"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.
- Patient Information:
Details with Side Effects
(memantine hydrochloride) Extended Release Capsules
What is NAMENDA XR and what is it used for?
NAMENDA XR belongs to a class of substances called NMDA antagonists. It is used for the treatment of patients with Alzheimer's disease.
Do not take NAMENDA XR in the following cases:
If you know that you are allergic (hyper-sensitive) to memantine (the active substance in NAMENDA XR) or to any of the other ingredients of NAMENDA XR [see DESCRIPTION].
Take special care with NAMENDA XR if:
- You have, or ever had seizures.
- You have, or ever had difficulty passing urine.
If any of these apply to you, your doctor may need to monitor you more closely while you are on this medicine.
NAMENDA XR with food and drink:
NAMENDA XR may be taken with 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 [see DOSAGE AND ADMINISTRATION].
NAMENDA XR and older people:
NAMENDA XR can be used by patients over the age of 65, as well as by patients with Alzheimer's Disease who are aged 65 years or younger.
NAMENDA XR and children:
The use of NAMENDA XR in children is not recommended.
Tell your doctor if you are pregnant or planning to become pregnant. In the event of pregnancy, the benefits of NAMENDA XR must be assessed against the possible effects on your unborn child. Ask your doctor or pharmacist for advice before taking any medicine during pregnancy.
You should not breast-feed during treatment with NAMENDA XR. Ask your doctor or pharmacist for advice before taking any medicine while you are breast-feeding.
Taking other medicines:
Tell your doctor or pharmacist about any other medicines you are taking or have recently taken, including any you have taken without a prescription.
How to use NAMENDA XR:
Follow all instructions given to you by your doctor carefully, even if they differ from the ones given in this leaflet.
How to start treatment:
Treatment begins at a low dose (7 mg, once a day) and is gradually increased until the target dose (28 mg, once a day) is reached. To be effective, NAMENDA XR must be taken correctly, according to the following schedule:
Week 1: Start on Day 1
Take one 7 mg capsule each day.
Week 2: Start on Day 8
Take one 14 mg capsule each day.
Week 3: Start on Day 15
Take one 21 mg capsule each day.
Week 4: Start on Day 22
Take one 28 mg capsule each day. Once the target dose (28 mg, once a day) has been reached, you can continue with that daily schedule unless told otherwise by your healthcare professional. (For patients with severe renal impairment, 14 mg once a day is the recommended dose.)
During the course of treatment, your healthcare professional may change the dose to suit your individual needs.
If you are currently taking another formulation of memantine, talk to your healthcare professional about how to switch to NAMENDA XR.
What to do if you take more NAMENDA XR capsules than you should:
If you accidentally take more NAMENDA XR capsules than you should, inform your healthcare professional that you have accidentally taken more NAMENDA XR than you should have. You may require medical attention. Some people who have accidentally taken too much memantine have experienced dizziness, unsteadiness, weakness, tiredness, confusion, as well as other symptoms.
If you forget to take NAMENDA XR:
If you forget to take one dose of NAMENDA XR, do not double-up on your next dose. Take only your next dose as scheduled.
If you have forgotten to take NAMENDA XR for several days, do not take the next dose until you have talked to your healthcare professional.
Possible side effects:
Like all medicines, NAMENDA XR can cause side effects, although not everyone gets them.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
The most common side effects in patients taking NAMENDA XR were headache, diarrhea and dizziness.
How to store NAMENDA XR:
Do not use NAMENDA XR after the expiration date shown on the carton and bottle.
Store at 25°C (77°F).
Do not use any capsules of NAMENDA XR that are damaged or show signs of tampering.
Keep NAMENDA XR out of the reach and sight of children and pets.
Last reviewed on RxList: 7/21/2014
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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