Memantine and donepezil (oral route)


    Brand Name

    US Brand Name

    Namzaric

    Namzaric Titration Pack


    Description

    Memantine and donepezil combination is used to treat dementia (memory loss and mental changes) associated with moderate or severe Alzheimer's disease. Memantine and donepezil will not cure Alzheimer's disease, however, it may improve thinking ability, behavior, or functional ability.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Capsule, Extended Release

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of memantine and donepezil combination in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of memantine and donepezil combination in the elderly.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Bepridil
    • Cisapride
    • Dronedarone
    • Fluconazole
    • Ketoconazole
    • Levoketoconazole
    • Mesoridazine
    • Pimozide
    • Piperaquine
    • Posaconazole
    • Saquinavir
    • Sparfloxacin
    • Terfenadine
    • Thioridazine
    • Ziprasidone

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Abiraterone Acetate
    • Abiraterone Acetate, Micronized
    • Acetazolamide
    • Acetophenazine
    • Aclidinium
    • Acrivastine
    • Adagrasib
    • Alcaftadine
    • Alfentanil
    • Alfuzosin
    • Amantadine
    • Ambenonium
    • Amdinocillin
    • Amifampridine
    • Amineptine
    • Aminophylline
    • Amiodarone
    • Amisulpride
    • Amitriptyline
    • Amitriptylinoxide
    • Amoxapine
    • Amphetamine
    • Ampicillin
    • Anagrelide
    • Anisotropine
    • Antazoline
    • Apomorphine
    • Aripiprazole
    • Aripiprazole Lauroxil
    • Arsenic Trioxide
    • Asenapine
    • Astemizole
    • Atazanavir
    • Atomoxetine
    • Atropine
    • Azatadine
    • Azelastine
    • Azithromycin
    • Azlocillin
    • Bacampicillin

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Ramelteon

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Bitter Orange
    • Grapefruit Juice

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Asthma, or
    • Lung disease (such as COPD), or
    • Peptic ulcers, or history of or
    • Seizures, or history of or
    • Urinary tract blockage or difficult urination—Use with caution. May make these conditions worse.
    • Heart problems—Donepezil may have unwanted effects on heart rate.
    • Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

    Proper Use

    Take this medicine exactly as directed by your doctor in order to improve your condition as much as possible. Do not take more of it or less of it, and do not take it more or less often than your doctor ordered.

    This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

    You may take this medicine with or without food.

    Swallow the delayed-release capsule whole. Do not crush, divide, or chew it.

    If you have trouble swallowing the capsules, you may open it and sprinkle the contents on applesauce. This mixture must be swallowed immediately without chewing. Do not chew or crush it.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage form (delayed-release capsules):
      • For moderate to severe Alzheimer's disease:
        • Adults—One capsule once a day at bedtime.
        • Children—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.


    Precautions

    It is important that your doctor check your progress at regular visits. This is necessary to allow dose adjustments and to reduce any unwanted effects.

    Before you have any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Taking memantine and donepezil combination together with certain medicines that are used during surgery or dental or emergency treatments may increase the effects of those medicines and cause unwanted effects.

    Tell you doctor right away if you have bloody or black tarry stools, constipation, severe stomach pain, or vomiting of blood or material that looks like coffee grounds. These may be symptoms of stomach or bowel bleeding.

    Some people who have used this medicine developed problems such as nausea, severe vomiting, loss of appetite, diarrhea, and weight loss. Talk with your doctor before using this medicine if you have any concerns.

    If you think that you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of this medicine may cause convulsions (seizures) or serious effects on your heart and your breathing. Signs of overdose include increased watering of mouth, increased sweating, low blood pressure, muscle weakness, severe nausea, severe vomiting, slow heartbeat, and troubled breathing.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    Incidence not known

    • Bloody or black, tarry stools
    • chest pain or discomfort
    • decreased urination
    • lightheadedness, dizziness, or fainting
    • pain in the lower abdomen, groin, upper back or sides
    • seizures
    • severe stomach pain
    • slow or irregular heartbeat
    • sweating
    • trouble breathing
    • unusual tiredness
    • vomiting of blood or material that looks like coffee grounds

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Incidence not known

    • Constipation
    • decreased appetite
    • diarrhea
    • nausea
    • vomiting

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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