Galantamine ER by Sanis

Brand Name

Galantamine ER by Sanis

Common Name

galantamine

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

Galantamine belongs to the family of medications called cholinesterase inhibitors. It is used to treat symptoms of mild-to-moderate Alzheimer's disease.

Alzheimer's disease is caused by the constant degeneration of certain nerve cells in the brain that make a chemical called acetylcholine. This chemical is thought to be important for the processes of learning and memory. Galantamine prevents the breakdown of acetylcholine, thereby increasing its levels in the brain. Galantamine is of the most benefit in mild-to-moderate disease and is of little benefit when the disease becomes severe.

Galantamine may improve cognitive function (memory, orientation, and language) and general ability to perform activities of daily living.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The usual recommended starting dose of galantamine is 8 mg once daily. After at least 4 weeks of treatment, the dose may be increased to 16 mg once daily. After at least 4 more weeks of treatment, the dose may be increased further to 24 mg once daily.

Galantamine capsules should be taken once daily in the morning with food. Swallow the capsules whole. Do not open, divide, crush, or chew them.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

People with Alzheimer's disease and their caregivers should be aware that if treatment has been interrupted for several days or longer, this medication should be restarted at the lowest dose and then increased to the most current dose. If several doses are missed, do not restart galantamine on your own. It will be necessary to start at a lower dose and gradually increase to your previous dose. Consult your doctor if you miss several doses in a row.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

8 mg
Each hard gelatin, extended-release capsule with a white body and white cap, with "MYLAN" over "GT8" printed in black ink on the body and the cap, contains 8 mg of galantamine as galantamine hydrochloride. Nonmedicinal ingredients: colloidal silicon dioxide, gelatin, hydrogenated vegetable oil, magnesium stearate, polyvinyl acetate, povidone, sodium lauryl sulphate, and titanium dioxide, printing ink: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, and shellac.

16 mg
Each hard gelatin, extended-release capsule with a pale pink body and pale pink cap, with "MYLAN" over "GT16" printed in black ink on the body and the cap, contains 16 mg of galantamine as galantamine hydrochloride. Nonmedicinal ingredients: colloidal silicon dioxide, gelatin, hydrogenated vegetable oil, magnesium stearate, polyvinyl acetate, povidone, sodium lauryl sulphate, titanium dioxide, and FD&C Red 40; printing ink: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, and shellac.

24 mg
Each hard gelatin, extended-release capsule with a caramel body and caramel cap, with "MYLAN" over "GT24" printed in black ink on the body and the cap, contains 24 mg of galantamine as galantamine hydrochloride. Nonmedicinal ingredients: colloidal silicon dioxide, gelatin, hydrogenated vegetable oil, magnesium stearate, polyvinyl acetate, povidone, sodium lauryl sulphate, titanium dioxide, FD&C Blue 1, FD&C Yellow 6, and red iron oxide; printing ink: black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, and shellac.

Who should NOT take this medication?

Do not take this medication if you are allergic to galantamine or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal pain
• blurred vision
• diarrhea
• fever
• flushing
• general feeling of being unwell
• headache
• heartburn
• leg cramps
• lightheadedness or dizziness
• loss of appetite
• muscle spasms
• nausea
• runny nose
• sweating
• tingling sensation in the hands or feet
• tiredness
• trouble sleeping
• vomiting
• weakness
• weight loss

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• behavior changes (e.g., agitation, aggressiveness, confusion)
• chest pain
• decreased control of movement
• difficulty holding urine
• difficulty swallowing
• fainting
• falls
• hallucinations (seeing or hearing things that are not there)
• high blood pressure (e.g., dizziness, headache, vision changes, shortness of breath)
• low blood pressure (e.g., dizziness or fainting, especially when rising from a lying or sitting position)
• ringing in the ears
• signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, cuts that don't stop bleeding)
• signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of low potassium levels in the blood (e.g., weakness, fatigue, muscle cramps, irregular heartbeat)
• signs of urinary tract infection (e.g., blood in urine, pain or burning while urinating, need to urinate more often than normal)
• slow or irregular heartbeat (less than 50 beats per minute)
• tremor

Stop taking the medication and seek immediate medical attention if any of the following occur:

• seizures
• severe confusion
• signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
• signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
• symptoms of a severe allergic reaction (e.g., itching or skin rash; shortness of breath; swelling of the face, lips, or tongue)
• thoughts of self-harm or suicide

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Bladder problems: Galantamine can make it more difficult to empty the bladder and may contribute to urinary tract problems. If you have bladder problems or a history of urinary tract problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/reduced alertness: Galantamine may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.

