Galantamine Hydrobromide, Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to treat certain kinds of dementia. Take it exactly as directed.
• Occasionally, this medicine may cause serious internal bleeding, ulcers, or perforation of the stomach or intestines.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: cholinesterase inhibitor

Generic and brand names: galantamine hydrobromide, oral; Razadyne; Razadyne ER

What is this medicine used for?

This medicine is taken by mouth to treat dementia caused by Alzheimer's disease. It is not a cure, but it may slow the progress of the disease.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• An enlarged prostate gland or trouble urinating
• An ulcer or intestinal bleeding
• Heart disease or an irregular heartbeat
• Kidney problems
• Liver problems
• Lung disease such as asthma or COPD
• Seizures

Tell your healthcare provider if you smoke or drink alcohol. Alcohol and smoking may increase the risk of ulcers or stomach bleeding. Also be sure to let your provider know if you are taking medicines such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), aspirin, or products that contain aspirin.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without talking with your healthcare provider.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. This medicine must be taken regularly every day to be effective. Your healthcare provider will start you on a low dose and gradually increase the dose.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine may come in the form of tablets, extended-release tablets, or liquid. If you have extended-release tablets, do not break, crush, or chew them. Swallow them whole. Ask your pharmacist if you have the extended-release tablets.

If you are using the liquid, use a specially marked measuring device to measure each dose. The average household teaspoon may not hold the right amount of liquid. Stir the dose in 4 ounces of water and drink it right away. Ask your pharmacist if you have any questions about how to use the liquid.

Take this medicine with meals to lessen the chance the drug will upset your stomach. Drink plenty of water while you are taking this medicine.

What if I miss a dose?

If you miss a dose, take it as soon as you remember, unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider. If you miss 3 or more days of treatment, the dosage must be started at a low level again and gradually increased to its previous level.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: severe nausea, vomiting, stomach cramps, diarrhea, muscle spasms, weakness, watery eyes, drooling, sweating, slow or irregular heartbeat, chest pain, dizziness, lightheadedness, fainting, seizures.

What should I watch out for?

If you develop hives, an itchy rash, or peeling skin, stop taking the medicine and contact your provider right away. These may be signs of a serious skin reaction.

This medicine may make you feel drowsy or dizzy. Do not drive or operate machinery unless you are fully alert. Do not drink alcohol while you are taking this medicine.

You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help.

Occasionally, this medicine may cause bleeding, ulcers, or perforation of the stomach, small intestine, or large intestine. These problems may happen with or without warning symptoms. If you have abdominal pain, a black tarry bowel movement, or a bloody bowel movement, stop taking this medicine and contact your healthcare provider right away.

If nausea, vomiting, or diarrhea become a problem during treatment with this medicine, talk with your healthcare provider about this. This medicine may also cause weight loss. Monitor your weight regularly as instructed by your healthcare provider.

Your healthcare provider will want to check you regularly to see how this medicine affects you. Keep all appointments.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. It may increase the action of medicines they may give you to relax your muscles.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, tightness in your chest, swelling of your tongue or throat, trouble breathing); seizures; fainting.

Serious (Report these to your healthcare provider right away.): Slow or irregular heartbeat; severe dizziness; unusual tiredness or weakness; trouble urinating; blood in the urine; black or tarry bowel movements; severe stomach cramps; breathing problems; new or worsening depression; hallucinations; rash, blisters or peeling skin.

Other: Nausea, dizziness, vomiting, trouble sleeping, loss of appetite, unexplained weight loss, drowsiness, diarrhea, nervousness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alcohol
• Antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), metronidazole, moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), and telithromycin (Ketek)
• Anticholinergic medicines such as benztropine (Cogentin), bethanechol (Urecholine), clidinium/chlordiazepoxide (Librax), dicyclomine (Bentyl), glycopyrrolate (Cuvposa, Robinul), hyoscyamine (HyoMax, Levbid, Levsin), propantheline, scopolamine (Transderm Scop), and trihexyphenidyl
• Antidepressants such as amitriptyline, citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), nortriptyline (Pamelor), and sertraline (Zoloft)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and meclizine (Dramamine)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol) and phenytoin (Dilantin, Phenytek)
• Aspirin and other salicylates
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Bladder control medicines such as darifenacin (Enablex), mirabegron (Myrbetriq), oxybutynin (Ditropan XL, Oxytrol), solifenacin (VESIcare), tolterodine (Detrol), and trospium
• Cancer medicines such as arsenic trioxide (Trisenox), ceritinib (Zykadia), crizotinib (Xalkori), imatinib (Gleevec), nilotinib (Tasigna), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cimetidine (Tagamet)
• Doxepin (Silenor)
• Heart medicines such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, procainamide, propafenone (Rythmol), and quinidine
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Hydroxychloroquine (Plaquenil)
• Ketoconazole (Nizoral)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Muscle relaxants such as cyclobenzaprine (Amrix) and orphenadrine (Norflex)
• Natural remedies such as ginkgo biloba and St. John’s wort
• Nausea medicines such as ondansetron (Zofran) and trimethobenzamide (Tigan)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Other Alzheimer's disease medicines such as donepezil (Aricept) and rivastigmine (Exelon)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)

Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

---

This advisory includes selected information only and may not include all side effects of this medicine or drug interactions with other medicines, Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.