Apo-Galantamine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

APO-GALANTAMINE is used to treat the symptoms of mild to moderate Alzheimer’s disease (a type of dementia), a disease that alters brain function. Alzheimer’s disease causes increasing memory loss, confusion and behavioural changes, which make it increasingly difficult to carry out normal daily activities.

This medication should only be taken after proper diagnosis of your condition has been made by your doctor.

What it does:

This medication is one of a group of drugs called “cholinesterase inhibitors” which are used to treat the symptoms of mild to moderate Alzheimer’s disease. Dementia due to Alzheimer’s disease is believed to be related to lack of a substance in the brain called acetylcholine, a substance which is thought to be necessary for good brain function. APO-GALANTAMINE increases the amount of this substance in the brain, improving memory.

When it should not be used:

Do not use APO-GALANTAMINE if you/the person you are caring for:

• are/is allergic to galantamine hydrobromide or to any non-medicinal ingredient in the formulation
• have/has ever had an allergic reaction to a similar type of medicine

• are/is a child under 18 years of age

• Unless you/the person you are caring for have been diagnosed with Alzheimer’s Disease

What the medicinal ingredient is:

galantamine hydrobromide

What the nonmedicinal ingredients are:

The inactive ingredients are microcrystalline cellulose, corn starch, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol, and titanium dioxide. The 8 mg tablet also contains red ferric oxide. The 12 mg tablet also contains sunset yellow aluminum lake 40%.

What dosage forms it comes in:

Tablets: 4 mg, 8 mg, 12 mg

WARNINGS AND PRECAUTIONS

BEFORE you use APO-GALANTAMINE talk to your doctor or pharmacist if you/the person you are caring for have, or had, any of the following:

• heart condition
• an ulcer or history of ulcers in the stomach or gut
• a blockage of the stomach or in the gut
• seizures [or fits] (such as epilepsy)
• a respiratory disease that affects breathing (such as asthma or obstructive pulmonary disease)
• problems passing urine
• an increased risk of developing ulcers (for example you are taking non-steroidal

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• anti-inflammatory drugs (NSAIDS) or high doses of acetylsalicylic acid [ASA (Aspirin^®)]
• liver or kidney problems

• pregnant or planning to become pregnant

• breast-feeding or planning to breast-feed
• having an operation with general anesthesia (medication that puts you to sleep)
• taking any other medications, including prescription, over-the-counter, herbal medicines or natural health products

Talk to your doctor right away if you have any skin rashes or inflammation, blisters or swelling of the skin.

Also tell your doctor if you recently had an operation on the stomach, gut or bladder.

APO-GALANTAMINE can cause weight loss. Your doctor will check your weight regularly while you are taking APO-GALANTAMINE.

Driving and using machines: Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely. APO-GALANTAMINE may make you feel dizzy or sleepy, especially during the first few weeks of treatment. If APO-GALANTAMINE affects you, do not drive or use any tools or machinery

INTERACTIONS WITH THIS MEDICATION

Always tell your doctor, nurse or pharmacist if you are taking any other medicines, either prescription, over-the-counter, herbal medicines, or natural health products, because taking some medicines together can be harmful.

APO-GALANTAMINE should not be used with medicines that work in a similar way.

The following may interact with APO-GALANTAMINE:

• anticholinergics (such as drugs for diarrhea, Parkinson’s disease, or airway spasms)
• medicines taken for heart conditions or high blood pressure (such as digoxin or beta-blockers)
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or high doses of acetylsalicylic acid [ASA (Aspirin^®)], which can increase the risk of ulcers
• antidepressants (such as amitriptyline, fluoxetine, fluvoxamine or paroxetine)
• ketoconazole (an antifungal)
• erythromycin (an antibiotic)
• quinidine (for irregular heart beat)

APO-GALANTAMINE may affect some anesthetics. If you are going to have an operation under a general anesthetic, tell the doctor that you are taking APO-GALANTAMINE, well in advance.

PROPER USE OF THIS MEDICATION

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Usual dose:

APO-GALANTAMINE is started at a low dose and then slowly increased, to the most suitable dose, depending on how you respond to the treatment. APO-GALANTAMINE tablets should be taken twice a day, preferably with the morning and evening meals.

If you have liver or kidney problems, your doctor may give you a reduced dose of APO-GALANTAMINE or may decide this medicine is not suitable for you.

While you are taking APO-GALANTAMINE

Drink plenty of liquids, to keep yourself hydrated.

Your doctor will need to see you regularly, to check that this medicine is working and to discuss how you are feeling.

REMEMBER: This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms appear to be similar to yours.

Overdose:

The signs of overdose may include:

• severe nausea and vomiting, abdominal cramps, sweating
• weak muscles, difficulty breathing

• seizures (fits)

  • low blood pressure, abnormal heart rhythm that may cause loss of consciousness

Missed Dose:

If you forget to take a dose, do not worry, wait and take the next dose at the usual time. Do NOT take two doses at once.

If your treatment is interrupted for several days or longer, do NOT re-initiate treatment without contacting your doctor.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

If side effects occur, they are mainly experienced early in the treatment or when the dose is increased. Most tend to disappear gradually as the body adapts to the treatment; for example, nausea (feeling sick) and vomiting (being sick) generally pass after a few days. However, you should tell your healthcare professional about any side effects, especially if they persist.

Other possible side effects include:

• abdominal pain, diarrhea, indigestion, decreased appetite
• difficulty swallowing
• weight loss
• flushing
• dehydration (sometimes severe)
• weakness
• fever
• malaise
• leg cramps
• muscle spasms
• tingling in the hands or feet
• ringing in the ears
• headache
• dizziness
• blurred vision
• tiredness, sleepiness or sleeplessness
• depression
• runny nose

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• sweating
• urinary tract infection, incontinence
• falling, sometimes resulting in injury
• trembling

Serious side effects and what to do about them

Serious side effects and what to do about them

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Serious side effects and what to do about them

Serious side effects and what to do about them

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Serious side effects and what to do about them

If you are caring for a patient with Alzheimer’s disease who has new symptoms you should discuss them with his or her healthcare professional.

If you feel unwell in the ways described in this section or any other way, or have any symptoms that you do not understand, or find distressing, you should contact your doctor immediately. If you experience side effects that are severe, stop taking the drug and contact your healthcare professional immediately.

This is not a complete list of side effects. For any unexpected effects while taking APO-GALANTAMINE, contact your healthcare professional.

HOW TO STORE IT

APO-GALANTAMINE tablets should be stored between 15°C to 30°C.

Keep out of the reach and sight of children.

Medicines can be kept for a limited period only. Therefore, do not use APO-GALANTAMINE after the date (month and year) printed after “EXP”, even if it has been stored properly. Always return old medicines to your pharmacist.

Reporting Side Effects

MORE INFORMATION

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If you want more information about APO-GALANTAMINE:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.

Last Revised: February 24, 2023