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Memantine and Donepezil Extended-Release: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Being discontinued since June 15, 2026
Strength:
14 mg, 10 mg, 28 mg, 10 mg, 7 mg, 10 mg, 21 mg, 10 mg
Brand names:
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Memantine and Donepezil Extended-Release

What are memantine and donepezil hydrochlorides extended-release capsules?

  • Memantine and donepezil hydrochlorides extended-release capsules is a prescription medicine used to treat moderate to severe dementia in people with Alzheimer’s disease. Memantine and donepezil hydrochlorides extended-release capsules contain 2 medicines, memantine HCl, an NMDA receptor antagonist, and donepezil HCl, an acetylcholinesterase inhibitor. Memantine and donepezil hydrochlorides extended-release capsules are for people who are taking donepezil HCl 10 mg.
  • It is not known if memantine and donepezil hydrochlorides extended-release capsules are safe and effective in children.

Do not take memantine and donepezil hydrochlorides extended-release capsules if you have an allergy to memantine HCl, donepezil HCl, medicines that contains piperidines, or any of the ingredients in memantine and donepezil hydrochlorides extended-release capsules. See the end of this leaflet for a complete list of ingredients in memantine and donepezil hydrochlorides extended-release capsules.

Before taking memantine and donepezil hydrochlorides extended-release capsules, tell your doctor about all of your medical conditions, including if you:

  • have heart problems including an irregular, slow, or fast heartbeat.
  • have asthma or lung problems.
  • have seizures.
  • have stomach ulcers.
  • have bladder or kidney problems.
  • have liver problems.
  • have surgical, dental, or other medical procedures scheduled and anesthesia may be used.

  • are pregnant or plan to become pregnant. It is not known if memantine and donepezil hydrochlorides extended-release capsules can harm an unborn baby.

  • are breast-feeding or plan to breastfeed. It is not known if memantine hydrochloride and donepezil hydrochloride passes into breast milk. Talk to your doctor about the best way to feed your baby if you take memantine and donepezil hydrochlorides extended-release capsules.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take memantine and donepezil hydrochlorides extended-release capsules?

  • Take memantine and donepezil hydrochlorides extended-release capsules exactly as your doctor tells you to take it.
  • Do not change your dose or stop taking memantine and donepezil hydrochlorides extended-release capsules without talking to your doctor.
  • Take memantine and donepezil hydrochlorides extended-release capsules by mouth 1 time each evening before going to bed.

  • Take memantine and donepezil hydrochlorides extended-release capsules with or without food.

  • Memantine and donepezil hydrochlorides extended-release capsules may be opened and sprinkled on applesauce before swallowing. Sprinkle all of the medicine in the capsule on the applesauce. Do not divide the dose.
  • If you do not open and sprinkle memantine and donepezil hydrochlorides extended-release capsules on applesauce, the memantine and donepezil hydrochlorides extended-release capsules must be swallowed whole. Do not divide, chew, or crush memantine and donepezil hydrochlorides extended-release capsules.
  • If you miss a dose take memantine and donepezil hydrochlorides extended-release capsules at your next scheduled dose. Do not take 2 doses of memantine and donepezil hydrochlorides extended-release capsules at the same time.
  • Do not use any memantine and donepezil hydrochlorides extended-release capsules that are damaged or show signs of tampering.
  • If you take too much memantine and donepezil hydrochlorides extended-release capsules, call 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 memantine and donepezil hydrochlorides extended-release capsules?

Memantine and donepezil hydrochlorides extended-release capsules may cause serious side effects, including:

  • muscle problems if you need anesthesia
  • slow heartbeat and fainting. This happens more often in people with heart problems. Call the doctor right away if the patient faints while taking memantine and donepezil hydrochlorides extended-release capsules.
  • more stomach acid. This raises the chance of ulcers and bleeding especially when taking memantine and donepezil hydrochlorides extended-release capsules. The risk is higher for patients who had ulcers, or take aspirin or other NSAIDs.
  • nausea and vomiting
  • difficulty passing urine
  • seizures
  • worsening of lung problems in people with asthma or other lung disease.

