MEMANTINE HYDROCHLORIDE (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Memantine Hydrochloride Extended-Release Capsules , 7 mg are white to off-white coated pellets filled in the yellow opaque cap/yellow opaque body hard gelatin capsules imprinted with “M 7” on cap with black ink.

Bottle of 30 NDC 59651-404-30

Bottle of 90 NDC 59651-404-90

Memantine Hydrochloride Extended-Release Capsules , 14 mg are white to off-white coated pellets filled in the yellow opaque cap/dark green opaque body hard gelatin capsules imprinted with “M 14” on cap with black ink.

Bottle of 30 NDC 59651-405-30

Bottle of 90 NDC 59651-405-90

Memantine Hydrochloride Extended-Release Capsules , 21 mg are white to off-white coated pellets filled in the white to off-white cap/dark green opaque body hard gelatin capsules imprinted with “M 21” on cap with black ink.

Bottle of 30 NDC 59651-406-30

Bottle of 90 NDC 59651-406-90

Memantine Hydrochloride Extended-Release Capsules , 28 mg are white to off-white coated pellets filled in the dark green opaque cap/dark green opaque body hard gelatin capsules imprinted with “M 28” on cap with white ink.

Bottle of 30 NDC 59651-407-30

Bottle of 90 NDC 59651-407-90

Titration Pack
Contains 28 capsules (7 x 7 mg, 7 x 14 mg, 7 x 21 mg, 7 x 28 mg) NDC 59651-408-28

Store memantine hydrochloride extended-release capsules at 20° to 25°C (68° to 77°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 capsules, 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 capsules only once per day, as prescribed.
  • Instruct patients and caregivers that memantine hydrochloride extended-release capsules capsules be swallowed whole. Alternatively, memantine hydrochloride extended-release capsules 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 capsules that are damaged or show signs of tampering.
  • If a patient misses a single dose of memantine hydrochloride extended-release capsules, 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 capsules for several days, dosing should not be resumed without consulting that patient’s healthcare professional.
  • Advise patients and caregivers that memantine hydrochloride extended-release capsules may cause headache, diarrhea, and dizziness.

All brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India
Issued: June 2021

Patient Information

Memantine Hydrochloride Extended-Release Capsules

[ mem’ an teen hye” droe klor’ ide ]

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

It is not known if memantine hydrochloride extended-release capsules are 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 capsules 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 capsules.

Tell your doctor about all the medicines you take, including prescription and non-prescription 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 capsules 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 capsule, 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, 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.

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

Inactive ingredients: ethylcellulose, hypromellose, polyethylene glycol, sugar spheres [which contains starch (maize) and sucrose] and talc. The hard gelatin capsule shell contains gelatin, iron oxide yellow and titanium dioxide. In addition the 14 mg, 21 mg and 28 mg hard gelatin capsule shell contains FD&C blue 1 and FD&C yellow 6. The 7 mg, 14 mg and 21 mg capsules are imprinted with black ink containing black iron oxide, potassium hydroxide and shellac. The 28 mg capsules are imprinted with white ink containing potassium hydroxide, shellac and titanium dioxide.

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.

For more information about memantine hydrochloride extended-release capsules, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.

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

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India
Issued: June 2021

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.