Gender: Women are more likely to experience side effects such as nausea and vomiting. This is also more likely to happen for women who are underweight.

Heart disease: Galantamine can cause slowed heart rate, affecting people with congestive heart failure (CHF) or coronary artery disease (CAD). If you have a heart condition, including blood pressure problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: If you have kidney disease or decreased kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Galantamine is not recommended for people with severely reduced kidney function.

Liver function: If you have liver disease or reduced liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Galantamine is not recommended for people with severely reduced liver function.

Lung disease: Galantamine can worsen the symptoms of breathing problems, such as asthma or chronic obstructive pulmonary disease (COPD) emphysema, and bronchitis. If you have asthma, COPD, or any other breathing problem, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Movement disorders: Galantamine may cause movement problems such as slow movements, stiffness, tremor, and other symptoms similar to Parkinson's disease such as restlessness, tremor, muscle spasms, or uncontrolled movements of the face, arms or legs. Contact your doctor if you experience any of these effects.

Seizures: An increase in seizures has been reported by people taking galantamine. It is unclear whether this is because of the medication or the Alzheimer's disease. If you have or have had a seizure disorder, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Stomach ulcers: Galantamine can cause an increase in the amount of acid produced by the stomach, increasing the risk for stomach ulcers. If you have or have had stomach problems, or take nonsteroidal anti-inflammatory (NSAIDs) medications, you are at increased risk of stomach problems with this medication. If you have any of these conditions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Surgery: Galantamine can cause changes in how some medications used in surgery affect the body. If you are scheduled for surgery, let your medical team know that you are taking this medication.

Weight loss: People taking galantamine may experience significant weight loss. In some cases, this weight loss is unhealthy and may cause additional health problems. Let your doctor know about any weight loss that occurs.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if galantamine passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children. Galantamine is not intended to be used by children.

Seniors: People over 85 years of age may be at risk of more extreme weight loss when taking galantamine.

What other drugs could interact with this medication?

There may be an interaction between galantamine and any of the following:

• other acetylcholinesterase inhibitors (e.g., donepezil, rivastigmine)
• aclidinium
• alpha-agonists (e.g., clonidine, methyldopa)
• amiodarone
• antihistamines (e.g., azelastine, chlorpheniramine, dimenhydrinate, diphenhydramine, loratadine, rupatadine)
• antipsychotic medications (e.g., cariprazine, chlorpromazine, clozapine, haloperidol, olanzapine, risperidone, quetiapine)
• atropine
• benztropine
• beta-blockers (e.g., atenolol, carvedilol, metoprolol, propranolol, timolol)
• bupropion
• cholinergic agonists (e.g., bethanechol, pilocarpine)
• clarithromycin
• clidinium
• cobicistat
• corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone, methylprednisolone)
• cyclobenzaprine
• darifenacin
• digoxin
• diltiazem
• dipyridamole
• disopyramide
• dronedarone
• ethopropazine
• fentanyl
• fesoterodine
• flecainide
• glycopyrrolate
• HIV protease inhibitors (e.g., atazanavir, darunavir, lopinavir, ritonavir)
• ipratropium
• ivabradine
• ketoconazole
• lanreotide
• midodrine
• mifepristone
• monoamine oxidase inhibitors (MAOIs; phenelzine, moclobemide, selegiline, tranylcypromine)
• nirmatrelvir
• octreotide
• orphenadrine
• oxybutynin
• pasireotide
• pizotifen
• propiverine
• protein kinase inhibitors (e.g., alectinib, ceritinib, crizotinib)
• scopolamine
• selective serotonin reuptake inhibitors (SSRIs; e.g., fluoxetine, paroxetine)
• sphingosine 1-phosphate receptor (S1P) receptor inhibitors (e.g., fingolimod, ponesimod, siponimod)
• thalidomide
• tiotropium
• tizanidine
• tofacitinib
• tolterodine
• tricyclic antidepressants (e.g., amitriptyline, desipramine, nortriptyline)
• trihexyphenidyl
• trospium
• umeclidinium
• verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Galantamine-ER-by-Sanis