Namenda XR

Namenda XR is part of the drug class:

• Other anti dementia drugs

You should not take Namenda XR if you are allergic to any of its ingredients. Tell your doctor if you are allergic to Namenda XR or any other medicines.

Namenda XR can make you drowsy. Do not drive a car or operate machinery until you know how this medicine affects you.

Poor liver or kidney function can lead to an increase in the level of Namenda XR in the body. This may increase your risk of side effects. Tell your doctor if you have liver or kidney disease.

In case of overdose, call your local poison control center. If the victim has collapsed or is not breathing, call local emergency services at 911. Symptoms of overdose may include:

• restlessness 
• hallucination (seeing things or hearing voices that do not exist) 
• sleepiness 
• loss of consciousness 

Because strategies for the management of overdose are continually evolving, it is advisable to contact a poison control center to determine the latest recommendations for the management of an overdose of any drug.

Use Namenda XR as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Swallow whole. Do not chew or crush.
• Do not take any capsules that do not look normal or are damaged.
• You may sprinkle contents of capsule on applesauce. Do not chew.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you miss taking this medicine for a few days in a row, call your doctor before you start taking it again.

Each capsule contains 7 mg, 14 mg, 21 mg, or 28 mg of memantine HCl.

• The 7 mg capsules are a yellow opaque capsule, with “FLI 7 mg” black imprint.
• The 14 mg capsules are a yellow cap and dark green opaque body capsule, with “FLI 14 mg” black imprint on the yellow cap.
• The 21 mg capsules are a white to off-white cap and dark green opaque body capsule, with “FLI 21 mg” black imprint on the white to off-white cap.
• The 28 mg capsules are a dark green opaque capsule, with “FLI 28 mg” white imprint.

Genitourinary Conditions

Conditions that raise urine pH may decrease the urinary elimination of memantine resulting in increased plasma levels of memantine [see Drug Interactions (7.1)].

Carcinogenesis, Mutagenesis, Impairment of Fertility

There was no evidence of carcinogenicity in a 113-week oral study in mice at doses up to 40 mg/kg/day (7 times the maximum recommended human dose [MRHD] on a mg/m2 basis). There was also no evidence of carcinogenicity in rats orally dosed at up to 40 mg/kg/day for 71 weeks followed by 20 mg/kg/day (14 and 7 times the MRHD on a mg/m2 basis, respectively) through 128 weeks.

Memantine produced no evidence of genotoxic potential when evaluated in the in vitro S. typhimurium or E. coli reverse mutation assay, an in vitro chromosomal aberration test in human lymphocytes, an in vivo cytogenetics assay for chromosome damage in rats, and the in vivo mouse micronucleus assay. The results were equivocal in an in vitro gene mutation assay using Chinese hamster V79 cells.

No impairment of fertility or reproductive performance was seen in rats administered up to 18 mg/kg/day (6 times the MRHD on a mg/m2 basis) orally from 14 days prior to mating through gestation and lactation in females, or for 60 days prior to mating in males.

Animal Toxicology and /or Pharmacology

Memantine induced neuronal lesions (vacuolation and necrosis) in the multipolar and pyramidal cells in cortical layers III and IV of the posterior cingulate and retrosplenial neocortices in rats, similar to those which are known to occur in rodents administered other NMDA receptor antagonists. Lesions were seen after a single dose of memantine. In a study in which rats were given daily oral doses of memantine for 14 days, the no-effect dose for neuronal necrosis was 4 times the maximum recommended human dose (MRHD of 28 mg/day) on a mg/m2 basis.

In acute and repeat-dose neurotoxicity studies in female rats, oral administration of memantine and donepezil in combination resulted in increased incidence, severity, and distribution of neurodegeneration compared with memantine alone. The no-effect levels of the combination were associated with clinically relevant plasma memantine and donepezil exposures.

The relevance of these findings to humans is unknown.

7 mg Capsule

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

14 mg Capsule

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

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.

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

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.

Distributed by:
Allergan USA, Inc.
Irvine, CA 92612

Manufactured by:
Forest Laboratories Ireland Ltd

Licensed from Merz Pharmaceuticals GmbH

© 2017 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 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 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 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:

• 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.

