"Today, the U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of noticeable (overt) dementia.
(memantine hydrochloride) Extended-Release Capsules
Read this Patient Information that comes with NAMENDA XR 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 NAMENDA XR?
NAMENDA XR is a prescription medicine used for the treatment of moderate to severe dementia in people with Alzheimer's disease. NAMENDA XR belongs to a class of medicines called NMDA (N-methyl-D-aspartate) inhibitors.
It is not known if NAMENDA XR is safe and effective in children.
Who should not take NAMENDA XR?
Do not take NAMENDA XR if you are allergic to memantine or any of the other ingredients in NAMENDA XR. See the end of this leaflet for a complete list of ingredients in NAMENDA XR.
What should I tell my doctor before taking NAMENDA XR?
Before you take NAMENDA XR, 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 NAMENDA XR will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if NAMENDA XR passes into your breast milk. You and your doctor should decide if you will take NAMENDA XR or breastfeed.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Taking NAMENDA XR with certain other medicines may affect each other. Taking NAMENDA XR 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 NAMENDA XR?
- Your doctor will tell you how much NAMENDA XR to take and when to take it.
- Your doctor may change your dose if needed.
- NAMENDA XR may be taken with food or without food.
- NAMENDA XR 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, NAMENDA XR capsules must be swallowed whole and never crushed, divided or chewed.
- Do not use any capsules of NAMENDA XR 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 NAMENDA XR.
- If you forget to take one dose of NAMENDA XR, do not double up on the next dose. You should take only the next dose as scheduled.
- If you have forgotten to take NAMENDA XR for several days, you should not take the next dose until you talk to your doctor.
- If you take too much NAMENDA XR, call your doctor or poison control center at 1800-222-1222 right away, or go to the nearest hospital emergency room.
What are the possible side effects of NAMENDA XR?
NAMENDA XR may cause side effects, including:
The most common side effects of NAMENDA XR include:
These are not all the possible side effects of NAMENDA XR. 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 NAMENDA XR?
- Store NAMENDA XR at room temperature between 68°F to 77°F (20°C to 25°C).
What are the ingredients in NAMENDA XR?
Active ingredient: memantine hydrochloride Inactive ingredients: sugar spheres, polyvinylpyrrolidone, hypromellose, talc,
polyethylene glycol, ethylcellulose, ammonium hydroxide, oleic acid, and medium chain triglycerides
Keep NAMENDA XR and all medicines out of the reach of children.
General information about the safe and effective use of NAMENDA XR:
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take NAMENDA XR for a condition for which it was not prescribed. Do not give NAMENDA XR to other people, even if they have the same condition. It may harm them.
This Patient Information leaflet summarizes the most important information about NAMENDA XR. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about NAMENDA XR that was written for healthcare professionals.
For more information about NAMENDA XR, go to www.namendaxr.com, or call Forest Laboratories, Inc. at 1-800-678-1605.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 10/14/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Namenda XR Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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