Razadyne (Galantamine Hydrobromide)

(ga lan' ta meen)

Galantamine is used to treat the symptoms of Alzheimer's disease (AD; a brain disease that slowly destroys the memory and the ability to think, learn, communicate and handle daily activities). Galantamine is in a class of medications called acetylcholinesterase inhibitors. It works by increasing the amount of a certain natural substance in the brain that is needed for memory and thought. Galantamine may improve the ability to think and remember or slow the loss of these abilities in people who have AD. However, galantamine will not cure AD or prevent the loss of mental abilities at some time in the future.

Galantamine comes as a tablet, an extended-release (long-acting) capsule, and a solution (liquid) to take by mouth. The tablets and liquid are usually taken twice a day, preferably with the morning and evening meals. The extended-release capsules are usually taken once a day in the morning. Take galantamine at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take galantamine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. You are less likely to experience side effects of galantamine if you follow the exact dosing schedule prescribed by your doctor. Galantamine may upset your stomach, especially at the beginning of your treatment. Take galantamine with food and drink 6 to 8 glasses of water every day. This may decrease the chance that you will have an upset stomach during your treatment. Your doctor will probably start you on a low dose of galantamine and gradually increase your dose, not more often than once every 4 weeks. Continue to take galantamine even if you feel well. Do not stop taking galantamine without talking to your doctor. If you do stop taking galantamine for a few days or longer, call your doctor before you start to take galantamine again. Your doctor will probably tell you to start with the lowest dose of galantamine and gradually increase your dose to the dose you had been taking. Before you take galantamine oral solution for the first time, read the written instructions that come with it. Ask your doctor or pharmacist to show you how to take the oral solution. To take the oral solution, follow these steps:

• Open the child-proof cap by pushing the cap down while turning it to the left. Remove the cap.
• Pull the pipette (the tube that you use to measure the dose of galantamine) out of its case.
• Place the pipette fully into the bottle of galantamine.
• While holding the bottom ring of the pipette, pull the pipette plunger up to the marking that shows the dose your doctor prescribed.
• Hold the bottom ring of the pipette and remove the pipette from the bottle. Be careful not to push the plunger in.
• Prepare 3 to 4 ounces (about 1/2 cup [90 to 120 milliliters]) of any non-alcoholic beverage. Empty all the medicine from the pipette into the beverage by pushing the plunger all the way in.
• Stir the beverage well.
• Drink all of the mixture right away.
• Put the plastic cap back on the bottle of galantamine and turn the cap to the right to close the bottle.
• Rinse the empty pipette by putting its open end into a glass of water, pulling the plunger out, and pushing the plunger in to remove the water.

Before taking galantamine,
• tell your doctor and pharmacist if you are allergic to galantamine, any other medications, or any of the inactive ingredients in galantamine tablets, solution, or extended-release capsules. Ask your pharmacist for a list of the inactive ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: ambenonium chloride (Mytelase); amitriptyline (Elavil); anticholinergic medications such as atropine (Atropen, Sal-Tropine), belladonna (in Donnatal, Bellamine, Bel-Tabs, others); benztropine (Cogentin), biperiden (Akineton); clidinium (in Librax), dicyclomine (Bentyl), glycopyrrolate (Robinul), hyoscyamine (Cytospaz-M, Levbid, Levsin), ipratropium (Atrovent, in Combivent), oxybutynin (Ditropan), procyclidine (Kemadrin), propantheline (Pro-Banthine), scopolamine (Scopace, Transderm-Scop), tiotropium (Spiriva), tolterodine (Detrol), and trihexyphenidyl; certain antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); bethanechol (Urecholine);cevimeline (Evoxac); cimetidine (Tagamet); clarithromycin (Biaxin, in Prevpac); digoxin (Lanoxin); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); heart medications; nefazodone; neostigmine (Prostigmin);other medications for Alzheimer's disease; medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); medications for high blood pressure; paroxetine (Paxil); pyridostigmine (Mestinon); and quinidine (Quinidex). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had asthma or any other lung disease; an enlarged prostate; ulcers; seizures; irregular heartbeat; or heart, kidney, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking galantamine, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking galantamine.
• you should know that galantamine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• remember that alcohol can add to the drowsiness caused by this medication.

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

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Galantamine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• loss of appetite
• stomach pain
• heartburn
• weight loss
• extreme tiredness
• dizziness
• pale skin
• headache
• shaking of a part of your body that you cannot control
• depression
• difficulty falling asleep or staying asleep
• runny nose

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• difficulty urinating
• blood in the urine
• pain or burning while urinating
• seizures
• slowed heartbeat
• fainting
• shortness of breath
• black and tarry stools
• red blood in the stools
• bloody vomit
• vomit that looks like coffee grounds

Galantamine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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.