Memantine (Page 5 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Memantine hydrochloride tablets USP, 10 mg are grey colored, capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘597’ on other side. They are supplied:

Overbagged with 10 tablets per bag, NDC 55154-7637-0

Store at 20°-25°C (68°-77°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 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 tablets, 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 tablets for several days, dosing should not be resumed without consulting that patient’s healthcare professional.

All other trademarks are the property of their respective owners.

Patient Information

Memantine Hydrochloride Tablets, USP

(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 is memantine hydrochloride?

Memantine hydrochloride is a prescription medicine used for the treatment of moderate to severe dementia in people with Alzheimer’s disease. Memantine hydrochloride belongs 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 tablets. 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 daf

• 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 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 tablets.

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

Taking memantine hydrochloride with certain other medicines may affect each other. Taking memantine hydrochloride 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 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 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 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 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 tablets include:

• dizziness

• confusion

• headache

• 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 20°-25°C (68°-77°F).

What are the ingredients in memantine hydrochloride tablets?

Active ingredients: memantine hydrochloride

Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, povidone and talc. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, polyethylene glycol, titanium dioxide, FD & C Yellow #6 and FD & C blue #2 (5 mg tablets), black iron oxide (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 call 1-888-375-3784.

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

RX Only

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally – 500 090 INDIA

Distributed By:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

Distributed by:

Cardinal Health

Dublin, OH 43017

L52113961118

Revised: 1118

Dispense with Patient Information Sheet available at:

www.drreddys.com/pi/memantinetabs.pdf

Package/Label Display Panel

Memantine Hydrochloride Tablets, USP 10 mg

10 Tablets

Bag Label
(click image for full-size original)
MEMANTINE
memantine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-7637(NDC:0904-6506)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MEMANTINE HYDROCHLORIDE (MEMANTINE) MEMANTINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE K12
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
FD&C BLUE NO. 2
POLYETHYLENE GLYCOL, UNSPECIFIED
FERROSOFERRIC OXIDE
TALC
Product Characteristics
Color GRAY Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code RDY;597
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-7637-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the BAG (55154-7637-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090048 07/20/2015
Labeler — Cardinal Health (603638201)

Revised: 02/2020 Cardinal Health

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