Pronunciation:

benz-ga-LAN-ta-meen

Brand Names:

• Zunveyl

Dosage Forms:

• Tablet, Delayed Release

Classifications:

Therapeutic—

Central Nervous System Agent

Pharmacologic—

Cholinesterase Inhibitor, Centrally/Peripherally Acting

Uses of This Medicine:

Benzgalantamine is used to treat mild to moderate dementia (memory loss and mental changes) in patients with Alzheimer's disease.

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

Before Using This Medicine:

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.

Children—

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

Older adults—

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

Breast-feeding—

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.

Other medicines—

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Heart rhythm problems or
• Lung or breathing problems (eg, asthma, obstructive pulmonary disease), history of or
• Seizures or
• Stomach bleeding or ulcers, history of or
• Trouble urinating—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Kidney disease, severe or
• Liver disease, severe—Use is not recommended in patients with these conditions.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

You may take this medicine with or without food.

Swallow the delayed-release tablet whole. Do not split, crush, or chew it.

Drink plenty of liquids while you are using this medicine.

Do not drink alcohol while you are using this medicine.

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 tablets):
  • For dementia in Alzheimer's disease:
    • Adults—At first, 5 milligrams (mg) 2 times a day. Your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 30 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, 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 While Using This Medicine:

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome and acute generalized exanthematous pustulosis. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

Check with your doctor right away if you have chest pain or discomfort, lightheadedness, dizziness, or fainting, slow or irregular heartbeat, sweating, trouble breathing, or unusual tiredness. These may be symptoms of heart rhythm problems (eg, slow heartbeat, AV block).

This medicine may cause bleeding in your stomach or bowels. Check with your 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.

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 of This Medicine:

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:

Less common

Discouragement

fainting

feeling sad or empty

irritability

lack of appetite

lack of interest or pleasure

tiredness

trembling or shaking of the hands or feet

trouble concentrating

trouble sleeping

shakiness in the legs, arms, hands, feet

sleepiness or unusual drowsiness

Rare

Blurred vision

chest pain

confusion

decreased urination

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry mouth

fast, irregular, pounding, or racing heartbeat or pulse

feeling of warmth

increase in heart rate

lightheadedness

pounding, slow heartbeat

rapid breathing

redness of the face, neck, arms and occasionally, upper chest

sunken eyes

sweating

thirst

trouble breathing

unusual tiredness or weakness

wrinkled skin

Incidence not known

Blistering, peeling, or loosening of the skin

chills

cough

dark urine

diarrhea

difficulty swallowing

drooling

itching

joint or muscle pain

light-colored stools

loss of balance control

muscle trembling, jerking, or stiffness

nausea and vomiting

pounding in the ears

red irritated eyes

red skin lesions, often with a purple center

restlessness

seeing, hearing, or feeling things that are not there

shaking or jerking of one area or side of the body

shuffling walk

skin itching, rash, or redness

sore throat

sores, ulcer, or white spots in the mouth or on the lips

swelling of the face, throat, or tongue

uncontrolled movement, especially the face, neck, and back

upper right abdominal or stomach pain

yellow eyes and skin

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:

More common

Decreased appetite

Less common

Acid or sour stomach

belching

decreased weight

falls

general feeling of discomfort or illness

heartburn

indigestion

lack or loss of strength

stomach pain, discomfort, or upset

tearing of the skin

unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

Rare

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change or loss of taste

muscle weakness

unusually deep sleep

unusually long duration of sleep

Incidence not known

Continuing ringing or buzzing or other unexplained noise in ears

hearing loss

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.