Galantamine improves the function of nerve cells in the brain. It works by preventing the breakdown of a chemical called acetylcholine (ah see til KO leen). People with dementia usually have lower levels of this chemical, which is important for the processes of memory, thinking, and reasoning.

Galantamine is used to treat mild to moderate Alzheimer's type dementia.

Galantamine may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

The galantamine extended-release capsule is usually taken once per day in the morning. Follow your doctor's instructions.

The galantamine short-acting tablet or the oral solution (liquid) are usually given two times per day, with meals. Follow your doctor's instructions.

The extended-release capsule works best if you take it with food.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Take galantamine with a full glass of water. Drink 6 to 8 full glasses of water each day to keep from getting dehydrated while taking this medication.

If you need surgery, tell the surgeon ahead of time that you are using galantamine. You may need to stop using the medicine for a short time.

If you have stopped taking galantamine for any reason, talk with your doctor before you start taking it again. You may need to restart the medication at a lower dose.

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

Usual Adult Dose for Alzheimer's Disease:

Immediate release tablet and oral solution:
Initial dose: 4 mg orally twice a day, preferably with morning and evening meals
-After a minimum of four weeks, increase to 8 mg twice a day, then after an additional 4 weeks, may increase to 12 mg twice a day
Maintenance dose: 16 to 24 mg per day given in 2 divided doses
Maximum dose: 24 mg/day

Extended release capsule:
Initial dose: 8 mg orally once a day, preferably with the morning meal
-After 4 weeks, dose should be increased to 16 mg once a day, a further increase to 24 mg once a day may be considered after a minimum of 4 weeks of taking 16 mg/day
Maintenance dose: 16 to 24 mg orally once a day based on clinical benefit and tolerability
Maximum dose: 24 mg/day

Conversion from Immediate-Release (IR) Tablets or Oral Solution to Extended-Release (ER) Capsules:
-Take the last dose of IR formulation n in the evening prior to starting ER capsule; start ER capsule following morning at once a day dosing
-Converting from IR to ER should occur at the same total daily dosage

Comments:
-During clinical trials, an immediate-release dose of 32 mg per day was found to be less well tolerated and did not increase clinical benefit; dosing at 24 mg/day was not found to provide statistically significant increased clinical benefit from 16 mg/day; however, it might provide additional benefit for some patients.
-Dose increases should be based upon assessment of clinical benefit and tolerability of the previous dose.
-If therapy is interrupted for more than 3 days, the patient should be restarted at the lowest dosage and the dosage escalated to current dose.

Use: For the treatment of mild to moderate dementia of the Alzheimer's type.

You should not use galantamine if you are allergic to it.

To make sure galantamine is safe for you, tell your doctor if you have:

• urination problems;

• heart disease or a heart rhythm disorder;

• a history of stomach ulcer or bleeding;

• seizures or epilepsy;

• kidney disease;

• liver disease; or

• a history of asthma or chronic obstructive pulmonary disease (COPD).

It is not known whether galantamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether galantamine passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe nausea, vomiting, stomach cramps, muscle weakness or spasm, watery eyes, drooling, increased urination or bowel movements, sweating, slow heart rate, feeling light-headed or fainting, and seizure (convulsions).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Galantamine can cause serious skin reactions. Stop using galantamine and call your doctor at once if you have the first signs of any skin rash, no matter how mild.

Galantamine may cause serious side effects. Call your doctor at once if you have:

• chest pain, slow heart rate;

• little or no urinating;

• blood in your urine;

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• a light-headed feeling, like you might pass out; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects of galantamine may include:

• nausea, vomiting, diarrhea, loss of appetite;

• headache, dizziness; or

• weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• atropine;

• cold or allergy medicine that contains an antihistamine (Benadryl and others);

• medicine to treat Parkinson's disease;

• medicine to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;

• bladder or urinary medicines--darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin;

• bronchodilators--aclidinium, ipratropium, or tiotropium;

This list is not complete. Other drugs may interact with galantamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.