Memantine Hydrochloride (Page 4 of 5)

16 HOW SUPPLIED/STORAGE AND HANDLING

Memantine hydrochloride tablets, USP 5 mg:
Orange, modified Capsule shape tablet, embossed with “W121” on one side and plain on the other side.

Bottle of 60 NDC# 59115-172-60

Memantine hydrochloride tablets, USP 10 mg:
Gray, modified Capsule shape tablet, embossed with “W122” on one side and plain on the other side.

Bottle of 60 NDC# 59115-173-60

Store Memantine hydrochloride tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature ].

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling ( Patient Information and Instructions for Use).

To assure safe and effective use of memantine hydrochloride tablets, 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 tablets. They should be warned not to use any tablets of memantine hydrochloride tablets 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.

*Trademarks are the property of their respective owners.

Distributed by:
West-Ward Pharmaceutical s C o r p.
Eatontown , NJ 07724 USA

Manufactured by:
HIKMA Pharmaceuticals LLC.
P.O Box 182400
Amman 11118- Jordan
Revised May 2016

PATIENT INFORMATION

M emantine H ydrochloride Tablets, USP

(me-MAN-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 M emantine H ydrochloride 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 M emantine H ydrochloride Tablets ?

Do not take M emantine H ydrochloride 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 H ydrochloride Tablets ?

Before you take Memantine H ydrochloride 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 Tablets pass into your breast milk. You and your doctor should decide if you will take Memantine Hydrochloride Tablets or breastfeed.

Tell your doctor about all the medicines you take , including prescription and non-prescription 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 H ydrochloride 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 H ydrochloride Tablets ?

Memantine H ydrochloride Tablets may cause side effects, including:

The most common side effects of Memantine Hydrochloride Tablets 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 H ydrochloride Tablets ?

  • Store Memantine Hydrochloride Tablets at room temperature between 68°F to 77°F (20°C to 25°C).

What are the ingredients in Memantine H ydrochloride Tablets ?

Memantine H ydrochloride T ablets:

Active ingredients: Memantine Hydrochloride

Inactive ingredients: Lactose monohydrate fast flow, microcrystalline Cellulose, Colloidal silicon dioxide, Croscarmellose Sodium, Talc Powder Extra pure, and magnesium stearate

Inactive ingredients of tablet film coating: Opadry Orange (15B230001); Hypromellose, Titanium dioxide, Polyethylene Glycol/Macrogol, FD&C Yellow #6 / sunset Yellow FCF Aluminum Lake, Polysorbate 80 and FD&C Blue #2 / Indigo Carmine Aluminum Lake (5 mg Tablets), and Opadry Grey (15B275000); Hypromellose, Titanium dioxide, Polyethylene Glycol/Macrogol, Polysorbate 80 and Black Iron Oxide (10 mg Tablets).

Keep Memantine H ydrochloride Tablets and all medicines out of the reach of children.

General information about the safe and effective use of Memantine H ydrochloride 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.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Distributed by:
West-Ward Pharmaceutical Corp.
Eatontown, NJ 07724 — USA

Manufactured by:
HIKMA Pharmaceuticals LLC.
P.O. Box 182400
Amman 11118 – Jordan

Revised May 2016

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 © 2020. All Rights Reserved.