The most common side effects of memantine HCl include:

  • headache
  • diarrhea
  • dizziness

The most common side effects of donepezil HCl include:

  • diarrhea
  • not wanting to eat (anorexia)
  • bruising

These are not all the possible side effects of memantine and donepezil hydrochlorides extended-release capsules. 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 and donepezil hydrochlorides extended-release capsules?

Store memantine and donepezil hydrochlorides extended-release capsules at room temperature, about 68°F to 77°F (20°C to 25°C). Capsules should be stored in the original prescription container or other light resistant container.

General information about the safe and effective use of memantine and donepezil hydrochlorides extended-release capsules.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use memantine and donepezil hydrochlorides extended-release capsules for a condition for which it was not prescribed. Do not give memantine and donepezil hydrochlorides extended-release capsules to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or doctor for information about memantine and donepezil hydrochlorides extended-release capsules that is written for health professionals.

What are the ingredients in memantine and donepezil hydrochlorides extended-release capsules?

Active ingredients: memantine hydrochloride, USP and donepezil hydrochloride, USP

Inactive ingredients:

Memantine and donepezil hydrochlorides extended-release capsules (7 mg/10 mg) contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (corn starch, sucrose), talc and triethyl citrate. The hard gelatin capsules contain D&C yellow no.10, FD&C blue no. 1, gelatin, sodium lauryl sulfate and titanium dioxide. The black monogramming ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution and purified water.

Memantine and donepezil hydrochlorides extended-release capsules ( 14 mg/10 mg) contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (corn starch, sucrose), talc and triethyl citrate. The hard gelatin capsules contain D&C yellow no.10, FD&C blue no. 1, gelatin, sodium lauryl sulfate and titanium dioxide. The white monogramming ink contains butyl alcohol, dehydrated alcohol, isopropyl alcohol, sodium hydroxide, propylene glycol, povidone, shellac and titanium dioxide.

Memantine and donepezil hydrochlorides extended-release capsules (21 mg/10 mg) contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (corn starch, sucrose), talc and triethyl citrate. The hard gelatin capsules contain D&C yellow no.10, FD&C red no. 40, gelatin, sodium lauryl sulfate and titanium dioxide. The black monogramming ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution and purified water.

Memantine and donepezil hydrochlorides extended-release capsules (28 mg/10 mg ) contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (corn starch, sucrose), talc and triethyl citrate. The hard gelatin capsules contain D&C yellow no.10, FD&C red no. 40, gelatin, sodium lauryl sulfate and titanium dioxide. The black monogramming ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution.

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

*All trademarks are the property of their respective owners.

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Rev. 12-2024-01

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 208328 · View the label on DailyMed

Revision date stated in the text: December 2024

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Memantine and Donepezil Extended-Release

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Cholinesterase Inhibitor, N-methyl-D-aspartate Receptor Antagonist
Active ingredients Memantine hydrochloride, Donepezil hydrochloride 10 mg
Dosage form Capsule, extended release
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) AMNEAL
FDA approval ANDA 208328Abbreviated New Drug Application (ANDA) – generic drug Approved January 27, 2017
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 4 labelers list this drug on DailyMed
Drug shortage
  • Being discontinued since June 15, 2026
Packages (NDC)
Package
14 mg, 10 mg – 30 in 1 bottle NDC 69238-1248-3
14 mg, 10 mg – 90 in 1 bottle NDC 69238-1248-9
28 mg, 10 mg – 30 in 1 bottle NDC 69238-1247-3
28 mg, 10 mg – 90 in 1 bottle NDC 69238-1247-9
7 mg, 10 mg – 30 in 1 bottle NDC 69238-1552-3
7 mg, 10 mg – 90 in 1 bottle NDC 69238-1552-9
21 mg, 10 mg – 30 in 1 bottle NDC 69238-1553-3
21 mg, 10 mg – 90 in 1 bottle NDC 69238-1553-9

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.