Distributed by:
Allergan USA, Inc.
Irvine, CA 92612

Manufactured by:
Forest Laboratories Ireland Ltd

Licensed from Merz Pharmaceuticals GmbH

Revised: 10/2016

© 2017 Allergan. All rights reserved

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

NDC 0456-3407-33

30 capsules

Rx Only

Once-Daily

Namenda XR®

(memantine HCl) extended release capsules

7 mg

AllerganTM

Distributed by:
Allergan USA, Inc., Irvine, CA 92612

NDC 0456-3428-33

30 capsules

Rx Only

Once-Daily

Namenda XR®

(memantine HCl) extended release capsules

28 mg

AllerganTM

Distributed by:
Allergan USA, Inc., Irvine, CA 92612

Applies to memantine: oral capsule extended release, oral kit, oral solution, oral tablet

General

The most common adverse reactions (frequency of at least 5% and higher than placebo) were dizziness, headache, confusion, constipation, and diarrhea.[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, hypotension, bradycardia, angina pectoris, phlebitis, deep thrombophlebitis, cardiac arrest
Uncommon (0.1% to 1%): Cardiac failure, venous thrombosis/thromboembolism
Frequency not reported: Postural hypotension, rhythm and rate disturbance (e.g., atrial fibrillation), QTc prolongation, ischemic event and sudden death (e.g., myocardial infarction), embolism, venous thrombosis/thromboembolism[Ref]

Dermatologic

Common (1% to 10%): Purpura, rash, basal cell carcinoma
Frequency not reported: Dermatitis, skin disorder, skin ulceration, bullous eruption, pruritus, increased sweating
Postmarketing reports: Stevens Johnson syndrome[Ref]

Endocrine

Common (1% to 10%): Hyperglycemia, diabetes mellitus
Frequency not reported: Aggravated diabetes mellitus[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, diarrhea, abdominal pain, vomiting, nausea, gastroenteritis
Frequency not reported: Diverticulitis, dyspepsia, hemorrhoids, gastric ulcer, ileus
Postmarketing reports: Pancreatitis[Ref]

Genitourinary

Common (1% to 10%): Urinary incontinence, fecal incontinence, urinary tract infection, hyperuricemia, micturition frequency
Frequency not reported: Cystitis, pyuria, hematuria[Ref]

Hepatic

Common (1% to 10%): Increased ALT, increased AST, increased gamma-glutamyl transferase (GGT), increased phosphatase alkaline, elevated liver function test
Postmarketing reports: Hepatitis, bilirubinemia[Ref]

Hypersensitivity

Common (1% to 10%): Drug hypersensitivity[Ref]

Metabolic

Common (1% to 10%): Increased weight, decreased weight, anorexia, dehydration, hypokalemia
Frequency not reported: Increased appetite, hypernatremia, hyponatremia[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, leg pain, hypertonia, arthrosis, muscle weakness, myalgia, skeletal pain[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, somnolence, balance disorders, abnormal gait, syncope, coma
Uncommon (0.1% to 1%): Seizures
Frequency not reported: Aphasia, speech disorder, hyperkinesia, dyskinesia, dementia, partial epileptic seizure, convulsions, tremor, extrapyramidal disorder, transient ischemic attack, vertigo, numbness, paresthesia, stupor, cerebrovascular disorder, intracranial hemorrhage[Ref]

Ocular

Common (1% to 10%): Cataract, conjunctivitis[Ref]

Other

Common (1% to 10%): Fatigue, peripheral edema, pain, influenza, inflicted injury, fall, dependent edema, tooth ache, tooth caries, edema, abrasion
Uncommon (0.1% to 1%): Fungal infections
Frequency not reported: Fever, asthenia, tiredness, chest pain, menstrual disorder[Ref]

Psychiatric

Common (1% to 10%): Confusion, hallucination, anxiety, depression, aggression, agitation, insomnia, delusion, sleep disorder, abnormal crying
Frequency not reported: Increased libido, mental status changes, nervousness, excitation/mania, suicide attempt, psychotic reactions
Postmarketing reports: Suicidal ideation, suicide, psychotic reactions[Ref]

Respiratory

Common (1% to 10%): Coughing, dyspnea, bronchitis, pneumonia, upper respiratory tract infection, apnea, rhinitis
Frequency not reported: Atelectasis[Ref]

Hematologic

Frequency not reported: Anemia
Postmarketing reports: Agranulocytosis, leukopenia (including neutropenia), pancytopenia, thrombocytopenia, thrombotic thrombocytopenic purpura, increased erythrocyte sedimentation rate (ESR), leucocytosis[Ref]

Renal

Frequency not reported: Abnormal renal function, renal calculus
Postmarketing reports: Acute renal failure (including increased creatinine, renal insufficiency)[Ref]

Some side effects of Namenda XR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.