Product Information

Galantamine

What is this medicine?

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 dementia caused by Alzheimer's disease. Galantamine may also be used for purposes not listed in this medication guide.

How should I use this medicine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

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. Breaking or opening the pill may cause too much of the drug to be released at one time.

Measure the liquid using only the special dose-measuring device provided. Empty the medicine into 3 to 4 ounces of any non-alcoholic beverage. Stir this mixture and drink all of it right away. Rinse the dose-measuring device with water after each use.

The liquid form of this medication comes with patient instructions for safe and effective use. Follow these directions carefully. 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.

What should I tell my health care provider before I take this medicine?

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

To make sure you can safely take galantamine, tell your doctor if you have any of these other conditions:

• 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).

FDA pregnancy category B. Galantamine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether galantamine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

What happens if I miss a dose?

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.

What happens if I overdose?

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).

What should I avoid while taking galantamine?

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

What may interact with this medicine?

Tell your doctor about all other medicines you use, especially:

• donepezil (Aricept);
• erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole);
• ketoconazole (Nizoral);
• paroxetine (Paxil);
• rivastigmine (Exelon);
• atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);
• bladder or urinary medicines such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
• bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
• irritable bowel medicines such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro-Banthine);
• NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or ulcer medications such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

This list is not complete and there are many other drugs that can interact with galantamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

What should I watch for while using this medicine?

Before taking galantamine, tell your doctor if you have urination problems, heart disease, a heart rhythm disorder, stomach ulcers or bleeding, a seizure disorder, kidney disease, liver disease, or asthma.

Stop using galantamine and call your doctor at once if you have chest pain, slow heart rate, blood in your stools, coughing up blood, decreased urination, weakness, confusion, extreme thirst, or hot, dry skin.

There are many other drugs that can interact with galantamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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

What side effects may I notice from this medicine?

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

Stop using galantamine and call your doctor at once if you have a serious side effect such as:

• chest pain, slow heart rate;
• feeling like you might pass out;
• blood in your urine or stool;
• coughing up blood or vomit that looks like coffee grounds;
• painful or difficult urination;
• urinating less than usual or not at all;
• weakness, confusion, decreased sweating, extreme thirst, hot dry skin; or
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• feeling tired, dizzy, or drowsy;
• headache, blurred vision, runny nose;
• depression, sleep problems (insomnia);
• nausea, vomiting, stomach pain, loss of appetite;
• weight loss; or
• unusual or unpleasant taste in your mouth.

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.