Prescription Drug Information: Memantine Hydrochloride (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

10 mg Tablet: Gray color, capsule shape, film-coated tablet, debossed with “CL28” on one side and plain on the other side.
Bottle of 30 NDC # 68788-7165-3

Bottle of 60 NDC # 68788-7165-6

Bottle of 90 NDC # 68788-7165-9


Store memantine hydrochloride tablets 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].

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information ).
To assure safe and effective use of memantine hydrochloride, the following information and instructions provided in the patient information section should be discussed with patients and caregivers.
Patients/caregivers should be instructed to follow the dose titration schedule provided by their physician or healthcare professional for memantine hydrochloride. They should be warned not to use any tablets of memantine hydrochloride that are damaged or show signs of tampering.
If a patient misses a single dose of memantine hydrochloride, 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 for several days, dosing should not be resumed without consulting that patient’s healthcare professional.

Manufactured for :
Macleods Pharma USA, Inc.
Plainsboro, NJ 08536
Manufactured by:
Macleods Pharmaceuticals Ltd.
Baddi, Himachal Pradesh, INDIA

Revised: September 2019

PM01915504

.

PATIENT INFORMATION

Memantine Hydrochloride Tablets
[mem’ an teen hye” droe klor’ ide]

Read this Patient Information that comes with memantine hydrochloride tablets 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 tablets?
Memantine hydrochloride tablets are a prescription medicine used for the treatment of moderate to severe dementia in people with Alzheimer’s disease. Memantine hydrochloride tablets belong to a class of medicines called NMDA (N-methyl-D-aspartate) inhibitors.
It is not known if memantine hydrochloride tablets are safe and effective in children.
Who should not take memantine hydrochloride tablets?
Do not take memantine hydrochloride tablets if you are allergic to memantine or any of the ingredients in memantine hydrochloride. See the end of this leaflet for a complete list of ingredients in memantine hydrochloride tablets.
What should I tell my doctor before taking memantine hydrochloride tablets?
Before you take memantine hydrochloride tablets, 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 tablets will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if memantine hydrochloride passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take memantine hydrochloride tablets.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Taking memantine hydrochloride tablets with certain other medicines may affect each other. Taking memantine hydrochloride tablets 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 tablets?
• Your doctor will tell you how much memantine hydrochloride tablets to take and when to take it.
• Your doctor may change your dose if needed.
• Memantine hydrochloride tablets can be taken with food or without food.
• Do not use any tablets of memantine hydrochloride tablets that are damaged or show signs of tampering.
• If you forget to take one dose of memantine hydrochloride tablets, 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 tablets for several days, you should not take the next dose until you talk to your doctor.
• If you take too much memantine hydrochloride tablets, call your doctor or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.

What are the possible side effects of memantine hydrochloride tablets?
Memantine hydrochloride tablets may cause side effects, including:
The most common side effects of memantine hydrochloride include:
• dizziness
• headache
• confusion
• constipation
These are not all the possible side effects of memantine hydrochloride tablets. 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 tablets?
• Store memantine hydrochloride tablets at room temperature between 59°F to 77°F (15°C to 30°C).
What are the ingredients in memantine hydrochloride tablets?
Memantine hydrochloride tablets:
Active ingredients: memantine hydrochloride
Inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate.
Inactive ingredients of tablet film coating: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol, polyethylene glycol 400 and iron oxide black (10 mg tablets).

Keep memantine hydrochloride tablets and all medicines out of the reach of children.
General information about the safe and effective use of memantine hydrochloride tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take memantine hydrochloride tablets for a condition for which it was not prescribed. Do not give memantine hydrochloride tablets 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 tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about memantine hydrochloride tablets that was written for healthcare professionals.
For more information about memantine hydrochloride tablets call Macleods Pharma USA, Inc. at 1-888-943-3210.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Manufactured for :
Macleods Pharma USA, Inc.
Plainsboro, NJ 08536
Manufactured by:
Macleods Pharmaceuticals Ltd.
Baddi, Himachal Pradesh, INDIA
Revised: January 2019
PM01915604

Repackaged By: Preferred Pharmaceuticals Inc.

PACKAGE LABEL PRINCIPAL DISPLAY PANEL — 10 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-10 mg

NDC 68788-7165

Rx only

Label Memantine Hydrochloride Tablets USP

10 mg

Memantine HCL Tablets 10mg
(click image for full-size original)

MEMANTINE HYDROCHLORIDE memantine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7165(NDC:33342-298)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEMANTINE HYDROCHLORIDE (MEMANTINE) MEMANTINE HYDROCHLORIDE 10 mg
Product Characteristics
Color GRAY (gray) Score no score
Shape CAPSULE (capsule) Size 12mm
Flavor Imprint Code CL;28
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7165-3 30 TABLET in 1 BOTTLE None
2 NDC:68788-7165-6 60 TABLET in 1 BOTTLE None
3 NDC:68788-7165-9 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202840 06/05/2018
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-7165)

Revised: 07/2021 Preferred Pharmaceuticals Inc.

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