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Description

Galantamine is used to treat the symptoms of mild to moderate Alzheimer's disease. Galantamine will not cure Alzheimer's disease, and it will not stop the disease from getting worse. However, galantamine can improve thinking ability in some patients with Alzheimer's disease

In Alzheimer's disease, many chemical changes take place in the brain. One of the earliest and biggest changes is that there is less of a chemical called acetylcholine (ACh). ACh helps the brain to work properly. Galantamine slows the breakdown of ACh, so it can build up and have a greater effect. However, as Alzheimer's disease gets worse, there will be less and less ACh, so galantamine may not work as well.

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

This product is available in the following dosage forms:

• Capsule, Extended Release
• Tablet
• Solution

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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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of galantamine in children with use in other age groups. Use in children is not recommended.

Geriatric

Galantamine levels are higher in older adults than in healthy young subjects.

Pregnancy

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. 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:

• Asthma (or history of) or
• Lung disease—May make breathing problems worse

• Epilepsy or history of seizures—Galantamine may cause seizures

• Heart problems, including slow heartbeat or heart block (slow and irregular heartbeat)—May make condition worse

• Kidney problems or
• Liver problems—Your doctor may need to adjust your dose. If the problems are severe, you should not take galantamine.

• Mild cognitive impairment (memory problems)—Galantamine should not be used for this condition.

• Stomach ulcer (or history of) or
• Urinary tract blockage or difficult urination—Galantamine may make these conditions worse

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Proper Use

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.

If you are taking the tablets or oral solution: Take this medicine with your morning and evening meals.

If you are taking the extended-release capsules: Take this medicine with your morning meal.

Follow the instruction sheet for the proper dosing of the oral solution and ask your doctor or pharmacist if you have any questions.

Make sure that you are drinking plenty of fluids while you are taking this medicine.

• For oral dosage forms (oral solution and tablets):
  • For treatment of Alzheimer's disease:
    • Adults—To start, take 4 mg (milligrams) two times a day. Your doctor may increase your dose gradually if you are doing well on this medicine.
• For long acting oral dosage forms (extended-release capsules):
  • For treatment of Alzheimer's disease:
    • Adults—To start, take 8 mg one time a day. Your doctor may increase your dose gradually if you are doing well on this medicine.

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.

Do not take your morning and evening doses close together.

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.

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Precautions

It is very important that your doctor check you at regular visits.

Tell your doctor if your symptoms get worse, or if you notice any new symptoms.

Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines, such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.

Galantamine causes a large number of patients to have problems with their stomachs and intestines. Tell your doctor about any nausea, vomiting, diarrhea, stomach pain or loss of appetite.

If you think you or someone else may have taken an overdose of galantamine, get emergency help at once. Taking an overdose of galantamine may lead to convulsions (seizures) or shock. Some signs of shock are large pupils, irregular breathing, and fast weak pulse. Other signs of an overdose are severe nausea and vomiting, increasing muscle weakness, greatly increased sweating, and greatly increased watering of the mouth.

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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 as soon as possible if any of the following side effects occur:

• Chest pain or discomfort
• Shortness of breath

• Attack, assault, force
• Bloody or black, tarry stools
• Confusion
• Constipation
• Convulsions
• Decreased urination
• Dry mouth
• Increase in heart rate
• Increased thirst
• Irregular heartbeat
• Mood changes
• Muscle pain or cramps
• Numbness or tingling in hands, feet, or lips
• Rapid breathing
• Severe stomach pain
• Sunken eyes
• Vomiting of blood or material that looks like coffee grounds
• Wrinkled skin

• Cramping
• Defecation or urination, uncontrolled
• Dizziness
• Drooling
• Fainting
• Increased sweating
• Low blood pressure
• Muscle weakness
• Seizures
• Slow heart beat
• Severe nausea or vomiting
• Slow or troubled breathing
• Tearing of the eyes
• Watering of the mouth

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:

• Bladder pain
• Bloody or cloudy urine
• Diarrhea
• Difficult, burning, or painful urination
• Discouragement
• Feeling sad or empty
• Frequent urge to urinate
• Irritability
• Loss of appetite
• Loss of interest or pleasure
• Lower back or side pain
• Nausea
• Tiredness
• Trouble concentrating
• Vomiting
• Weight loss

• Abdominal pain
• Pale skin
• Troubled breathing with activity
• Slow or irregular heartbeat (less than 50 beats per minute)
• Light-headedness
• Dizziness or fainting
• Unusual tiredness or weakness
• Indigestion
• Headache
• Blood in urine
• Lower back pain
• Pain or burning while urinating
• Trouble sleeping
• Unable to sleep
• Sleepiness
• Sleeplessness
• Stuffy nose
• Unusual bleeding or bruising
• Unusual drowsiness
• High or low blood pressure
• Tremor

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

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