Namenda XR (Allergan, Inc.): FDA Package Insert, Page 5 (2024)

16 HOW SUPPLIED/STORAGE AND HANDLING

7 mg Capsule

Yellow opaque capsule, with “FLI 7 mg” black imprint.

Bottle of 30: NDC# 0456-3407-33

14 mg Capsule

Yellow cap and dark green opaque capsule with “FLI 14 mg” black imprint on the yellow cap.

Bottle of 30: NDC# 0456-3414-33

Bottle of 90: NDC# 0456-3414-90

21 mg Capsule

White to off-white cap and dark green opaque capsule, with “FLI 21 mg” black imprint on the white to off-white cap.

Bottle of 30: NDC# 0456-3421-33

28 mg Capsule

Dark green opaque capsule, with “FLI 28 mg” white imprint.

Bottle of 30: NDC# 0456-3428-33

Bottle of 90: NDC# 0456-3428-90

Titration Pack NDC# 0456-3400-29

Contains 28 capsules (7 x 7 mg, 7 x 14 mg, 7 x 21 mg, 7 x 28 mg)

Store NAMENDA XR at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

• To assure safe and effective use of NAMENDA XR, the information and instructions provided in the patient information section should be discussed with patients and caregivers.
  
• Instruct patients and caregivers to take NAMENDA XR only once per day, as prescribed.
  
• Instruct patients and caregivers that NAMENDA XR capsules be swallowed whole. Alternatively, NAMENDA XR capsules may be opened and sprinkled on applesauce and the entire contents should be consumed. The capsules should not be divided, chewed or crushed.
  
• Warn patients not to use any capsules of NAMENDA XR that are damaged or show signs of tampering.
  
• If a patient misses a single dose of NAMENDA XR, that patient should not double up on the next dose. The next dose should be taken as scheduled. If a patient fails to take NAMENDA XR for several days, dosing should not be resumed without consulting that patient’s healthcare professional.
  
• Advise patients and caregivers that NAMENDA XR may cause headache, diarrhea, and dizziness.

Made in Ireland.

Distributed by:

Allergan USA, Inc.

Madison, NJ 07940

Licensed from Merz Pharmaceuticals GmbH & Co.

NAMENDA XR^® is a registered trademark of Merz Pharma GmbH & Co KGaA

All other trademarks are the property of their respective owners.

Allergan and its design are trademarks of Allergan, Inc.

Patented. See www.allergan.com/patents

© 2019 Allergan. All rights reserved.

Patient Information

NAMENDA XR ^® [Nuh-MEN-dah Eks-Are]

(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 N-methyl-D-aspartate (NMDA) 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 i f 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 memantine passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take NAMENDA XR.

Tell your doctor about all the medicines you take , including prescription and non-prescription 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 1-800-222-1222, or go to the nearest hospital emergency room right away.

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:

• headache
  
• diarrhea
  
• dizziness

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 Allergan at 1-800-678-1605.

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

Made in Ireland

Distributed by:
Allergan USA, Inc.
Madison, NJ 07940
Licensed from Merz Pharmaceuticals GmbH & Co. KGaA

NAMENDA XR^® is a registered trademark of Merz Pharma GmbH & Co. KGaA

Allergan^® and its design are trademarks of Allergan, Inc.

Revised: 11/2019

© 2019 Allergan. All rights reserved.

PRINCIPAL DISPLAY PANEL

NDC 0456-3407-33
30 capsules
Rx only

Once-Daily
Namenda XR®
(memantine HCI) extended release capsules7 mg