-06

30 Capsules

Memantine Hydrochloride Extended-release Capsules, 21 mg

Rx Only

NDC 68180-248-06

30 Capsules

Memantine Hydrochloride Extended-release Capsules, 28 mg

Rx Only

NDC 68180-249-06

30 Capsules

MEMANTINE HYDROCHLORIDE memantine hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-246 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEMANTINE HYDROCHLORIDE (MEMANTINE) MEMANTINE HYDROCHLORIDE 7 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 ETHYLCELLULOSES FD&C RED NO. 40 FERROSOFERRIC OXIDE GELATIN HYPROMELLOSES POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE

Product Characteristics Color YELLOW ((YELLOW (OPAQUE))) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code LU;O61 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-246-06 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:68180-246-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:68180-246-02 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206028 02/20/2018

MEMANTINE HYDROCHLORIDE memantine hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-249 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEMANTINE HYDROCHLORIDE (MEMANTINE) MEMANTINE HYDROCHLORIDE 28 mg

Inactive Ingredients Ingredient Name Strength ETHYLCELLULOSES FD&C BLUE NO. 1 FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN HYPROMELLOSES POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE

Product Characteristics Color GREEN ((DARK GREEN)) Score no score Shape CAPSULE Size 16mm Flavor Imprint Code LU;O64 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-249-13 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68180-249-11) 1 NDC:68180-249-11 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (68180-249-13) 2 NDC:68180-249-06 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:68180-249-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None 4 NDC:68180-249-02 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206028 02/20/2018

MEMANTINE HYDROCHLORIDE memantine hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-247 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEMANTINE HYDROCHLORIDE (MEMANTINE) MEMANTINE HYDROCHLORIDE 14 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 ETHYLCELLULOSES FD&C BLUE NO. 1 FD&C RED NO. 40 FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN HYPROMELLOSES POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE

Product Characteristics Color YELLOW (YELLOW OPAQUE) , GREEN (DARK GREEN OPAQUE) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code LU;O62 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-247-13 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (68180-247-11) 1 NDC:68180-247-11 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the CARTON (68180-247-13) 2 NDC:68180-247-06 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:68180-247-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None 4 NDC:68180-247-02 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206028 02/20/2018

MEMANTINE HYDROCHLORIDE memantine hydrochloride capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-248 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MEMANTINE HYDROCHLORIDE (MEMANTINE) MEMANTINE HYDROCHLORIDE 21 mg

Inactive Ingredients Ingredient Name Strength ETHYLCELLULOSES FD&C BLUE NO. 1 FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN HYPROMELLOSES POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE

Product Characteristics Color WHITE (WHITE OPAQUE) , GREEN (DARK GREEN OPAQUE) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code LU;O63 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-248-06 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None 2 NDC:68180-248-09 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None 3 NDC:68180-248-02 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206028 02/20/2018

Labeler — Lupin Pharmaceuticals, Inc. (089153071)

Registrant — LUPIN LIMITED (675923163)

Establishment
Name	Address	ID/FEI	Operations
LUPIN LIMITED		863645527	MANUFACTURE (68180-246), MANUFACTURE (68180-247), MANUFACTURE (68180-248), MANUFACTURE (68180-249), PACK (68180-246), PACK (68180-247), PACK (68180-248), PACK (68180-249)

Revised: 11/2020 Lupin Pharmaceuticals, Inc.