galantamine ER 16 mg 24 hr capsule,extended release

Generic name:
Galantamine extended-release capsule - oral

Pronunciation
(ga-LAN-tuh-meen)

Brand name(s)
Razadyne ER

Galantamine is used to treat mild to moderate confusion (dementia) related to Alzheimer's disease. It does not cure Alzheimer's disease, but it may improve memory, awareness, and the ability to perform daily functions. This medication works by restoring the balance of certain natural substances (neurotransmitters) in the brain.

Take this medication by mouth with food as directed by your doctor, usually once daily in the morning with breakfast. This medication may be taken on an empty stomach if necessary. Drink plenty of fluids with this medication unless instructed otherwise. To lower your risk of side effects, your dosage will be gradually increased to your target dose. The dosage is based on your medical condition and response to treatment.

Swallow the capsules whole. Do not crush or chew the capsules. Doing so can destroy the long action of the drug and may increase side effects.

If you stop taking galantamine for several days, consult your doctor or pharmacist before restarting it. Your dosage should be reduced to lower the risk of side effects. Your dosage should then be increased gradually. Follow all your doctor's dosing instructions exactly.

Use this medication regularly in order to get the most benefit from it. Do not stop taking it or increase the dosage unless your doctor instructs you to do so.

It may take at least 4 weeks of continued use before the full benefit of this drug takes effect.

Tell your doctor if your condition gets worse.

Nausea, vomiting, diarrhea, dizziness, drowsiness, loss of appetite, and weight loss may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• unusually slow heartbeat
• difficult urination

Get medical help right away if you have any very serious side effects, including:

• seizures
• black/bloody stools
• vomit that looks bloody or like coffee grounds
• severe stomach/abdominal pain
• fast/irregular heartbeat
• severe dizziness
• fainting

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking galantamine, tell your doctor or pharmacist if you are allergic to it; or to daffodil plants; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver problems
• kidney problems
• stomach/intestinal problems (such as ulcers, bleeding)
• heart problems (such as sick sinus syndrome, bradycardia, AV block, arrhythmias)
• breathing/lung problems (such as severe asthma, COPD-chronic obstructive pulmonary disease)
• seizures
• problems urinating (such as due to enlarged prostate)

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Galantamine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using galantamine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using galantamine safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications can affect the removal of galantamine from your body, which may affect how galantamine works. Examples include amitriptyline, azole antifungals (such as ketoconazole), quinidine, SSRI antidepressants (such as paroxetine), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include muscle weakness or twitching, severe stomach cramping, slow or shallow breathing, slow/fast/irregular heartbeat, fainting, and seizures.

Do not share this medication with others.

Since galantamine may cause loss of appetite and weight loss, your doctor should monitor your weight before and during treatment with this medication.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.